In a Phase 2 clinical trial, the combination of ROCAPULDENCEL-T (AGS-003) plus sunitinib was associated with a median Overall Survival that was two times longer than has been reported in independent studies of sunitinib and other targeted therapies alone in patients with newly diagnosed advanced RCC. In this trial, ROCAPULDENCEL-T (AGS-003) was well tolerated with no serious adverse events attributed to ROCAPULDENCEL-T (AGS-003). It was successfully produced at a central manufacturing facility, with delivery to multiple clinical trial sites throughout North America.
We have continued the development of ROCAPULDENCEL-T (AGS-003) for the treatment of RCC and other cancers. Currently, the Phase 3 ADAPT trial of ROCAPULDENCEL-T (AGS-003) in combination with sunitinib / targeted therapy is ongoing for the treatment of newly diagnosed patients with advanced RCC, versus sunitinib/targeted therapy alone, in a protocol developed under Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). We opened the ADAPT trial for enrollment in January 2013 and dosed the first patient in May 2013. In July 2015 we completed enrollment in the trial, enrolling 462 patients with the goal of collecting 290 events for the primary endpoint of overall survival. We enrolled these patients at 107 clinical sites in North America, Europe and Israel. Under the trial protocol, these patients were randomized to the combination treatment arm (ROCAPULDENCEL-T (AGS-003) plus sunitinib / targeted therapy) or the standard-of-care treatment arm (sunitinib / targeted therapy alone) on a two-to-one basis.
Based upon the actual rate of enrollment and projected event rate as defined in the protocol, we anticipate having a sufficient number of events to permit the primary analysis and assessment of overall survival to occur in the first half of 2017. In June 2016, the independent data monitoring committee, or IDMC, for the ADAPT trial recommended that the ADAPT trial continue based on results of the IDMC’s scheduled interim review of the safety and efficacy data. The next IDMC meeting is planned to occur in February 2017.
We are also supporting investigator-initiated Phase 2 trials in patients with early stage RCC and non-small cell lung cancer, and plan to support investigator-initiated trials of ROCAPULDENCEL-T (AGS-003) in muscle invasive bladder cancer and in combination with checkpoint inhibitors in RCC.
Argos is not presently supporting an Expanded Access Program (EAP) for its immunotherapy platform. An EAP is planned to be initiated based on positive data from our ongoing Phase 3 ADAPT trial of Rocapuldencel-T (AGS-003) in advanced renal cell carcinoma (RCC) in parallel with finalizing our Biologics Licensing Application (BLA) to the Food and Drug Administration (FDA) for regulatory approval. Specific information regarding the initiation of an EAP, including contact information, request process, criteria and timelines, will be posted on our website at that time.