Efficacy of pembrolizumab monotherapy for advanced gastric/gastroesophageal junction cancer with programmed death ligand 1 combined positive score ≥10

Zev A. Wainberg; Charles S. Fuchs; Josep Tabernero; Kohei Shitara; Kei Muro; Eric Van Cutsem; Yung Jue Bang; Hyun Cheol Chung; Kensei Yamaguchi; Eniko Varga; Jen Shi Chen; Daniel Hochhauser; Peter Thuss-Patience; Salah Eddin Al-Batran; Marcelo Garrido; Uma Kher; Chie Schin Shih; Sukrut Shah; Pooja Bhagia; Joseph Chao

doi:10.1158/1078-0432.CCR-20-2980

Efficacy of pembrolizumab monotherapy for advanced gastric/gastroesophageal junction cancer with programmed death ligand 1 combined positive score ≥10

Zev A. Wainberg, Charles S. Fuchs, Josep Tabernero, Kohei Shitara, Kei Muro, Eric Van Cutsem, Yung Jue Bang, Hyun Cheol Chung, Kensei Yamaguchi, Eniko Varga, Jen Shi Chen, Daniel Hochhauser, Peter Thuss-Patience, Salah Eddin Al-Batran, Marcelo Garrido, Uma Kher, Chie Schin Shih, Sukrut Shah, Pooja Bhagia, Joseph Chao

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

35 Citations (Scopus)

Abstract

Purpose: Pembrolizumab demonstrated efficacy in PD-L1-positive [combined positive score (CPS) ≥1] advanced gastric/gastroesophageal junction (G/GEJ) cancer in the first-, second-, and thirdline setting in KEYNOTE-062, KEYNOTE-061, and KEYNOTE- 059, respectively. To better delineate the specificity of CPS as a predictor of clinical outcomes, we analyzed pembrolizumab efficacy in patients with CPS ≥ 10 in these trials. Patients and Methods: Included were patients with CPS ≥ 10 tumors from KEYNOTE-059 cohort 1 (pembrolizumab, n = 46; post hoc), KEYNOTE-061 (pembrolizumab, n= 53; chemotherapy, n = 55; post hoc), and KEYNOTE-062 (pembrolizumab, n = 92; chemotherapy, n = 90; primary). Efficacy outcomes were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR). Results: In KEYNOTE-059, median follow-up was 6 months, median OS was 8 months [95% confidence interval (CI), 5.8-11.1], ORR was 17%, and median (range) DOR was 21 months (3+ to 35+). In KEYNOTE-061, median follow-up was 9 months, median OS (pembrolizumab vs. chemotherapy) was 10 versus 8 months (HR, 0.64; 95% CI, 0.41-1.02), median PFS was 3 months versus 3 months (HR, 0.86; 95% CI, 0.56-1.33), ORR was 25% versus 9%, and median (range)DORwas not reached (4 to 26+months) versus 7 months (3-7). In KEYNOTE-062, median follow-up was 11 months, median OS (pembrolizumab vs. chemotherapy) was 17 months versus 11 months (HR, 0.69; 95% CI, 0.49-0.97), median PFS was 3 months versus 6 months (HR, 1.09, 95% CI; 0.79-1.49), ORR was 25% versus 38%, and median (range) DOR was 19 months (1+ to 34+) versus 7 months (2+ to 30+). Conclusions: This comprehensive analysis showed consistent improvements toward more favorable clinical outcomes with pembrolizumab across lines of therapy in patients with CPS ≥ 10 G/GEJ cancer.

Original language	English
Pages (from-to)	1923-1931
Number of pages	9
Journal	Clinical Cancer Research
Volume	27
Issue number	7
DOIs	https://doi.org/10.1158/1078-0432.CCR-20-2980
Publication status	Published - 2021 Apr

Bibliographical note

Funding Information:
The authors thank the patients and their families and all investigators and site personnel. The authors also thank Eric Rubin of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. Medical writing and/or editorial assistance was provided by Holly C. Cappelli, PhD, CMPP, and Brian Szente, PhD, of ApotheCom (Yardley, PA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ.

Publisher Copyright:
© 2021 American Association for Cancer Research.

All Science Journal Classification (ASJC) codes

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1158/1078-0432.CCR-20-2980

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Wainberg, Z. A., Fuchs, C. S., Tabernero, J., Shitara, K., Muro, K., Van Cutsem, E., Bang, Y. J., Chung, H. C., Yamaguchi, K., Varga, E., Chen, J. S., Hochhauser, D., Thuss-Patience, P., Al-Batran, S. E., Garrido, M., Kher, U., Shih, C. S., Shah, S., Bhagia, P., & Chao, J. (2021). Efficacy of pembrolizumab monotherapy for advanced gastric/gastroesophageal junction cancer with programmed death ligand 1 combined positive score ≥10. Clinical Cancer Research, 27(7), 1923-1931. https://doi.org/10.1158/1078-0432.CCR-20-2980

@article{bf9d90db2bc541dd8f62a92c24c38e39,

title = "Efficacy of pembrolizumab monotherapy for advanced gastric/gastroesophageal junction cancer with programmed death ligand 1 combined positive score ≥10",

abstract = "Purpose: Pembrolizumab demonstrated efficacy in PD-L1-positive [combined positive score (CPS) ≥1] advanced gastric/gastroesophageal junction (G/GEJ) cancer in the first-, second-, and thirdline setting in KEYNOTE-062, KEYNOTE-061, and KEYNOTE- 059, respectively. To better delineate the specificity of CPS as a predictor of clinical outcomes, we analyzed pembrolizumab efficacy in patients with CPS ≥ 10 in these trials. Patients and Methods: Included were patients with CPS ≥ 10 tumors from KEYNOTE-059 cohort 1 (pembrolizumab, n = 46; post hoc), KEYNOTE-061 (pembrolizumab, n= 53; chemotherapy, n = 55; post hoc), and KEYNOTE-062 (pembrolizumab, n = 92; chemotherapy, n = 90; primary). Efficacy outcomes were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR). Results: In KEYNOTE-059, median follow-up was 6 months, median OS was 8 months [95% confidence interval (CI), 5.8-11.1], ORR was 17%, and median (range) DOR was 21 months (3+ to 35+). In KEYNOTE-061, median follow-up was 9 months, median OS (pembrolizumab vs. chemotherapy) was 10 versus 8 months (HR, 0.64; 95% CI, 0.41-1.02), median PFS was 3 months versus 3 months (HR, 0.86; 95% CI, 0.56-1.33), ORR was 25% versus 9%, and median (range)DORwas not reached (4 to 26+months) versus 7 months (3-7). In KEYNOTE-062, median follow-up was 11 months, median OS (pembrolizumab vs. chemotherapy) was 17 months versus 11 months (HR, 0.69; 95% CI, 0.49-0.97), median PFS was 3 months versus 6 months (HR, 1.09, 95% CI; 0.79-1.49), ORR was 25% versus 38%, and median (range) DOR was 19 months (1+ to 34+) versus 7 months (2+ to 30+). Conclusions: This comprehensive analysis showed consistent improvements toward more favorable clinical outcomes with pembrolizumab across lines of therapy in patients with CPS ≥ 10 G/GEJ cancer.",

author = "Wainberg, {Zev A.} and Fuchs, {Charles S.} and Josep Tabernero and Kohei Shitara and Kei Muro and {Van Cutsem}, Eric and Bang, {Yung Jue} and Chung, {Hyun Cheol} and Kensei Yamaguchi and Eniko Varga and Chen, {Jen Shi} and Daniel Hochhauser and Peter Thuss-Patience and Al-Batran, {Salah Eddin} and Marcelo Garrido and Uma Kher and Shih, {Chie Schin} and Sukrut Shah and Pooja Bhagia and Joseph Chao",

note = "Funding Information: The authors thank the patients and their families and all investigators and site personnel. The authors also thank Eric Rubin of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. Medical writing and/or editorial assistance was provided by Holly C. Cappelli, PhD, CMPP, and Brian Szente, PhD, of ApotheCom (Yardley, PA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. Publisher Copyright: {\textcopyright} 2021 American Association for Cancer Research.",

year = "2021",

month = apr,

doi = "10.1158/1078-0432.CCR-20-2980",

language = "English",

volume = "27",

pages = "1923--1931",

journal = "Clinical Cancer Research",

issn = "1078-0432",

publisher = "American Association for Cancer Research Inc.",

number = "7",

}

Wainberg, ZA, Fuchs, CS, Tabernero, J, Shitara, K, Muro, K, Van Cutsem, E, Bang, YJ, Chung, HC, Yamaguchi, K, Varga, E, Chen, JS, Hochhauser, D, Thuss-Patience, P, Al-Batran, SE, Garrido, M, Kher, U, Shih, CS, Shah, S, Bhagia, P & Chao, J 2021, 'Efficacy of pembrolizumab monotherapy for advanced gastric/gastroesophageal junction cancer with programmed death ligand 1 combined positive score ≥10', Clinical Cancer Research, vol. 27, no. 7, pp. 1923-1931. https://doi.org/10.1158/1078-0432.CCR-20-2980

TY - JOUR

T1 - Efficacy of pembrolizumab monotherapy for advanced gastric/gastroesophageal junction cancer with programmed death ligand 1 combined positive score ≥10

AU - Wainberg, Zev A.

AU - Fuchs, Charles S.

AU - Tabernero, Josep

AU - Shitara, Kohei

AU - Muro, Kei

AU - Van Cutsem, Eric

AU - Bang, Yung Jue

AU - Chung, Hyun Cheol

AU - Yamaguchi, Kensei

AU - Varga, Eniko

AU - Chen, Jen Shi

AU - Hochhauser, Daniel

AU - Thuss-Patience, Peter

AU - Al-Batran, Salah Eddin

AU - Garrido, Marcelo

AU - Kher, Uma

AU - Shih, Chie Schin

AU - Shah, Sukrut

AU - Bhagia, Pooja

AU - Chao, Joseph

N1 - Funding Information: The authors thank the patients and their families and all investigators and site personnel. The authors also thank Eric Rubin of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. Medical writing and/or editorial assistance was provided by Holly C. Cappelli, PhD, CMPP, and Brian Szente, PhD, of ApotheCom (Yardley, PA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. Publisher Copyright: © 2021 American Association for Cancer Research.

PY - 2021/4

Y1 - 2021/4

N2 - Purpose: Pembrolizumab demonstrated efficacy in PD-L1-positive [combined positive score (CPS) ≥1] advanced gastric/gastroesophageal junction (G/GEJ) cancer in the first-, second-, and thirdline setting in KEYNOTE-062, KEYNOTE-061, and KEYNOTE- 059, respectively. To better delineate the specificity of CPS as a predictor of clinical outcomes, we analyzed pembrolizumab efficacy in patients with CPS ≥ 10 in these trials. Patients and Methods: Included were patients with CPS ≥ 10 tumors from KEYNOTE-059 cohort 1 (pembrolizumab, n = 46; post hoc), KEYNOTE-061 (pembrolizumab, n= 53; chemotherapy, n = 55; post hoc), and KEYNOTE-062 (pembrolizumab, n = 92; chemotherapy, n = 90; primary). Efficacy outcomes were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR). Results: In KEYNOTE-059, median follow-up was 6 months, median OS was 8 months [95% confidence interval (CI), 5.8-11.1], ORR was 17%, and median (range) DOR was 21 months (3+ to 35+). In KEYNOTE-061, median follow-up was 9 months, median OS (pembrolizumab vs. chemotherapy) was 10 versus 8 months (HR, 0.64; 95% CI, 0.41-1.02), median PFS was 3 months versus 3 months (HR, 0.86; 95% CI, 0.56-1.33), ORR was 25% versus 9%, and median (range)DORwas not reached (4 to 26+months) versus 7 months (3-7). In KEYNOTE-062, median follow-up was 11 months, median OS (pembrolizumab vs. chemotherapy) was 17 months versus 11 months (HR, 0.69; 95% CI, 0.49-0.97), median PFS was 3 months versus 6 months (HR, 1.09, 95% CI; 0.79-1.49), ORR was 25% versus 38%, and median (range) DOR was 19 months (1+ to 34+) versus 7 months (2+ to 30+). Conclusions: This comprehensive analysis showed consistent improvements toward more favorable clinical outcomes with pembrolizumab across lines of therapy in patients with CPS ≥ 10 G/GEJ cancer.

AB - Purpose: Pembrolizumab demonstrated efficacy in PD-L1-positive [combined positive score (CPS) ≥1] advanced gastric/gastroesophageal junction (G/GEJ) cancer in the first-, second-, and thirdline setting in KEYNOTE-062, KEYNOTE-061, and KEYNOTE- 059, respectively. To better delineate the specificity of CPS as a predictor of clinical outcomes, we analyzed pembrolizumab efficacy in patients with CPS ≥ 10 in these trials. Patients and Methods: Included were patients with CPS ≥ 10 tumors from KEYNOTE-059 cohort 1 (pembrolizumab, n = 46; post hoc), KEYNOTE-061 (pembrolizumab, n= 53; chemotherapy, n = 55; post hoc), and KEYNOTE-062 (pembrolizumab, n = 92; chemotherapy, n = 90; primary). Efficacy outcomes were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR). Results: In KEYNOTE-059, median follow-up was 6 months, median OS was 8 months [95% confidence interval (CI), 5.8-11.1], ORR was 17%, and median (range) DOR was 21 months (3+ to 35+). In KEYNOTE-061, median follow-up was 9 months, median OS (pembrolizumab vs. chemotherapy) was 10 versus 8 months (HR, 0.64; 95% CI, 0.41-1.02), median PFS was 3 months versus 3 months (HR, 0.86; 95% CI, 0.56-1.33), ORR was 25% versus 9%, and median (range)DORwas not reached (4 to 26+months) versus 7 months (3-7). In KEYNOTE-062, median follow-up was 11 months, median OS (pembrolizumab vs. chemotherapy) was 17 months versus 11 months (HR, 0.69; 95% CI, 0.49-0.97), median PFS was 3 months versus 6 months (HR, 1.09, 95% CI; 0.79-1.49), ORR was 25% versus 38%, and median (range) DOR was 19 months (1+ to 34+) versus 7 months (2+ to 30+). Conclusions: This comprehensive analysis showed consistent improvements toward more favorable clinical outcomes with pembrolizumab across lines of therapy in patients with CPS ≥ 10 G/GEJ cancer.

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Efficacy of pembrolizumab monotherapy for advanced gastric/gastroesophageal junction cancer with programmed death ligand 1 combined positive score ≥10

Abstract

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