Innovent and IASO Bio Receive the NMPA’s Approval of Fucaso (equecabtagene autoleucel) for the Treatment of Relapsed or Refractory Multiple Myeloma
Shots:
- The NMPA has approved the NDA for Fucaso to treat adult patient r/r MM. The approval was based on the P-I/II trial evaluating equecabtagene autoleucel while 103 patients received 1.0×106 CAR-T cells/kg dose with a median follow-up of 13.8mos.
- The results showed ORR (96%) in 101 evaluable patients; sCR/CR rate (74.3%), mTTR (16 days), 12mos. PFS rate (78.8%), MRD negativity (95%), and all sCR/CR patients achieved MRD negativity, 9 out of 12 patients with prior CAR-T therapy achieved CR, and 5 with sCR (incl. 4 with sustained sCR for ~18mos. post-infusion), sCR/CR (78.7%) in patients without prior CAR-T therapy
- 1 achieved grade ≥3 CRS & 2 with grade 1-2 ICANS while all patients with CRS or ICANS recovered after the treatment. Patients completed 12 & 24mos. follow-ups after infusion, the therapy was still detectable in 50% & 40% respectively, 19.4% were ADA+
Ref: PR Newswire | Image: Innovent
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