- Avelumab shows antitumor activity and acceptable safety in heavily pretreated patients with recurrent or refractory ovarian cancer who progressed on platinum-based chemotherapy.
- Responses were irrespective of programmed death-ligand 1 (PD-L1) and BRCA status.
Why this matters
- Standard therapies for platinum-resistant or -refractory disease show limited benefits.
- Findings warrant further evaluation.
- Phase 1b, open-label JAVELIN Solid Tumor study of 125 patients with heavily pretreated recurrent or refractory ovarian cancer who progressed on platinum-based chemotherapy.
- Funding: Merck KGaA, Darmstadt, Germany.
- Patients received median 3 lines of prior chemotherapy.
- Objective response rate (ORR) was 9.6% and immune-related ORR was 12.8%.
- 8.8% of patients had partial responses and 0.8% had complete response.
- Disease control rate was 52.0%.
- Median time to response was 8.9 weeks and median duration of response was 10.4 months.
- Median PFS was 2.6 (95% CI, 1.4-2.8) months and OS was 11.2 (95% CI, 8.7-15.4) months.
- ORR in patients with PD-L1-positive and -negative tumors was 11.8% and 7.9%, respectively.
- ORR in patients with BRCA-mutated and -wildtype tumors was 12.5% and 7.9%, respectively.
- Treatment-related adverse event (AE) rate: any grade, 68.8%; grade 3-4, 7.2%.
- 33.6% of patients reported serious AEs.
- 20.0% of patients experienced infusion-related AEs and 16.8% had immune-related AEs.
- Other common any-grade AEs were fatigue (13.6%), diarrhea (12.0%), and nausea (11.2%).
- Single-arm design.