Merck and Gilead Sciences reported positive Phase 3 results for their investigational once-weekly HIV treatment while also announcing the discontinuation of a late-stage lung cancer study involving their oncology medicines.
The companies said their single-tablet HIV regimen, which combines islatravir and lenacapavir (IS/LEN), met the primary objectives in the Phase 3 ISLEND-1 and ISLEND-2 studies. The trials enrolled people living with HIV who had already achieved virological suppression using either Gilead’s Biktarvy or other standard antiretroviral therapies.
According to the companies, after 48 weeks of treatment, the weekly IS/LEN regimen demonstrated non-inferiority to Biktarvy and other standard therapies in maintaining virological suppression. The studies compared the investigational regimen against patients who remained on Biktarvy or other standard-of-care antiretroviral treatments.
Merck and Gilead did not release detailed efficacy data in their announcement but stated that additional results will be presented at a future medical congress. The companies also said they plan to submit the ISLEND data to regulatory authorities globally.
BMO Capital Markets described the developments in a note issued Monday as “Sweet and sour,” referring to the contrasting outcomes from the HIV and cancer programs.
The analysts said the latest HIV readout could establish IS/LEN as the first long-acting oral HIV treatment and strengthen the companies’ position in the market. BMO characterized the results as incrementally positive and said the regimen could help Gilead reach a subset of virologically suppressed patients who would prefer less frequent oral treatment options. The analysts also stated that, with these findings, Gilead continues to stay ahead of the HIV treatment curve.
For Merck, BMO said the ISLEND results could help the company become a more meaningful competitor in HIV as it seeks to strengthen its presence in the indication. The companies have indicated that the data will be submitted to regulatory authorities worldwide following the completion of the studies.
The positive HIV results were announced on the same day that the companies disclosed a setback in their oncology collaboration. Merck and Gilead said they would discontinue the Phase 3 KEYNOTE-D46 trial, also known as EVOKE-03, which was evaluating Gilead’s antibody-drug conjugate Trodelvy in combination with Merck’s Keytruda in patients with PD-L1-positive metastatic non-small cell lung cancer (NSCLC).
An independent data monitoring committee found a numerical improvement in progression-free survival for the combination compared with Keytruda alone. However, the improvement did not achieve statistical significance.
The committee also concluded that it would be unlikely for the combination to produce a significant overall survival benefit at the final analysis. Based on that assessment, the companies decided to end the program.
According to BMO, the outcome adds to previous challenges for Trodelvy, particularly in NSCLC. The analysts noted that a first-line approval in the indication would have supported accelerated revenue growth for the product.
Trodelvy had previously failed a Phase 3 study in NSCLC. According to a January 2024 readout cited in the source material, the drug did not significantly improve overall survival compared with docetaxel. BMO noted that the latest outcome adds to those earlier setbacks for the drug in lung cancer.
Trodelvy generated $1.4 billion in revenue in 2025, representing growth of 6% during the year.
and Gilead have announced encouraging Phase 3 clinical trial results for an investigational HIV treatment, providing a significant boost to ongoing efforts to improve long-term care for people living with HIV. The positive findings demonstrate the continued commitment of Merck and its partners to developing innovative therapies that address unmet medical needs in infectious diseases.
The successful outcome represents an important achievement for Merck, reinforcing the company’s position as a major contributor to advancements in HIV research and treatment innovation.
Positive Phase 3 Results Strengthen HIV Pipeline
The latest Phase 3 data suggest that the investigational therapy met key study objectives, supporting its potential role in future HIV treatment strategies. For Merck, the results offer a promising opportunity to expand its infectious disease portfolio while helping patients gain access to more effective and convenient treatment options.
Strategic Implications for Merck
The contrasting outcomes illustrate the dynamic nature of drug development. The HIV success provides momentum for Merck and Gilead, while the lung cancer trial conclusion offers valuable scientific insights that may inform future oncology research efforts.
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