Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Sunday an expansion of the global Phase 3 MarsLight-11 trial, which is evaluating IBI363 (Takeda R&D code: TAK-928) in patients with squamous non-small cell lung cancer (NSCLC) whose disease has progressed on or after chemotherapy and immunotherapy, to include patients with non-squamous NSCLC.

IBI363/TAK-928 is a potential first-in-class alpha-biased IL-2/PD-1 bispecific fusion protein being jointly developed by Innovent and Japanese pharmaceutical company Takeda (TSE:4502) (NYSE:TAK) globally.

The evaluation of IBI363/TAK-928 in non-squamous NSCLC will be conducted as a new sub study of MarsLight-11, a global, multicentre, randomised, controlled Phase 3 study. MarsLight-11 will therefore be comprised of two independent sub studies, one in squamous NSCLC and the other in non-squamous NSCLC. Each sub study will evaluate the efficacy and safety of IBI363 monotherapy versus docetaxel in patients with unresectable, locally advanced or metastatic NSCLC whose disease has progressed during or after treatment with platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.

IBI363/TAK-928 functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363/TAK-928 is designed to maintain its affinity for IL-2R alpha, while reducing binding to IL-2R beta and IL-2R gamma, with the aim of minimising toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2 to the tumour.

IBI363/TAK-928 is being evaluated in a series of clinical trials globally, including a pivotal Phase II study in China in previously untreated acral and mucosal melanoma; a global multi-centre Phase III trial in immunotherapy-resistant squamous and non-squamous NSCLC; and a pivotal Phase III study in China in advanced CRC refractory or intolerant to standard therapy. In parallel, multiple Phase Ib/II trials are evaluating IBI363/TAK-928 in NSCLC and CRC including the first-line and later line settings, and in additional tumour types.

IBI363/TAK-928 has received two Fast Track Designations (FTD) from the US FDA and three Breakthrough Therapy Designations (BTD) from China's NMPA.