China-based biopharmaceutical company Innovent Biologics (HKEX: 01801) said on Monday that the China National Medical Products Administration (NMPA) has accepted for review a new indication application for sintilimab in combination with Nolgileucel Injection (GC101) to treat patients with unresectable or metastatic melanoma that has progressed after at least two prior systemic therapies, including PD-1 antibody treatment.

The application is supported by results from the pivotal Phase II MIZAR-003 study, a multicentre, randomised, open-label trial evaluating GC101 with sintilimab in melanoma patients who failed or were intolerant to anti-PD-1 antibody therapy.

Among advanced melanoma patients who had failed prior anti-PD-1 therapy and received a median of two previous systemic treatment lines, median progression-free survival was 4.3 months in the experimental arm versus 1.6 months in the chemotherapy control arm, representing a 57% reduction in the risk of disease progression or death (HR=0.43; P=0.0002).

Innovent Biologics said adverse reactions in the experimental arm were manageable, with grade 3 or higher events mainly related to preconditioning-induced haematologic toxicity. Median adverse event duration was eight days compared with 13 days in the control arm, and most patients recovered without additional intervention.

If approved, the melanoma indication would become the 11th approved use for sintilimab.