Disis ML, et al. - In a cohort of patients with previously treated recurrent or refractory ovarian cancer, researchers evaluated the effectiveness and safety of avelumab, an anti–programmed death-ligand 1 agent. According to phase 1b data from the JAVELIN Solid Tumor trial, avelumab showed antitumor activity and acceptable safety in patients with recurrent or refractory ovarian cancer who were heavily pretreated.

Methods

• Between November 6, 2013, and August 27, 2015, 125 patients with advanced ovarian cancer who had received chemotherapy including a platinum agent were recruited.
• From December 31, 2016, to October 9, 2018, statistical analysis was performed.
• Main intervention included patients received avelumab, 10 mg/kg, every 2 weeks until disease progression, unacceptable toxic effects, or withdrawal from the study.
• In this cohort, prespecified end points included confirmed best overall response (per Response Evaluation Criteria In Solid Tumors, version 1.1), immune-related best overall response, duration of response, progression-free survival, overall survival, results of programmed death-ligand 1 expression–based analyses, and safety.

Results

• The study included a total of 125 women (median age, 62.0 years [range, 27-84 years]) who received a median of 3 prior lines of treatment (range, 0-10) for advanced disease.
• Patients received avelumab for a median of 2.8 months (range, 0.5-27.4 months), with a median 26.6 months (range, 16-38 months) follow-up.
• There was a confirmed objective response in 12 patients (9.6%; 95% CI, 5.1%-16.2%), including a complete response in 1 patient (0.8%) and a partial response in 11 patients (8.8%).
• It was noted that the 1-year progression-free survival rate was 10.2% (95% CI, 5.4%-16.7%) and median overall survival was 11.2 months (95% CI, 8.7-15.4 months).
• Infusion-related reactions occurred in 25 patients (20.0%).
• Fatigue (17 [13.6%]), diarrhea (15 [12.0%]), and nausea (14 [11.2%]) were other frequent treatment-related adverse events (any grade event occurring in ≥10% of patients).
• Investigators found that grade 3 or higher treatment-related adverse events occurred in 9 patients (7.2%), of which only the level of lipase increased (3 [2.4%]) occurred in more than 1 patient.
• They observed that 21 patients (16.8%) had an immune-related adverse event of any grade.
• There were no treatment- related deaths.