In the interview with Allen Wilbanks of OncologyTube, Peter Langmuir, the Vice President of Oncology Drug Development at Incyte, discussed the Agave 201 trial and its outcomes. Mr. Langmuir explained, “The Agave 201 trial was a clinical trial in patients with chronic GVHD, looking at the drug axatilimab, a monoclonal antibody against the CSF1 receptor. That was originally developed by our partners at syntax. And this trial was initiated by them to do two things. First of all, one was to try to identify the most appropriate dose of axatilimab to use in these patients based on both safety and efficacy, but also to have a sufficient number of patients that could potentially use the trial to be used as a pivotal trial to support registration.”
Regarding the overall response rates in the Agave 201 trial, Mr. Langmuir noted, “All three of the cohorts met the primary endpoint of overall response rate. So in other words, for each of the three dose levels, the lower bound of that 95% confidence interval was greater than 30%. The actual response rates by cycle seven, day one. So the primary endpoint at the 0.3 milligram per kilogram dose level was 74%. For the one milligram per kilogram dose, it was 67%. And for the three milligram per kilogram dose, it was 50%.”
He also discussed the durability of responses, stating, “Our estimate right now is that 60% of the patients who responded at the 0.3 milligram per kilogram dose level have continued to maintain their response at 12 months.”
When asked about the potential benefits of axotelimab for patients who received multiple prior lines of therapy, Mr. Langmuir emphasized, “The fact that we were able to have a high proportion of patients experiencing response to this drug again really supports the idea that this is a different mode of action that’s providing different benefits to these patients.”
Regarding safety, he mentioned, “The safety profile was very similar to what we saw in the phase one-two trial… So overall, it seemed to be generally fairly well tolerated, particularly at the 0.3 milligram per kilogram dose.”
Mr. Langmuir also discussed future plans, saying, “We’re going to be looking to see if there are opportunities beyond that as well.”
In summary, Peter Langmuir discussed the Agave 201 trial, its positive outcomes, and the potential of axatilimab as a treatment option for patients with chronic GVHD, highlighting its differentiated mode of action and potential benefits for heavily pre-treated patients.