Innovent Biologics has announced updated data from the phase 1 clinical study of its first-in-class PD-1/IL-2α-bias bispecific fusion protein IBI363 in the treatment of advanced immunotherapy (IO)-resistant non-small cell lung cancer (NSCLC).
Updated data from this study conducted in China, showed that after extended follow-up, IBI363 continued to demonstrate a manageable long-term safety profile in IO-resistant NSCLC. Notably, the long-term follow-up data showed strong overall survival (OS) in both squamous NSCLC and adenoNSCLC, supporting the durable benefits driven by IBI363’s unique dual mechanism of immune checkpoint blockade plus cytokine agonism.
Based on the data from this study, IBI363 has entered a global Phase 3 clinical study (MarsLight-11) for IO-resistant squamous NSCLC, the clinical trial design of which will also be presented at this ASCO. Pending regulatory communications, initiation of a global Phase 3 clinical study of IBI363 for IO-resistant non-squamous NSCLC is also planned.
The updated data on IBI363 monotherapy in subjects with advanced showed a total of 136 subjects with NSCLC who had received IBI363 monotherapy (2 μg/kg QW~4mg/kg Q3W).
All 67 squamous NSCLC patients had no known EGFR mutations. Among them, 28 patients received IBI363 at 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 31 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg Q3W dose group, the median PFS reached 10.1 (95%CI 6.0, 14.0) months, and the median OS achieved 18.2 (95%CI 10.7, NE; maturity 48.4%) months, with a 24-month OS rate of 47.8% (95%CI 28.7, 64.7).
Among the 58 patients with EGFR wild-type adenoNSCLC, 30 patients received IBI363 at 0.6 mg/kg Q2W or 1 mg/kg Q2W or 1.5 mg/kg Q3W, and 25 patients received IBI363 at 3 mg/kg Q3W. In the 3 mg/kg dose group, the median PFS reached 4.2 (95%CI 3.0, 7.0) months, and the median OS achieved 15.2 months (95%CI 9.6, NE; maturity 56.0%), with a 24-month OS rate of 42.7% (95%CI 23.1, 61.0).
IBI363 showed a favourable safety profile in long-term follow-up
In the long-term follow-up of the overall population (n = 136), IBI363 demonstrated a favourable safety profile: treatment-emergent adverse events (TEAEs) of grade 3 or above were present in 48.5% of patients.
The most common adverse events were mainly arthralgia (52.2%, ≥grade 3 3.7%), anaemia (46.3%, ≥grade 3 4.4%), and rash (39.0%, ≥grade 3 8.8%), which were mostly controllable and manageable with mild-to-moderate AEs. No new safety signals were observed.
In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 globally and co-commercialise IBI363 in the US, and Takeda will exclusively commercialise IBI363 worldwide other than the US and greater China.
