A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects With Advanced Recurrent Ovarian Cancer (KEYNOTE-100)

Recurrent ovarian cancer; Cohort A: 1-3 prior therapies, 3-12 months Treatment Free Interval (TFI), Cohort B: 4-6 prior therapies, ≥3 months TFI

376; median 2 prior therapies

Recurrence

Open-Label, Non-randomized

CBR, ORR, DCR, DoR, OS, evaluated per RECIST

Exploratory: PD-L1 protein

ORR: 8.5% (7CR, 25PR, n=376)
DCR: 37.5% (7CR, 25PR, 109SD, n=376)
CBR: 22.1%
DoR: 10.2 months
OS: 18.7 months

Exploratory analysis CPS<1 (n=141) vs CPS ≥1 (n=197) vs CPS ≥10 (n=82):
ORR: 5.0 (7PR) vs 10.2 (7CR, 13PR) vs 17.1% (7CR, 7PR)
DCR: 32.6 (7PR, 39SD) vs 38.1 (7CR, 13PR, 55SD) vs 41.5% (7CR, 7PR, 20SD)

Serious AE: 2 treatment related deaths (1 Stevens-Johnson syndrome, 1 hypoaldosteronism)
Grade 3-4 AE: overall (20.5%)

Modest anti-tumor activity with acceptable safety profile

Matulonis UA et al. Antitumor Activity and Safety of Pembrolizumab in Patients with Advanced Recurrent Ovarian Cancer: Results from the Phase 2 KEYNOTE-100 Study. Ann Oncol (2019) 30: 1080-1087
https://www.ncbi.nlm.nih.gov/pubmed/31046082

Matulonis U et al. Final results from the KEYNOTE-100 trial of pembrolizumab in patients with advanced recurrent ovarian cancer. J Clin Oncol (2020) 38 (suppl; abstr 6005)
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.6005