ASCO 2016: Nivolumab Alone or With Ipilimumab Effective in SCLC

Patients with relapsed small cell lung cancer (SCLC) now have more options according to study results first presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 3–7, 2016, in Chicago (abstract 100). The study, CheckMate 032, was designed to evaluate nivolumab (Opdivo) alone and also combined with ipilimumab (Yervoy) in advanced tumors including SCLC.

Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor already approved for patients previously treated for metastatic non-small cell lung cancer (NSCLC) in the United States and for squamous NSCLC in Europe. Nivolumab plus ipilimumab, a cytotoxic T-lymphocyte antigen-4 immune checkpoint inhibitor (CTLA-4), has shown durable responses in multiple tumor types.

The objective response rate (ORR) for nivolumab alone was 10% among all patients, and when combined with ipilimumab, the response reached 20%; however, toxicity also increased with the combination arms.

“Although this was a small number of patients with a relatively short follow-up, I am excited about it because the early data we are seeing is that immunotherapy is probably going to have a major impact on this disease,” Scott Joseph Antonia, MD, PhD, of Moffitt Cancer Center, said to ASCO Daily News. “What may be distinguishing about immunotherapy is the durability of responses. It is early yet, with just 18 months of follow-up, but we have some patients who responded and remain in response for those 18 months.”

Responses were observed independent of platinum sensitivity and PD-L1 expression.

Of the 180 patients that were enrolled (n = 80, N3; n = 47, N1 + I3; n = 53, N3 + I1), 127 patients in the N3 and N1 + I3 cohorts, 56% received ≥2 prior regimens and 30% were platinum resistant.

Grade 3 and 4 treatment-related adverse events (TRAEs) occurred in 11% of patients in N3 and 32% of patients in N1 + I3; 5% and 13% discontinued due to TRAEs, respectively. One treatment-related death due to myasthenia gravis occurred (N1 + I3 arm).

The researchers concluded that nivolumab monotherapy and nivolumab plus ipilimumab showed durable objective responses and manageable safety, although had higher toxicities observed with the combination therapies, in previously treated SCLC.