MCDERMOTT, D. F., J. L. LEE, G. A. BJARNASON, J. M. G. LARKIN, R. A. GAFANOV, M. D. KOCHENDERFER, N. V. JENSEN, F. DONSKOV, J. MALIK, Alexandr POPRACH, S. S. TYKODI, T. ALONSO-GORDOA, D. C. CHO, P. F. GEERTSEN, M. A. C. DURAN, C. DISIMONE, R. K. SILVERMAN, R. F. PERINI, C. SCHLOSS and M. B. ATKINS. Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma. Journal of clinical oncology. 2318 MILL ROAD, STE 800, ALEXANDRIA, VA: AMER SOC CLINICAL ONCOLOGY, 2021, vol. 39, No 9, p. 1020-1030. ISSN 0732-183X. Available from: https://dx.doi.org/10.1200/JCO.20.02363.
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Basic information
Original name Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma
Authors MCDERMOTT, D. F. (guarantor), J. L. LEE, G. A. BJARNASON, J. M. G. LARKIN, R. A. GAFANOV, M. D. KOCHENDERFER, N. V. JENSEN, F. DONSKOV, J. MALIK, Alexandr POPRACH (203 Czech Republic, belonging to the institution), S. S. TYKODI, T. ALONSO-GORDOA, D. C. CHO, P. F. GEERTSEN, M. A. C. DURAN, C. DISIMONE, R. K. SILVERMAN, R. F. PERINI, C. SCHLOSS and M. B. ATKINS.
Edition Journal of clinical oncology, 2318 MILL ROAD, STE 800, ALEXANDRIA, VA, AMER SOC CLINICAL ONCOLOGY, 2021, 0732-183X.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30204 Oncology
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 50.717
RIV identification code RIV/00216224:14110/21:00124210
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1200/JCO.20.02363
UT WoS 000655499200009
Keywords in English Advanced Clear Cell Renal Cell Carcinoma; Pembrolizumab Monotherapy; First-Line Therapy
Tags 14110811, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 17/2/2022 08:27.
Abstract
PURPOSE Pembrolizumab, a programmed death 1 inhibitor, demonstrated promising single-agent activity in untreated patients with various cancer types. The phase II KEYNOTE-427 study evaluated efficacy and safety of single-agent pembrolizumab in treatment-naive patients with advanced clear cell renal cell carcinoma (ccRCC; cohort A) and advanced non-ccRCC (cohort B). Results of cohort A are reported. METHODS In this open-label, single-arm phase II study, patients with advanced ccRCC received pembrolizumab 200 mg every 3 weeks for <= 24 months. The primary end point was objective response rate by RECIST, version 1.1. RESULTS In the total population (N = 110), median time from enrollment to data cutoff was 35.9 (range, 29.5-40.3) months. Objective response rate was 36.4% with four (3.6%) complete responses and 36 (32.7%) partial responses; disease control rate was 58.2% (95% CI, 48.4 to 67.5). Most patients (68.2%) had a decrease in target lesions, including 30.9% with a reduction >= 60%. Median duration of response was 18.9 (range, 2.3-37.6+) months; 64.1% of responders had a response >= 12 months (Kaplan-Meier). Median progression-free survival was 7.1 months (95% CI, 5.6 to 11.0). Median overall survival was not reached; 12-month and 24-month overall survival rates were 88.2% and 70.8%, respectively. Durable responses were observed across all International Metastatic RCC Database Consortium categories. Grade 3-5 treatment-related adverse events were reported in 30.0% of patients, of which colitis and diarrhea were most frequent. CONCLUSION Single-agent pembrolizumab showed promising antitumor activity as a first-line treatment in patients with advanced ccRCC, with durable responses across International Metastatic RCC Database Consortium categories. Safety and tolerability profile of pembrolizumab monotherapy was comparable to what has been previously described in other tumor types.
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