Rocapuldencel-T Improves Survival in Renal Cell Carcinoma Patients, Phase 3 Trial Suggests

Rocapuldencel-T Improves Survival in Renal Cell Carcinoma Patients, Phase 3 Trial Suggests

Adding Rocapuldencel-T (AGS-003) to standard-of-care treatment may lengthen the survival of patients with newly diagnosed metastatic renal cell carcinoma, according to data presented at the European Society for Medical Oncology (ESMO) 2017 Congress, in Madrid, Spain, and reported in a press release.

The poster was titled, “Interim Analysis of the Phase 3 ADAPT Trial Evaluating Rocapuldencel-T (AGS-003), an Individualized Immunotherapy for the Treatment of Newly-Diagnosed Patients with Metastatic Renal Cell Carcinoma (mRCC).” It gathered data from the ongoing ADAPT Phase 3 trial (NCT01582672).

Rocapuldencel-T, developed by Argos Therapeutics, is a promising immunotherapy created with information for each patient’s tumor and their own dendritic cells, which are key cells in the immune system. Using RNA molecules from the tumor, researchers activate the patient’s immune cells, inducing them to attack cells with that unique molecular signature.

The strategy also triggers the production of memory immune cells, giving long-term efficacy to the therapy.

Conducted in North America, Europe, and Israel, the multicenter ADAPT trial enrolled 462 mRCC patients eligible for surgical kidney removal. Participants were randomized to receive rocapuldencel-T plus standard-of-care therapy or standard-of-care alone. Rocapuldencel-T was given in eight injections during the first year followed by quarterly boosters.

After a median follow-up of 20 months, the majority of patients in both treatment groups were still alive. No survival benefit was seen among the overall population. Median overall survival was 27.7 months in the rocapuldencel-T group compared with 32.4 months in the control group.

But data from patients with the longest follow-up suggest a potential benefit for the combination. Among the first 102 participants receiving the combination, and 52 patients receiving control treatment, rocapuldencel-T increased survival from 22.2 months to 30.1 months.

The researchers observed a statistically significant association between overall survival and increased number of memory immune cells in the 114 patients who had received seven doses of rocapuldencel-T.

The drug was well-tolerated and had a safety profile consistent with previous reports from a Phase 2 trial (NCT00272649).

In February, the trial’s Independent Data Monitoring Committee recommended the study be halted because the predetermined survival benefit had not been reached by the third interim analysis.

But based on the overall safety and survival data demonstrated to date, as well as the drug’s mechanism of action, which involves the production of memory immune responses, the U.S. Food and Drug Administration agreed to keep ADAPT open. Additional data are expected during the first half of 2018.