No survival benefit with nivolumab vs. chemotherapy in platinum-resistant ovarian cancer
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Nivolumab did not improve overall survival compared with gemcitabine or pegylated liposomal doxorubicin in platinum-resistant ovarian cancer; however, it was better tolerated, according to results presented at ESMO Virtual Congress 2020.
“Currently, no treatment for platinum-resistant ovarian cancer shows sufficient efficacy; therefore, there is a high demand for novel treatment,” Kohei Omatsu, MD, PhD, from The Cancer Institute Hospital of JFCR, Tokyo, Japan, said during a presentation. “A phase 2 study has shown promising results with nivolumab therapy, reporting an overall response rate of 15%, including two patients with durable complete responses and an encouraging safety profile.”
In this multicenter, open-label randomized phase 3 study, researchers compared OS, PFS and safety between nivolumab vs. chemotherapy, either gemcitabine or pegylated liposomal doxorubicin (GEM/PLD).
Investigators randomly assigned 316 patients with platinum-resistant (advanced or recurrent) ovarian cancer and no prior GEM/PLD treatment to nivolumab (Opdivo, Bristol-Myers Squibb; IV 240 mg every 2 weeks) or GEM/PLD (GEM 1000 mg/m2 for 30 minutes on days 1, 8 and 15, then every 4 weeks; or PLD 50 mg/m2 every 4 weeks). They first stratified patients for histological type (clear cell carcinoma vs. others) and number of prior chemotherapy regimens after diagnosis of resistance (0 or 1), according to the abstract.
Treatment continued until disease progression or unacceptable toxicity. The researchers evaluated tumors every 8 weeks through week 48, then every 12 weeks.
Analysis indicated no statistically significant difference between nivolumab and GEM/PLD in OS (HR = 1.03; 95% CI, 0.8-1.3); median OS was 10.12 months with nivolumab and 12.09 months with chemotherapy. PFS was similar between the groups as well (HR = 1.46; 95% CI, 1.15-1.85); median PFS was 2.04 months with nivolumab and 3.84 months with GEM/PLD.
“Although our study did not demonstrate superior efficacy of nivolumab compared with GEM or PLD in patients with platinum-resistant ovarian cancer, nivolumab was better tolerated than chemotherapy. Among patients who did respond, the duration of response was longer with nivolumab than with GEM or PLD,” Omatsu said.
The researchers found that the rate of treatment-related grade 3/4 adverse events higher with GEM/PLD compared with nivolumab (68.4% vs. 22.4%) and there was no difference in the toxicity profile of nivolumab from that previously reported.“Nivolumab may be a promising treatment option for patients with clear cell carcinoma, although further investigation is required to confirm this,” he concluded.
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Omatsu K, et al. Abstract 807O. Presented at: European Society for Medical Oncology Virtual Congress 2020; Sept. 19-21, 2020.
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