KEYNOTE-012
Pembrolizumab in recurrent or metastatic squamous cell carcinoma of the head and neck: head and neck cohorts of the KEYNOTE-012 multi-cohort phase 1b study
Phase 1NCT01848834
- Population
- Recurrent or metastatic squamous cell carcinoma of the head and neck (cohort 1: PD-L1-positive; expansion cohort: biomarker-unselected)
- Design
- Open-label, multicentre phase 1b, single-arm cohorts (no control group). Cohort 1 (Seiwert): 60 PD-L1-positive patients (at least 1% of tumour or stroma cells) treated with pembrolizumab 10 mg per kilogram every 2 weeks; primary outcomes were safety and centrally reviewed overall response (RECIST 1.1); the response analysis covered 45 evaluable patients. Expansion cohort (Chow): 132 patients irrespective of PD-L1 or HPV status treated with pembrolizumab 200 mg every 3 weeks; primary end points were overall response rate per central imaging vendor and safety. The registry record covers the whole multi-tumour study and lists phase 1.
- Primary endpoint
- ORR
- Arms
- Pembrolizumab 10 mg/kg, PD-L1-positive cohort (experimental, n = 60): Pembrolizumab 10 mg per kilogram intravenously every 2 weeks
- Pembrolizumab 200 mg, expansion cohort (experimental, n = 132): Pembrolizumab 200 mg intravenously every 3 weeks
- People
- Seiwert TY, senior author Chow LQ, KEYNOTE-012
Show the numbers
| Endpoint | Analysis | Pembrolizumab 10 mg/kg, PD-L1-positive cohort / Pembrolizumab 200 mg, expansion cohort | Control | Effect |
|---|---|---|---|---|
| ORRPD-L1-positive cohort, full analysis set (45 evaluable patients; 60 enrolled and treated) | primarySeiwert 2016 | 18% (8–32%) | — | Single-arm cohort. Response by central review was 25% (4 of 16 patients; 95% CI 7-52) in HPV-positive and 14% (4 of 29 patients; 95% CI 4-32) in HPV-negative patients. |
| ORRExpansion cohort, patients who received at least one dose (132 enrolled) | primaryChow 2016 | 18% (12–26%) | — | Single-arm cohort, biomarker-unselected. Response by investigator review was 20% (95% CI 13 to 28). Median duration of response was not reached. Six-month progression-free survival was 23% and six-month overall survival 59%. Response was 22% in PD-L1-positive versus 4% in PD-L1-negative patients (P = .021). |
| Endpoint | Analysis | Pembrolizumab 10 mg/kg, PD-L1-positive cohort / Pembrolizumab 200 mg, expansion cohort | Control | Effect |
|---|---|---|---|---|
| ORRPD-L1-positive cohort, full analysis set (45 evaluable patients; 60 enrolled and treated) | primarySeiwert 2016 | 18% (8–32%) | — | Single-arm cohort. Response by central review was 25% (4 of 16 patients; 95% CI 7-52) in HPV-positive and 14% (4 of 29 patients; 95% CI 4-32) in HPV-negative patients. |
| ORRExpansion cohort, patients who received at least one dose (132 enrolled) | primaryChow 2016 | 18% (12–26%) | — | Single-arm cohort, biomarker-unselected. Response by investigator review was 20% (95% CI 13 to 28). Median duration of response was not reached. Six-month progression-free survival was 23% and six-month overall survival 59%. Response was 22% in PD-L1-positive versus 4% in PD-L1-negative patients (P = .021). |
Appears in
Sources
Seiwert TY, Burtness B, Mehra R, Weiss J, Berger R, Eder JP, et al. Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial. Lancet Oncol. 2016;17(7):956-965.
Chow LQM, Haddad R, Gupta S, Mahipal A, Mehra R, Tahara M, et al. Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort. J Clin Oncol. 2016;34(32):3838-3845.