Gilead, Merck Report Positive Phase III HIV Study Data, End NSCLC Study
π¬ Gilead and Merck announced positive Phase III data from ISLEND-1 and ISLEND-2 studies evaluating an investigational once-weekly oral HIV treatment combining islatravir and lenacapavir.
β Both studies met their primary efficacy endpoint at week 48, demonstrating non-inferior efficacy compared to Biktarvy in ISLEND-1 and standard of care regimens in ISLEND-2.
π‘οΈ The investigational regimen showed a safety profile comparable to comparator treatments with no new safety concerns identified during the trials.
π Gilead's shares gained 2.2% year-to-date, contrasting with an industry decline of 3.1%, following the positive HIV study results.
π The new combination therapy could become the first long-acting oral HIV treatment with weekly dosing, offering a more convenient option for patients if approved.
π Gilead and Merck plan to submit ISLEND trial data to regulatory authorities worldwide and present findings at an upcoming scientific conference.
π° Gilead raised its 2026 sales guidance for lenacapavir (Yeztugo) to $1 billion, positioning the drug for blockbuster status in its first full year on the market.
π Lenacapavir's approval for HIV prevention has significantly boosted Gilead's HIV franchise due to its twice-yearly dosing compared to daily oral pills.
β οΈ Concurrently, Merck and Gilead announced the discontinuation of the Phase III KEYNOTE-D46/EVOKE-03 study evaluating Trodelvy with Keytruda for metastatic non-small cell lung cancer.
π The discontinued NSCLC study showed a numerical but not statistically significant improvement in progression-free survival compared to Keytruda alone.
π₯ Gilead's Trodelvy is currently approved for metastatic triple-negative breast cancer and continues to gain market share in the second-line setting.
π¬ Gilead has submitted supplemental biologics license applications seeking approval of Trodelvy for first-line use in metastatic triple-negative breast cancer patients.
π Keytruda alone accounts for around 50% of Merck's sales and is approved for several types of cancer.
π GSK continues to grow its HIV business driven by strong patient demand for long-acting injectable medicines like Cabenuva and Apretude.
π Gilead currently holds a Zacks Rank #3 (Hold) according to the article's stock rating system.
- Gilead and Merck announced positive data from two late-stage Phase III HIV studies, ISLEND-1 and ISLEND-2, demonstrating that the investigational once-weekly oral regimen of islatravir/lenacapavir met primary efficacy endpoints at week 48.
- In ISLEND-1, the new regimen demonstrated non-inferior efficacy compared to Biktarvy, while in ISLEND-2 it achieved non-inferior results versus standard daily oral antiretroviral therapies.
- The investigational combination could become the first long-acting oral HIV treatment with weekly dosing, potentially offering a more convenient option for people living with HIV if approved.
- Gilead's shares have gained 2.2% year to date against the industry's decline of 3.1%, reflecting strong market performance following the positive study results.
- The FDA approved lenacapavir for prevention under the brand name Yeztugo in 2025, significantly boosting Gilead's HIV franchise with a blockbuster potential of $1 billion in 2026 sales guidance.
- Gilead raised its 2026 sales guidance to $1 billion for lenacapavir, positioning the drug to achieve blockbuster status in its first full year on the market.
- Trodelvy continues to gain market share in the second-line setting for metastatic triple-negative breast cancer, with Gilead having submitted two supplemental biologics license applications seeking approval for first-line use.
- Gilead and Merck discontinued the Phase III KEYNOTE-D46/EVOKE-03 study evaluating Trodelvy combined with Keytruda for metastatic NSCLC after the external Data Monitoring Committee determined the likelihood of achieving a statistically significant overall survival benefit was low.
- The combination therapy showed only a numerical improvement in progression-free survival compared to Keytruda alone, which did not achieve statistical significance, raising concerns about the efficacy of this potential first-line treatment approach.
- Gilead faces increasing competition from long-acting injectable HIV medicines like Cabenuva and Apretude from GSK, as well as other competitors in the HIV franchise market.