Vodobatinib is a new tyrosine kinase inhibitor. It is a drug that is very specific. It has very few off-targets [inaudible] the different BCR-ABL notably those in the [inaudible] receptor. It works against most of the mutants of BCR-ABL, except T315I. It does not work against T315I. The results that are being presented are the results from the Phase I study, particularly, the dose-escalation and dose-expansion component, focusing specifically on the response according to the number of prior TKIs that the patients had received before...
Vodobatinib is a new tyrosine kinase inhibitor. It is a drug that is very specific. It has very few off-targets [inaudible] the different BCR-ABL notably those in the [inaudible] receptor. It works against most of the mutants of BCR-ABL, except T315I. It does not work against T315I. The results that are being presented are the results from the Phase I study, particularly, the dose-escalation and dose-expansion component, focusing specifically on the response according to the number of prior TKIs that the patients had received before. So grouping them into those that had received, at most, two prior TKIs and patients that had received three or more prior TKIs. Also, looking at patients that had received previously ponatinib and patients that had received previously asciminib as more and more we see those patients.
The results are actually very good. The response rate, both looking in terms of a complete cytogenetic response is very good. It happens quickly. By six months, about half of the patients have already achieved a cytogenetic response; and the molecular response, by six months, about a quarter of the patients have achieved a major molecular response. And it continues improving by 24 months to about 35%.
Importantly, the responses are equally good, if anything, perhaps even a little bit better on the more heavily treated patients that have received three or more prior tyrosine kinase inhibitors. Also, it’s very good for patients who have received previously ponatinib. For example, by 24 months, 50% of the patients that had received previously ponatinib already have achieved a major molecular response. These responses tend to be durable, so most of the patients continue on study. Very few patients have discontinued, and yet the duration of cytogenetic and the major molecular response is beyond one year.
Also, very importantly, the drug has been very well tolerated, very minimal toxicity, really no major adverse events, and that includes cardiovascular toxicity. Really, really very minimal. A very well tolerated drug with high efficacy. Even in patients who have received prior ponatinib. This is important because there’s an ongoing Phase II study that’s precisely targeting those patients that have received multiple TKIs, including ponatinib. We’re very hopeful that that study will demonstrate that efficacy and, hopefully, lead to the approval of this drug.
