SAN FRANCISCO and SUZHOU, China, May 22, 2026
Innovent Biologics announced encouraging preliminary Proof-of-Concept (PoC) clinical data for IBI363, its first-in-class PD-1/IL-2α-bias bispecific fusion protein, in combination with platinum-based chemotherapy for the first-line treatment of advanced non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The study focused on patients with PD-L1 negative or low-expression tumors, a population that continues to face limited benefit from currently available immunotherapies. The preliminary findings showed high objective response rates, durable anti-tumor activity, and manageable safety, positioning IBI363 as a potentially important next-generation immuno-oncology candidate for advanced lung cancer treatment
Strong Efficacy Seen in PD-L1 Negative and Low-Expression NSCLC
The Phase 1 PoC clinical study evaluated multiple dosing regimens of IBI363 combined with platinum-doublet chemotherapy (PDC) in previously untreated locally advanced or metastatic NSCLC patients without EGFR, ALK, or ROS1 alterations. As of the December 22, 2025 data cutoff, a total of 80 patients had been enrolled, including patients with PD-L1 TPS below 50%, of which 65.2% had PD-L1 TPS below 1%. The study explored whether IBI363’s dual mechanism could overcome the resistance limitations seen with conventional PD-1 therapies in low PD-L1 tumors.
The most promising results came from the 3→1.5 mg/kg dosing regimen, where patients received 3 mg/kg during cycle 1 followed by 1.5 mg/kg every three weeks alongside chemotherapy. In this cohort, the therapy achieved an impressive objective response rate (ORR) of 86.4%, a confirmed ORR of 81.8%, and a 100% disease control rate (DCR). Responses were consistent across both squamous and non-squamous NSCLC subtypes, highlighting broad anti-tumor potential. By comparison, historical studies such as KEYNOTE-407 and KEYNOTE-189 demonstrated substantially lower ORRs in similar PD-L1 low or negative populations treated with PD-1 inhibitors plus chemotherapy.
Innovent stated that the unique biology of IBI363 may explain the strong activity regardless of PD-L1 expression. Unlike standard checkpoint inhibitors, IBI363 combines PD-1 blockade with selective IL-2 pathway activation, designed to stimulate effector T cells while minimizing toxicity associated with traditional IL-2 therapies. According to the company, the initial higher dose may rapidly activate immune responses and reshape the tumor microenvironment, while the lower maintenance dose helps sustain anti-tumor activity over longer treatment periods.
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Favorable Safety Profile Supports Continued Development
Safety findings from the study were also encouraging. The recommended 3→1.5 mg/kg regimen demonstrated a lower rate of severe treatment-related adverse events compared with the fixed-dose cohorts. Grade 3 or higher treatment-emergent adverse events occurred in 65.2% of patients in the optimized dosing group, compared with 93.1% in the 3 mg/kg cohort and 82.1% in the 1.5 mg/kg cohort. The most common adverse events included anemia, neutrophil count decrease, white blood cell decrease, arthralgia, and platelet count decrease. Innovent noted that the overall safety and tolerability profile supports continuous administration, which may ultimately translate into more durable long-term outcomes.
Dr. Hui Zhou, Chief R&D Officer of Innovent’s oncology pipeline, said the data validate the company’s strategy of using a tailored immune activation approach to address the limitations of existing immunotherapies. He emphasized that IBI363 demonstrated particularly strong activity in PD-L1 negative and low-expression NSCLC, an area of major unmet medical need in lung cancer treatment.
Global Development Plans Expand for IBI363
Following these early results, Innovent has selected the 3→1.5 mg/kg dosing strategy as the recommended regimen for future development. The company has already initiated the second stage of the study, a randomized head-to-head clinical trial comparing IBI363 plus chemotherapy versus pembrolizumab plus chemotherapy in first-line advanced NSCLC patients across all PD-L1 expression levels.
IBI363 is currently being evaluated in multiple global clinical programs across NSCLC, colorectal cancer, and melanoma. The therapy has already received two U.S. FDA Fast Track Designations and three Breakthrough Therapy Designations from China’s NMPA. In 2025, Innovent entered a major global collaboration with Takeda Pharmaceutical Company for co-development and commercialization of IBI363 worldwide, significantly strengthening the program’s global expansion strategy.
Source: Innovent Biologics press release
