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Roche Notches Big IO Win With Tecentriq/Avastin Combo In First-Line HCC

 
• By Joseph Haas

Following quickly on a Bristol trial failure with Opdivo in first-line HCC, Roche’s PD-L1 inhibitor looks poised to be the first immunotherapy approved in the setting, with plans for US, EU and China filings.

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Roche hopes to offer the first OS improvement in more than a decade in HCC

Roche appears to have made some progress carving out a niche versus checkpoint inhibitor leaders Merck & Co. Inc. and Bristol-Myers Squibb Co., as its combination regimen of PD-L1 inhibitor Tecentriq and anti-VEGF therapy Avastin bested standard-of-care Nexavar in first-line hepatocellular carcinoma (HCC) for patients not eligible for surgery.

Roche subsidiary Genentech Inc. announced on 21 October that the combo met the co-primary endpoints of overall survival (OS)...

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Atai Gives Up On Recognify’s Schizophrenia Drug After Phase IIb Miss

 
• By Joseph Haas

Set to merge with Beckley Psytech, Atai will focus on psychedelic candidates for treatment-resistant depression while Recognify will analyze Phase IIb data for possible next steps.

Celcuity Preps For Potentially Huge Market After Phase III Gedatolisib Win

 
• By Alaric DeArment

The biotech announced positive results in the PIK3CA wild-type population in second-line HR+/HER2- breast cancer for its PAM inhibitor.

Roche Unveils Alzheimer’s Phase III Plan And Preclinical Study

 
• By Andrew McConaghie

The trontinemab Phase III study is due to get underway this year, with Roche confident its brainshuttle technology will help it surpass approved rivals.

Bayer’s Elinzanetant Is Latest Drug Hit By FDA Review Delays

 
• By Kevin Grogan

Comes Days After PDUFA Pushback For GSK's Blenrep.

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Pipeline Watch: Twelve Approvals And Six Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Bristol Appoints AstraZeneca’s Massacesi As Next CMO

 
• By Jessica Merrill

Chief Medical Officer Samit Hirawat will step down to pursue new career opportunities, the company said.

Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 
• By Andrew McConaghie

The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.