Trial of dinutuximab for small cell lung cancer misses primary endpoint
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The addition of dinutuximab to irinotecan failed to extend OS among patients with relapsed or refractory small cell lung cancer, according to topline data from a randomized phase 2/phase 3 trial released by the agent’s manufacturer.
Dinutuximab (Unituxin, United Therapeutics) is a GD2-binding monoclonal antibody. It is approved in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2 and 13-cis-retinoic acid for treatment of pediatric patients with high-risk neuroblastoma who achieved partial response or better to first-line multiagent, multimodality therapy.
The open-label, multicenter DISTINCT study included 471 patients with relapsed or refractory small cell lung cancer treated at 198 centers in 22 countries in North America, Europe and the Asia-Pacific region.
Researchers randomly assigned patients 2:2:1 to second-line treatment with irinotecan alone (n = 190), irinotecan and dinutuximab (n = 187) or topotecan alone (n = 94).
OS in the dinutuximab-irinotecan group compared with the irinotecan monotherapy group served as the primary objective. Results showed no statistically significant OS benefit with the addition of dinutuximab.
“We thank the principal investigators, patients and their families for participating in the DISTINCT study,” Gil Golden, MD, PhD, chief medical officer of United Therapeutics, said in a company-issued press release. “We're clearly disappointed with the DISTINCT results but we’ll continue to seek out underappreciated avenues in our core therapeutic areas addressing rare diseases in oncology and pulmonary hypertension. In addition, we look forward to announcing the results of our INCREASE study by the end of the first quarter or shortly thereafter.”
Dinutuximab exhibited a safety profile consistent with that observed in prior studies.
Complete data from the DISTINCT study will be submitted for presentation at an upcoming conference and to peer-reviewed publications.