Phase 2 Multicohort Study to Evaluate the Safety and Efficacy of Novel Treatment Combinations in Patients With Recurrent Ovarian Cancer

Trial ID # NCT03574779; OPAL
Phase II
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Niraparib
Alternate Drug Names MK4827, Zejula
Drugs in Trial Bevacizumab, Niraparib, Dostarlimab
Eligible Participant

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

Patients Enrolled

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

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, PFS, evaluated per RECIST

Biomarkers

Exploratory: prior Bev

Efficacy

ORR: 17.9% (7PR, n=39)
DCR: 76.9% (7PR, 23SD, n=39)
PFS: 7.6 months

Exploratory analysis: prior Bev:
w/ prior bev (n=17): ORR: 6% (1PR)
w/o prior bev (n=22): ORR: 27% (6PR)

Clinically Significant Adverse Events

Serious AE: thrombocytopenia (7.3%), anemia (4.9%), hypertension (4.9%)
Grade 3-4 AE: hypertension (22.0%), fatigue (17.1%), anemia (17.1%), 1 grade 4 bowel perforation assessed as related to Bev

Conclusion

Triplet therapy with niraparib, dostarlimab, and bevacizumab is tolerable and demonstrates clinical activity in patients with BRCA WT platinum resistant ovarian cancer without HRR gene mutations

Reference

Liu J et al. An open-label phase II study of dostarlimab (TSR-042), bevacizumab (bev), and niraparib combination in patients (pts) with platinum-resistant ovarian cancer (PROC): Cohort A of the OPAL trial. SGO (2021) abstract 10415
https://www.clearityfoundation.org/wp-content/uploads/2021/03/SGO-10415-Liu-OPAL-NirBevDos.pdf

Liu J et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2021/03/SGO-OPAL-poster.pdf

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