Merck Stresses Overall Survival In Keytruda/Chemo '189 Trial Revamp

Merck is changing the statistical analysis of combination study in first-line lung cancer to include dual endpoints of progression-free-survival and overall survival, and has withdrawn a filing for the combination in Europe based on mid-stage data.

Malignant effusion: Pleural fluid cytology of lung (pulmonary) adenocarcinoma, a type of non small cell carcinoma.

Any change to the design of the immuno-oncology combination trials in lung cancer attracts enormous attention. Just one day after Bristol-Myers Squibb Co. was grilled over the CheckMate 227 study of its PD-1 inhibitor Opdivo (nivolumab) with the CTLA-4 inhibitor Yervoy in non-small cell lung cancer, Merck & Co. Inc. came under fierce questioning as it announced a delay and endpoint change to the eagerly awaited KEYNOTE-189 study of its PD-1 inhibitor Keytruda (pembrolizumab) with chemotherapy in first-line NSCLC.

For Bristol, CheckMate 227 is its final big shot at the first-line non-small cell lung cancer market, and investors and...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Immuno-oncology

Sino Biopharm Scoops LaNova In Chinese Pharma’s Biggest Biotech Buyout So Far

 

Sino Biopharm will pay almost $1bn to acquire what target LaNova’s CEO described as an “exploding” pipeline, which includes six clinical-stage candidates in the oncology area.

Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie

 

Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.

AbbVie Licenses IGI’s ISB 2001 In Second Myeloma Trispecific Deal For 2025

 

IGI CEO Cyril Konto said in an interview that his company picked AbbVie for its agility, drug development acumen and expertise in areas like intellectual property and legal affairs.

Stock Watch: US CAR-T And Vaccine Actions: Net Negative For Access

 
• By 

Relaxing CAR-T restrictions may not be an access panacea because of patient fragility and lack of payer incentive. Conversely, the ACIP’s recent recommendation on Thiomersal-containing flu vaccines is probably the thin edge of a more restrictive wedge.

More from Anticancer

Actuate Is Looking For A Buyer To Advance Pancreatic Cancer Candidate

 

After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.

Novartis Upbeat Even With Entresto Expiry Looming

 
• By 

Swiss major confident that new oncology drugs will fill revenue gap.

Sellas Targets Tambiciclib To Adverse-Risk Frontline AML Patients After Phase II Success

 

The biotech announced positive Phase II data for the drug combined with AbbVie/Roche’s Venclexta and BMS’s Vidaza in relapsed/refractory acute myeloid leukemia.