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MedNess: bite-size biopharma and medtech news

23rd March, 2022
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MedNess This Week
HIGHLIGHTS
 
Drug Approvals
U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for EGFR Therapeutics Targeting Ex 19 Del or Ex 21 Substitutions in NSCLC
“Cancer treatment decision-making is growing more complex as we learn more about the mutations that drive cancers to grow and new treatments become available to target those changes,” said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. “We believe securing a third group companion diagnostic approval for FoundationOne CDx is another critical step toward simplifying the decision-making process for oncologists and their patients by allowing them to uncover all FDA approved treatment options for this indication through one test.”
FDA approves BRACAnalysis® CDx as a Companion Diagnostic for Lynparza® in Early Breast Cancer
“This most recent regulatory approval confirms the benefits of using biomarkers to help guide care for patients with breast cancer,” said Nicole Lambert, chief operating officer, Myriad Genetics. “Data from the OlympiA trial and numerous other clinical studies continue to demonstrate the power of BRACAnalysis CDx as an effective test for patients deciding on their best treatment options. More patients with breast cancer now potentially qualify for BRCA testing.”
Regulatory News
KEYLYNK-010 Trial Evaluating KEYTRUDA® in Combination with LYNPARZA® in Patients with mCRPC to Stop for Futility
“There remains a significant unmet need for patients diagnosed with advanced prostate cancer, who have a poor prognosis after not responding to initial therapy,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Merck continues to evaluate the combination of KEYTRUDA and LYNPARZA in a range of cancers, and to research other KEYTRUDA-based combinations for patients with advanced prostate cancer. We are grateful to the patients, their families and the investigators who made this study possible.”
NCCN Updates Designation of Monjuvi(R) (tafasitamab-cxix) to Preferred Regimen in its Clinical Practice Guidelines in Oncology for B-cell Lymphomas
"Updates to NCCN Guidelines are made periodically when additional efficacy and safety data are available, providing current information on the use of cancer therapies," said Joe Horvat, U.S. General Manager, MorphoSys. "Monjuvi is a targeted immunotherapy that addresses an immediate medical need for certain adult patients living with Diffuse Large B-cell Lymphoma. We are gratified the NCCN panel acknowledged the additional data submitted for Monjuvi and updated the designation of Monjuvi in combination with lenalidomide to a Preferred Regimen in its Clinical Practice Guidelines in Oncology."
Trial Results
FAILED TRIAL: Ph 3 PIVOT IO-001 Trial of Bempegaldesleukin + Opdivo in 1L Unresectable/ Metastatic Melanoma fails to meet primary endpoint of OS improvement
“While we are surprised and deeply disappointed in these results for the melanoma study, we will continue to await initial results from our first two ongoing studies in renal cell carcinoma and urothelial cancer, which are currently expected in the first half of 2022,” said Jonathan Zalevsky, chief research and development officer of Nektar Therapeutics. “We look forward to collaborating with BMS to evaluate the data from these other studies to guide the future development of bempegaldesleukin. Nektar remains dedicated to the development of therapeutics to treat cancer and auto-immune disease.”
LYNPARZA® Reduced Risk of Death by 32% in Patients With gBRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer in Ph 3 OlympiA Trial
Professor Andrew Tutt, global chair of the OlympiA trial and professor of oncology, The Institute of Cancer Research, London, and King’s College London, said, “OlympiA’s latest results are great news for patients with a specific inherited form of breast cancer. Most breast cancers are identified in the early stages and many patients will do very well, but for those with higher risk disease at diagnosis, the risk of cancer returning can be unacceptably high. OlympiA has now shown that olaparib not only reduced the risk of recurrence, but also improved overall survival for women with high risk early-stage breast cancer and a BRCA1/2 mutation and is an exciting demonstration of the benefits of targeting the specific biology of disease for these women.”
Click here for more Trial Results
Trial/Program Status
ECOG-ACRIN opens a new NCI-MATCH treatment arm for dMMR and LAG-3-positive cancers as it continues to locate patients with BRAF mutations
"These two highly-focused arms illustrate the ability of precision medicine trials to be nimble in response to positive findings, and to develop positive efficacy signals into studies that have the potential to change clinical practice,” said Peter J. O'Dwyer, MD (pictured), group co-chair of the ECOG-ACRIN Cancer Research Group, which is co-leading the trial with the National Cancer Institute.
MedNess Business
Onco-News
Sanofi and Seagen announce collaboration to develop and commercialize multiple novel antibody-drug conjugates
John Reed, M.D., Ph.D., Global Head of Research and Development, Sanofi, commented, “This collaboration will enable the synergistic combination of molecules and platforms to produce candidate medicines with the potential of bringing renewed hope to cancer patients and their families. We look forward to joining forces with Seagen to collaboratively design and develop promising medicines by advancing antibody-drug conjugate science.”
IDEAYA and Pfizer Expand Clinical Trial Collaboration and Supply Agreements for Evaluation of Darovasertib and Crizotinib Combination in Metastatic Uveal Melanoma and Additional cMET-Driven Tumors
"We are pleased to have Pfizer's support in connection with a potential registrational clinical trial as our clinical data on the darovasertib / crizotinib combination in MUM continues to mature.  Our preliminary clinical data on the darovasertib and crizotinib combination in MUM, reported in December 2021, showed robust clinical activity with a manageable side effect profile. We have an opportunity to positively impact the treatment of patients in this high unmet medical need population," said Dr. Matthew Maurer, M.D., Vice President and Head of Clinical Oncology and Medical Affairs at IDEAYA Biosciences.
Collated by: Richa Tewari, PhD 
Editors' Desk
Richa Tewari, PhD
Oncology News
Debarati Banik
HealthIT
Sohini Dutta
BioPharma News
MedNess Plus
Manoj Mishra
Neuroimmunology and immunotherapies
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
Nisha Peter, PhD
Consulting Editor
 
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The editors take care to share authentic information.  In case of any discrepancies please write to medness.newsletter@gmail.com
The sponsors do not have any influence on the nature or kind of the news/analysis reported in MedNess. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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Content Editors: Richa Tewari , Esha Sehanobish , Rinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
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