Merck and Gilead Discontinue Phase 3 KEYNOTE-D46/EVOKE-03 Study for Lung Cancer Treatment
Merck and Gilead Provide Update on Phase 3 KEYNOTE-D46/EVOKE-03 Study
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Merck and Gilead have halted the Phase 3 KEYNOTE-D46/EVOKE-03 study, which tested the combination of Trodelvy and KEYTRUDA for treating metastatic non-small cell lung cancer. The decision follows a recommendation from the Data Monitoring Committee, citing insufficient statistical significance in progression-free survival and overall survival outcomes.
- 01The KEYNOTE-D46/EVOKE-03 study involved approximately 620 patients with untreated metastatic non-small cell lung cancer expressing PD-L1.
- 02Trodelvy (sacituzumab govitecan-hziy) was tested alongside KEYTRUDA (pembrolizumab) against KEYTRUDA alone.
- 03The study showed a numerical improvement in progression-free survival but failed to achieve statistical significance.
- 04No new safety signals were identified in the combination therapy, and the safety profile was consistent with previous data.
- 05Merck will inform study investigators and advise participants to consult their physicians regarding treatment options.
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Merck (known as MSD outside the U.S.) and Gilead Sciences, Inc. have announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 clinical trial, which evaluated the combination of Gilead's Trodelvy (sacituzumab govitecan-hziy) and Merck's KEYTRUDA (pembrolizumab) for patients with previously untreated metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. The decision was made following a review by the external Data Monitoring Committee (eDMC), which found that while there was a numerical improvement in progression-free survival (PFS), it did not reach statistical significance, and the likelihood of achieving significant overall survival (OS) was deemed unlikely. The safety profile of the combination was consistent with known data, and no new safety concerns were raised. The companies expressed gratitude to all participants in the study and will present the data at a future medical meeting. Regulatory authorities have been notified of the study's discontinuation, and ongoing studies involving Trodelvy and KEYTRUDA remain unaffected.
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The discontinuation of this study may affect treatment options for patients with advanced lung cancer, highlighting the need for ongoing research in this area.
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