On Monday, Gilead Sciences Inc. (NASDAQ:GILD) and Merck &amp; 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.



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<h2>Once-Weekly HIV Regimen Meets Late-Stage Trial Goals</h2>



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.



<h2>Regulatory Filings Planned Following HIV Results</h2>



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.



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Photo by Sundry Photography via Shutterstock

GILD

Gilead and Merck discontinued the Phase 3 KEYNOTE-D46/EVOKE-03 trial for Trodelvy plus Keytruda in lung cancer due to lack of statistical significance in progression-free survival. Separately, they reported positive Phase 3 results for an investigational once-weekly oral HIV regimen combining islatravir and lenacapavir, which met primary efficacy endpoints. Regulatory filings are planned for the HIV treatment.

Gilead And Merck End Trodelvy-Keytruda Lung Cancer Trial