A second interim analysis of
In ADAPT, 462 patients with previously untreated advanced or metastatic renal cell carcinoma (mRCC) were randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib versus sunitinib monotherapy, after undergoing cytoreductive nephrectomy.
In February 2017, the trial’s Independent Data Monitoring Committee had reviewed the data and concluded that the trial was unlikely to demonstrate a statistically significant improvement in median overall survival in the combination arm and recommended halting the trial. However, the principal investigators and the company, Argos Therapeutics, considered the data too immature to observe the delayed effects associated with immunotherapy and decided to continue the trial. They submitted a protocol amendment to the Food and Drug Administration adding additional co-primary endpoints, and in April of last year, met with the Food and Drug Administration, which accepted the amendment and agreed to continuation of the trial, according to a company press release issued in November.
In the latest interim analysis, which was conducted following an additional 51 deaths, median overall survival for the intent-to-treat patient population was 28.2 months for the combination arm (95% confidence interval, 23.4, 35.2) compared with 31.2 months (95% CI, 23.0, 44.5) for the control arm; this was one of four new co-primary endpoints. The hazard ratio was 1.10 (95% CI, 0.85, 1.42).
Other co-primary endpoints that were evaluated, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, did not demonstrate a favorable result, Argos Therapeutics said in a recent press release.
Rocapuldencel-T “consists of autologous dendritic cells programmed with amplified RNA from a patient’s primary tumor” and is “designed to overcome immunosuppression and induce broadly reactive, long-lasting anti-tumor memory T cells” according to the early interim analysis presented at the European Society for Medical Oncology (ESMO) 2017. The drug is also being evaluated in non–small cell lung cancer and bladder cancer.