Key insights
- Merck and Gilead Sciences have discontinued a Phase 3 lung cancer drug trial evaluating Trodelvy in combination with Keytruda. While a numerical improvement in progression-free survival was seen, it did not reach statistical significance. This setback for the combination therapy suggests potential headwinds for these specific drug development programs, though the companies' overall financial health remains robust. The news is a minor negative for the healthcare sector due to the failed trial.
RAHWAY, N.J. & FOSTER CITY, Calif. - Merck (NYSE:MRK) and Gilead Sciences (NASDAQ:GILD) announced today the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 study evaluating Gilead’s Trodelvy in combination with Merck’s Keytruda compared to Keytruda monotherapy in patients with previously untreated metastatic non-small cell lung cancer whose tumors expressed PD-L1 with a tumor proportion score of 50% or higher.
The decision follows a recommendation from the external Data Monitoring Committee after reviewing data from the pre-specified final analysis of progression-free survival and interim analysis of overall survival, according to a press release statement.
A numerical improvement in progression-free survival was observed but did not reach statistical significance. The probability of achieving statistically significant overall survival is unlikely at the planned final analysis. The safety profile of Trodelvy in combination with Keytruda was consistent with the known safety of each agent, with no new safety signals identified.
Approximately 620 patients were enrolled across study sites worldwide in the trial, which was sponsored by Merck. Patients were randomized to receive either Trodelvy plus Keytruda or Keytruda monotherapy.
Regulatory authorities have been informed. Merck will inform study investigators of the recommendation and advise patients in the study to speak to their physician regarding treatment. There are no changes to ongoing Trodelvy or Merck studies.
The data will be presented at a future medical meeting. Despite this setback, Gilead maintains a perfect Piotroski Score of 9, indicating strong financial health, according to InvestingPro data. The company has raised its dividend for 11 consecutive years, currently yielding 2.54%. InvestingPro subscribers have access to over 10 additional exclusive tips about Gilead, plus comprehensive Pro Research Reports covering this and 1,400+ other US equities.
Non-small cell lung cancer accounts for approximately 80% to 85% of lung cancers, and nearly half of these patients are diagnosed only after the disease has spread. The 5-year survival rate for metastatic non-small cell lung cancer is less than 10%.
Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.
In other recent news, Gilead Sciences reported positive results from its Phase 3 IDEAL study for Livdelzi (seladelpar), a treatment for primary biliary cholangitis (PBC). The study showed that the drug led to a significant normalization of alkaline phosphatase levels in patients compared to a placebo after 52 weeks. Additionally, Gilead presented data from a post hoc analysis of its Phase 3 ASSURE study, indicating sustained normalization of alkaline phosphatase in PBC patients over 12 and 24 months. In a strategic move, Gilead Sciences and Lakefront Biotherapeutics completed their acquisition of Ouro Medicines to advance T cell engager therapies for autoimmune diseases. The acquisition was valued at $1,675 million, with potential milestone payments up to $500 million. RBC Capital reiterated its Sector Perform rating on Gilead Sciences, maintaining a price target of $122.00. The firm commented on Gilead’s position in the in vivo CAR-T therapy space, noting its potential to transform the cell therapy sector. RBC Capital also hosted a discussion on Gilead’s HIV franchise, highlighting the outlook for current and next-generation HIV treatments.
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