Study: Nivolumab Plus Ipilimumab May Benefit Patients with Ovarian Cancer

Adding a CTLA4 targeted therapy to a regimen with the checkpoint inhibitor nivolumab could improve tumor response and progression-free survival (PFS) hazard rates for women with current epithelial ovarian cancer, according to a clinical trial analysis.

The trial, NRG-GY003, assessed the difference in tumor response proportions in 100 women between 2 treatment regimens over a 6-month period. Patients were given either nivolumab alone or a combination of ipilimumab and nivolumab followed by maintenance nivolumab.

After 6 months, 12.2% of patients treated with nivolumab alone experienced a tumor response compared with 31.4% of patients treated with the combination regimen. Following a 6-month evaluation period, 1 additional response appeared in the latter treatment group. The platinum-free interval stratified hazard ratio (HR) for PFS was 0.528 (95% Cl 0.339 to 0.821) and the respective HR for death was 0.789 (95% Cl 0.439-1.418).

Additionally, adverse events were more prevalent in the patients treated with the combination regimen, but there were no new safety signals and no treatment-related deaths.

“From my perspective, this is the first evidence that the addition of CTLA4 targeted therapy to the PD-1 targeted therapy in patients with ovarian cancer may be more beneficial than PD-1 targeted therapy alone,” abstract lead author Robert A. Burger, MD, professor of obstetrics and gynecology at the Perelman School of Medicine at the University of Pennsylvania, said in a statement.

The trial was not designed to detect a difference in overall survival and there was no preliminary evidence to indicate a detrimental effect from treatment with the combination regimen.

The results were presented as a late-breaking abstract oral presentation at the 17^th Biennial Meeting of the International Gynecological Cancer Society in Kyoto, Japan.

References

Burger RA, Sill M, Zamarin D, et al. NRG Oncology phase 2 randomized trial of nivolumab with or without ipilimumab in patients with persistent or recurrent ovarian cancer. Abstract presented at the Biennial Meeting of the International Gynecological Cancer Society, Kyoto, Japan.

The Addition of a CTLA4 Targeted Therapy to a PD-1 Targeted Therapy Could Benefit Women with Ovarian Cancer [news release]. NRG Oncology’s website. https://www.nrgoncology.org/Portals/0/News/Press%20Releases/2018/FINAL_NRG-GY003_Press%20Release%209.19.2018.pdf?ver=2018-09-19-085238-407. Accessed September 19, 2018.