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. https://www.evaluate.com/vantage/articles/events/conferences-snippets/aacr-2023-not-so-fast-keytruda-biliary-tract-cancer | ||
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