Merck and Gilead Discontinue Phase 3 KEYNOTE-D46/EVOKE-03 Lung Cancer Study After Data Review
Merck and Gilead Discontinue Phase 3 KEYNOTE-D46/EVOKE-03 Lung Cancer Study After Data Review
Merck and Gilead Sciences have announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 study, a late-stage clinical trial evaluating Trodelvy in combination with Keytruda for certain patients with previously untreated metastatic non-small cell lung cancer.
The decision followed a recommendation from an external Data Monitoring Committee after reviewing the study’s planned analysis. The trial compared Gilead’s Trodelvy with Merck’s Keytruda against Keytruda alone in patients whose tumors expressed high levels of PD-L1. The companies said progression-free survival showed a numerical improvement, but the result did not reach statistical significance, and overall survival was unlikely to meet the trial’s goal at the final analysis.
Why the Study Was Stopped
The KEYNOTE-D46/EVOKE-03 trial was designed to test whether adding Trodelvy to Keytruda could improve outcomes compared with Keytruda alone. According to the companies, the study did not meet the needed statistical threshold for progression-free survival. In addition, the chance of showing a statistically significant overall survival benefit was considered unlikely.
Importantly, Merck and Gilead reported that the safety profile of the combination was consistent with the known safety profiles of each medicine. No new safety signals were identified. Regulatory authorities have been informed, and investigators will be notified so patients can discuss next steps with their physicians.
About the KEYNOTE-D46/EVOKE-03 Trial
The global, open-label, randomized Phase 3 study enrolled approximately 620 patients worldwide. It focused on patients with previously untreated metastatic non-small cell lung cancer whose tumors had PD-L1 tumor proportion scores of at least 50% and did not have certain EGFR, ALK, or ROS1 genomic alterations.
Participants were assigned to receive either Trodelvy plus Keytruda or Keytruda alone. The study’s main goals were progression-free survival and overall survival, while secondary measures included response rate, duration of response, patient-reported outcomes, and safety.
What This Means for Lung Cancer Research
The discontinuation is a setback for this specific combination in the tested patient group, but it does not end the broader research programs for either medicine. Merck and Gilead stated that there are no changes to other ongoing studies involving Trodelvy or Merck’s cancer research programs.
Non-small cell lung cancer remains one of the most challenging cancers to treat, especially after it has spread. While immunotherapy has improved outcomes for many patients, not every patient responds, and researchers continue to study new combinations that may improve survival and quality of life.
About Trodelvy and Keytruda
Trodelvy is an antibody-drug conjugate developed by Gilead. It targets Trop-2, a protein found in several tumor types. The medicine is already approved in multiple countries for certain breast cancer indications and continues to be studied in other cancers.
Keytruda, developed by Merck, is an anti-PD-1 immunotherapy designed to help the immune system detect and fight tumor cells. It is widely studied across many cancer types and treatment settings.
Company Response
Merck and Gilead thanked the patients, families, healthcare professionals, and investigators who took part in the trial. The companies said the data from the study will be presented at a future medical meeting, which may provide more detailed insight into the trial results.
Although the outcome was not what researchers hoped for, the findings still add to scientific understanding of lung cancer treatment and may help guide future clinical trial designs.
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