Argos Therapeutics was told last year it should stop the phase 3 trial of its kidney cancer vaccine due to futility, but it pressed on, leaving the study open while it examined data with the FDA. Now it is conceding defeat, terminating the trial and mulling options to stay alive, including a sale or merger.
The phase 3 trial tested its candidate rocapuldencel-T in combination with Pfizer's Sutent in patients with newly diagnosed metastatic renal cell carcinoma. In February 2017, an independent data monitoring committee told Argos that, based on an interim analysis, the study was "unlikely to demonstrate a statistically significant improvement in overall survival" in the treatment arm.
It enrolled 462 patients with previously untreated disease, two-thirds of whom were treated with the rocapuldencel-T/Sutent combo, with the remaining third receiving Sutent alone after undergoing cytoreductive nephrectomy, or kidney removal surgery. The four co-primary endpoints were: overall median survival, overall survival for patients who were alive at the time of analysis and at the 12-month mark, and five-year survival.
The combo treatment failed to beat placebo in overall median survival (28.2 months versus 31.2 months), and the overall survival data didn't look good either.
"Based upon review of the interim data, the company does not believe that it would achieve these endpoints if the trial were to be continued," Argos said in a statement.
And that's not all the company reviewed—taking a good look at its "internal programs, resources and capabilities," Argos will consider "a wide range of strategic alternatives," including a merger or a sale. While considering these options doesn't mean the company will actually take any of them, Argos expects to be delisted from the Nasdaq as it will be unable to fulfill the exchange's listing requirements.
Argos nosedived 64% in premarket trading, mirroring the 60% drop from February last year. Rocapuldencel-T joins an ever-growing list of high-promise cancer vaccines that disappointed in the clinic.