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MedNess: bite-size biopharma and medtech news

8th June, 2022
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MedNess This Week
HIGHLIGHTS
 
Drug Approvals
FDA Approves Two Opdivo®-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma
“Today brings welcome news for many advanced or metastatic esophageal squamous cell carcinoma patients and oncologists,” said Jaffer A. Ajani, M.D., CheckMate -648 co-first author and lead U.S. investigator, and professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. “Unresectable advanced or metastatic esophageal squamous cell carcinoma is a challenging disease, and there’s a need for additional treatment options that may extend survival in the first-line setting.3,4 In the CheckMate -648 trial, two nivolumab-based combinations showed a survival benefit compared to chemotherapy alone, offering new treatment options regardless of PD-L1 status.”
FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma
"We are proud of today's FDA approval of a third indication for Kymriah. We hope this treatment option that has the potential for long-lasting results may help break the unrelenting cycle of treatment for patients with follicular lymphoma,” said Victor Bulto, President, Novartis Innovative Medicines US. “We are on a mission to build on our pioneering work in cell therapy and continue to innovate for patient impact.”
Trial Results
EF-31 Phase 2 Pilot Study Evaluating Tumor Treating Fields Together with SoC Chemotherapy Meets Primary Endpoint for First-Line Treatment of Gastric Cancer
“The EF-31 outcomes are encouraging in a historically difficult to treat cancer,” said Dr. Jin Li, Head of Department of Oncology, Shanghai East Hospital, Tongji University School of Medicine. “The addition of Tumor Treating Fields to standard-of-care chemotherapy could lead to impactful changes in the treatment of gastric cancer patients and I look forward to confirming these data in additional clinical studies.”
Trial/Program Status
Phase 2 Trial of Berzosertib in Combination With Topotecan Discontinues in patients with relapsed, platinum-resistant SCLC
“While we did not see the outcomes we hoped for with this combination in this particularly challenging population of patients with platinum-resistant SCLC, we are confident in the potential of ATR inhibition, as combination with chemotherapy is only one avenue to take advantage of DNA Damage Response. We continue to progress our oral ATR inhibitor, M1774, and other investigational treatments in our DDRi portfolio as we evaluate the totality of data for berzosertib to assess our path forward,” said Zazulina.
TRE-515 Ph 1 Solid Tumors Trial Dose Escalates To Fourth Cohort After Safety Review Committee Determines Primary Trial Endpoint Achieved
Dr. Michael Shepard, Trethera Scientific Advisory Board member and Lasker laureate, commented, “These results hold importance in several ways.  First, they allow us to continue the study safely to its conclusion, which indicates a positive trend toward safety and tolerability, the primary focus of this and any Phase 1a clinical trial.  However, these unexpected observations of first antitumor activity indicate the therapeutic potential for TRE-515 in solid tumor patients with considerable cancer burden. We look forward to completing dose escalation and sharing first data at target dose next year.”
Click here for more Trial Statuses
Conference Coverage: ASCO 2022 Highlights
  1. ADCETRIS® (brentuximab vedotin) Plus SoC chemo Demonstrates Superior EFS vs SoC Alone in Children and Young Adults with Previously Untreated High-Risk Hodgkin Lymphoma
  2. Adjuvant Treatment With KEYTRUDA® Demonstrates Statistically Significant & Clinically Meaningful Improvement in dMFS in Patients With Resected Stage IIB or IIC Melanoma in Ph 3 KEYNOTE-716 Trial
  3. Calquence plus obinutuzumab demonstrated sustained survival benefit in 1st-line CLL with 90% of patients surviving five years in ELEVATE-TN trial
  4. Cullinan Oncology to Present Updated Data Demonstrating the Therapeutic Potential of CLN-081 in Patients with EGFR Exon 20 Insertion Mutation Positive NSCLC
  5. Eisai Presents New Findings for Farletuzumab Ecteribulin from the platinum-resistant ovarian cancer (PROC) cohort expansion of Ph 1 study (Study 101)
  6. Enhertu reduced the risk of disease progression or death by 50% vs. chemotherapy in patients with HER2-low metastatic breast cancer with HR-positive and HR-neg disease
  7. Gritstone Announces Updated Overall Survival Results in Advanced Colorectal Cancer Patients from Phase 1/2 Study of GRANITE and Trial in Progress
  8. HOOKIPA announces positive Phase 1 data and Phase 2 plans for HB-200 program for the treatment of advanced head and neck cancers
  9. Immutep Reports Positive Overall Response Rate in its Phase II Clinical Trial in 1st line NSCLC for PD-L1 All-Comers
  10. Kazia Presents Positive Final Data From Phase II Study Of Paxalisib In Newly Diagnosed Glioblastoma
  11. Longer-term Data from CARTITUDE-1 Study Demonstrate Continued Deep and Durable Responses to CARVYKTI™ (ciltacabtagene autoleucel) in Heavily Pretreated Patients with Relapsed or Refractory Multiple Myeloma
  12. Merus Presents Clinical Data on Zenocutuzumab (Zeno) in NRG1-fusion (NRG1+) Cancer
  13. OncXerna Therapeutics Announces Data Showing the Phase 2 GBM Trial of Bavituximab with ChemoRT and Adjuvant Temozolomide Met its Primary Endpoint
  14. Pfizer Announces Overall Survival Results from Phase 3 PALOMA-2 Trial of IBRANCE® for the First-Line Treatment of ER+, HER2- Metastatic Breast Cancer
  15. Pfizer Presents First Data from Planned Interim Analysis of Pivotal Phase 2 MagnetisMM-3 Trial of BCMA-CD3 Bispecific Antibody Elranatamab Under Investigation for Relapsed/Refractory Multiple Myeloma
  16. Phase 3 SHINE Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen Significantly Reduced the Risk of Disease Progression or Death in Older Patients with Newly Diagnosed Mantle Cell Lymphoma
  17. Puma Biotechnology Presents Final Results from the Biliary Tract Cohort of the Phase 2 SUMMIT ‘Basket’ Trial of Neratinib
  18. Positive Ph 1 Data from mRNA-based Individualized Neoantigen Specific Immunotherapy in Patients with Resected Pancreatic Cancer presented
  19. Sub-analyses of Landmark ZUMA-7 Trial Reinforce Yescarta® CAR T-cell Therapy Superiority Over Standard of Care (SOC) as Initial Treatment for Patients With Relapsed or Refractory Large B-cell Lymphoma (LBCL)
  20. Taiho Oncology Announces Updated Efficacy and Safety Data for Futibatinib in Cholangiocarcinoma
  21. Tecartus® Car T-cell Therapy Demonstrates Strong Overall Survival Rates and Continued Durable Responses in Long-Term Follow-Up of Two Pivotal Studies Including Longest Ever Follow-Up of a CAR T-cell Therapy in Mantle Cell Lymphoma
  22. Updated Data for Janssen's Bispecific Teclistamab Suggest Continued Deep and Durable Responses in the Treatment of Patients with RRMM
  23. Yescarta® CAR T-cell Therapy Demonstrates Consistent Survival Outcomes and Safety in Real-World Setting Regardless of Race and Ethnicity
  24. Zai Lab to Present New PRIME Subgroup Analysis for Niraparib in Ovarian Cancer
MedNess Business
Onco-News
Bristol Myers Squibb to Acquire Turning Point Therapeutics for $76.00 per share
“The acquisition of Turning Point Therapeutics further broadens our leading oncology franchise by adding a best-in-class, late-stage precision oncology asset,” said Giovanni Caforio, M.D., Board Chair and Chief Executive Officer, Bristol Myers Squibb. “With this transaction, we are continuing our strong track record of strategic business development to further enhance our growth profile.”
Repare Therapeutics Announces a Worldwide License and Collaboration Agreement with Roche for Camonsertib (RP-3500)
“Camonsertib has the potential to help cancer patients across numerous solid tumors as a monotherapy and possibly in combination with other agents," said Kim Seth, Ph.D., EVP and Head of Business & Corporate Development at Repare. “Given the encouraging data Repare has generated for camonsertib as a potentially best-in-class ATR inhibitor with a promising tolerability profile and patient selection insights in areas of high unmet medical need, and Roche’s leading global footprint and unique expertise in precision oncology, we are confident that Roche is the ideal partner for us to drive the broad global development and commercialization of camonsertib.”
Click here for more mergers, acquisitions and business news
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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