![]() ![]() ![]() Fundingįunding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Medical writing and/or editorial assistance was provided by Christine McCrary Sisk. Pembro + chemo showed a statistically significant and clinically meaningful improvement in OS vs chemo alone in pts with previously untreated locally recurrent inoperable or metastatic TNBC whose tumors expressed PD-L1 (CPS ≥10). Grade 3-5 treatment-related AE rates were 68.1% with pembro + chemo (2 deaths) vs 66.9% with chemo (0 deaths). For all endpoints, the pembro treatment effect increased with PD-L1 enrichment. Pembro + chemo improved ORR in pts with CPS ≥10 tumors. The benefit of pembro + chemo on PFS was consistent with the prior results. The p-value boundary for a significant OS benefit of pembro + chemo in pts with CPS ≥1 tumors was not met and formal testing in ITT was not performed. Pembro + chemo significantly improved OS vs chemo alone in pts with CPS ≥10 tumors (Table). ResultsĪs of June 15, 2021, median follow-up was 44.1 mo. AEs were monitored throughout the study and graded per NCI CTCAE v4.0. Dual primary endpoints are PFS (RECIST v1.1 by BICR) and OS in pts with PD-L1+ tumors (CPS ≥10 and ≥1) and all pts (ITT). Pts were stratified by chemo type (taxane or gemcitabine-carboplatin), PD-L1 status (CPS ≥1 or <1) and prior (neo)adjuvant treatment with same-class chemo (yes or no). MethodsĨ47 pts with de novo metastasis or ≥6 mo DFI were randomized 2:1 to pembro + chemo (nab-paclitaxel, paclitaxel, or gemcitabine-carboplatin) or pbo + chemo for up to 35 administrations of pembro/pbo or until progression/intolerable toxicity. We present final results for the dual primary endpoint of OS and other study endpoints. 16 Barts Cancer Institute, Centre for Experimental Cancer Medicine, EC1M 6BQ - London/GBĪ prior interim analysis of KEYNOTE-355 (NCT02819518) showed that first-line pembrolizumab (pembro) + chemotherapy (chemo) significantly improved PFS vs placebo (pbo) + chemo in patients (pts) with metastatic TNBC whose tumors expressed PD-L1 (CPS ≥10) (HR, 0.65, 95% CI, 0.49–0.86 one-sided P=0.0012 ).15 Merck Research Laboratories, Merck & Co., Inc., Kenilworth/US.14 Division Of Cancer Research, Peter Maccallum Cancer Centre, Melbourne, Australia The Sir Peter Maccallum Department Of Medical Oncology, University of Melbourne, Parkville/AU.13 Medical Faculty, Ege University Medical School, 35100 - Izmir/TR.12 Hematology & Oncology, Oncomedica S.A., Monteria/CO.11 Department Of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, 540-0006 - Osaka/JP.10 Department Of Breast Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP.9 International Breast Cancer Center (ibcc), Quiron Group, Barcelona/ES.8 Oncology Research Unit, Hospital São Lucas, PUCRS, Porto Alegre/BR.7 Department Of Oncology, Republican Clinical Oncology Dispensary, Republic of Bashkortostan/RU.6 Oncology Institute, Arturo Lopez Perez Foundation, Santiago/CL.5 Cancer Center, Pantai Hospital, Kuala Lumpur/MY.4 Department Of Internal Medicine, Seoul National University Hospital, Seoul/KR.3 Princess Margaret Cancer Centre, University of Toronto, M5G 1Z5 - Toronto/CA.2 International Breast Cancer Center (ibcc), Quiron Group, Madrid and Barcelona, Spain Vall d'Hebron Institute of Oncology, Barcelona, Spain Universidad Europea de Madrid, Faculty of Biomedical and Health Sciences, Department of Medicine, 28670 - Madrid/ES.1 Department Of Hematology/oncology, University of California San Francisco Comprehensive Cancer Center, 94115 - San Francisco/US. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |