Gilead’s $4.9 billion bet on Forty Seven has run into a delay. Weeks after Takeda’s rival drug flunked a pivotal trial, Gilead has pushed back the release of data from a phase 1b study designed to support accelerated approval.
The data drop on magrolimab in the blood cancer myelodysplastic syndrome (MDS), which was scheduled for this year, is now penciled in (PDF) for the first quarter of 2022. Analysts at Jefferies said the delay is “in part due to GILD still talking to FDA on filing requirements, particularly after Takeda just failed a Phase III in MDS after strong Phase IB CR rates in MDS.”
Takeda reported the failure of NEDD8-activating enzyme inhibitor pevonedistat in patients with MDS and a set of related conditions in September, despite an earlier-phase study linking it to an increased complete response rate versus the control.
Talking to investors after disclosing the delay, Merdad Parsey, M.D., Ph.D., chief medical officer at Gilead, said “we continue to evolve our clinical programs in the context of the recent development in the MDS therapeutic landscape.” The phase 1b data continue to "mature,” Parsey said, but will now be shared later than previously expected.
RELATED: Gilead strikes $4.9B Forty Seven acquisition, paying a hefty premium for cancer drug
Gilead has discussed the potential to seek accelerated approval on the strength of the phase 1b data and then confirm the effect of magrolimab in MDS by delivering results from a phase 3 study that is already enrolling patients. The plan is supported by the breakthrough designation Gilead picked up after linking magrolimab plus Bristol Myers Squibb’s Vidaza to a complete response rate of 42%.
The complete response rate seen at the interim analysis of the phase 1b clinical trial suggested the anti-CD47 antibody may improve outcomes in previously untreated patients with intermediate-, high- or very high-risk MDS. However, the failure of Takeda in phase 3 after its pevonedistat-Vidaza cocktail recorded a 52% complete response rate in higher-risk MDS shows how early clinical results can fail to translate into pivotal success.