Safety profile as expected
Treatment-related adverse events were reported for most patients (64/71, 90.1%), with grade 3-4 events in about half (50.7%). The most common event was grade 1-2 nausea (40.8%), with anemia at 32.4% and alanine aminotransferase (ALT) increases and fatigue both at 28.2%. Adverse events led to discontinuation in 23.9% of patients, with anemia and increased ALT leading both at 4.2%. Grade 3-4 adverse events led to discontinuation in 15.5% of patients. Investigators reported no treatment-related deaths. “The safety profile of nivolumab plus rucaparib was as expected based on the individual components with no new safety signals,” Dr. Petrylak said.
Longer follow-up is needed, Dr. Petrylak added, to better characterize the clinical benefits of adding nivolumab to rucaparib for this population.
Discussion moderator Guilia Baciarello, MD, Milan, asked how much nivolumab added to the rucaparib benefit. Dr. Petrylak responded, “We really can’t determine how much it’s adding because the single-agent data, particularly with the checkpoints, is generally very low. I can’t recall any published data with nivolumab as a single agent, but for example with pembrolizumab or atezolizumab in unselected patients it’s 5%-10%. So, we really can’t tell how much nivolumab added in the BRCA positive patients.”
Dr. Baciarello asked, “Will there be a nivolumab versus rucaparib trial in HRD positive patients?”
“I think that’s something that needs to be considered. I think we may also want to consider doing a broader phase II in that group of patients to really nail down the signal. That’s under discussion,” Dr. Petrylak said.
The study was funded by Bristol Myers Squibb. Dr. Petrylak disclosed numerous financial interests including personal and consulting fees.
This article was updated Sept. 24, 2021.