Table 1 Summary of pembrolizumab efficacy and safety in advanced malignancies other than melanoma and NSCLC
From: Pembrolizumab
Study (clinical trials.gov identifier) | N | Study design | Pembrolizumab dose/schedule | Efficacy (RECIST v1.1, central review) | Safety |
|---|---|---|---|---|---|
HNSCC | |||||
KEYNOTE-012 | 60 | Phase I, international, open-label, nonrandomized cohort of PD-L1-positive advanced HNSCC | 10 mg/kg Q2W | • ORR: 20 % | • Grade 3-4 DRAEs: 17 % |
(NCT01848834) [23] | |||||
• Median duration of response: NR (range 8+ to 41+ weeks) | • DR discontinuations: not reported | ||||
• Median PFS: 9.3 weeks (95 % CI: 8.0–20.1) | • DR deaths: none | ||||
• Median OS: 12.6 months | |||||
• 6-month OS rate: 65 % | |||||
Gastric cancer | |||||
KEYNOTE-012 | 39 | Phase I, international, open-label, nonrandomized cohort of PD-L1-positive advanced gastric cancer | 10 mg/kg Q2W | • ORR: 22 % | • Grade 3-4 DRAEs: 10 % |
(NCT01848834) [24] | |||||
• Median duration of response: 24 weeks (range 8+ to 33+ weeks) | • DR discontinuations: none | ||||
• Median PFS: 1.9 months (95 % CI: 1.8–3.5) | • DR deaths: n = 1 | ||||
• Median OS: NR | |||||
• 6-month OS rate: 69 % | |||||
Urothelial cancer | |||||
KEYNOTE-012 | 33 | Phase I, international, open-label, nonrandomized cohort of PD-L1-positive advanced urothelial cancer | 10 mg/kg Q2W | • ORR: 25 % | • Grade 3-4 DRAEs: 15 % |
(NCT01848834) [25] | |||||
• Median duration of response: NR (range 16 to 50+ weeks) | • DR discontinuations: 3 % | ||||
• Median PFS: 2 months (95 % CI: 1.7–4.0) | • DR deaths: none | ||||
• Median OS: 9.3 months | |||||
• 12-month OS rate: 55 % | |||||
Triple-negative breast cancer | |||||
KEYNOTE-012 | 32 | Phase I, international, open-label, nonrandomized cohort of PD-L1-positive advanced triple-negative breast cancer | 10 mg/kg Q2W | • ORR: 19 % | • Grade 3-4 DRAEs: 16 % |
(NCT01848834) [26] | |||||
• Median duration of response: NR (range 15 to 40+ weeks) | • DR discontinuations: 3 % | ||||
• Median PFS: 1.9 months (95 % CI: 1.7–5.4) | • DR deaths: n = 1 | ||||
• OS: not reported | |||||
Hodgkin lymphoma | |||||
KEYNOTE-013 | 29 | Phase I, international, open-label, nonrandomized cohort of PD-L1-positive Hodgkin lymphoma | 10 mg/kg Q2W | • ORR: 66 % | • Grade 3-4 DRAEs: 10 % |
(NCT01953692) [27] | |||||
• Median duration of response: NR (range 1+ to 185+ days) | • DR discontinuations: not reported | ||||
• PFS: not reported | • DR deaths: n = 0 | ||||
• OS: not reported | |||||