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KEYNOTE-002

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)

Phase 2N = 540NCT01704287

Population
Melanoma progressing within 24 weeks after at least two ipilimumab doses and, if BRAF V600 mutation-positive, after a BRAF or MEK inhibitor or both
Design
Randomised (1:1:1) phase 2 trial of pembrolizumab 2 mg per kilogram or 10 mg per kilogram every 3 weeks versus investigator-choice chemotherapy (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine or oral temozolomide); assignment between pembrolizumab and chemotherapy was open-label, dose masked. The abstract reports the primary end point, progression-free survival, at the prespecified second interim analysis in the intention-to-treat population.
Primary endpoint
PFS
Arms
  • Pembrolizumab 2 mg per kilogram (experimental, n = 180): Pembrolizumab 2 mg per kilogram intravenously every 3 weeks
  • Pembrolizumab 10 mg per kilogram (experimental, n = 181): Pembrolizumab 10 mg per kilogram intravenously every 3 weeks
  • Investigator-choice chemotherapy (control, n = 179): Investigator-choice chemotherapy: paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine or oral temozolomide
People
Ribas A, senior author Daud A
PFSHR 0.57 (95% CI 0.45–0.73)Δ 6-month PFS+18 pointsPFSHR 0.50 (95% CI 0.39–0.64)Δ 6-month PFS+22 points
Show the numbers
Results reported for KEYNOTE-002
EndpointAnalysisPembrolizumab 2 mg per kilogram / Pembrolizumab 10 mg per kilogramInvestigator-choice chemotherapyEffect
PFSinterimRibas 201534% at 6 mo (27–41%)16% at 6 mo (10–22%)HR 0.57 (95% CI 0.45–0.73)P<0.0001Based on 410 progression-free survival events at the second interim analysis; 6-month rates.
PFSinterimRibas 201538% at 6 mo (31–45%)16% at 6 mo (10–22%)HR 0.50 (95% CI 0.39–0.64)P<0.0001Based on 410 progression-free survival events at the second interim analysis; 6-month rates.
Results reported for KEYNOTE-002
EndpointAnalysisPembrolizumab 2 mg per kilogram / Pembrolizumab 10 mg per kilogramInvestigator-choice chemotherapyEffect
PFSinterimRibas 201534% at 6 mo (27–41%)16% at 6 mo (10–22%)HR 0.57 (95% CI 0.45–0.73)P<0.0001Based on 410 progression-free survival events at the second interim analysis; 6-month rates.
PFSinterimRibas 201538% at 6 mo (31–45%)16% at 6 mo (10–22%)HR 0.50 (95% CI 0.39–0.64)P<0.0001Based on 410 progression-free survival events at the second interim analysis; 6-month rates.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.570.45–0.73
PFS0.50.39–0.64
Primary publication: Ribas A, Puzanov I, Dummer R, Schadendorf D, Hamid O, Robert C, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015;16(8):908-18. PubMedDOI

Appears in

Sources

  1. Ribas A, Puzanov I, Dummer R, Schadendorf D, Hamid O, Robert C, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015;16(8):908-18.

    PubMedDOI