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ESMO 2017: Rocapuldencel-T in Metastatic Renal Cell Carcinoma

Posted: Thursday, September 14, 2017

A novel individualized immunotherapeutic agent, rocapuldencel-T, demonstrated a potential survival benefit in patients with newly diagnosed metastatic renal cell carcinoma, according to interim results from the phase III ADAPT trial, presented by Robert Figlin, MD, of Cedars-Sinai Medical Center, Los Angeles, at the 2017 European Society for Medical Oncology (ESMO) Congress (Abstract 1137O).

The study included 462 patients with synchronous, clear cell metastatic renal cell carcinoma who were eligible for nephrectomy at 107 sites across North America, Europe, and Israel. Patients were randomized 2:1 to receive either rocapuldencel-T plus the standard of care or the standard of care alone.

At a median follow-up of 20 months, the majority of patients in both treatment groups were still alive. A review of the data from the first third of patients randomized (n=154) suggests “a potential survival benefit for the combination worthy of further assessment,” the investigators reported. The treatment combination also resulted in a statistically significant association between overall survival and an increase in the number of rocapuldencel-T–induced memory T cells.

Although trial discontinuation was advised in February 2017 because the overall survival hazard ratio in the treatment arm was greater than the predefined futility boundary, the investigators plan to further assess the long-term effects of this immunotherapy.