China-based biopharmaceutical company Innovent Biologics Inc (HKEX: 01801) announced on Wednesday that the first patient has been dosed in a pivotal study evaluating IBI363 (Takeda R&D code: TAK-928), a potential first-in-class PD-1/IL-2 alpha-biased bispecific fusion protein, in combination with bevacizumab, versus investigator's choice of therapy in patients with advanced colorectal cancer (CRC) that is refractory or intolerant to standard treatment.

This is the third pivotal registrational clinical study initiated for IBI363 and marks a critical step forward for investigational next-generation immuno-oncology (IO) therapies in overcoming colorectal cancer, a classic 'immune-cold' tumour, Innovent said. Previously initiated studies of IBI363 include a pivotal Phase 2 clinical study in China for IO-naïve melanoma (acral and mucosal subtypes). A global, multi-centre, Phase 3 clinical study in IO-resistant squamous non-small cell lung cancer (NSCLC) has also been initiated.

As part of a licence and collaboration agreement, Innovent and Takeda are co-developing IBI363/TAK-928 globally and will co-commercialise the product in the United States. Takeda will exclusively commercialise IBI363/TAK-928 worldwide outside of the US and Greater China.

The multicentre, randomised, open-label, Phase 3 clinical study is designed to evaluate the efficacy and safety of IBI363 in combination with bevacizumab compared with investigator's choice of therapy in patients with advanced colorectal cancer who have failed or are intolerant to standard therapies. A total of 550 patients are to be enrolled, and the primary endpoint is overall survival.

This study is being conducted in China where Innovent holds development and commercialisation rights for IBI363/TAK-928.

In a Phase 1 clinical study for the treatment of advanced colorectal cancer, IBI363 in combination with bevacizumab demonstrated encouraging efficacy signals and a manageable safety profile.