KEYNOTE-590：一线食管癌达到主要终点

才饮长沙水 又食武昌鱼

评估Keytruda+顺铂+5-FU 对比 顺铂+5-FU  一线的局部进展或转移性食管癌的KN590临床3期研究达到了期主要终点OS和PFS，根据IDMC的期中分析，相比单独化疗，Keytruda联合化疗给ITT群体的OS和PFS带来具有统计学显著差异且具有临床意义的提升——这种生存获益不区分组织分型，同样也达到了次要终点ORR：Keytruda联合化疗也带来了显著提升，安全谱与先前报道一致。ESMO2020见。

唯一的意外就是不区分组织分型：至于腺癌里面是怎样一种程度的获益，或者是不是受到PD-L1+占比的影响等等，只能下个月知道了

https://clinicaltrials.gov/ct2/show/NCT03189719

又是一堆主要终点：

CPS ≥10 的ESCC、ESCC、CPS ≥10及ITT群体的OS

ESCC、CPS ≥10及ITT群体的PFS

KEYTRUDA Is First Anti-PD-1 Therapy in Combination With Chemotherapy to Show Superior Survival Benefit as First-Line Treatment for Patients With Esophageal Cancer Regardless of Histology

Results of Phase 3 KEYNOTE-590 Trial to be Submitted to Global Regulatory Authorities

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-590 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (cisplatin plus 5-fluorouracil [5-FU]), met its primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with locally advanced or metastatic esophageal cancer. Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS and PFS compared with chemotherapy (cisplatin plus 5-FU), the current standard of care, in the intention-to-treat (ITT) population. The study also met the key secondary endpoint of objective response rate (ORR), with significant improvements for KEYTRUDA in combination with chemotherapy compared with chemotherapy alone. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be shared with global regulatory authorities and have been submitted for presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

“Esophageal cancer is a devastating malignancy with a high mortality rate and few treatment options in the first-line setting beyond chemotherapy,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “In this pivotal study, KEYTRUDA plus chemotherapy resulted in superior overall survival compared with the current standard of care in the full study population and across all patient groups evaluated. These results build upon our research reinforcing the survival benefits of KEYTRUDA, and we look forward to engaging regulatory authorities as quickly as possible.”

KEYTRUDA is currently approved in the U.S. and China as monotherapy for the second-line treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10). Merck is continuing to study KEYTRUDA across multiple settings and stages of gastrointestinal cancer – including gastric, hepatobiliary, esophageal, pancreatic, colorectal and anal cancers – through its broad clinical program.