一时瑜亮

KN859：Pembro 联合化疗(CAPEOX or FP)对比安慰剂联合化疗用于1L HER2- GC/GEJC

主要终点：全人群OS  12.9 vs 11.5 mo (HR 0.78)

关键次要终点：全人群PFS 6.9 vs 5.6 mo，ORR 51 vs 42%，DoR 8.0 vs 5.7mo

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亚裔和CAPEOX化疗方案的亚组更获益一些

KN859 vs CM649

虽然化疗方案有差异，也选不同的kit，但总的来说在全人群及PD-L1 CPS≥1&10的人群的OS获益还是接近的

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. 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.