Keynote 355 pembrolizumab1/2/2024 ![]() PFS and OS among patients with PD-L1-positive tumors and among the intention-to-treat population served as the primary endpoints. less than 1) and prior treatment in the neoadjuvant or adjuvant setting with the same class of chemotherapy.Īlthough the study was not designed to compare the efficacy of the chemotherapy regimens, when asked which chemotherapy partner works best with pembrolizumab, Rugo said nab-paclitaxel and paclitaxel both are good options for patients without resistance to taxanes. Stratification factors included chemotherapy type on study, PD-L1 tumor status (CPS of 1 or greater vs. ![]() About 75% of patients had PD-L1 tumor expression with a CPS of 1 or greater, and 38% had a PD-L1 CPS of 10 or greater. The other 281 patients received chemotherapy alone.īaseline characteristics were well-balanced between the treatment groups, Rugo said. Researchers randomly assigned 566 women to 200 mg pembrolizumab every 3 weeks plus investigator’s choice of chemotherapy, including nab-paclitaxel (Abraxane, Celgene), paclitaxel or gemcitabine/carboplatin, for up to 35 administrations. Part two of KEYNOTE-355 included 847 adults (median age, 53 years 68% white) with previously untreated locally recurrent or metastatic triple-negative breast cancer and a disease-free interval of at least 6 months following chemotherapy completion for early-stage disease. These results served as the basis for FDA approval of the combination for this patient population. Previous results of the randomized phase 3 KEYNOTE-355 trial showed statistically significant improvement in PFS with the addition of the anti-PD-1 therapy pembrolizumab (Keytruda, Merck) to chemotherapy as first-line treatment of patients with metastatic triple-negative breast cancer and a PD-L1 combined positive score (CPS) of 10 or greater. : NCT03221426.Īdjuvant therapy chemotherapy gastric cancer gastroesophageal junction cancer immunotherapy neoadjuvant therapy pembrolizumab surgery.“These results support as a new standard-of-care treatment regimen for patients with locally recurrent, unresectable or metastatic whose tumors express PD-L1 with of 10 or more,” Rugo said. To describe the design and rationale for the global, multicenter, randomized, double-blind, Phase III KEYNOTE-585 study to evaluate the efficacy and safety of pembrolizumab plus chemotherapy compared with placebo plus chemotherapy as neoadjuvant/adjuvant treatment for localized gastric or gastroesophageal junction adenocarcinoma. Combining chemotherapy with pembrolizumab in the neoadjuvant/adjuvant setting may benefit patients with locally advanced, resectable disease. In patients with advanced gastric or gastroesophageal junction adenocarcinoma, pembrolizumab has demonstrated promising efficacy and manageable safety as monotherapy in previously treated patients and as first-line therapy in combination with cisplatin and 5-fluorouracil. Despite widespread adoption of multimodality perioperative treatment strategies, 5-year overall survival rates remain low. Surgical resection is the only curative treatment option for gastric cancer. 11 Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.10 National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.9 Institute of Clinical Cancer Research, UCT University Cancer Center Frankfurt, Steinbacher Hohl 2-26, Frankfurt 60488, Germany.8 Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USA.7 Yonsei Cancer Hospital, Yonsei University Health System, 50-1 Yonsei-Ro Seodaemun-gu, Seoul 03722, Republic of Korea.6 Memorial Sloan Kettering Cancer Center, 300 East 66th Street, BAIC 1031, New York, NY 10065, USA.5 Vall d'Hebron University Hospital & Institute of Oncology (VHIO), Vall d'Hebron 119-129, 08035 Universitat Autònoma de Barcelona, Barcelona, Spain.4 National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.3 Yale Cancer Center and Smilow Cancer Hospital, 333 Cedar Street, New Haven, CT 06510, USA. ![]()
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