SACRAMENTO, Calif. and DENVER, May 02, 2022 (GLOBE NEWSWIRE) -- California-based UC Davis Health and Colorado-based BioIntelliSense, a continuous health monitoring and clinical intelligence company, today announced a strategic collaboration that advances remote patient monitoring (RPM) across care settings using the FDA-cleared BioIntelliSense wearable technology and algorithmic-based BioCloud™ data analytics.
The BioIntelliSense BioSticker™ and BioButton® medical grade wearable devices enable continuous multi-parameter monitoring of a comprehensive range of 20+ vital signs and physiologic biometrics for up to 30 days on a single use device. The award-winning wearable device portfolio and advanced analytics provide a comprehensive set of leading indicators for the early identification and detection of adverse trends to facilitate improved patient monitoring safety and efficacy from in-hospital to home. The recent introduction of the BioButton Rechargeable device is an evolutionary step forward in delivering a simplified and cost-effective continuous monitoring solution for in-patient and longitudinal care management of patients with chronic, complex conditions.
The UC Davis Health and BioIntelliSense Collaboration
At the center of this strategic collaboration is a committed virtual care strategy that includes the deployment of BioIntelliSense’s data-driven clinical intelligence platform, to create a new standard of remote care, that reduces the cost and burden of traditional methods of vital sign collection.
“Remote care represents a safe and effective way for many people, especially in rural and low-income communities, to access necessary health care services in more convenient ways. As one of the nation’s leaders in telehealth, we’ve seen how real-time technology connects expertise with need, closing large time-lapse gaps in health care delivery,” said David Lubarsky, CEO of UC Davis Health. “Now, with continuous and simultaneous Internet connectivity enabling even more remote care, we can have hospital-level monitoring of multiple vital signs wherever patients are in-hospital, traveling, or at home. Patients will benefit from lower levels of human monitoring and shorter hospital stays. Providers will immediately be able to note any deviations from expected recovery or response to treatment, and communicate with the patient, family caregivers and other providers as soon as the continuous monitoring predicts a potential or real negative turn in health. This near real-time remote monitoring will lead to more timely interventions and better health outcomes, achieved in lower acuity settings that are more patient- and family-friendly, such as the patient’s home.”
As a leading academic medical center with a patient-centered focus on digital transformation, UC Davis Health is poised to rapidly advance remote care initiatives with BioIntelliSense that combine an effortless user experience with medical grade clinical accuracy. The introduction of BioIntelliSense’s medical grade continuous data and smart alerting technology within the in-patient setting, beyond the Intensive Care Unit, provides clinicians a unique opportunity to gain a high-resolution view of a patient’s health status. The passive collection of continuous multi-parameter data and sophisticated algorithms enables better recognition of hemodynamic stability that can lead to earlier hospital discharge, resulting in increased patient satisfaction and savings. The benefits of this continuous care model extend beyond the hospital to the home by providing a scalable platform for monitoring vital signs, symptoms, and physiologic biometrics for earlier detection of adverse trends without the cost and complexity of traditional RPM.
“We formed CoLab at UC Davis Health to support open innovation with industry, pharma and payers by co-designing, co-validating and co-transforming breakthrough technologies in digital health, devices and AI,” said Ashish Atreja, CIO and Chief Digital Health Officer at UC Davis Health. “We are thrilled about partnership with BioIntelliSense that supports our strategic goal of delivering high acuity care at home that is grounded in equity so no patient gets left behind.”
In the coming months, UC Davis Health and BioIntelliSense will bring together their brightest minds and best resources to co-validate continuous care models and iteratively learn how best to deliver an exceptional patient and clinical experience while prioritizing patient safety and efficacy at scale. And in the process, they’ll expand access to BioIntelliSense’s remote care solution to create a more equitable, accessible and affordable continuous monitoring experience across patient populations and care settings.
“We are proud to embark on this strategic collaboration with UC Davis Health to advance remote care for patients across the care continuum,” said James Mault, MD, Founder and CEO of BioIntelliSense. “With cost effective, data-driven continuous care, we can bend the cost curve and extend the reach of advanced remote care technologies to improve how we treat and care for patients with complex conditions including oncology, orthopedics, cardiac, infectious disease and renal disease.”
UC Davis Health is improving lives and transforming health care by providing excellent patient care, conducting groundbreaking research, fostering innovative, interprofessional education, and creating dynamic, productive partnerships. UC Davis Health harnesses the power of an entire university’s nationally-ranked resources and research to tackle the most pressing health care issues facing the world today. As the northern California region's only academic health center, UC Davis Health is focused on discovering and sharing knowledge and providing the highest quality of care and serves as a hub of innovation that encompasses UC Davis Medical Center, UC Davis School of Medicine, The Betty Irene Moore School of Nursing at UC Davis, and UC Davis Medical Group.
BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM). Its medical-grade Data-as-a-Service (DaaS) platform seamlessly captures multi-parameter vital signs, physiological biometrics and symptomatic events through an effortless patient experience. The FDA-cleared BioSticker™ and medical-grade BioButton® devices make remote monitoring and early detection simple. Through the platform’s advanced analytics, clinicians have access to high-resolution patient trending and reporting to enable medical grade remote care from in-hospital to home.
Learn how BioIntelliSense is redefining remote patient monitoring through medical-grade and cost-effective data services or visit our website at BioIntelliSense.com. Follow BioIntelliSense on Twitter and LinkedIn for the latest news and information.
The accelerator will accept 10 startups focused on increasing access to healthcare, reducing disparities by managing social determinants of health and using data for equity in healthcare. The companies will receive connections to venture capital firms, help with business planning, AWS training, opportunities to work with AWS partners, and go-to-market planning.
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Our five leading Oncology medicines have each set new standards for patient outcomes across many cancers. Our data at ASCO will showcase our continued investment in driving innovation with these medicines as well as their long-term impact in real-world settings. In particular, the groundbreaking data from DESTINY-Breast04 will show the potential of ENHERTU to treat patients with HER2-low metastatic breast cancer who have never before been eligible for HER2-targeted treatments.”
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “At AstraZeneca, we are pioneering new biomarkers and novel therapeutic modalities in our ambition to attack cancer from every angle and deliver personalized medicines to more patients. The results from DESTINY-Breast04 support the potential for ENHERTU to redefine the classification and treatment of breast cancer across the spectrum of HER2 expression. We are also excited to share promising clinical data for our bispecific PD1-CTLA4 antibody MEDI5752 in advanced renal cell carcinoma, designed to have both of these clinically validated checkpoint targets in one molecule, delivering efficacy with an improved tolerability profile.”
Leading through disruption in breast cancer A late-breaking plenary presentation will highlight the potentially practice-changing results of the DESTINY-Breast04 trial ofENHERTU in patients with HER2-low metastatic breast cancer. DESTINY-Breast04 is the first-ever Phase III trial of a HER2-directed therapy to show statistically significant and clinically meaningful benefit in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor status compared to standard-of-care chemotherapy.
Additionally, data from a retrospective study will estimate the prevalence of HER2-low breast cancer and describe its clinical and pathological characteristics, to help identify patients with HER2-low expressing tumors who may benefit from HER2-targeted therapy.
Further results will be shared from dose-finding and dose-expansion studies of ENHERTU in combination with other anti-cancer agents in patients with advanced or metastatic HER2-positive breast cancer (DESTINY-Breast07) and HER2-low breast cancer (DESTINY-Breast08).
Data will also be presented from a safety follow-up of the DESTINY-Breast03 Phase III trial of ENHERTU in the treatment of patients with unresectable or metastatic HER2-positive breast cancer previously treated with trastuzumab and a taxane. ENHERTU was recently approved in the US for patients in this setting.
Revealing the full potential of an industry-leading portfolio and pipeline Beyond breast cancer, AstraZeneca will share results from multiple trials highlighting its focus on delivering life-changing cancer medicines for patients with high unmet need. Data will also support the Company’s commitment to realizing the full potential of its leading medicines with ongoing analyses, real-world data and research into novel combinations.
MEDI5752 – An oral presentation will share safety and clinical activity results for MEDI5752 in patients with advanced renal cell carcinoma as a monotherapy treatment. MEDI5752 is a novel bispecific antibody that simultaneously targets the immune checkpoint proteins PD-1 and CTLA-4.
CALQUENCE® (acalabrutinib) – Updated data from the ELEVATE-TN and ASCEND Phase III trials will highlight long-term safety and efficacy results of CALQUENCE in patients with chronic lymphocytic leukemia (CLL) regardless of line of therapy.
Presentations include updated data with approximately five-years of median follow-up from the ELEVATE-TN trial, which has demonstrated sustained clinical benefit of CALQUENCE either in combination with obinutuzumab or as monotherapy compared to obinutuzumab plus chlorambucil, providing flexibility to tailor treatment for adults with treatment-naïve CLL.
Additionally, updated results from the ASCEND Phase III trial with approximately four years of median follow-up will highlight the sustained reduction of disease progression or death for CALQUENCE compared to idelalisib plus rituximab or bendamustine plus rituximab in patients with relapsed or refractory CLL, as well as a maintained safety profile.
IMFINZI® (durvalumab) – Patient-reported outcomes from the HIMALAYA trial will highlight quality of life for patients treated with a single priming dose of tremelimumab added to IMFINZI in 1st-line unresectable liver cancer (STRIDE regimen). HIMALAYA is the first Phase III trial to show that a dual immunotherapy regimen has improved OS versus sorafenib in this setting. Tremelimumab with IMFINZIwas recently accepted under Priority Review in the US by the Food and Drug Administration (FDA) based on this trial.
Patient-reported outcomes will also be presented from the TOPAZ-1 trial of IMFINZIplus standard-of-care chemotherapy (gemcitabine plus cisplatin) in 1st-line advanced biliary tract cancer. TOPAZ-1 is the first Phase III trial to show improved survival with an immunotherapy combination versus chemotherapy alone in this setting.
An additional regional subgroup analysis for the TOPAZ-1 trial will compare efficacy outcomes, including OS, for Asian patients with other geographies. IMFINZIplus chemotherapy was recently granted Priority Review in the US by the FDA based on this trial.
Further clinically relevant safety data from the positive POSEIDON Phase III trial of IMFINZI, tremelimumab and chemotherapy in 1st-line metastatic non-small cell lung cancer (NSCLC) will also be presented.
LYNPARZA® (olaparib) – Data from the PROpel Phase III trial will further reinforce the safety profile of LYNPARZA plus abiraterone in the treatment of 1st-line metastatic castration-resistant prostate cancer (mCRPC). These data build on PROpel efficacy data, which demonstrated that this combination significantly delayed disease progression versus standard-of-care abiraterone in 1st-line mCRPC in patients with or without homologous recombination repair gene mutations. LYNPARZA is the first PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent versus abiraterone alone in this setting.
TAGRISSO® (osimertinib) – Results will be shared from the externally sponsored OPAL Phase II trial in previously untreated EGFR-mutated (EGFRm) NSCLC that evaluated whether the addition of platinum-based chemotherapy to TAGRISSO can improve patient outcomes. This combination is also being tested in the ongoing FLAURA2 Phase III trial.
Real-world data will also be presented to better inform unmet needs and treatment strategies among patients with resectable early-stage NSCLC, providing valuable insights into EGFRm disease prevalence and rates of recurrence, despite adjuvant chemotherapy, in this population. TAGRISSO is approved for the adjuvant treatment of early-stage (IB, II and IIIA) EGFRm NSCLC based on the ADAURA Phase III trial.
Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with, Daiichi Sankyo Company Limited to develop and commercialize ENHERTU and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) to develop and commercialize LYNPARZA.
Key AstraZeneca presentations during ASCO 2022
Antibody drug conjugates
Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Results of DESTINY-Breast04, a randomized, phase 3 study.
Abstract #LBA3 Plenary Session June 5, 2022 2:17pm (CDT)
Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients (pts) with HER2-positive (HER2+) unresectable and/or metastatic breast cancer (mBC): Safety follow-up of the randomized, phase 3 study DESTINY-Breast03.
Abstract #1000 Oral Abstract Session Breast Cancer—Metastatic June 4, 2022 1:15pm (CDT)
Dose-finding and -expansion studies of trastuzumab deruxtecan in combination with other anti-cancer agents in patients (pts) with advanced/metastatic HER2+ (DESTINY-Breast07 [DB-07]) and HER2-low (DESTINY-Breast08 [DB-08]) breast cancer (BC).
Abstract #3025 Poster Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology June 5, 2022 8:00am (CDT)
Durvalumab (D) +/- tremelimumab (T) + chemotherapy (CT) in first-line (1L) metastatic (m) NSCLC: AE management in POSEIDON.
Safety and clinical activity of MEDI5752, a PD-1/CTLA-4 bispecific checkpoint inhibitor, as monotherapy in patients (pts) with advanced renal cell carcinoma (RCC): Preliminary results from an FTIH trial.
Abstract #107 Clinical Science Symposium Bispecifics: Are Two Better Than One? June 5, 2022 10:33am (CDT)
DNA damage response
Maintenance olaparib in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) by somatic (s) or germline (g) BRCA and other homologous recombination repair (HRR) gene mutation status: Overall survival (OS) results from the ORZORA study.
Abstract #5519 Poster Discussion Session Gynecologic Cancer June 4, 2022 4:30pm (CDT)
Thiery- Vuillemin, A
Tolerability of abiraterone (abi) combined with olaparib (ola) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Further results from the phase III PROpel trial.
Abstract #5019 Poster Discussion Session Genitourinary Cancer—Prostate, Testicular, and Penile June 6, 2022 5:26pm (CDT)
Olaparib plus abiraterone as first-line therapy in men with metastatic castration-resistant prostate cancer: Pharmacokinetics data from the PROpel trial.
Abstract #5050 Poster Session Genitourinary Cancer—Prostate, Testicular, and Penile June 6, 2022 1:15pm (CDT)
Real-world effectiveness of first-line maintenance olaparib in women with BRCA-mutated advanced ovarian cancer: U.S. retrospective cohort study.
Abstract #5518 Poster Discussion Session Gynecologic Cancer June 4, 2022 4:30pm (CDT)
Tumor drivers and resistance
Fulvestrant plus capivasertib versus fulvestrant plus placebo after relapse or progression on an aromatase inhibitor in metastatic, estrogen receptor–positive breast cancer (FAKTION): Overall survival and updated progression-free survival data with enhanced biomarker analysis.
Abstract #1005 Oral Abstract Session Breast Cancer—Metastatic June 4, 2022 2:39pm (CDT)
A phase II study of osimertinib in combination with platinum plus pemetrexed in patients with EGFR-mutated, advanced non–small cell lung cancer: The OPAL study (NEJ032C/LOGIK1801).
Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: Five-year follow-up of ELEVATE-TN.
Abstract #7539 Poster Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia June 4, 2022 8:00am (CDT)
U.S. Important Safety Information for ENHERTU
Indications ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:
Unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either:
o In the metastatic setting, or
o In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy
Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen
WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY
Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms.
Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.
Warnings and Precautions
Interstitial Lung Disease / Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.
Metastatic Breast Cancer In clinical studies, of the 491 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, ILD occurred in 13% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 1.4% of patients treated with ENHERTU. Median time to first onset was 5.5 months (range: 1.1 to 20.8).
Locally Advanced or Metastatic Gastric Cancer In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21.0).
Neutropenia Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less. Reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3ºC or a sustained temperature of ≥38ºC for more than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one level.
Metastatic Breast Cancer In clinical studies, of the 491 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in 68% of patients. Eighteen percent had Grade 3 or 4 decrease in neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 6 to 664). Febrile neutropenia was reported in 1.2% of patients.
Locally Advanced or Metastatic Gastric Cancer In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients.
Left Ventricular Dysfunction Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.
Metastatic Breast Cancer In the 491 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU 5.4 mg/kg, 13 cases (2.6%) of asymptomatic LVEF decrease were reported.
Locally Advanced or Metastatic Gastric Cancer In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF.
Embryo-Fetal Toxicity ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months after the last dose of ENHERTU.
Additional Dose Modifications Thrombocytopenia For Grade 3 thrombocytopenia (platelets <50 to 25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less. Reduce dose by one level.
Adverse Reactions Metastatic Breast Cancer The pooled safety population for patients with metastatic breast cancer reflects exposure to ENHERTU at 5.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) in 491 patients in DESTINY-Breast03, DESTINY-Breast01, and Study DS8201-A-J101. The median duration of treatment was 13 months (range: 0.7 to 37). In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (78%), decreased white blood cell count (74%), decreased hemoglobin (68%), decreased neutrophil count (68%), increased aspartate aminotransferase (58%), fatigue (57%), decreased lymphocyte count (56%), vomiting (50%), decreased platelet count (49%), increased alanine aminotransferase (48%), increased blood alkaline phosphatase (45%), alopecia (41%), constipation (35%), hypokalemia (33%), decreased appetite (32%), diarrhea (31%), musculoskeletal pain (28%), increased transaminases (27%), respiratory infection (24%), headache (21%), and abdominal pain (21%).
DESTINY-Breast03 The safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg in DESTINY-Breast03. ENHERTU was administered by intravenous infusion once every three weeks. The median duration of treatment was 14 months (range: 0.7 to 30).
Serious adverse reactions occurred in 19% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were vomiting, interstitial lung disease, pneumonia, pyrexia, and urinary tract infection. Fatalities due to adverse reactions occurred in 0.8% of patients including COVID-19 and sudden death (one patient each).
ENHERTU was permanently discontinued in 14% of patients, of which ILD/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 44% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, leukopenia, anemia, thrombocytopenia, pneumonia, nausea, fatigue, and ILD/pneumonitis. Dose reductions occurred in 21% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were nausea, neutropenia, and fatigue.
Locally Advanced or Metastatic Gastric Cancer The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma in DESTINY‑Gastric01. Patients intravenously received at least one dose of either ENHERTU (N=125) 6.4 mg/kg once every three weeks or either irinotecan (N=55) 150 mg/m2 biweekly or paclitaxel (N=7) 80 mg/m2 weekly for 3 weeks. The median duration of treatment was 4.6 months (range: 0.7 to 22.3) in the ENHERTU group and 2.8 months (range: 0.5 to 13.1) in the irinotecan/paclitaxel group.
Serious adverse reactions occurred in 44% of patients receiving ENHERTU 6.4 mg/kg. Serious adverse reactions in >2% of patients who received ENHERTU were decreased appetite, ILD, anemia, dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of patients: disseminated intravascular coagulation, large intestine perforation, and pneumonia occurred in one patient each (0.8%).
ENHERTU was permanently discontinued in 15% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 62% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, decreased appetite, leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia, upper respiratory tract infection, diarrhea, and hypokalemia. Dose reductions occurred in 32% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were neutropenia, decreased appetite, fatigue, nausea, and febrile neutropenia.
The most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (75%), decreased white blood cell count (74%), decreased neutrophil count (72%), decreased lymphocyte count (70%), decreased platelet count (68%), nausea (63%), decreased appetite (60%), increased aspartate aminotransferase (58%), fatigue (55%), increased blood alkaline phosphatase (54%), increased alanine aminotransferase (47%), diarrhea (32%), hypokalemia (30%), vomiting (26%), constipation (24%), increased blood bilirubin (24%), pyrexia (24%), and alopecia (22%).
Use in Specific Populations
Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months following the last dose of ENHERTU.
Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose.
Females and Males of Reproductive Potential: Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 7 months following the last dose. Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months following the last dose. Infertility: ENHERTU may impair male reproductive function and fertility.
Pediatric Use: Safety and effectiveness of ENHERTU have not been established in pediatric patients.
Geriatric Use: Of the 491 patients with HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, 22% were ≥65 years and 4% were ≥75 years. No overall differences in efficacy within clinical studies were observed between patients ≥65 years of age compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged ≥65 years (60%) as compared to younger patients (49%). Of the 125 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg in DESTINY-Gastric01, 56% were ≥65 years and 14% were ≥75 years. No overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients.
Renal Impairment: A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Monitor patients with moderate or severe renal impairment.
Hepatic Impairment: In patients with moderate hepatic impairment, due to potentially increased exposure, closely monitor for increased toxicities related to the topoisomerase inhibitor.
To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.
SELECT SAFETY INFORMATION FOR CALQUENCE® (acalabrutinib)
INDICATION AND USAGE CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
SELECT SAFETY INFORMATION Serious adverse events, including fatal events, have occurred with CALQUENCE, including serious and opportunistic infections, hemorrhage, cytopenias, second primary malignancies, and atrial fibrillation and flutter. The most common adverse reactions (≥ 30%) of any grade in patients with CLL were anemia, neutropenia, thrombocytopenia, headache, upper respiratory tract infection, and diarrhea.
SELECT SAFETY INFORMATION FOR IMFINZI® (durvalumab) Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection. IMFINZI can cause severe or life-threatening infusion-related reactions. Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody.
Advise women not to become pregnant or breastfeed during treatment with IMFINZI and for at least 3 months after the last dose.
In the PACIFIC trial, the most frequent serious adverse reactions reported in at least 2% of patients were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). In the CASPIAN trial, the most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%) and COPD (1.1%).
Most common adverse reactions (≥20% of patients with unresectable, Stage III NSCLC) were cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash. Most common adverse reactions (≥20% of patients with extensive-stage SCLC) were, nausea, fatigue/asthenia, alopecia.
The safety and effectiveness of IMFINZI have not been established in pediatric patients.
IMFINZI is indicated for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
SELECT SAFETY INFORMATION for LYNPARZA® (olaparib) tablets LYNPARZA is associated with serious, potentially fatal risks, including myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), pneumonitis. Additionally, serious, potentially fatal risk of venous thromboembolic events has been reported with LYNPARZA in mCRPC. LYNPARZA can also cause fetal harm.
U.S. FDA-APPROVED INDICATIONS
LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
First-Line Maintenance BRCAm Advanced Ovarian Cancer For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
First-Line Maintenance HRD Positive Advanced Ovarian Cancer in Combination with Bevacizumab In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:
a deleterious or suspected deleterious BRCA mutation, and/or
Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
Maintenance Recurrent Ovarian Cancer For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.
Advanced gBRCAm Ovarian Cancer For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
gBRCAm, HER2-Negative Metastatic Breast Cancer For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
First-Line Maintenance gBRCAm Metastatic Pancreatic Cancer For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
Please click here for complete Prescribing Information, including Patient Information (Medication Guide).
SELECT SAFETY INFORMATION FOR TAGRISSO® (osimertinib)
There are no contraindications for TAGRISSO
TAGRISSO is associated with several serious and sometimes fatal adverse reactions, including interstitial lung disease/pneumonitis, QTc interval prolongation, cardiomyopathy, keratitis, erythema multiforme and Stevens-Johnson syndrome, and embryo-fetal toxicity
The most common adverse reactions (≥20%) were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue, and decreased appetite
U.S. FDA-APPROVED INDICATIONS
TAGRISSO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy
AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.
About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on Twitter @AstraZenecaUS.
Marlborough, MA, April 27, 2021 --(PR.com)-- ettain health and CloudWave are pleased to announce the formation of a strategic partnership to provide a complete portfolio of consulting, talent, professional services, and IT solutions to the healthcare market. ettain health offers advisory, recruitment, and managed solutions for healthcare organizations. Combined with CloudWave’s expertise architecting and delivering multi-cloud solutions, the partnership offers hospitals a premier option to implement, operate, and optimize their IT systems with experienced, top-tier applications talent and engineering resources.
This partnership joins two leading providers of healthcare solutions. CloudWave serves more than 600 hospitals with IT infrastructure, technical consulting, and managed services, and operates more than 125 hospital environments in the OpSus Healthcare Cloud and AWS. ettain health’s team of more than 500 consultants and employees provides healthcare IT talent and performance-focused solutions to over 1,000 healthcare customers.
Together, ettain health and CloudWave are uniquely positioned to assist hospitals with their critical technology, business, and patient care initiatives. This partnership joins experienced and knowledgeable technical, application, and project resources with proven infrastructure architectures and innovative managed cloud services to provide a full spectrum of services to support healthcare IT needs. The result is a powerful set of offerings with seamless IT and applications support, a streamlined “one contact/one contract” approach for all personalized services, competitive pricing, and unmatched expertise.
“The team at ettain health is excited to partner with CloudWave,” said Davin Juckett, President of ettain health, a division of ettain group. “Together, we bring expanded capabilities to the healthcare market at large. ettain health’s healthcare IT solutions and experience across all major EHRs, combined with CloudWave’s experience delivering innovative IT solutions, presents tremendous possibilities to our clients and consultants.”
“By joining forces with ettain health, CloudWave is looking forward to offering current and prospective healthcare customers a more comprehensive set of services and solutions. The value, depth of knowledge, and full spectrum of IT options that we’re able to offer as a team is exceptional. I’m excited to see the impact that our combined strengths will have on hospitals, enabling them to execute new IT strategies, optimize systems, improve operations, and save money,” said Erik Littlejohn, President and CEO of CloudWave.
About ettain health ettain health, a division of ettain group, is led by business, technology, and clinical experts that support our customers in selecting, implementing, and optimizing their information technology investments. We are committed to providing customized solutions and connecting talent to meet critical needs of healthcare customers nationwide. We invest in knowing your facility, your team, and the culture paramount to your patient experience. With deep experience across Epic, Cerner, MEDITECH (certified MEDITECH Expanse consulting firm), and other major EHRs, ettain health is the partner you can trust to provide expertise, and deliver and manage top talent across the full spectrum of healthcare IT projects. https://ettaingroup.com/
About CloudWave CloudWave helps hospitals bring public, private, and cloud edge resources together into a single operating environment. Our OpSus Cloud Services deliver managed hosting, disaster recovery, systems management, security, backup, and archiving services to healthcare. www.gocloudwave.com.
"Mirvie is a trailblazer in a field desperate for innovation to address the often devastating and costly lifetime consequences of pregnancy complications," Min Cui, founder and managing director of Decheng Capital, said in a statement. "This funding syndicate is committed to supporting Mirvie’s objective to provide clinicians, expecting parents and babies with breakthrough innovation that makes what is impossible today into a reality."
Nurse practitioner support platform Greater Good Health raised $10 million in a funding round led by LRVHealth.
Other participants in the round include Martin Ventures, Health Velocity Capital and Optum Ventures as well as angel investors. Greater Good's platform includes tools for scheduling, professional development, wellness and stress management, and networking with other nurse practitioners. It launched out of stealth in December, and has now raised $13 million in total funding.
Doximity, a networking platform for healthcare professionals, posted revenue of $93.7 million for its fourth quarter that ended on March 31, compared with $66.7 million in the prior-year quarter.
The company's net income came to $36.7 million compared with $21.5 million last year. Doximity also posted results for its fiscal 2022, bringing in $343.5 million compared with $206.9 million for fiscal 2021, which ended on March 31, 2021. It reported a full-year net income of $154.8 million, compared with $50.2 million.
For its upcoming quarter that will end June 30, Doximity posted revenue guidance between $88.6 million and $89.6 million. For the full year, which will end March 31, 2023, it predicts revenue between $454 million and $458 million.
During an earnings call, Doximity cofounder and CEO Jeff Tangney said the company surpassed two million registered members during the quarter and recorded record highs in use for its fax, e-signature and telehealth products. It also announced and wrapped up its acquisition of physician-scheduling and messaging app Amion during its Q4.
Freenome’s platform uses machine learning models to analyze tumor and non-tumor signals, with the goal of detecting cancer in its earliest, most treatable stages with a single blood draw. The aim is to innovate a more patient-centric approach to multi-cancer detection, reducing diagnostic complexity and optimizing processes for clinical efficiency.
Melissa Hanna, CEO and cofounder of maternal health startup Mahmee, sat down with MobiHealthNews to discuss how their platform aims to improve pregnancy and postpartum care, the company's recent $9.2 million Series A raise and the growing digital maternal health landscape. This interview was edited for clarity and length.
MobiHealthNews: Can you tell me a bit about how Mahmee works from the patient perspective?
Melissa Hanna: New and expecting parents can join Mahmee for free. And the core aspect of that experience for anyone who's joining includes the unified health record for mom and baby. So, they're able to link together health record information from the mother's medical history and pregnancy history to the childbirth experience, and baby's birth story and first year of life. So, we really focus on conception through the baby's first year of life and documenting all of the aspects of care and health that happened during that time.
Another part of that is access to the national Mahmee network of providers that are using our software across the country. [They] are primarily community-based birth and infant care professionals. So those are folks that may be midwives, doulas, lactation consultants, home visiting nurses or home health providers, nutritionists, therapists, social workers. They're all types of community-based professionals that patients are likely to interface with at some point during their maternity experience but are often not considered core members of the patient's care team the way that OB-GYNs and pediatricians are.
SAN FRANCISCO, February 18, 2022 (Newswire.com) - Innovaccer Inc., the Health Cloud company, today announced it has been listed as a partner vendor of choice in the January 2022 Gartner® report, "Quick Answer: Use FHIR to Jump-Start Clinical Data Integration for U.S. Healthcare Payers." The report provides a framework for healthcare payer CIOs to jump-start enterprise CDI investment and encourages payers to embrace Fast Healthcare Interoperability Resources (FHIR) as the new common language for healthcare data exchange to meet the requirements of the U.S. Centers for Medicare and Medicaid Services (CMS) interoperability mandate.
Per Gartner, "Many payers have been working for years on initiatives that depend on successful CDI, including building a longitudinal health record, improving revenue from risk and quality programs, or better coordinating care. The vast majority of payers, however, have not achieved scale in these use cases nor have they significantly increased the percentage of providers exchanging clinical data electronically. Enterprise CDI has been elusive due to a number of factors, including a lack of:
Clear technical, content, and vocabulary standards for clinical and administrative data
Provider trust in payer clinical data use beyond explicit attribute and use-case-level agreements
Financial incentives for providers to establish and maintain CDI interfaces with payers
Specific business value assessments and reasonable ROI targets for CDI initiatives
Strategic support for CDI use cases beyond compliance from executive leadership"
According to the Gartner report, standardization makes scaling possible, and innovative approaches and leading CDI vendors, such as Innovaccer, help substantially to resolve the standards barriers to achieving CDI at scale. This includes establishing FHIR as the basis for data exchange between healthcare participants, with standards defined and governed by the ONC's rule, defining OAuth 2.0 as the standard authorization framework governing entities' data access via APIs, OpenID Connect as the standard authentication protocol, and defining the U.S. Core Data for Interoperability clinical data requirements and associated code sets.
The report includes examples of enterprise CDI business cases to justify the investment.
Per Gartner, "In addition to CMS mandates, payers face an increasing regulatory emphasis on improving administrative process timeliness and transparency. This environment creates an opportunity for payers to differentiate with integrated — even automated — workflows, delivering quantifiable value to providers who participate in CDI. Committing to reducing administrative burden and associated costs with CDI initiatives will help payers overcome the trust gap and negotiate broader data usage agreements."
The Innovaccer Health Cloud®, which comprises the Innovaccer Data Activation Platform, its Application Suite, and a broad range of modular Innovation Accelerators that speed development of new solutions, natively supports FHIR for industry standard healthcare data interoperability. The Health Cloud unifies healthcare data across disparate IT systems and care settings to create a single, longitudinal patient record that includes all healthcare data sources—including clinical, claims, labs, pharmacy, and even external third-party data sources (such as social determinants of health)—providing a comprehensive view of the patient for point-of-care insights that can drive profound improvements in clinical, operational, and financial outcomes.
"We are honored to be named in the Gartner report as a Representative Vendor," said Abhinav Shashank, co-founder, and CEO of Innovaccer. "In building our clinical data integration framework, we realized that the adoption of FHIR was essential for secure communication and for improving collaboration between payers and providers. To us, the Gartner acknowledgment of Innovaccer and of the importance of adopting FHIR as an industry-standard demonstrates and supports the business case for an enterprise-wide CDI strategy. With a health cloud, payers can unify their healthcare data and streamline the work of extracting value from data—integrating it from various sources. That's the promise of the cloud revolution for healthcare—to innovate much faster and achieve the holy grail of integration and interoperability."
Learn more about the state of CDI adoption in the recently published Innovaccer white paper, "Advancing a data integration strategy: Overcoming long-standing challenges to realize a meaningful change in care management."
Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner's Research and Advisory organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.
Gartner, Quick Answer: Use FHIR to Jump-Start Clinical Data Integration for U.S. Healthcare Payers, Mandi Bishop, January 11, 2022
Innovaccer Inc., the Health Cloud company, is a leading San Francisco-based healthcare technology company committed to helping healthcare care as one. The Innovaccer Health CloudⓇ unifies patient data across systems and settings, and empowers healthcare organizations to rapidly develop scalable, modern applications that improve clinical, operational, and financial outcomes. Innovaccer's solutions have been deployed across more than 1,000 care settings in the U.S., enabling more than 37,000 providers to transform care delivery and work collaboratively with payers and life sciences companies. Innovaccer has helped organizations unify health records for more than 24 million people and generate more than $600 million in savings. For more information, please visit innovaccer.com.
In the case that the Supreme Court decides to end the constitutional right to abortion enshrined in Roe v. Wade, virtual care will become very important to those wishing to seek abortions, as many may travel across state lines to access virtual visits from their cars.
Telehealth organizations and privacy groups are concerned that law enforcement from states barring abortions may seek digital evidence of those who are looking for abortions, searching though search histories and phone location data.
"We're going to see a huge focus on surveillance of telemedicine and online abortion services," Albert Fox Cahn, head of the nonprofit Surveillance Technology Oversight Project, told Politico.