(Ovarian Cancer) Is Opdivo + Yervoy Effective?
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On April 10, 2020, Dmitriy Zamarin published in the Journal of Clinical Oncology the "Efficacy and Safety Results of Combined Anti-PD-1 Antibody Opdivo (nivolumab) Plus Anti-CTLA-4 Antibody Yervoy (ipilimumab) in Previously Treated, Recurrent Ovarian Cancer Patients in a Phase II Clinical Trial."
This Phase II clinical trial randomly assigned previously treated, recurrent ovarian cancer patients in a 1:1 ratio to:
- Opdivo monotherapy group (every 2 weeks, N=49)
- Opdivo + Yervoy group (4 cycles every 3 weeks, then Opdivo monotherapy every 2 weeks as maintenance for up to 42 cycles, N=51)
The primary endpoint was the response rate within 6 months, and secondary endpoints were progression-free survival and overall survival.
This trial was initiated because the objective response rate for anti-PD-1 antibody Opdivo in previously treated recurrent ovarian cancer patients was 8-10% with median PFS of approximately 2 months, while combining anti-PD-1 and anti-CTLA-4 antibody drugs was confirmed to increase antitumor efficacy.
Trial results:
- Primary endpoint — response rate within 6 months: Opdivo monotherapy 12.2% vs. Opdivo + Yervoy 31.4%
- Secondary endpoint — median PFS: Opdivo monotherapy 2 months vs. Opdivo + Yervoy 3.9 months, with a 47% reduction in PFS risk in the Opdivo + Yervoy group, showing significant improvement. The 6-month PFS rates were 16.3% vs. 25.5%.
- Median OS: Opdivo monotherapy 21.8 months vs. Opdivo + Yervoy 28.1 months, with a 21% reduction in OS risk in the Opdivo + Yervoy group.
Safety: Grade 3 or higher adverse event rates: Opdivo monotherapy 33% vs. Opdivo + Yervoy 49%. Grade 3 or higher adverse events observed in the Opdivo + Yervoy group included elevated pancreatic enzymes, elevated liver enzymes, anemia, colitis, and diarrhea.
Based on the Phase II trial results, Dmitriy Zamarin concluded: "Combined anti-PD-1 antibody Opdivo plus anti-CTLA-4 antibody Yervoy in previously treated, recurrent ovarian cancer patients showed sustained antitumor effects with significantly improved progression-free survival. The adverse event profile was consistent with those observed in other clinical trials."
Source: Randomized Phase II Trial of Nivolumab Versus Nivolumab and Ipilimumab for Recurrent or Persistent Ovarian Cancer: An NRG Oncology Study (J Clin Oncol. 2020 Apr 10:JCO1902059. doi: 10.1200/JCO.19.02059.)
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