On Monday, Gilead Sciences Inc. (NASDAQ:GILD) and Merck & Co. Inc. (NYSE:MRK) on Monday discontinued the Phase 3 KEYNOTE-D46/EVOKE-03 trial evaluating Trodelvy plus Keytruda in previously untreated metastatic non-small cell lung cancer with high PD-L1 expression, following a Data Monitoring Committee review of progression-free survival and interim overall survival data.
While the combo showed a numerical improvement in progression-free survival, it did not reach statistical significance, and investigators said the probability of achieving a meaningful overall survival benefit at final analysis was low. Safety remained consistent with known profiles, with no new signals identified. Full data will be presented at a future medical meeting.
Separately, the companies reported positive Phase 3 results for an investigational once-weekly oral HIV regimen combining islatravir and lenacapavir, which met its primary efficacy endpoint in two studies.
Once-Weekly HIV Regimen Meets Late-Stage Trial Goals
The Phase 3 ISLEND-1 and ISLEND-2 trials evaluated the safety and efficacy of the oral single-tablet regimen in people living with HIV who were already virologically suppressed.
According to the companies, the primary endpoint in both studies measured the percentage of participants with HIV-1 RNA levels of at least 50 copies/mL at Week 48 under the FDA snapshot algorithm.
In the ISLEND-1 study, patients switched from Biktarvy to the once-weekly islatravir/lenacapavir regimen. The treatment was found to be statistically non-inferior to Biktarvy.
Meanwhile, in the open-label ISLEND-2 trial, the regimen demonstrated statistical non-inferiority compared with standard-of-care daily oral antiretroviral therapies.
The companies said the safety profile of the combination was generally comparable to the comparator regimens in both studies, with no new safety concerns identified.
Regulatory Filings Planned Following HIV Results
Gilead and Merck said they plan to submit the Phase 3 findings to regulatory authorities worldwide and present detailed data at a future scientific congress.
The investigational combination targets multiple stages of HIV-1 replication. If approved, the treatment could offer virologically suppressed patients a long-acting, once-weekly oral single-tablet option.
GILD and MRK Stock Price Activity: Gilead Sciences shares were down 2.28% at $125.18, and Merck shares were up 0.46% at $120.07 at the time of publication on Tuesday, according to Benzinga Pro data.
Photo by Sundry Photography via Shutterstock
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