Dr. Malhotra on the Safety Profile of Plinabulin/Nivolumab/Ipilimumab in Relapsed SCLC

Jyoti Malhotra, MD, MPH, medical oncologist, Rutgers Cancer Institute of New Jersey, assistant professor of medicine, Robert Wood Johnson Medical School, discusses the safety profile of plinabulin in combination with nivolumab (Opdivo) and ipilimumab (Yervoy) in relapsed/refractory small cell lung cancer (SCLC).

The results of a phase 1 study (NCT03575793), which were presented during the 2021 ASCO Annual Meeting, demonstrated that the combination of plinabulin, nivolumab, and ipilimumab was safe and well tolerated among 16 patients with extensive-stage SCLC who had progressed on or after prior platinum-based chemotherapy.

The maximum tolerated dose of plinabulin was 30 mg/m², says Malhotra. Regarding safety, 50% of patients experienced at least 1 grade 3 or higher treatment-related adverse effect (TRAE). The most common TRAEs were nausea, infusion-related reactions, vomiting, diarrhea, and fatigue.

Immune-related AEs (irAEs) were rare; 1 patient each had grade 3 or higher colitis, transaminitis, and elevated lipase, Malhotra explains. Notably, these AEs were resolved with steroids, Malhotra adds. It is hypothesized that because plinabulin inhibits phosphodiesterase-4, it can mitigate some of the irAEs associated with checkpoint inhibitors, concludes Malhotra.