The company said Wednesday that the pairing of PD-L1 inhibitor Imfinzi and CTLA-4 inhibitor tremelimumab did not prolong overall survival in previously untreated metastatic non-small cell lung cancer. The Phase III results are the latest in a string of failures for the combination.
The company said the Phase III CASPIAN study of Imfinzi in first-line, extensive-stage small-cell lung cancer was successful, but did not disclose further details. Roche's Tecentriq is already approved for that indication, which accounts for two-thirds of SCLC cases.
Greenway Health blends smart technology with human expertise to elevate revenue cycle.
The company joins a small but growing list of firms developing drugs targeting CD47, the "don't eat me" immune checkpoint. Another company, further ahead in development, is Forty Seven.
The PD-L1 inhibitor is the first new drug for ES-SCLC in more than 20 years. Meanwhile, Merck is also running a Phase III study of its PD-1 inhibitor in first-line ES-SCLC.
The drug received accelerated approval for combination with Celgene's Abraxane based on Phase III data. According to a study, PD-L1-positive patients account for 26 percent of TNBC patients overall.
Two drugs - Pfizer and Merck KGaA's Bavencio and AstraZeneca's Imfinzi - saw Phase III trials fail, while anticipated negative results prompted Roche to withdraw Tecentriq from regulatory review.
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Data from the Phase III MYSTIC study showed Imfinzi and tremelimumab did not extend survival in first-line NSCLC. AstraZeneca's shares were down on the news.
Kyoto University's Tasuku Honjo and MD Anderson's James Allison will share the prize for work that led to immunotherapy drugs like Keytruda and Yervoy.
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Both Roche and AstraZeneca have been caught off guard with Phase 3 data readouts that failed to meet their respective primary endpoints.
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The balance of power in the anti-PD-L1 therapy duel has once again shifted with a first-line therapy win by Keytruda for non-small cell lung cancer