A Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments And/Or Combinations of Treatments in Participants With Ovarian Cancer (OPAL)

Platinum resistant or refractory ovarian cancer with no prior PARP inhibitor or PD-1/PD-L1 inhibitor

41; median 2 prior therapies; 44% primary platinum resistant; 90% BRCA WT or unknown; 83% w/o HRR gene mutations or unknown

Recurrence

Open-Label, Non-randomized

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

Exploratory: prior Bev

ORR: 17.1% (1CR, 6PR)
DCR: 73.2% (1CR, 6PR, 23SD)
PFS: 7.9 months
DoR: 11.8 months
OS: 22.1 months

Exploratory analysis: prior Bev:
w/ prior bev (n=17): ORR: 6%
w/o prior bev (n=22): ORR: 27%

Serious AE: thrombocytopenia (7.3%), anemia (4.9%), hypertension (4.9%)
Grade 3-4 AE: hypertension (26.8%), fatigue (17.1%), anemia (17.1%), 1 grade 4 bowel perforation assessed as related to Bev

Triplet therapy with niraparib, dostarlimab, and bevacizumab is tolerable and demonstrates moderate clinical activity in patients with BRCA WT platinum resistant ovarian cancer

Liu JF et al. Niraparib, Dostarlimab, and Bevacizumab as Combination Therapy in Pretreated, Advanced Platinum-Resistant Ovarian Cancer: Findings From Cohort A of the OPAL Phase II Trial. JCO Precis Oncol (2024) 8:e2300693
https://pubmed.ncbi.nlm.nih.gov/38754056/