After starring at ASH last fall, Gilead’s new Forty Seven crew colors in more promising data for magrolimab at ASCO
We now know the full, early-stage story behind the drug that inspired Gilead CEO Dan O’Day’s recent $5 billion acquisition of Forty Seven.
Following up on their ASCO abstract from a couple of weeks ago, the team at Forty Seven is making their return appearance this week holding clearly promising early-stage data on their lead drug magrolimab as they ponder whether they should roll on a quest to obtain an accelerated approval.
“I think the efficacy is there. This Phase Ib could support single-arm accelerated approval,” says Mark Chao, a Forty Seven founder and clinical development chief at the biotech sub. “Our drug actually has activity in very hard to treat patients.”
That makes this drug a standout among the CD47 “don’t eat me” pathway crowd, which has not measured up in many other cases. This drug is the brainchild of Stanford’s legendary Irv Weissman, and it may be his legacy.
At ASH last fall, Forty Seven made a huge splash with its first cut of the positive data, spurring a soaring share price as Gilead closed in for the buyout.
The new data also underscore the promise this drug has in other cancers, Chao adds, as Gilead and the new crew at Forty Seven look to expand their horizons.
Researchers have data on 68 patients who have been treated with magrolimab plus azacitidine in a single arm study involving cases of untreated higher-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia.
Of the 33 MDS patients, 30 (91%) scored an objective response, with 14 (42%) demonstrating a complete response. And there was evidence of a deepening response, with 56% of MDS patients achieving a CR after a minimum of 6 months of followup.
On the AML side, 64% (n=16/25) of patients evaluable for efficacy achieved an objective response, including 56% (n=14/25) with a CR or a CR with incomplete blood count recovery. And there was a subset of high-risk patients who did particularly well: TP53-mutant AML (n=12), with 75% achieving a CR or CRi. Median duration of response and median overall survival have not yet been reached in MDS, AML or TP53- mutant AML.
“The signal is real and continues to be encouraging,” adds Chao, “encouraging on where else we could go.”
One of the next stops is at the FDA, where they’ll be following up with regulators who have been eager to try out new cancer drugs where physicians have few choices.
Social: Dan O’Day, Gilead CEO (Keystone via AP)