Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: Pooled analyses after long-term follow-up in KEYNOTE-012

Ranee Mehra, Tanguy Y. Seiwert, Shilpa Gupta, Jared Weiss, Iris Gluck, Joseph P. Eder, Barbara Burtness, Makoto Tahara, Bhumsuk Keam, Hyunseok Kang, Kei Muro, Ravit Geva, Hyun Cheol Chung, Chia Chi Lin, Deepti Aurora-Garg, Archana Ray, Kumudu Pathiraja, Jonathan Cheng, Laura Q.M. Chow, Robert Haddad

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Abstract

Background: Second-line treatment options for advanced head and neck squamous cell carcinoma (HNSCC) are limited. The phase Ib KEYNOTE-012 study evaluated the safety and the efficacy of pembrolizumab for the treatment of HNSCC after long-term follow-up. Methods: Multi-centre, non-randomised trial included two HNSCC cohorts (initial and expansion) in which 192 patients were eligible. Patients received pembrolizumab 10 mg/kg every 2 weeks (initial cohort; N = 60) or 200 mg every 3 weeks (expansion cohort; N = 132). Co-primary endpoints were safety and overall response rate (ORR; RECIST v1.1; central imaging vendor review). Results: Median follow-up was 9 months (range, 0.2-32). Treatment-related adverse events (AEs) of any grade and grade 3/4 occurred in 123 (64%) and 24 (13%) patients, respectively. No deaths were attributed to treatment-related AEs. ORR was 18% (34/192; 95% CI, 13-24%). Median response duration was not reached (range, 2+ to 30+ months); 85% of responses lasted ≥6 months. Overall survival at 12 months was 38%. Conclusions: Some patients received 2 years of treatment and the responses were ongoing for more than 30 months; the durable anti-tumour activity and tolerable safety profile, observed with long-term follow-up, support the use of pembrolizumab as a treatment for recurrent/metastatic HNSCC.

Original languageEnglish
Pages (from-to)153-159
Number of pages7
JournalBritish journal of cancer
Volume119
Issue number2
DOIs
Publication statusPublished - 2018 Jul 17

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Safety
Therapeutics
Carcinoma, squamous cell of head and neck
pembrolizumab
Survival
Neoplasms

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Mehra, Ranee ; Seiwert, Tanguy Y. ; Gupta, Shilpa ; Weiss, Jared ; Gluck, Iris ; Eder, Joseph P. ; Burtness, Barbara ; Tahara, Makoto ; Keam, Bhumsuk ; Kang, Hyunseok ; Muro, Kei ; Geva, Ravit ; Chung, Hyun Cheol ; Lin, Chia Chi ; Aurora-Garg, Deepti ; Ray, Archana ; Pathiraja, Kumudu ; Cheng, Jonathan ; Chow, Laura Q.M. ; Haddad, Robert. / Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma : Pooled analyses after long-term follow-up in KEYNOTE-012. In: British journal of cancer. 2018 ; Vol. 119, No. 2. pp. 153-159.
@article{77655904364c42d08563d1e83d3883d8,
title = "Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: Pooled analyses after long-term follow-up in KEYNOTE-012",
abstract = "Background: Second-line treatment options for advanced head and neck squamous cell carcinoma (HNSCC) are limited. The phase Ib KEYNOTE-012 study evaluated the safety and the efficacy of pembrolizumab for the treatment of HNSCC after long-term follow-up. Methods: Multi-centre, non-randomised trial included two HNSCC cohorts (initial and expansion) in which 192 patients were eligible. Patients received pembrolizumab 10 mg/kg every 2 weeks (initial cohort; N = 60) or 200 mg every 3 weeks (expansion cohort; N = 132). Co-primary endpoints were safety and overall response rate (ORR; RECIST v1.1; central imaging vendor review). Results: Median follow-up was 9 months (range, 0.2-32). Treatment-related adverse events (AEs) of any grade and grade 3/4 occurred in 123 (64{\%}) and 24 (13{\%}) patients, respectively. No deaths were attributed to treatment-related AEs. ORR was 18{\%} (34/192; 95{\%} CI, 13-24{\%}). Median response duration was not reached (range, 2+ to 30+ months); 85{\%} of responses lasted ≥6 months. Overall survival at 12 months was 38{\%}. Conclusions: Some patients received 2 years of treatment and the responses were ongoing for more than 30 months; the durable anti-tumour activity and tolerable safety profile, observed with long-term follow-up, support the use of pembrolizumab as a treatment for recurrent/metastatic HNSCC.",
author = "Ranee Mehra and Seiwert, {Tanguy Y.} and Shilpa Gupta and Jared Weiss and Iris Gluck and Eder, {Joseph P.} and Barbara Burtness and Makoto Tahara and Bhumsuk Keam and Hyunseok Kang and Kei Muro and Ravit Geva and Chung, {Hyun Cheol} and Lin, {Chia Chi} and Deepti Aurora-Garg and Archana Ray and Kumudu Pathiraja and Jonathan Cheng and Chow, {Laura Q.M.} and Robert Haddad",
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Mehra, R, Seiwert, TY, Gupta, S, Weiss, J, Gluck, I, Eder, JP, Burtness, B, Tahara, M, Keam, B, Kang, H, Muro, K, Geva, R, Chung, HC, Lin, CC, Aurora-Garg, D, Ray, A, Pathiraja, K, Cheng, J, Chow, LQM & Haddad, R 2018, 'Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: Pooled analyses after long-term follow-up in KEYNOTE-012', British journal of cancer, vol. 119, no. 2, pp. 153-159. https://doi.org/10.1038/s41416-018-0131-9

Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma : Pooled analyses after long-term follow-up in KEYNOTE-012. / Mehra, Ranee; Seiwert, Tanguy Y.; Gupta, Shilpa; Weiss, Jared; Gluck, Iris; Eder, Joseph P.; Burtness, Barbara; Tahara, Makoto; Keam, Bhumsuk; Kang, Hyunseok; Muro, Kei; Geva, Ravit; Chung, Hyun Cheol; Lin, Chia Chi; Aurora-Garg, Deepti; Ray, Archana; Pathiraja, Kumudu; Cheng, Jonathan; Chow, Laura Q.M.; Haddad, Robert.

In: British journal of cancer, Vol. 119, No. 2, 17.07.2018, p. 153-159.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma

T2 - Pooled analyses after long-term follow-up in KEYNOTE-012

AU - Mehra, Ranee

AU - Seiwert, Tanguy Y.

AU - Gupta, Shilpa

AU - Weiss, Jared

AU - Gluck, Iris

AU - Eder, Joseph P.

AU - Burtness, Barbara

AU - Tahara, Makoto

AU - Keam, Bhumsuk

AU - Kang, Hyunseok

AU - Muro, Kei

AU - Geva, Ravit

AU - Chung, Hyun Cheol

AU - Lin, Chia Chi

AU - Aurora-Garg, Deepti

AU - Ray, Archana

AU - Pathiraja, Kumudu

AU - Cheng, Jonathan

AU - Chow, Laura Q.M.

AU - Haddad, Robert

PY - 2018/7/17

Y1 - 2018/7/17

N2 - Background: Second-line treatment options for advanced head and neck squamous cell carcinoma (HNSCC) are limited. The phase Ib KEYNOTE-012 study evaluated the safety and the efficacy of pembrolizumab for the treatment of HNSCC after long-term follow-up. Methods: Multi-centre, non-randomised trial included two HNSCC cohorts (initial and expansion) in which 192 patients were eligible. Patients received pembrolizumab 10 mg/kg every 2 weeks (initial cohort; N = 60) or 200 mg every 3 weeks (expansion cohort; N = 132). Co-primary endpoints were safety and overall response rate (ORR; RECIST v1.1; central imaging vendor review). Results: Median follow-up was 9 months (range, 0.2-32). Treatment-related adverse events (AEs) of any grade and grade 3/4 occurred in 123 (64%) and 24 (13%) patients, respectively. No deaths were attributed to treatment-related AEs. ORR was 18% (34/192; 95% CI, 13-24%). Median response duration was not reached (range, 2+ to 30+ months); 85% of responses lasted ≥6 months. Overall survival at 12 months was 38%. Conclusions: Some patients received 2 years of treatment and the responses were ongoing for more than 30 months; the durable anti-tumour activity and tolerable safety profile, observed with long-term follow-up, support the use of pembrolizumab as a treatment for recurrent/metastatic HNSCC.

AB - Background: Second-line treatment options for advanced head and neck squamous cell carcinoma (HNSCC) are limited. The phase Ib KEYNOTE-012 study evaluated the safety and the efficacy of pembrolizumab for the treatment of HNSCC after long-term follow-up. Methods: Multi-centre, non-randomised trial included two HNSCC cohorts (initial and expansion) in which 192 patients were eligible. Patients received pembrolizumab 10 mg/kg every 2 weeks (initial cohort; N = 60) or 200 mg every 3 weeks (expansion cohort; N = 132). Co-primary endpoints were safety and overall response rate (ORR; RECIST v1.1; central imaging vendor review). Results: Median follow-up was 9 months (range, 0.2-32). Treatment-related adverse events (AEs) of any grade and grade 3/4 occurred in 123 (64%) and 24 (13%) patients, respectively. No deaths were attributed to treatment-related AEs. ORR was 18% (34/192; 95% CI, 13-24%). Median response duration was not reached (range, 2+ to 30+ months); 85% of responses lasted ≥6 months. Overall survival at 12 months was 38%. Conclusions: Some patients received 2 years of treatment and the responses were ongoing for more than 30 months; the durable anti-tumour activity and tolerable safety profile, observed with long-term follow-up, support the use of pembrolizumab as a treatment for recurrent/metastatic HNSCC.

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