AACR 2023 – not so fast for Keytruda in biliary tract cancer

Merck & Co looked like it might match Astrazeneca with a first-line biliary track cancer approval, but full results from the Keynote-966 study have added uncertainty. Keynote-966, testing Keytruda plus chemo, was toplined positive for overall survival versus chemo in January, but data just presented at AACR raise fresh questions. Though on a cross-trial basis the all-important OS result looks similar to that seen in Astra’s registrational Topaz-1 study of Imfinzi plus chemo, the numerical PFS benefit in Keynote-966 is not statistically significant. More puzzlingly, there is no remission rate benefit at all in the Merck trial, which also saw a greater rate of severe adverse events overall and a numerically higher rate of treatment-related deaths than Topaz-1. It was already clear that Imfinzi’s win in Topaz-1 was borderline, but with no immunotherapies approved first line the FDA gave the Astra drug a swift green light last September. Whether the agency will be similarly generous to Keytruda is now the question.

The battle in 1st-line bile duct cancer
Topaz-1 Keynote-966
Imfinzi + chemo, vs chemo Keytruda + chemo, vs chemo
mOS 12.8mth vs 11.5mth 12.7mth vs 10.9mth
HR=0.80 (p=0.021) HR=0.83 (p=0.003)
mPFS 7.2mth vs 5.7mth 6.5mth vs 5.6mth
HR=0.75 (p=0.001) HR=0.86 (p=0.23)*
ORR 26.6% vs 18.7% 28.7% vs 28.5%*
Grade 3/4 AEs 75.7% vs 77.8% 85.3% vs 84.1%
Treatment-related deaths 2/341 vs 1/344 8/533 vs 3/536
Note: *not statistically significant. Source: Asco-GI 2022 & AACR 2023.

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