Innovent Expands Phase 3 Trial of Lung Cancer Drug Candidate IBI363 to Nonsquamous Disease

Innovent Biologics is expanding the global Phase 3 trial of its immuno-oncology candidate IBI363 to include patients with nonsquamous non-small cell lung cancer.

According to BioPharma Asia Pacific on the 29th (local time), Innovent said it would add a cohort of patients with nonsquamous non-small cell lung cancer to the global Phase 3 MarsLight-11 trial, which is underway in patients with squamous non-small cell lung cancer.

The expansion broadens the scope of the existing trial, which was evaluating patients with squamous non-small cell lung cancer whose disease progressed despite chemotherapy and immunotherapy. Innovent said the expansion marks an important milestone in IBI363’s development.

IBI363 is a first-in-class interleukin-2 (IL-2)/PD-1 bispecific fusion protein being co-developed with Takeda Pharmaceutical. Takeda’s research and development code name for the candidate is TAK-928.

The evaluation in nonsquamous non-small cell lung cancer will be conducted as a new sub-study of MarsLight-11. The trial will therefore comprise two independent sub-studies: one in squamous non-small cell lung cancer and one in nonsquamous non-small cell lung cancer.

Each sub-study will compare the efficacy and safety of IBI363 monotherapy with docetaxel in patients with unresectable locally advanced or metastatic non-small cell lung cancer whose disease progressed during or after treatment with platinum-based chemotherapy and anti-PD-1/anti-PD-L1 immunotherapy.