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Merck Oncology Strategy: With First-Line Lung Data, A New Day Dawns For Keytruda

 
• By Jessica Merrill

Merck claims to have the broadest clinical development program for an anti-PD-1/L1 drug, with more than 270 trials under way testing Keytruda in 30 tumor types and 100 combinations.

For Merck & Co. Inc., succeeding in immuno-oncology centers on the PD-1 inhibitor Keytruda (pembrolizumab). The company is moving aggressively to expand Keytruda into as many indications as possible, and during a briefing at the American Society of Clinical Oncology (ASCO) meeting in June, management claimed the drug is being tested in the broadest clinical development program for an anti-PD-1/L1 in the industry.

Keytruda is being tested in more than 270 trials in 30 types of tumors, including in100 combination studies, the company...

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CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 
• By Michael McCaughan

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

More from R&D

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
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Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.