Keynote 590 trial11/14/2023 ![]() ![]() “With this approval of Keytruda plus chemotherapy – the first for an anti-PD-1 regimen in the first-line setting – we can now provide patients with an immunotherapy treatment option earlier in the course of treatment that has been shown to significantly improve survival.” “In China, esophageal and gastroesophageal junction cancers are leading causes of death, and there have been few treatment advances for patients over the past several decades,” said Scot Ebbinghaus, MD, vice president, clinical research, Merck Research Laboratories, the developer of pembrolizumab. Secondary end points included investigator-assessed objective response rate and duration of response. The primary end points were investigator-assessed PFS and OS via RECIST v1.1 criteria in the overall study population, in those with PD-L1 expression (combined positive score ≥10), and in those with squamous histology. ![]() Patients were stratified based on region (Asia vs non-Asia), disease (ESCC vs esophageal cancer), and performance status (0 vs 1). To be eligible for enrollment, patients had to have metastatic esophageal cancer or esophageal squamous cell carcinoma, be treatment naïve, have an ECOG performance status of 0 or 1, and have measurable disease. ![]() 5-FU could also be given per local standard for up to 2 years. In the multicenter, double-blind, placebo-controlled KEYNOTE-590 trial, 749 patients with locally advanced unresectable or metastatic esophageal or GEJ carcinoma (Siewert type I) who were ineligible for surgery or definitive chemoradiation were randomized 1:1 to receive cisplatin at 80 mg/m2 on day 1 every 3 weeks for up to 6 cycles plus 5-FU at 800 mg/m2 daily on days 1 to 5 every 3 weeks, with or without pembrolizumab at 200 mg on day 1 every 3 weeks. Pembrolizumab is also approved in China as a second-line treatment for select patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (≥10). Safety findings of 51 Chinese patients with esophageal carcinoma enrolled on the study showed that the profile of pembrolizumab in this population was consistent with prior safety data with the PD-1 inhibitor. “This approval for Keytruda provides an important new option to patients with advanced esophageal carcinoma in China who currently have limited available treatment options in the first-line setting.” “Compared to the rest of the world, China has a disproportionate number of patients who are diagnosed with and who die from esophageal cancer, the fifth most commonly diagnosed cancer and the fourth leading cause of cancer-related death in the country,” said Shen Lin, MD, vice president, Clinical Oncology, Beijing Cancer Hospital and Peking University, and deputy director, Beijing Institute for Cancer Research in China. ![]() The approval is based on findings from the phase 3 KEYNOTE-590 trial (NCT03189719), in which pembrolizumab demonstrated a statistically significant improvement in progression-free and overall survival (OS) vs 5-fluorouracil (5-FU) and cisplatin alone in this patient population. The National Medical Products Administration in China has approved pembrolizumab (Keytruda) for use in combination with platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic esophageal carcinoma or gastroesophageal junction (GEJ) cancer. This article originally appeared on OncLive ![]()
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