Lenacapavir Sodium

Dive Brief:Merck & Co. and partner Gilead Sciences on Monday reported a setback in one late-stage study in lung cancer, but success in two other Phase 3 trials testing an HIV treatment theyre working on.In one announcement, the companies said theyre halting a trial testing Gileads Trodelvy with Mercks Keytruda in frontline, non-small cell lung cancer. Study monitors found a numerical improvement in tumor progression that didnt reach significance, and determined a survival benefit was unlikely.In the other release, the partners revealed an HIV tablet combining Mercks islatravir and Gileads lenacapavir benefited people who switched off of other treatments in two Phase 3 studies. They intend to seek approval of the combination, which could be the first oral, once-weekly treatment for HIV.They didnt specify when an application might be completed, however.Dive Insight:The trio of study results appeared to impact both companies more negatively, given the high-profile nature of the setback in lung cancer.The EVOKE-03 study was another chance for Gilead to validate the hefty $21 billion purchase price it paid for Trodelvys developer Immunomedics. That treatment hasnt been as big a seller as Gilead once envisioned, and has stumbled in multiple other studies. But success in a study in frontline lung cancer, one of the most common tumor types, wouldve helped.The study was also a chance for Merck to extend its dominance in lung cancer, for which Keytruda is a pillar of care. The trial tested Trodelvy, an antibody-drug conjugate aimed at the protein TROP2, alongside Keytruda in the first-line setting. But some analysts were skeptical of the studys chances, given the way it was designed the companies didnt only focus on TROP2-expressing tumors and Trodelvys other struggles.The readout additionally carries implications for another ADC Merck is investing heavily in. Called sacituzumab tirumotecan, or sac-TMT, Merck licensed it from Kelun Biotech and has place it in a sprawling Phase 3 programthat includes 17 studies targeting a range of tumor types. Merck believes the ADC could become a cornerstone drug, and recently spotlighted results from a Phase 3 study in Chinaat the American Society of Clinical Oncology conference.Analysts and investors have been debating whether those findings might carry over to a global study in first-line lung cancer thats now underway. Merck has expressed optimism, citing certain technical differences with sac-TMT. But he EVOKE-03 results could put greater investor scrutiny on sac-TMT data coming from China until the global translation is proven, wrote Leerink Partners Daina Graybosch.Graybosch expected the stocks for both companies to trade lower given outsized investor attention on the more negative of the two announcements. Shares of Gilead dipped 3%, while Mercks stock was only slightly down.Yet the HIV findings could ultimately offset those negatives. Despite a concerted push into oncology, Gileads core business remains its HIV drugs. Its already added to that portfolio with last years approval of a preventive shot called Yeztugo. Another drug for the switch market could boost that business, as some 20% of patients change treatment regimens each year, Graybosch wrote.The positive results also amount to another win for Mercks HIV franchise this year, following the April approval of Idvynso,RBC Capital Markets analyst Trung Huynh wrote in a separate note. '

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.