Detailed Information on Publication Record
2021
Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma
MCDERMOTT, D. F., J. L. LEE, G. A. BJARNASON, J. M. G. LARKIN, R. A. GAFANOV et. al.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
Language
English
Type of outcome
Článek v odborném periodiku
Field of Study
30204 Oncology
Country of publisher
United States of America
Confidentiality degree
není předmětem státního či obchodního tajemství
References:
Impact factor
Impact factor: 50.717
RIV identification code
RIV/00216224:14110/21:00124210
Organization unit
Faculty of Medicine
UT WoS
000655499200009
Keywords in English
Advanced Clear Cell Renal Cell Carcinoma; Pembrolizumab Monotherapy; First-Line Therapy
Tags
International impact, Reviewed
Změněno: 17/2/2022 08:27, Mgr. Tereza Miškechová
Abstract
V originále
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.