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MedNess: bite-size biopharma and medtech news

4th May, 2022
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MedNess This Week
HIGHLIGHTS
 
Drug Approvals
European Commission Approves KEYTRUDA® for Patients With MSI-H or dMMR Tumors in Five Different Types of Cancer
“Our company has a strong track record of applying precision medicine, through biomarkers like MSI-H and dMMR, to help identify patients most likely to respond to KEYTRUDA based on the genetic makeup of their individual cancer,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “For patients with MSI-H/dMMR colorectal cancer, KEYTRUDA monotherapy was approved in Europe as a first-line option in January 2021. Building on that approval, we are pleased that KEYTRUDA is now approved for the treatment of additional MSI-H/dMMR tumors, in certain second- or later-line patients with colorectal, endometrial, gastric, small intestine or biliary cancer.”
European Commission Approves KEYTRUDA® + Chemo +/- Bevacizumab for PD-L1 (CPS ≥1)+ve Patients With Persistent, Recurrent or Metastatic Cervical Cancer
“After many years of limited progress in developing new treatment options for persistent, recurrent or metastatic cervical cancer, we saw notable improvements in overall survival in KEYNOTE-826, with a 36% reduction in the risk of death,” said Dr. Nicoletta Colombo, associate professor, University of Milan-Bicocca, and director, Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. “With today’s approval, healthcare providers in the EU will be able to offer certain patients with advanced cervical cancer a long-awaited immunotherapy option that has shown significant improvement in overall survival.”
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Regulatory News
FDA Fast Track Designation for Ofra-Vec for the Treatment of Platinum-Resistant Ovarian Cancer
“We are pleased to receive FDA Fast Track designation for ofra-vec in platinum-resistant ovarian cancer. The Fast Track designation can facilitate the process towards potential registration and, importantly, may help expedite the time to market for ofra-vec, if approved,” said Prof. Dror Harats, M.D., chief executive officer of VBL Therapeutics. “The readout of the progression free survival primary endpoint in the OVAL trial will be an important milestone for VBL in the second half of this year. We believe that, if positive, this will support a Biologics License Application submission to the FDA.”
Enhertu Granted Breakthrough Therapy Designation in the US for Patients with HER2-Low Metastatic Breast Cancer
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca said: “Today’s news is a significant validation of the potential we see for the historic DESTINY-Breast04 trial to enable a paradigm shift in how breast cancer is classified by targeting the full spectrum of HER2 expression. Enhertu continues to show transformative potential, and this milestone represents an important advance for patients with HER2-low metastatic breast cancer who are in urgent need of new treatment options and better outcomes.”
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Trial Results
Updated Results from Ph 3 RATIONALE-309 Trial of Tislelizumab in First-Line RM-NPC presented
“These updated findings further support tislelizumab in combination with chemotherapy as a potential standard-of-care first-line therapy for patients with RM-NPC,” said Mark Lanasa, Chief Medical Officer, Solid Tumors at BeiGene. “This study’s acceptance for presentation as part of the high-profile virtual ASCO Plenary Series underscores the potential for tislelizumab plus chemotherapy to be a practice-changing option for patients with this disease.”
Tislelizumab + chemo significantly improved OS as first-line treatment for advanced esophageal cancer in Ph 3 RATIONALE-306 study
"People living with esophageal cancer experience painful everyday challenges and typically have a poor prognosis, with a five-year survival rate of around five percent for metastatic cases, underscoring the urgency for more immunotherapy options,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development. “We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”
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Trial/Program Status
First patient dosed in Ph 3 trial, PACIFIC-9, evaluating durvalumab in combination with monalizumab or oleclumab in patients with unresectable, Stage III NSCLC
“We are very pleased that our key late-stage asset, monalizumab, has progressed into a second Phase 3 trial with our partner, AstraZeneca. The launch of PACIFIC-9 represents an important financial milestone for Innate, as it triggers a $50 million milestone payment that reinforces our cash position,” said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. “Based on the recent COAST clinical trial results, we are excited about the potential of extending the clinical benefit of durvalumab with the addition of monalizumab in patients with unresectable, Stage III NSCLC.”
Positive DMC Review of Pivotal Trial of Iopofosine in Waldenstrom’s Macroglobulinemia Announced; study to continue
“We remain highly encouraged with the consistent performance of iopofosine I-131 in this difficult-to-treat refractory patient population,” said James Caruso, president and chief executive officer of Cellectar. “We have alignment with the FDA on a 20% major response rate hurdle as the primary endpoint of our pivotal study. In a poster presented at ASCO 2021, we showed an 83.3% major response rate with one complete response in six WM patients, which served as the basis for our pursuing this indication.”
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MedNess Business
Onco-News
Regeneron To Acquire Checkmate Pharmaceuticals And Its Investigational Immune Activator For Potential Use In Multiple Tumor Types
"As we continue to advance and expand our research efforts in immuno-oncology, the acquisition of Checkmate will add a promising new modality to Regeneron's toolkit of potential approaches for difficult-to-treat cancers," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "The unique combination of a differentiated Toll-like receptor 9 with other antibody-based oncology agents may result in increased clinical benefit and provide new treatment options for patients in need. We look forward to welcoming the Checkmate team and their complementary scientific acumen to the Regeneron family."
Legend Biotech Achieves Milestone Under Collaboration Agreement with Janssen Biotech, Inc. for BCMA CAR-T
  • Legend Biotech entered into the agreement with Janssen to develop, manufacture and commercialize cilta-cel for the treatment of multiple myeloma.
  • Under the agreement, Legend Biotech received an upfront payment of $350 million and is entitled to receive additional payments upon achievement of landmarks for development, production performance, regulatory and sales.
  • The global agreement specifies a 50-50 cost and profit-sharing agreement in all markets, excluding Greater China, where the split is 70 percent for Legend and 30 percent for Janssen.
  • Including the $50 million payment announced above, Legend has achieved $300 million in milestone payments during the collaboration.
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Collated by: Richa Tewari, PhD 
Editors' Desk
Richa Tewari, PhD
Oncology News
Debarati Banik
HealthIT
Sohini Dutta
BioPharma News
MedNess Plus
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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