Merck and Gilead reported mixed results across two Phase 3 areas: Gilead’s Trodelvy missed in first-line lung cancer, while a once-weekly oral HIV combination program showed success. The Trodelvy outcome centers on the Evoke-03/Keynote-D46 study in PD-L1-high non-small cell lung cancer. In that trial, an external data monitoring committee recommended stopping after the progression-free survival endpoint failed to meet targets, with overall survival unlikely to achieve statistical significance. For HIV, Merck’s islatravir plus Gilead’s lenacapavir met primary endpoints in two Phase 3 trials in virologically suppressed adults. The HIV success strengthens the potential path to a weekly oral therapy regimen, while the lung cancer failure narrows the commercial runway for Trodelvy in first-line NSCLC. For the broader oncology and infectious-disease markets, the combined readout reinforces how quickly modality fortunes can diverge between programs.
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