IBI351 combined with cetuximab is intended for the treatment of NSCLC harbouring a KRASG12C mutation. Credit: crystal light / Shutterstock.

Innovent Biologics and Merck have entered a clinical trial collaboration and supply agreement for the combination therapy of IBI351 (GFH925) and cetuximab (ERBITUX).

The combination therapy is intended to treat patients with non-small cell lung cancer (NSCLC) harbouring a KRASG12C mutation.

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Innovent will carry out a multi-centre Phase Ib study in China to assess the treatment’s anti-tumour activity and safety in Chinese patients.

Merck will supply cetuximab, an IgG1 monoclonal antibody targeting the epidermal growth factor receptor, for the trial.

Innovent Biologics senior vice-president Dr Hui Zhou said: “The combination of a KRASG12C inhibitor and an epidermal growth factor receptor (EGFR) inhibitor has shown efficacy in heavily pre-treated patients with metastatic colorectal cancer.

“Preclinical studies of IBI351 and cetuximab combination therapy also demonstrated potential anti-tumour activity in NSCLC.

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“Innovent has observed favourable safety and promising antitumour activity of IBI351 monotherapy in previously-treated advanced NSCLC harbouring KRASG12C mutation, and we will potentially expand treatment lines, hoping to provide better treatment options for more cancer patients.”

GFH925 was discovered by GenFleet Therapeutics and targets the GTP/GDP exchange by modifying the cysteine residue of the KRASG12C protein covalently and irreversibly.

In September 2021, GenFleet and Innovent signed an exclusive license agreement to develop and commercialise IBI351 in mainland China, Hong Kong, Macau and Taiwan.

The agreement also includes additional option-in rights for development and commercialisation worldwide.

Innovent is currently conducting a single-arm registrational trial of IBI351 monotherapy in previously treated advanced NSCLC patients with KRASG12C mutation in China.

The new drug application (NDA) filing for this trial is expected by the end of this year.

Last month, Innovent reported that its Phase ll trial of 9mg of mazdutide (IBI362) to treat Chinese adults with obesity achieved the 24-week primary endpoint.

A total of 80 patients with obesity who had a body mass index of more than 30.0kg/m² were enrolled in the placebo-controlled, double-blind study.