Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

iStock, Diana Danchenko While Merck and Gilead Sciences reported back-to-back late-stage victories for their weekly HIV pill, the partners also discontinued a Phase 3 program for their cancer combo after disappointing lung cancer survival data. Monday was a mixed bag for Merck and Gilead Sciences, which notched key Phase 3 victories for their weekly HIV pill but reported disappointing late-stage data for their lung cancer combo. “Sweet and sour,” BMO Capital Markets quipped in a Monday evening note. On the sweet side, the latest readout could establish the investigational drug—a single-tablet combo of islatravir and lenacapavir (IS/LEN)—as “the first long-acting oral HIV treatment, strengthening Gilead/Merck’s positioning in the market.” This win, however, may be “muted” by the failure of the investigational regimen comprising Gilead’s antibody-drug conjugate Trodelvy with Merck’s PD-1 blockbuster Keytruda to significantly improve survival in patients with metastatic non-small cell lung cancer (NSCLC). On the HIV front, the pharma partners tested their single-pill drug combo in the Phase 3 ISLEND-1 and ISLEND-2 studies in patients with HIV who have been virologically suppressed either through Gilead’s Biktarvy or other standard-of-care antiretroviral therapies. At 48 weeks, the IS/LEN pill was non-inferior to Biktarvy or other standard regimens at maintaining virological suppression, according to a news release on Monday . BMO called this outcome “incrementally positive,” but said that IS/LEN could help the companies—Gilead in particular—access the “subset of virally suppressed patients who would prefer less frequent oral options.” With these findings, the analysts added, “Gilead continues to stay ahead of the HIV treatment curve.” For Merck, meanwhile, the ISLEND data could help the pharma establish itself “as a more meaningful competitor in HIV as the company aims to strengthen its presence in the indication,” BMO said. The companies did not provide specific data in their press announcement but promised to do so at a future medical congress. Merck and Gilead will also ISLEND data to regulatory authorities globally. The positive data in HIV could also help offset Gilead’s latest cancer blow. HIV Gilead, Merck Clear Path to Market for Daily HIV Pills With New Late-Stage Data At the 2026 Conference on Retroviruses and Opportunistic Infections, Gilead and Merck demonstrated that their respective daily oral HIV drugs can match current therapies in keeping the virus at bay. February 26, 2026 · 2 min read · Tristan Manalac Read more Also on Monday, Merck and Gilead announced that they would be discontinuing the Phase 3 KEYNOTE-D46 trial (also known as EVOKE-03), studying a combo regimen of Trodelvy and Keytruda in NSCLC patients with PD-L1-positive tumors. An independent data board found a “numerical improvement” in progression-free survival, but compared with Keytruda monotherapy, this effect fell short of statistical significance. The data committee also noted that it would be “unlikely” for the drug doublet to elicit significant overall survival improvements at the final analysis, prompting the companies to pull the plug on the program. For Gilead, this outcome “adds to challenging misses for Trodelvy,” BMO said, especially in NSCLC, where a first-line approval “would have supported accelerated revenue growth for the product.” Trodely previously failed a Phase 3 study in this indication, unable to significantly boost overall survival versus docetaxel, according to a January 2024 readout. Trodelvy grew 6% in 2025 to bring in $1.4 billion.

Gilead Sciences and Merck & Co. began the week with a mixed clinical scorecard.In back-to-back announcements Monday, the partners revealed they are discontinuing a Phase III study testing Gilead's TROP2-directed antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) in lung cancer, while at the same time touting the success of their experimental once-weekly HIV pill in two other late-stage trials.The oncology setback throws a wrench into Gilead's expansion plans for Trodelvy, which is currently approved for two forms of breast cancer and for urothelial cancer. Lung cancer is a key target, but success so far has been uneven; the Phase III EVOKE-01 trial testing the TROP2 ADC as monotherapy against docetaxel in second-line non–small-cell lung cancer (NSCLC) failed in 2024.'Numerical improvement'Meanwhile, the earlier mid-stage EVOKE-02 trial suggested that combining the drug with Keytruda could be promising in newly diagnosed patients, but that momentum doesn't appear to have carried into Phase III. As a result, the companies have decided to halt the EVOKE-03 trial (also known as KEYNOTE-D46).The study, which was testing the combo against Keytruda monotherapy, enrolled previously untreated metastatic NSCLC patients whose tumours expressed high levels of PD-L1. The decision followed a review by an external data monitoring committee, which found that although the Trodelvy-Keytruda combination produced a "numerical improvement" in progression-free survival, it failed to achieve statistical significance. The committee also concluded that the probability of achieving a significant overall survival benefit at the final analysis was "unlikely." No new safety signals were identified.The companies said there are no changes to other ongoing Trodelvy or Merck studies. The Trodelvy-Keytruda pairing was tested in the triple-negative breast cancer ASCENT-04 and ASCENT-05 studies in the first-line metastatic and high-risk adjuvant settings, respectively.Non-inferiority to Biktarvy, ARTWhile the oncology programme stumbled, Gilead and Merck delivered more encouraging news involving their ongoing HIV partnership.The investigational once-weekly single-tablet regimen combining Gilead's capsid inhibitor lenacapavir with Merck's islatravir, a nucleoside reverse transcriptase translocation inhibitor, met the primary endpoint in both Phase III ISLEND-1 and ISLEND-2 studies of virologically suppressed patients at week 48.In ISLEND-1, the regimen was found to be statistically non-inferior to Gilead's Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), while ISLEND-2 showed non-inferiority against a range of standard-of-care daily oral antiretroviral therapy (ART) regimens. Safety findings were generally similar to the comparator treatments.The companies said they intend to file the data with regulators around the world for what could become the first once-weekly oral treatment option for people with HIV.Lenacapavir is already on the market as Sunlenca for multi-drug-resistant HIV and Yeztugo as a twice-yearly preventive shot. In April, the FDA approved a once-daily single-tablet regimen combining islatravir with doravirine under the name Idvynso for adults with virologically suppressed HIV-1.