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Ipilimumab plus nivolumab for persistent or recurrent ovarian cancer
By: News Feed | Last updated: 7th October 2018 | In: Chemotherapy, Gynaecological Cancer, ImmunoOncology, Oncology
BMS, chemotherapy, CTLA4, gynecology, ipilimumab, nivolumab, Oncology, PD-1, Targeted Therapy
Adding ipilimumab (IPI [Yervoy®, Bristol-Myers Squibb]) to nivolumab (NIVO [Opdivo®, Bristol-Myers Squibb]) induction followed by maintenance with single-agent NIVO had a superior objective tumour response rate and progression-free survival (PFS) when compared to NIVO alone in patients with persistent or recurrent epithelial ovarian cancer. The results of the NRG-GY003 trial were presented at the 17th Biennial Meeting of the International Gynecologic Cancer Society (IGCS) in Kyoto, Japan.
“From my perspective, this is the first evidence that the addition of CTLA4–targeted therapy to PD-1–targeted therapy in patients with ovarian cancer may be more beneficial than PD-1–targeted therapy alone. Future directions could include a trial combining NIVO and IPI in front-line therapy as an adjunct to standard chemotherapy”
Robert A. Burger, MD
The Phase II, multicentre, open-Label NRG-GY003 (NCT02498600) trial allocated 100 women with persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer to receive NIVO (treatment arm 1 [TA1]) or induction IPI plus NIVO followed by maintenance NIVO (treatment arm 2 [TA2]). All participants had measurable disease, received 1-3 prior cytotoxic regimens, and had a platinum-free interval (PFI) <12 months. The primary endpoint was the objective tumour response rate (RECIST 1.1), and secondary endpoints included PFS, overall survival (OS), and adverse events (AEs).
Forty-nine women received treatment in TA1 and 51 women in TA2. The median age was 62 years, 82% had high-grade serous histology, and 63% had a PFI <6 months. Within 6 months of randomisation, 12.2% (6/49) of responses occurred in TA1 whereas 31.4% (16/51) of responses occurred in TA2 (OR=3.28; 85% CI >1.90). In the following 6 months, one more response was noted in TA2. The PFI stratified hazard ratio for PFS was 0.528 (95% CI, 0.339-0.821) with a respective hazard ratio for death of 0.789 (95% CI, 0.439-1.418).
No new safety signals were found. Grade ≥3 AEs occurred more often in TA2; 61 patients experienced Grade ≥3 AEs, 55% (27/49) of patients in TA 1 and 67% (34/51) of patients in TA2. No treatment-related deaths were reported.
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This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).