Argos Therapeutics said today that its lead product candidate rocapuldencel-T is likely to fail a Phase III trial assessing the cancer immunotherapy in combination with Pfizer’s Sutent® (sunitinib malate) and standard-of-care for metastatic renal cell carcinoma (mRCC).
Argos said its disclosure followed a planned interim data review from the Phase III ADAPT trial by the trial’s Independent Data Monitoring Committee. The committee recommended that the study be halted, concluding that it was unlikely to demonstrate a statistically significant improvement in the study’s primary endpoint of overall survival in the combination treatment arm using the intent-to-treat population.
“We are extremely disappointed with these results, which included 75% of the targeted events needed to permit the primary analysis and assessment of overall survival in the study,” Argos president and CEO Jeff Abbey said in a statement.
The company added that it was analyzing the preliminary trial data from ADAPT and plans to discuss the data with the FDA. Argos said it will decide its next steps for the rocapuldencel-T clinical program on the basis of these analyses and discussions.
In the meantime, Argos said it plans to leave the ADAPT trial open.
Rocapuldencel-T is an individualized immunotherapy designed to work by capturing mutated and variant antigens specific to a patient's tumor and inducing an immune response targeting that patient's tumor antigens.
The ADAPT trial evaluating rocapuldencel-T plus sunitinib/standard-of-care therapy versus standard-of-care therapy alone in newly diagnosed mRCC patients began in January 2013 and completed enrollment in July 2015. A total of 462 mRCC patients were randomized.
Investors reacted to the company’s announcement with a sell-off that sent Argos shares down nearly 70% from yesterday’s closing price of $4.40, to $1.33 as of 9:42 a.m.