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

26 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

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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.).

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JO - Cancer Science

JF - Cancer Science

SN - 1347-9032

IS - 3

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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

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