Innovent Expands Lung Cancer Trial to Include Non-Squamous NSCLC Patients

Innovent Biologics has announced the expansion of its global Phase 3 MarsLight-11 clinical trial, evaluating the investigational drug IBI363/TAK-928 for immunotherapy-resistant non-small cell lung cancer (NSCLC). The study will now include patients diagnosed with non-squamous NSCLC in addition to those with squamous NSCLC.

The trial, NCT07217301, will now consist of two independent substudies. Both will assess the efficacy and safety of IBI363 monotherapy compared to docetaxel in patients with unresectable, locally advanced or metastatic NSCLC whose disease has progressed after standard chemotherapy and anti-PD-1/PD-L1 immunotherapy.

IBI363/TAK-928 is a bispecific fusion protein developed jointly by Innovent and Takeda. It is designed to block the PD-1 pathway while selectively activating the IL-2 pathway, aiming to minimize toxicity and deliver IL-2 to the tumor microenvironment. The drug candidate has received Fast Track Designations from the U.S. FDA and Breakthrough Therapy Designations from China's NMPA.

This expansion represents a significant step in the development of IBI363/TAK-928, potentially broadening its applicability and offering new therapeutic avenues for a wider range of NSCLC patients who have limited treatment options after progression on current standards of care.