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A Lesson From Tecentriq’s Development

 
• By Mark Ratner

Roche chose not to limit enrollment to patients with high levels of PD-L1 expression when it moved Tecentriq into Phase II – unlike Merck, which did not include low PD-L1 expressers in its Keytruda lung cancer trials.

Roche’s Genentech Inc. unit enrolled all comers when it moved into Phase II in bladder cancer, the lead indication for Tecentriq (atezolizumab). It chose not to limit enrollment to patients with high levels of PD-L1 expression – unlike Merck & Co. Inc., which did not include low PD-L1 expressers in its Keytruda (pembrolizumab) lung cancer trials.

The tactic could have severely hindered Tecentriq’s chances, but when low PD-L1 expressers who didn’t have the high immune score...

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

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Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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Enabling Precision Medicine At Scale Through Digital Innovation And AI

 
• By Cristal Thompson and Justyna Anna Lisowska

AI is reshaping clinical trials by enabling precision medicine, accelerating patient stratification, optimizing trial design, and transforming complex data into actionable insights for faster, more effective drug development.

J&J Challenges Medtronic At The Top Of Medtech Rankings

 
• By Ashley Yeo

Medtronic held its grip on first place in the 2024 global medical device and diagnostics rankings after losing it two years ago to Abbott, which is now in third place behind fast-rising, acquisitive Johnson & Johnson MedTech.

‘By Most Measures A Failure’: Ten Years On From Teva-Actavis

 
• By Dean Rudge

A decade after Teva’s $40.5bn acquisition of Actavis Generics, the deal remains a defining moment for the company. This retrospective explores Teva’s hopes, consequences, leadership shifts, and the firm’s new growth strategy under CEO Richard Francis.