Open-Label, Single-Arm Phase II Study of Pembrolizumab
Monotherapy as First-Line Therapy in Patients With Advanced
Clear Cell Renal Cell Carcinoma

J 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.

Základní údaje

Originální název

Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma

Autoři

MCDERMOTT, D. F. (garant), 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 Česká republika, domácí), 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 a M. B. ATKINS

Vydání

Journal of clinical oncology, 2318 MILL ROAD, STE 800, ALEXANDRIA, VA, AMER SOC CLINICAL ONCOLOGY, 2021, 0732-183X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30204 Oncology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 50.717

Kód RIV

RIV/00216224:14110/21:00124210

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1200/JCO.20.02363

UT WoS

000655499200009

Klíčová slova anglicky

Advanced Clear Cell Renal Cell Carcinoma; Pembrolizumab Monotherapy; First-Line Therapy

Štítky

14110811, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 17. 2. 2022 08:27, Mgr. Tereza Miškechová

Anotace

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.

Citovat

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 a 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, roč. 39, č. 9, s. 1020-1030. ISSN 0732-183X. Dostupné z: https://dx.doi.org/10.1200/JCO.20.02363.

@article{1835000,
   author = {McDermott, D. F. and Lee, J. L. and Bjarnason, G. A. and Larkin, J. M. G. and Gafanov, R. A. and Kochenderfer, M. D. and Jensen, N. V. and Donskov, F. and Malik, J. and Poprach, Alexandr and Tykodi, S. S. and AlonsoandGordoa, T. and Cho, D. C. and Geertsen, P. F. and Duran, M. A. C. and DiSimone, C. and Silverman, R. K. and Perini, R. F. and Schloss, C. and Atkins, M. B.},
   article_location = {2318 MILL ROAD, STE 800, ALEXANDRIA, VA},
   article_number = {9},
   doi = {http://dx.doi.org/10.1200/JCO.20.02363},
   keywords = {Advanced Clear Cell Renal Cell Carcinoma; Pembrolizumab Monotherapy; First-Line Therapy},
   language = {eng},
   issn = {0732-183X},
   journal = {Journal of clinical oncology},
   title = {Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma},
   url = {https://ascopubs.org/doi/pdf/10.1200/JCO.20.02363},
   volume = {39},
   year = {2021}
}

TY  - JOUR
ID  - 1835000
AU  - McDermott, D. F. - Lee, J. L. - Bjarnason, G. A. - Larkin, J. M. G. - Gafanov, R. A. - Kochenderfer, M. D. - Jensen, N. V. - Donskov, F. - Malik, J. - Poprach, Alexandr - Tykodi, S. S. - Alonso-Gordoa, T. - Cho, D. C. - Geertsen, P. F. - Duran, M. A. C. - DiSimone, C. - Silverman, R. K. - Perini, R. F. - Schloss, C. - Atkins, M. B.
PY  - 2021
TI  - Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma
JF  - Journal of clinical oncology
VL  - 39
IS  - 9
SP  - 1020-1030
EP  - 1020-1030
PB  - AMER SOC CLINICAL ONCOLOGY
SN  - 0732183X
KW  - Advanced Clear Cell Renal Cell Carcinoma
KW  - Pembrolizumab Monotherapy
KW  - First-Line Therapy
UR  - https://ascopubs.org/doi/pdf/10.1200/JCO.20.02363
N2  - 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.
ER  -

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 a 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. \textit{Journal of clinical oncology}. 2318 MILL ROAD, STE 800, ALEXANDRIA, VA: AMER SOC CLINICAL ONCOLOGY, 2021, roč.~39, č.~9, s.~1020-1030. ISSN~0732-183X. Dostupné z: https://dx.doi.org/10.1200/JCO.20.02363.

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