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Bristol’s Checkmate-331 Failure Not Likely To Endanger SCLC Labeling For Opdivo

 
• By Joseph Haas

Opdivo failed to meet an overall survival endpoint in a Phase III confirmatory study in small-cell lung cancer. But several analysts think Bristol will keep the SCLC labeling obtained in August due to lack of treatment options for these patients.

Digital illustration of lung cancer cells in color background

The failure of Bristol-Myers Squibb Co.’s Opdivo to meet an overall survival endpoint compared to standard-of-care chemotherapy in a Phase III confirmatory trial in small-cell lung cancer is a disappointment, but several analysts predict that due to a lack of treatment options for patients, the PD-1 inhibitor will keep the third-line SCLC indication obtained less than two months ago.

Bristol reported top-line findings from the open-label Checkmate-331 study Oct. 12, showing Opdivo (nivolumab) failed to meet a primary endpoint...

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Genentech Gets Columvi Complete Response Following ODAC’s No

 
• By Joseph Haas

Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.

BMS’s Reblozyl Misses Primary Endpoint In Myelofibrosis Anemia

 
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AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
• By Vibha Ravi

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