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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.

In Partnership with Cerba Research

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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EU Medtech Outlook: The View From MedTech Europe Experts

 
• By Ashley Yeo

MedTech Forum 2025 was less MDR-focused than in previous years, as macro issues and exogenous threats were forced further into the center of medtech business thinking.

‘Confident In Lorundrostat’s Promise’: Mineralys CEO Talks Trials And Next Steps

 
• By Sushmita Panda

In a conversation with In Vivo, CEO Jon Congleton discusses Mineralys’s data-rich journey toward an NDA filing, the significance of recent trial wins and how its candidate may offer a dual benefit in blood pressure and renal protection.

BioBytes: Qubit Pharmaceuticals Unveils Quantum AI Model For Drug Discovery

 
• By David Wild

Qubit Pharmaceuticals and Sorbonne University launched a quantum AI model that could slash drug synthesis requirements and enable exploration of previously undruggable targets.