Advanced Cervical Cancer: Toxicity Management With Balstilimab + Zalifrelimab

Transcript:

Robert L. Coleman, MD, FACOG, FACS: With respect to adverse events, we fortunately have the benefit of time and experience. When these drugs were first introduced into solid tumor therapy, we were very nervous about the toxicities we might expect and how we might manage them. Many of those initial patients that I treated early on ended up in the hospital for observation. It also wasn’t exactly clear whether an adverse effect was going to emerge as significant enough that it needed to be addressed with treatments that required aggressive intervention, such as steroids or even more aggressive anti-inflammatory medications.

As we learned through that experience and adopted these therapies into cervix cancer, we have become not only more facile in our abilities to educate patients of what to expect, but also what we expect to see for patients on therapy and the timing of when those effects happen. With single-agent balstilimab, we saw an adverse event profile very similar to what we expected to see with other single-agent immune checkpoint inhibitors, with factors such as colitis, hypothyroidism, hyperthyroidism, diarrhea, and the effects of chronic therapy, such as fatigue and asthenia as common events. Fortunately, high-grade events of that nature were low, and most patients were able to stay on therapy without much interruption or discontinuation.

We also knew with respect to the combination of PD-1 and CTLA-4–based therapies that there were proportionately higher rates of all of these same adverse effects that we’re seeing with the combination, but high-grade events that led to treatment discontinuation are still around 10%. Interruption was around 12% and discontinuation was around 7%, which is an average of around 10%. These numbers have been relatively consistent. Fortunately, they’re far reduced from where we started. When I counsel patients on this combination, I usually say that we didn’t see anything new in the terms of safety signals and that the expectations for adverse events are in line with what we’ve previously done, with some of them being relatively early onset and some of them being later onset. The ones that are later onset can also be attributed to longer duration of specific therapy, which in a way is a reflection of efficacy.

Transcript edited for clarity.