Wednesday, October 27, 2021

ASH: Takeda pads case for new leukemia use with 5-year survival data

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 prior tyrosine kinase inhibitors prior to receiving its Iclusig, more than 50% of those who started on a 45 mg daily dose of the drug and scaled down to a 15 mg daily dose were still alive and hadn’t seen their disease worsen after five years.

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The results come from a subset analysis of the phase 2 Optic trial, which also showed that at the two-year mark, 93% of patients in that same group were still alive and 81% hadn’t seen their cancer progress.

“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.

RELATED: The top 15 pharma companies by 2026 salesTakeda

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 company has already filed a supplemental New Drug Application with the FDA that’s been granted priority review, and “this data sort of helps underpin the submission we have,” Warren said.

RELATED: Takeda shells out whopping $5.2B for Ariad, Iclusig and its fledgling med brigatinib

If Takeda can snag a green light, it will add broaden Iclusig’s use in CML; it’s currently cleared for CML patients for whom no other TKI therapy is indicated. The Japanese pharma picked up the treatment through its 2017 Ariad buy, which saw it lay down $5.2 billion.

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