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Argos' cancer treatment study recommended to be discontinued for futility

PBR Staff Writer Published 23 February 2017

An independent data monitoring committee (IDMC) has recommended Argos Therapeutics to halt the clinical trial of rocapuldencel-T cancer vaccine candidate, as it is unlikely to meet the primary endpoint.

The phase 3 ADAPT clinical trial, which is assessing rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of metastatic renal cell carcinoma (mRCC), has been concluded as futility based on the interim data analysis.

According to IDMC, the study is not likely to show a statistically significant improvement in overall survival in the combination treatment arm, utilizing the intent-to-treat population, which is primary endpoint of the trial.

Rocapuldencel-T is an individualized immunotherapy, which is designed to capture mutated and variant antigens that are specific to each patient's tumor and induce an immune response targeting that patient's tumor antigens.

From January 2013 to July 2015, the company had recruited newly diagnosed 462 mRCC patients in ADAPT trial to assess rocapuldencel-T plus sunitinib/standard-of-care therapy against standard-of-care therapy alone.

The rocapuldencel-T has been generally well-tolerated in the trial, said the IDMC.

Argos, along with its clinical and scientific advisors, is evaluating the preliminary ADAPT trial data set to share data with the US Food and Drug Administration (FDA). 

The company intends to stop the trial, while conducting ongoing data review and discussions with FDA.

Argos will take the next step on the trial program, based on the analyses and discussions.

Argos Therapeutics president and CEO Jeff Abbey said: "We are extremely disappointed with these results, which included seventy-five percent of the targeted events needed to permit the primary analysis and assessment of overall survival in the study.

"We sincerely appreciate the patients and investigators who have participated in the ADAPT Phase 3 trial, and remain convinced in the ability of precision immunotherapy to improve the lives of patients."

Image: Argos Therapeutics’s cancer vaccine candidate is unlikely to meet the primary endpoint. Photo: courtesy of jk1991 /