Great breakthrough in immunotherapy of esophageal cancer! Kestruda has been approved by FDA of the United States. It is a single drug for the treatment of PD-L1 positive patients

August 1, 2019 / BIOON / -- cancer immunotherapy giant Merck & Co recently announced that the US Food and Drug Administration (FDA) has approved the PD-1 tumor immunotherapy keytruda (coreda, common name: pembrolizumab, pabolizumab) as a single drug therapy, which is used for a detection method approved by the FDA to confirm the tumor Treatment of patients with recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who express PD-L1 (with positive score [CPS] ≥ 10) and who have been treated with one or more systemic therapies before "Historically, treatment options for patients with advanced esophageal cancer have been limited, especially after the disease has progressed," said Dr Jonathan Cheng, vice president of oncology clinical research, MSD research laboratory With this approval, keytruda is now the first anti-PD-1 therapy approved for the treatment of patients with recurrent locally advanced or metastatic esophageal squamous cell carcinoma (tumor expression PD-L1, CPS ≥ 10), which will provide doctors and patients in the United States with an important new single drug treatment program " This approval was based on data from two clinical studies keynote-181 (nct02564263) and keynote-180 (nct02559687) ——Keynote-181: This is a multicenter, randomized, open label, positive control study involving 628 patients with recurrent locally advanced or metastatic esophageal cancer who have progressed after first-line standard therapy In the study, patients were randomly assigned in a 1:1 ratio to receive keytruda or any of the following chemotherapy regimens selected by the investigator, all of which were administered intravenously (docetaxel, paclitaxel, irinotecan) The data showed that the OS risk ratios observed in ESCC, PD-L1 CPS ≥ 10 and all randomized patients were 0.77 (95% CI: 0.63, 0.96), 0.70 (95 CI: 0.52, 0.94), 0.89 (95% CI: 0.75, 1.05), respectively In a further examination, in ESCC patients with PD-L1 (CPS ≥ 10) tumor expression, the OS of patients randomly treated with keytruda showed improvement compared with the chemotherapy group In ESCC patients with tumor expression of PD-L1 (CPS ≥ 10), 68 events (80%) and 72 events (88%) were observed in keytruda group (n = 85) and chemotherapy group (n = 82) In terms of overall survival (OS), the median OS of keytruda group was 10.3 months (95% CI: 7.0,13.5), and that of chemotherapy group was 6.7 months (95% CI: 4.8,8.6) (HR = 0.64 [95% CI: 0.46,0.90]) In terms of PFS, the median PFS was 3.2 months (range: 2.1,4.4) in keytruda group and 2.3 months (range: 2.1,3.4) in chemotherapy group (HR = 0.66 [95% CI: 0.48,0.92]) In keytruda group, the overall response rate (ORR) was 22% (95% CI: 14.0,33.0), the complete response rate (CR) was 5% (n = 4), the partial response rate (PR) was 18% (n = 15); in chemotherapy group, Orr was 7% (95% CI: 3.0,15.0), Cr was 1% (n = 1), PR was 6% (n = 5) The median DOR of Keytruda group was 9.3 months (range: 2.1+, 18.8+), and that of chemotherapy group was 7.7 months (range: 4.3,16.8+) The mean exposure time of keytruda was 2.1 months (range: 1 day to 24.4 months) In this study, adverse reactions in patients with esophageal cancer were similar to those in 2799 patients with melanoma or non-small cell lung cancer (NSCLC) treated with keytruda alone ——Keynote-180: This is a multicenter, non randomized, open label study involving 121 patients with locally advanced or metastatic esophageal cancer who have progressed during or after receiving at least two systemic therapies for advanced disease In addition to the number of previous treatment regimens, the eligibility criteria for inclusion were similar to those of the keynote-181 study, and the dosage regimen was the same The results showed that in 35 ESCC patients with tumor expression of PD-L1 (CPS ≥ 10), Orr was 20% (95% CI: 8.0, 37.0) In 7 patients with remission, DOR ranged from 4.2 months to 25.1 + months, 5 patients (71%) had dor ≥ 6 months, 3 patients (57%) had dor ≥ 12 months Original source: FDA approvals new monetary indication for Merck's keytruda ® (pembrolizumab)