Results of phase III KEYNOTE-859 trial of Keytruda plus chemo showing improved OS in gastric or gastroesophageal junction adenocarcinoma presented at ESMO.- Merck Inc.
Merck Inc announced results from the pivotal Phase III KEYNOTE-859 trial investigating Keytruda (pembrolizumab) anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
After a median follow-up of 31.0 months (range, 15.3-46.3 months), Keytruda in combination with chemotherapy significantly improved overall survival (OS), reducing the risk of death by 22% (HR=0.78 [95% CI, 0.70-0.87]; p<0.0001) compared to chemotherapy alone for these patients, regardless of pd-l1 expression. median os was 12.9 months (95% ci, 11.9-14.0) for keytruda plus chemotherapy versus 11.5 months (95% ci, 10.6-12.1) for chemotherapy alone. these data are being presented during a european society for medical oncology (esmo) virtual plenary and are being submitted to regulatory authorities worldwide.></0.0001)>
Results from the KEYNOTE-859 trial were generally consistent across pre-specified subgroups. In addition to an improvement in OS, results showed Keytruda plus chemotherapy significantly improved progression-free survival (PFS) and objective response rate (ORR), which were both secondary endpoints of the trial, versus chemotherapy alone. Specifically, Keytruda plus chemotherapy reduced the risk of disease progression or death by 24% (HR=0.76 [95% CI, 0.67-0.85]; p<0.0001) with a median pfs of 6.9 months (95% ci, 6.3-7.2) for keytruda plus chemotherapy compared to 5.6 months (95% ci, 5.5-5.7) for chemotherapy alone. the orr was 51.3% (95% ci, 47.7-54.8), with a complete response (cr) rate of 9.5% and a partial response (pr) rate of 41.8%, for patients who received keytruda plus chemotherapy and 42.0% (95% ci, 38.5-45.5), with a cr rate of 6.2% and a pr rate of 35.7%, for those who received chemotherapy alone (p="0.00009)." median duration of response (dor), another secondary endpoint of the trial, was 8.0 months (range, 1.2+-41.5+) for keytruda plus chemotherapy versus 5.7 months (range, 1.3+-34.7+) for chemotherapy alone.></0.0001)>
Grade 3-5 treatment-related adverse events (TRAEs) occurred in 59.4% of patients receiving Keytruda plus chemotherapy and 51.1% of patients receiving chemotherapy alone; TRAEs led to death in eight (1.0%) versus 16 (2.0%) patients, respectively. No new safety signals were identified.
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