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By: scienterrific | Last updated: 7 October 2018 | In: Gynaecological Cancer, Oncology, Chemotherapy, Immunotherapy
Article Keywords
Oncology, PD-1, Targeted Therapy, nivolumab, ipilimumab, gynecology, BMS, chemotherapy, CTLA4
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.
IPI is an immune-checkpoint inhibitor targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA4) whereas NIVO is a programmed death 1 (PD-1) directed immune-checkpoint inhibitor.
“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.
References
Burger RA, International Gynecologic Cancer Society Meeting 2018; Abstract OC11
The ASCO Post http://www.ascopost.com/News/59329
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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).
© Copyright 2018 MediPaper Medical Communications Ltd. – Ipilimumab plus nivolumab for persistent or recurrent ovarian cancer
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© Copyright 2018 MediPaper Medical Communications Ltd. – Ipilimumab plus nivolumab for persistent or recurrent ovarian cancer
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