Argos Surges on Positive Phase III Kidney Cancer Data
By Alex Keown
Investors in beleaguered Argos Therapeutics are smiling this morning after the company announced some positive interim data for its Phase III kidney cancer drug, Rocapuldencel-T – a trial that some said should have been scrapped months ago.
Argos said data presented in a poster session at the Society for Immunotherapy of Cancer meeting in Maryland showed that administration of Rocapuldencel-T demonstrated statistically significant results in treating patients with metastatic renal cell carcinoma.
The interim data comes nearly nine months after the Independent Data Monitoring Committee for the Phase III ADAPT clinical trial recommended Argos discontinue the study. After an analysis of the data, the committee said they did not feel it was likely to show a statistically significant improvement in overall survival in the combination treatment arm. The move forced Argos to cut its staff by 38 percent. However the company wasn’t so sure it should cease the trial. It opted to continue the study based on several factors including “the degree of maturity of the data set, the mechanism of action of Rocapuldencel-T, which involves the induction of a long-term memory immune response, and the IDMC’s assessment of the safety profile of Rocapuldencel-T.” The company met with the U.S. Food and Drug Administration about continuing the trial. The FDA agreed that Argos could continue the trial based on its protocols.
It seems that Argos’ decision to stick with its therapy is paying off – for now. And investors are in agreement. Shares of Argos were up more than 35 percent this morning, hitting a high of 27 cents per share. However the stock is nowhere near recovering the losses it saw following the February recommendation to shut down the Phase III trial. At that time, shares of Argos were trading at $5.20 per share.
“As we have conducted additional analyses of the immunology data from the February 2017 interim analysis, we have been pleased to see that the data are generally supportive of our hypothesis regarding the intended mechanism of action of Rocapuldencel-T to induce an immune response against the tumor in patients with metastatic renal cell carcinoma. While we await further data from the next planned interim data analysis that we expect to be conducted during the first half of 2018, pending agreement with the FDA on a revised protocol that we plan to submit, we are encouraged to see these positive indicators of activity,” Charles Nicolette, chief scientific officer of Argos Therapeutics said in a statement.
In Argos’ poster presentation, the company said subjects for whom immune response data were analyzed, the number of antigen-specific memory T-cells was found to increase only after administration of Rocapuldencel-T. Argos said patients who received at least seven doses of its treatment saw a near doubling of antigen-specific memory T-cells after the seventh dose. Argos said this supports and builds on data presented earlier this fall at the European Society for Medical Oncology in Spain.
Argos has paired Rocapuldencel-T with sunitinib for the treatment of metastatic renal cell carcinoma in the Phase III trial. The study compares the combination treatment against sunitinib alone.
But, the news got a little bit better, Argos said. For those subjects who received seven doses of Rocapuldencel-T, there was a “statistically significant correlation” between survival and the change in the number of antigen-specific memory T-cells from baseline.