Innovent Biologics has announced an expansion of its global Phase III MarsLight-11 trial evaluating IBI363, also known as TAK-928, to non-small cell lung cancer (NSCLC) patients.
Initially focused on squamous NSCLC, the trial will now include those with non-squamous NSCLC, whose disease has progressed following chemotherapy and immunotherapy.
The MarsLight-11 study is a multicentre, randomised, controlled trial. With the latest expansion, it will consist of two substudies: one focusing on squamous NSCLC and the other on non-squamous NSCLC.
It will assess the safety and efficacy of IBI363 as a monotherapy in comparison to docetaxel, in patients with advanced or metastatic NSCLC.
IBI363, a potential first-in-class alpha-biased IL-2/PD-1 bispecific fusion protein, is being co-developed globally by Innovent and Takeda.
It works by blocking the PD-1/PD-L1 pathway while activating the IL-2 pathway selectively, aiming to reduce toxicity through targeted binding to specific IL-2 receptors.
This investigational immunotherapy is part of a series of global clinical trials, including a pivotal Phase II study in China for acral and mucosal melanoma and a Phase III study in advanced colorectal cancer.
Several Phase Ib/II trials are also underway, exploring the therapy in other settings and tumour types.
IBI363/TAK-928 has achieved recognition with two fast track designations from the US FDA and three breakthrough therapy designations from the China NMPA.
The collaboration between Innovent and Takeda began in October 2025 and involves co-development and commercialisation plans for the US, with Takeda handling markets outside the US and Greater China.
In November 2025, Innovent’s obesity drug showed success in another pivotal trial, meeting the primary and all key secondary endpoints.
In the Phase III GLORY-2 trial (NCT06164873), Xinermei (mazdutide) 9mg led to a weight reduction of 18.55%, compared to 3.02% in the placebo group after 60 weeks of treatment.
