Innovent Biologics, Inc. ("Innovent")...announced that a New Indication Application for sintilimab in combination with Nolgileucel injection (GC101) has been accepted for review by the China National Medical Products Administration (NMPA). (PRNewswire) - Oct 26, 2026 - "The application is proposed to be sintilimab in combination with Nolgileucel Injection (GC101) for the treatment of patients with unresectable or metastatic melanoma whose disease has progressed following at least two lines of prior systemic therapy, including PD-1 antibody therapy...The new indication application is primarily based on the results of the pivotal Phase II clinical study MIZAR-003...As of the data cutoff date of May 12, 2026, the primary endpoint was met...the median progression-free survival (mPFS) in the experimental arm reached 4.3 months, significantly superior to 1.6 months in the chemotherapy control arm, with a 57% reduction in the risk of disease progression or death (HR=0.43, 95% CI: 0.26–0.68; P=0.0002)."
China filing • Melanoma
|