Argos Therapeutics’ hopes of bringing lead cancer immunotherapy rocapuldencel-T to market anytime soon have been dashed after it flunked a pivotal phase III trial.
The independent data monitoring committee in the ADAPT study of the drug in patients with metastatic renal cell carcinoma (RCC) recommended that the trial be discontinued as there was little chance that Argos’ drug would meet its targets.
Rocapuldencel-T, a personalised immunotherapy that uses individual patients’ tumour antigens to stimulate the immune system against the cancer, was being tested as an add-on to standard therapy with Pfizer’s Sutent (sunitinib) and standard care in 462 RCC patients.
While the therapy was well-tolerated, it was “unlikely to demonstrate a statistically significant improvement in overall survival”, the trial’s primary endpoint, according to a company statement. The result adds to the growing list of failures among cancer vaccine candidates.
Shares in Argos lost two-thirds of their value after the news broke as investors grew concerned about the potentially broader implications on the company’s Arcelis individualised immunotherapy platform, which underpins its entire pipeline. An earlier programme in HIV failed to hit the mark in a phase II trial reported in 2015.
“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,” said Argos’ CEO Jeff Abbey.
The company said that the trial will remain open while it conducts additional analyses and has discussions with the FDA, adding that it will decide the next steps in the clinical development programme for rocapuldencel-T in the coming weeks.
The company provided no additional information on a conference call, and seems the result has come out of left field as just weeks ago Argos was buoyant about the prospects for rocapuldencel-T, announcing plans to take a lease on 40,000 sq. ft. of manufacturing space in January to support future domestic and international launches of its therapies.