Gilead and Merck Halt Lung Cancer Trial While Reporting HIV Treatment Success
Gilead And Merck End Trodelvy-Keytruda Lung Cancer Trial
Benzinga
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Gilead Sciences and Merck have stopped the Phase 3 KEYNOTE-D46/EVOKE-03 trial for Trodelvy and Keytruda in lung cancer due to insufficient survival benefits. Meanwhile, they announced positive results for a new once-weekly oral HIV regimen, which met primary efficacy endpoints in two studies.
- 01The Phase 3 KEYNOTE-D46/EVOKE-03 trial for Trodelvy and Keytruda was discontinued after a Data Monitoring Committee review.
- 02The combination treatment showed numerical improvement in progression-free survival but lacked statistical significance.
- 03Gilead and Merck reported successful Phase 3 results for an oral HIV regimen combining islatravir and lenacapavir, meeting primary efficacy endpoints.
- 04The HIV regimen demonstrated statistical non-inferiority compared to existing treatments in two separate trials.
- 05Both companies plan to submit findings for regulatory approval and present detailed data at future medical meetings.
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Gilead Sciences Inc. and Merck & Co. Inc. have discontinued the Phase 3 KEYNOTE-D46/EVOKE-03 trial, which assessed the combination of Trodelvy and Keytruda for treating metastatic non-small cell lung cancer with high PD-L1 expression. Despite showing a numerical improvement in progression-free survival, the results did not achieve statistical significance, and the likelihood of a meaningful overall survival benefit was deemed low. Safety profiles remained consistent with known data, with no new safety signals reported. In a separate development, the companies announced positive results from two Phase 3 trials for a once-weekly HIV treatment regimen combining islatravir and lenacapavir, which met its primary efficacy endpoint. This investigational regimen showed statistical non-inferiority compared to existing therapies, leading to plans for regulatory submissions. Full data from both studies will be presented at upcoming medical meetings.
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