View this email in your browser

MedNess: bite-size biopharma and medtech news

26th January, 2022
Subscribe here
MedNess This Week
HIGHLIGHTS
 
Regulatory News
  • FDA accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment in advanced NSCLC.
  • The target action date for the FDA decision is September 19, 2022.
  • The sBLA is supported by results from a randomized, multicenter Phase 3 trial that investigated Libtayo in combination with a physician's choice of platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone.
  • Enrolled patients (n=466) had locally advanced or metastatic NSCLC, irrespective of PD-L1 expression level or tumor histology, and with no ALK, EGFR or ROS1 aberrations.
  • A regulatory filing has also been recently submitted to the European Medicines Agency.
  • The Phase 3 trial supporting the sBLA was stopped early after the Libtayo combination demonstrated a significant overall survival improvement compared to chemotherapy alone.
Voluntarily withdrawal of the use of Zydelig for follicular lymphoma and small lymphocytic leukemia
  • In 2014, Zydelig® (idelalisib) received accelerated approval from the U.S. Food and Drug Administration (FDA) to treat relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL). Approval was based on a Phase 2 study in indolent non-Hodgkin lymphoma showing that 54% of those with FL and 58% of those with SLL had an objective response as assessed by an Independent Review Committee.
  • Continued approval for these indications was contingent upon providing evidence supporting the confirmation of clinical benefit in FL and SLL. With an evolved treatment landscape for FL and SLL, enrollment into the confirmatory study has been an ongoing challenge. As a result, Gilead formally notified the FDA of its decision to voluntarily withdraw these indications from the U.S. market.
  • Zydelig was also approved in 2014 to treat relapsed CLL in the U.S. Additionally, Zydelig has marketing authorization to treat CLL and FL in the EU, UK, Canada, Australia, New Zealand and Switzerland. None of these approvals are affected by the proposed withdrawal. Thus, Zydelig will remain on the market in the U.S. for CLL and for CLL and FL in the EU, UK, Canada, Australia, New Zealand, and Switzerland.
  • Gilead continues to work collaboratively with the FDA to complete the withdrawal of the FL and SLL indications in the U.S. and with healthcare professionals to support those currently being treated with Zydelig. People receiving Zydelig for relapsed FL or SLL in the U.S. should discuss their treatment options with their healthcare provider.
Click here for more Regulatory News
Trial Results
Sugemalimab Demonstrates Statistically Significant Overall Survival Benefit in Patients with Stage IV Non-Small Cell Lung Cancer
“We are highly encouraged to see that sugemalimab in combination with chemotherapy demonstrates significant clinical benefit, including improvement in both PFS and OS, when compared to placebo plus chemotherapy across a broad spectrum of patients with Stage IV non-small cell lung cancer in this Phase 3 study,” said Vince Miller, MD, physician-in-chief at EQRx. “Price remains a barrier to accessing innovative therapies for many people with lung cancer around the world, despite the availability of multiple anti-PD-(L)1 therapies. We look forward to engaging with global regulatory authorities with the aim of delivering a lower-cost treatment option to patients upon approval.”
Results From Ph 3 KEYNOTE-775/Study 309 Trial of KEYTRUDA + LENVIMA in Advanced Endometrial Carcinoma Published in the New England Journal of Medicine
“While rates of endometrial carcinoma continue to rise globally, patients with advanced or recurrent disease have limited options available to them once the disease progresses following platinum-based chemotherapy,” said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck Research Laboratories. “KEYNOTE-775/Study 309 is an important Phase 3 study that supported recent approvals of KEYTRUDA plus LENVIMA for certain types of advanced endometrial carcinoma in the U.S. and other countries around the world, where it became the first immunotherapy and tyrosine kinase inhibitor combination approved for these patients.”
Trial/Program Status
FDA Authorises Proceeding with Ph 1b Study of KO-539 in Acute Myeloid Leukemia
“I am very proud of our team for working diligently with the FDA and site investigators to resolve the partial clinical hold in such a timely manner,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Activities to resume patient screening are underway, and we look forward to expediting enrollment of patients in the Phase 1b study and determining the recommended Phase 2 dose for KO-539 in the coming months. Meanwhile, we continue to be encouraged by the safety, tolerability and clinical activity observed among currently enrolled patients and look forward to sharing a comprehensive update on the Phase 1 study at a future medical meeting.”
Collated by: Richa Tewari, PhD 
Neuroimmunology and immunotherapies
Compelling evidence for EBV as a greater risk factor in Multiple Sclerosis
Multiple sclerosis is a debilitating disease of the Central Nervous System (CNS), mostly affecting the young adult and affect greatly the quality of life. In MS autoreactive lymphocytes attacks the myelin sheaths, the covering of axons in the CNS. Though we do not know the exact triggers of MS, the genetic and environmental factors are implicated in the pathogenesis of Multiple Sclerosis. One of the environmental suspects in MS is Epstein Barr Virus, and it is difficult to study its causation as it takes a long time (approximately 10 years) after the infection to develop MS. The delay between EBV infection and the onset of MS may be due to the evolving relationship between the EB virus and the host immune system which can respond depending upon the reactivation of the latent virus. The 20 years longitudinal study conducted on 10 million young adults on active duty in the U.S. military where 955 individuals were diagnosed with MS has provided compelling and strong data to implicate EBV infection as a greater risk factor for MS (32-fold). From this cohort, a higher level of Neurofilament light chain (a biomarker for neurodegeneration) was detected in the serum of MS patients only after EBV infection but not with the infection with other viruses. This establishes EBV as one of the main risk factors in MS but could not explain how EBV contributes to MS pathogenesis. This question is elegantly answered in a recent article published in a Nature article and the researchers demonstrated the high-affinity molecular mimicry between EBV transcription factor EBNA1 and a brain protein glial cell adhesion molecule (GlialCAM) which provided the functional relevance to MS. The antibodies against EBV EBNA1 and GlialCAM proteins are rampant in MS patients. They also confirmed in an animal model of MS that EBNA1 immunization exacerbates the disease severity. Overall, this seminal work supports why B-cell depletion therapy has shown promise in MS and one reason would be depletion of memory B-cells, the primary reservoir site where EBV latency occurs. Certainly, this study will help in the development of novel MS therapies including vaccines against EBV or antiviral strategies against EBV.
Collated by: Manoj Mishra 
CONFERENCE COVERAGE: 2022 American Society for Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium

  1. Exelixis Announces Detailed Results for Cabozantinib in Combination with Immunotherapies in Patients with Advanced Colorectal Cancer 

  2. Imfinzi plus chemotherapy reduced risk of death by 20% in 1st-line advanced biliary tract cancer

  3. Imfinzi plus tremelimumab demonstrated unprecedented survival in 1st-line unresectable liver cancer with 31% of patients alive at three years

  4. ImmunityBio Announces Results of Ph 2 Metastatic Pancreatic Cancer Trial with mOS of 6.3 Months in Patients with Third-Line Disease, More than Doubling Historical Survival

  5. Leap Therapeutics to Present Positive New Data from the DisTinGuish Study of DKN-01 Plus Tislelizumab

  6. Merck’s KEYTRUDA Significantly Improved OS Versus Placebo in Certain Patients With Advanced HCC Previously Treated With Sorafenib

  7. Mirati Therapeutics Presents Positive Clinical Data with Investigational Adagrasib in Patients with KRASG12C-Mutated Gastrointestinal Cancers

  8. Oncolytics Biotech® Provides Enrollment Update on Multi-Indication Phase 1/2 Gastrointestinal Cancer Trial 

  9. Rafael Pharmaceuticals Announces Ongoing Successful Enrollment and Opening of Additional Sites for Ph 2 Clinical Trial of CPI-613® (Devimistat) in Combination with Gemcitabine and Cisplatin in Patients with Biliary Tract Cancer
Collated by: Richa Tewari, PhD 
MedNess Business
Onco-News
AstraZeneca and Scorpion Therapeutics enter agreement to discover, develop and commercialise novel cancer treatments against ‘undruggable’ targets
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Unlocking potentially transformative biology is pivotal for delivering the next wave of cancer treatments. Scorpion’s innovative platform is a strong strategic fit as we explore a range of new modalities across our broad drug discovery toolbox with promise to disrupt the activity of these highly-validated cancer targets.”
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
Darpan Chakraborty
Social Media Manager
IP & BioPharma News
 
Nisha Peter, PhD
Consulting Editor

 
Rinki Saha
BioPharma News
Managing Editor
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
Share Share
Tweet Tweet
Forward Forward
Subscribe
Disclaimer
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.
Copyright © 2019 MedNess , All rights reserved.
You are receiving this MedNess Newsletter as a subscriber on the list.

Cover Image : iStock
Images : Twitter , Unsplash.com
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
Our mailing address is:
MedNess
1150 First Ave. King of Prussia,, PA 19406

Want to change how you receive these emails?
You can update your preferences or unsubscribe from this list.