Innovent Biologics (HKEX: 01801), the Suzhou-based biopharmaceutical company, reported preliminary proof-of-concept data from the IBI363 NSCLC trial at the 2026 American Society of Clinical Oncology Annual Meeting, with the Phase Ib combination study showing an 86.4% objective response rate in PD-L1 negative or low-expressing patients treated with the optimized 3→1.5 mg/kg dosing regimen — a population historically underserved by current checkpoint inhibitor-based regimens. The Innovent Biologics clinical data, presented as an ASCO 2026 abstract, represent the first disclosed efficacy readout for IBI363 in the first-line advanced NSCLC treatment setting and provide early validation of a dose-titration strategy designed to balance immune activation with tolerability.
The Phase Ib study (NCT06468098) enrolled 80 patients with previously untreated locally advanced or metastatic NSCLC lacking sensitizing EGFR, ALK, or ROS1 alterations, with a data cutoff of December 22, 2025 and a median follow-up of 5.8 months.
The dose optimization phase evaluated three IBI363 regimens in combination with platinum-based chemotherapy in patients with PD-L1 expression below 50%. The optimized step-down 3→1.5 mg/kg regimen produced the strongest efficacy signal, achieving a confirmed ORR of 81.8% and a disease control rate of 100% in 22 patients, with responses observed across both squamous and non-squamous NSCLC subtypes. By comparison, the flat 1.5 mg/kg and 3 mg/kg regimens generated lower confirmed ORRs of 42.1% and 57.1%, respectively, supporting the company’s rationale that an initial higher-dose immune activation phase followed by lower maintenance dosing may improve the balance between efficacy and tolerability.
The study is an open-label, multicenter Phase Ib trial with a planned enrollment of 556 patients across advanced malignancies. The NSCLC cohort reported here represents a subset of 80 patients from the dose optimization stage, and the median follow-up of under six months limits conclusions about durability, progression-free survival, or overall survival. No randomized control arm was included in this stage of the trial, and the patient numbers within individual dose cohorts are small, constraining the precision of the response estimates. Innovent noted that the second stage of the proof-of-concept program — a randomized head-to-head comparison of the 3→1.5 mg/kg IBI363 plus chemotherapy regimen versus pembrolizumab plus chemotherapy across all PD-L1 expression levels — is currently ongoing. That stage will provide the first controlled efficacy comparison for IBI363 in this setting.
IBI363 is a PD-1/IL-2 bispecific immunotherapy designed to enhance anti-tumor T-cell activity while limiting the systemic toxicity historically associated with IL-2 therapies. The rationale for the step-down dosing schedule draws on the observation that immunotherapy-naive tumors exhibit lower baseline immunosuppression, allowing an initial higher IL-2 activation pulse followed by a lower maintenance dose to sustain the immune-sensitive microenvironment. The immunotherapy chemotherapy combination strategy is designed to leverage chemotherapy-induced antigen release to prime the immune response during cycle one.