About one-third of chronic myeloid leukemia (CML) patients don’t survive past the five-year mark, in part thanks to built-up resistance to treatment options. And that’s a stat Takeda’s trying to change.
The drugmaker Monday unveiled data showing that among patients who had already tried two or more tyrosine kinase inhibitors (TKIs), more than 60% of those who started on a 45-mg daily dose of Iclusig were still alive and hadn’t seen their disease worsen after five years.
A separate subset analysis showed that among patients in the 45 mg daily starting dose cohort who scaled that dose down to 15 mg after seeing a benefit, 93% were still alive and 81% hadn’t seen their cancer progress at the two-year mark.
“In totality these data collectively really paint a very strong picture of the efficacy in the resistant population that Iclusig has,” said Dion Warren, vice president and head of Takeda’s U.S. oncology business unit.
Importantly, the drug showed it could spur benefits in patients who had specific mutations—who are typically harder to treat—as well as patients who didn’t, Warren noted.
Those mutations develop frequently in CML patients, who “typically stay on therapy for quite a long time,” he said, adding that, for that reason, it’s “terribly important … for the physician to be able to have a medicine that works in both those patient populations.”
Takeda is hoping regulators find the data equally impressive. The FDA has granted priority review for an Iclusig label update, and “this data sort of helps underpin the submission we have,” Warren said.
If Takeda can snag that green light, it will broaden Iclusig’s use in CML; it’s currently cleared for CML patients ineligible for other TKI options. The Japanese pharma picked up Iclusig in 2017 through its $5.2 billion Ariad buy.
Editor's note: This story has been updated to reflect that the Iclusig data presented at ASH came from two separate analyses.