Pembrolizumab in Asia-Pacific patients with advanced head and neck squamous cell carcinoma: Analyses from KEYNOTE-012

Makoto Tahara; Kei Muro; Yasuhisa Hasegawa; Hyun Cheol Chung; Chia Chi Lin; Bhumsuk Keam; Kenichi Takahashi; Jonathan D. Cheng; Yung Jue Bang

doi:10.1111/cas.13480

Pembrolizumab in Asia-Pacific patients with advanced head and neck squamous cell carcinoma: Analyses from KEYNOTE-012

Makoto Tahara, Kei Muro, Yasuhisa Hasegawa, Hyun Cheol Chung, Chia Chi Lin, Bhumsuk Keam, Kenichi Takahashi, Jonathan D. Cheng, Yung Jue Bang

Department of Internal Medicine

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

31 Citations (Scopus)

Abstract

KEYNOTE-012 was a phase Ib, multicohort study designed to investigate efficacy and safety of pembrolizumab in advanced solid tumors. Results from the subset of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) from the Asia-Pacific region are reported. Patients with recurrent/metastatic HNSCC, measurable disease (RECIST version 1.1), and ECOG performance status (PS) 0-1 were eligible for enrollment in the HNSCC expansion cohort. Patients received pembrolizumab 200 mg every 3 weeks. Response was assessed every 8 weeks. Co-primary end-points were safety and overall response rate (RECIST version 1.1, central review). Secondary end-points included overall survival and response duration. Patients enrolled at any of the five centers throughout the Asia-Pacific region were included in these analyses. Twenty-six patients with HNSCC from the Asia-Pacific region received pembrolizumab. The median age was 62 years, 65% of patients had ECOG PS 1, and 62% had received two or more prior therapies for recurrent/metastatic disease. Sixteen (62%) patients experienced a treatment-related adverse event of any grade, including two (8%) patients who experienced one or more events of grade 3 severity. No treatment-related deaths occurred. The overall response rate was 19% (95% confidence interval, 7%-39%). After a median follow-up of 12 months (range, 2-21 months), a median response duration was not reached (range, 6 to 17+ months); four of five responses lasted ≥6 months. Median overall survival was 11.6 months (95% confidence interval, 4.7-17.7 months). Pembrolizumab was well tolerated and had durable antitumor activity in patients with HNSCC from the Asia-Pacific region. (Trial registration no. NCT01848834.).

Original language	English
Pages (from-to)	771-776
Number of pages	6
Journal	Cancer Science
Volume	109
Issue number	3
DOIs	https://doi.org/10.1111/cas.13480
Publication status	Published - 2018 Mar

Bibliographical note

Funding Information:
The study was designed and funded by Merck & Co., Inc. M.T. has received honoraria from Merck Serono. K.M. has received honoraria from Chugai, Takeda, Eli Lilly, Taiho Pharmaceutical, Merck Serono, and YaKult Pharmaceutical and research funding from Merck Sharp & Dohme Corp., Daiichi Sankyo, Ono Pharmaceuticals, Shionogi Pharmaceuticals, Kyowa Hakko Kirin, and Gilead Sciences. K.T. is an employee of MSD K.K. J.D.C. is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. and owns stock in the company. Y.J.B. has received research funding from Merck Sharp & Dohme Corp., Bristol-Myers Squibb, Ono Pharmaceuticals, Astra-Zeneca, Genentech-Roche, Merck Serono, Pfizer, and BeiGene. Y.H., H.C.C., C.C.L., and B.K. have no conflict of interest.

Publisher Copyright:
© 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

All Science Journal Classification (ASJC) codes

Oncology
Cancer Research

UN SDGs

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

Access to Document

10.1111/cas.13480

Cite this

@article{be536d3197b04124a5aab343433e06f2,

title = "Pembrolizumab in Asia-Pacific patients with advanced head and neck squamous cell carcinoma: Analyses from KEYNOTE-012",

abstract = "KEYNOTE-012 was a phase Ib, multicohort study designed to investigate efficacy and safety of pembrolizumab in advanced solid tumors. Results from the subset of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) from the Asia-Pacific region are reported. Patients with recurrent/metastatic HNSCC, measurable disease (RECIST version 1.1), and ECOG performance status (PS) 0-1 were eligible for enrollment in the HNSCC expansion cohort. Patients received pembrolizumab 200 mg every 3 weeks. Response was assessed every 8 weeks. Co-primary end-points were safety and overall response rate (RECIST version 1.1, central review). Secondary end-points included overall survival and response duration. Patients enrolled at any of the five centers throughout the Asia-Pacific region were included in these analyses. Twenty-six patients with HNSCC from the Asia-Pacific region received pembrolizumab. The median age was 62 years, 65% of patients had ECOG PS 1, and 62% had received two or more prior therapies for recurrent/metastatic disease. Sixteen (62%) patients experienced a treatment-related adverse event of any grade, including two (8%) patients who experienced one or more events of grade 3 severity. No treatment-related deaths occurred. The overall response rate was 19% (95% confidence interval, 7%-39%). After a median follow-up of 12 months (range, 2-21 months), a median response duration was not reached (range, 6 to 17+ months); four of five responses lasted ≥6 months. Median overall survival was 11.6 months (95% confidence interval, 4.7-17.7 months). Pembrolizumab was well tolerated and had durable antitumor activity in patients with HNSCC from the Asia-Pacific region. (Trial registration no. NCT01848834.).",

author = "Makoto Tahara and Kei Muro and Yasuhisa Hasegawa and Chung, {Hyun Cheol} and Lin, {Chia Chi} and Bhumsuk Keam and Kenichi Takahashi and Cheng, {Jonathan D.} and Bang, {Yung Jue}",

note = "Funding Information: The study was designed and funded by Merck & Co., Inc. M.T. has received honoraria from Merck Serono. K.M. has received honoraria from Chugai, Takeda, Eli Lilly, Taiho Pharmaceutical, Merck Serono, and YaKult Pharmaceutical and research funding from Merck Sharp & Dohme Corp., Daiichi Sankyo, Ono Pharmaceuticals, Shionogi Pharmaceuticals, Kyowa Hakko Kirin, and Gilead Sciences. K.T. is an employee of MSD K.K. J.D.C. is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. and owns stock in the company. Y.J.B. has received research funding from Merck Sharp & Dohme Corp., Bristol-Myers Squibb, Ono Pharmaceuticals, Astra-Zeneca, Genentech-Roche, Merck Serono, Pfizer, and BeiGene. Y.H., H.C.C., C.C.L., and B.K. have no conflict of interest. Publisher Copyright: {\textcopyright} 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.",

year = "2018",

month = mar,

doi = "10.1111/cas.13480",

language = "English",

volume = "109",

pages = "771--776",

journal = "Cancer Science",

issn = "1347-9032",

publisher = "Wiley-Blackwell",

number = "3",

}

Pembrolizumab in Asia-Pacific patients with advanced head and neck squamous cell carcinoma : Analyses from KEYNOTE-012. / Tahara, Makoto; Muro, Kei; Hasegawa, Yasuhisa; Chung, Hyun Cheol; Lin, Chia Chi; Keam, Bhumsuk; Takahashi, Kenichi; Cheng, Jonathan D.; Bang, Yung Jue.

In: Cancer Science, Vol. 109, No. 3, 03.2018, p. 771-776.

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

TY - JOUR

T1 - Pembrolizumab in Asia-Pacific patients with advanced head and neck squamous cell carcinoma

T2 - Analyses from KEYNOTE-012

AU - Tahara, Makoto

AU - Muro, Kei

AU - Hasegawa, Yasuhisa

AU - Chung, Hyun Cheol

AU - Lin, Chia Chi

AU - Keam, Bhumsuk

AU - Takahashi, Kenichi

AU - Cheng, Jonathan D.

AU - Bang, Yung Jue

N1 - Funding Information: The study was designed and funded by Merck & Co., Inc. M.T. has received honoraria from Merck Serono. K.M. has received honoraria from Chugai, Takeda, Eli Lilly, Taiho Pharmaceutical, Merck Serono, and YaKult Pharmaceutical and research funding from Merck Sharp & Dohme Corp., Daiichi Sankyo, Ono Pharmaceuticals, Shionogi Pharmaceuticals, Kyowa Hakko Kirin, and Gilead Sciences. K.T. is an employee of MSD K.K. J.D.C. is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. and owns stock in the company. Y.J.B. has received research funding from Merck Sharp & Dohme Corp., Bristol-Myers Squibb, Ono Pharmaceuticals, Astra-Zeneca, Genentech-Roche, Merck Serono, Pfizer, and BeiGene. Y.H., H.C.C., C.C.L., and B.K. have no conflict of interest. Publisher Copyright: © 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

PY - 2018/3

Y1 - 2018/3

N2 - KEYNOTE-012 was a phase Ib, multicohort study designed to investigate efficacy and safety of pembrolizumab in advanced solid tumors. Results from the subset of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) from the Asia-Pacific region are reported. Patients with recurrent/metastatic HNSCC, measurable disease (RECIST version 1.1), and ECOG performance status (PS) 0-1 were eligible for enrollment in the HNSCC expansion cohort. Patients received pembrolizumab 200 mg every 3 weeks. Response was assessed every 8 weeks. Co-primary end-points were safety and overall response rate (RECIST version 1.1, central review). Secondary end-points included overall survival and response duration. Patients enrolled at any of the five centers throughout the Asia-Pacific region were included in these analyses. Twenty-six patients with HNSCC from the Asia-Pacific region received pembrolizumab. The median age was 62 years, 65% of patients had ECOG PS 1, and 62% had received two or more prior therapies for recurrent/metastatic disease. Sixteen (62%) patients experienced a treatment-related adverse event of any grade, including two (8%) patients who experienced one or more events of grade 3 severity. No treatment-related deaths occurred. The overall response rate was 19% (95% confidence interval, 7%-39%). After a median follow-up of 12 months (range, 2-21 months), a median response duration was not reached (range, 6 to 17+ months); four of five responses lasted ≥6 months. Median overall survival was 11.6 months (95% confidence interval, 4.7-17.7 months). Pembrolizumab was well tolerated and had durable antitumor activity in patients with HNSCC from the Asia-Pacific region. (Trial registration no. NCT01848834.).

AB - KEYNOTE-012 was a phase Ib, multicohort study designed to investigate efficacy and safety of pembrolizumab in advanced solid tumors. Results from the subset of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) from the Asia-Pacific region are reported. Patients with recurrent/metastatic HNSCC, measurable disease (RECIST version 1.1), and ECOG performance status (PS) 0-1 were eligible for enrollment in the HNSCC expansion cohort. Patients received pembrolizumab 200 mg every 3 weeks. Response was assessed every 8 weeks. Co-primary end-points were safety and overall response rate (RECIST version 1.1, central review). Secondary end-points included overall survival and response duration. Patients enrolled at any of the five centers throughout the Asia-Pacific region were included in these analyses. Twenty-six patients with HNSCC from the Asia-Pacific region received pembrolizumab. The median age was 62 years, 65% of patients had ECOG PS 1, and 62% had received two or more prior therapies for recurrent/metastatic disease. Sixteen (62%) patients experienced a treatment-related adverse event of any grade, including two (8%) patients who experienced one or more events of grade 3 severity. No treatment-related deaths occurred. The overall response rate was 19% (95% confidence interval, 7%-39%). After a median follow-up of 12 months (range, 2-21 months), a median response duration was not reached (range, 6 to 17+ months); four of five responses lasted ≥6 months. Median overall survival was 11.6 months (95% confidence interval, 4.7-17.7 months). Pembrolizumab was well tolerated and had durable antitumor activity in patients with HNSCC from the Asia-Pacific region. (Trial registration no. NCT01848834.).

UR - http://www.scopus.com/inward/record.url?scp=85041698363&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85041698363&partnerID=8YFLogxK

U2 - 10.1111/cas.13480

DO - 10.1111/cas.13480

M3 - Article

C2 - 29284202

AN - SCOPUS:85041698363

VL - 109

SP - 771

EP - 776

JO - Cancer Science

JF - Cancer Science

SN - 1347-9032

IS - 3

ER -

Pembrolizumab in Asia-Pacific patients with advanced head and neck squamous cell carcinoma: Analyses from KEYNOTE-012

Abstract

Bibliographical note

All Science Journal Classification (ASJC) codes

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this