San Francisco, USA and Suzhou, ChinaMay 22, 2026 /PRNewswire/ — Innovent Biologics, Inc. (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases such as oncology, autoimmune, metabolic and cardiovascular, and ophthalmology, today announced the preliminary results of a Phase I Proof-of-Concept (PoC) study of IBI363 (Takeda development code: TAK-928), a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, in the first-line treatment of advanced non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The abstract summary is as follows, with detailed results to be formally presented during the conference.
This study is the first stage of a Phase I PoC clinical trial evaluating IBI363 in combination with platinum-based doublet chemotherapy (PDC) in patients with advanced NSCLC who have not received prior systemic therapy. It aims to explore the safety, efficacy, and dose optimization strategy of IBI363 combined with chemotherapy in the first-line treatment of NSCLC. Meanwhile, the dose optimization phase focuses on NSCLC patients with PD-L1 TPS <50% (including TPS 1-49% and TPS <1%), to initially explore the therapeutic potential of IBI363 in PD-L1-negative and low-expression NSCLC, an area of unmet clinical need.
Study results show that IBI363 demonstrates promising preliminary efficacy signals in the first-line treatment of PD-L1-negative and low-expression NSCLC, with the 3→1.5 mg/kg dosing regimen yielding the optimal overall benefit, showing robust objective response rate (ORR) and disease control rate (DCR), along with good safety and tolerability supporting long-term continuous dosing, which is expected to translate into more durable efficacy benefits with ongoing follow-up. Currently, the second stage of this PoC study, a randomized controlled trial comparing IBI363 3→1.5 mg/kg plus chemotherapy versus pembrolizumab plus chemotherapy for the first-line treatment of advanced NSCLC (all PD-L1 expression levels), is ongoing.
1) Key mechanistic rationale for dosing regimen design and dose selection in the immunotherapy-naïve population
Multiple studies indicate that in immunotherapy (IO)-naïve populations, the tumor microenvironment exhibits a lower degree of immunosuppression, allowing for an immune activation strategy of “igniting immunity followed by sustained stabilization.” Additionally, combination with chemotherapy can better facilitate antigen release and activate the immune system.
Therefore, a 3 mg/kg dose in the first cycle is considered for immune priming to rapidly expand effector T cells, enhance T cell infiltration, and create an IO-sensitive immune microenvironment. Subsequently, a maintenance phase with 1.5 mg/kg Q3W is used to sustain the IO-sensitive tumor microenvironment at a moderate dose, potentially extending the treatment duration and further improving efficacy. Such dosing strategies are also commonly seen in the design of other immunotherapies.
Based on this, the study designed and compared three IBI363 combination dosing regimens:
- 3→1.5 mg/kg dose group (first cycle: 3 mg/kg + PDC, subsequent cycles: 1.5 mg/kg Q3W + PDC);
- 1.5 mg/kg dose group (continuous 1.5 mg/kg Q3W + PDC);
- 3 mg/kg dose group (continuous 3 mg/kg Q3W + PDC).
2) Patient baseline and study design: Focus on dose strategy exploration in PD-L1-negative and low-expression NSCLC
This study enrolled patients who had not received prior systemic anti-tumor therapy and had no EGFR/ALK/ROS1 sensitizing mutations, aiming to evaluate the efficacy and safety of three IBI363 combination dosing regimens in patients with PD-L1-negative and low-expression NSCLC.
As of December 22, 2025, a total of 80 patients were enrolled in this study, including 11 in the safety run-in phase and 69 in the dose randomization phase. The groups were: 3→1.5 mg/kg (N = 23), 1.5 mg/kg (N = 28), and 3 mg/kg (N = 29). The median follow-up time was 5.8 months (range: 0.9–9.5 months).
- The overall median age was 64 years, 88.8% were male, 81.3% had an ECOG performance status score of 1, and 66.3% had squamous NSCLC. Baseline characteristics were balanced and comparable across the three groups.
- In the dose randomization phase, enrollment focused on NSCLC patients with PD-L1 TPS < 50%, of whom 65.2% had PD-L1 TPS < 1% and 34.8% had PD-L1 TPS 1-49%.
3) Efficacy analysis: IBI363 shows excellent response rates in first-line treatment of PD-L1-negative and low-expression NSCLC
In the dose optimization phase, the 3→1.5 mg/kg group (n=22) demonstrated an objective response rate (ORR) of 86.4%, with a confirmed ORR (cORR) of 81.8% and a disease control rate (DCR) of 100%. This efficacy was consistent across squamous (ORR 85.7%, n=14) and non-squamous (ORR 87.5%, n=8) subgroups. Additionally, durable efficacy signals were observed in the 3→1.5 mg/kg group with ongoing follow-up. The ORR for the 1.5 mg/kg group (n=19) and 3 mg/kg group (n=21) reached 57.9% (cORR 42.1%) and 66.7% (cORR 57.1%), respectively.
For patients with PD-L1-negative and low-expression NSCLC, existing immunotherapies offer limited benefits. In the Keynote-407 study, PD-1 combined with chemotherapy in first-line squamous NSCLC showed ORRs of 67.4% and 54.5% for the PD-L1 1-49% and PD-L1<1% subgroups, respectively. In the Keynote-189 study, PD-1 combined with chemotherapy in first-line non-squamous NSCLC showed ORRs of 50.0% and 33.1% for the PD-L1 1-49% and PD-L1<1% subgroups, respectively.
Previous studies have found that regardless of PD-L1 expression status, IBI363 exhibits potent anti-tumor activity in immunotherapy-resistant NSCLC, suggesting its unique mechanism of action may not depend on PD-L1 expression. This preliminary efficacy analysis shows that in the first-line treatment of PD-L1-negative and low-expression NSCLC, IBI363 combined with platinum-based doublet chemotherapy demonstrates impressive objective response rates, further validating IBI363 as a PD-1/IL-2α-bias bispecific fusion protein capable of exerting strong anti-tumor effects irrespective of PD-L1 expression status, supporting the potent immune activation effect of IL-2.
4) Safety analysis: Favorable safety supports continuous dosing and is expected to translate into more durable efficacy benefits
In terms of safety, the 3→1.5 mg/kg dose group showed a favorable safety profile. Across the entire population, the incidence of Grade ≥3 treatment-emergent adverse events (G3+ TEAEs) in the 3→1.5 mg/kg dose group was 65.2%, lower than that in the 3 mg/kg dose group (93.1%) and the 1.5 mg/kg dose group (82.1%). The favorable safety profile of the IBI363 3→1.5 mg/kg dose group is expected to extend the first-line treatment duration and potentially translate into durable efficacy benefits.
Common treatment-emergent adverse events (TEAEs) included: anemia (78.8%, Grade ≥3: 18.8%), neutropenia (75.0%, Grade ≥3: 42.5%), leukopenia (63.8%, Grade ≥3: 20.0%), arthralgia (51.3%, Grade ≥3: 2.5%), and thrombocytopenia (45.0%, Grade ≥3: 17.5%).
5) Conclusion and next steps:
Based on a comprehensive assessment of overall safety, depth of efficacy, and durability, 3→1.5 mg/kg is recommended as the regimen for further study of IBI363 combined with chemotherapy in the first-line setting. Currently, the second stage of this PoC study, a randomized controlled trial comparing 3→1.5 mg/kg IBI363 plus chemotherapy versus pembrolizumab plus chemotherapy for the first-line treatment of advanced NSCLC (all PD-L1 expression levels), is ongoing.
Dr. Hui Zhou, Chief Medical Officer of Oncology at Innovent Biologics, stated: “The design of IBI363 was precisely aimed at breaking through the bottlenecks of current immunotherapy. These clinical data show that by designing a dosing strategy aligned with the immune mechanism, we have effectively leveraged the powerful advantages of IL-2 pathway activation, demonstrating impressive response rates in the first-line treatment of PD-L1 low-expression and negative NSCLC. At the same time, the favorable safety and tolerability support long-term continuous dosing, which is expected to translate into more durable efficacy benefits with ongoing follow-up. This is not only a further validation of the mechanism but also an important practice in clinical application translation. We look forward to the continued follow-up of IBI363 in first-line NSCLC treatment and the accumulation of data from the ongoing PoC Phase II randomized controlled study, providing more robust evidence for the further development of IBI363.”
About IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein)
IBI363 is a first-in-class PD-1/IL-2α-bias bispecific fusion protein independently developed by Innovent, with dual functions of blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 has been engineered to retain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby reducing toxicity. The PD-1 binding arm can simultaneously achieve PD-1 blockade and selective delivery of IL-2. This differentiated strategy enables more precise and effective targeting and activation of tumor-specific T cell subsets.
Currently, IBI363 is undergoing a series of clinical trials globally, including a global multi-regional Phase III trial for immunotherapy-resistant squamous non-small cell lung cancer and a pivotal Phase II study in China for untreated acral and mucosal melanoma. Additionally, multiple Phase Ib/II trials are ongoing to evaluate IBI363 for the treatment of non-small cell lung cancer and colorectal cancer (including first-line and later-line treatments), as well as other tumor types. To date, IBI363 has received three Breakthrough Therapy Designations (BTD) from China’s NMPA and two Fast Track Designations (FTD) from the U.S. FDA.
In October 2025, Innovent entered into a strategic collaboration with Takeda Pharmaceutical Company. The parties will jointly develop IBI363 (Takeda development code: TAK-928) globally and co-commercialize it in the United States. Additionally, Innovent granted Takeda the commercialization rights for IBI363 in regions outside of Greater China and the United States.
About Innovent Biologics
“Start with integrity, succeed through action.” Developing high-quality biologics that are affordable to the public is the mission and goal of Innovent Biologics. Founded in 2011, Innovent is dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases such as oncology, autoimmune, metabolic, and ophthalmology, to benefit more lives. The company has 18 products approved for marketing: sintilimab injection (Tyvyt®), bevacizumab injection (Byvasda®), adalimumab injection (Sulinno®), rituximab injection (Dabberhua®), pemigatinib tablets (Pemazyre®), olverembatinib tablets (Nerlynx®), ramucirumab injection (Cyramza®), selpercatinib capsules (Retevmo®), equecabtagene autoleucel injection (Fucaso®), tafolecimab injection (Sibeprenlimab®), fluoxetinib tablets (Dabote®), pirtobrutinib tablets (Jaypirca®), taletrectinib capsules (Dabole®), lietinib tablets (Aoyixin®), teprotumumab N01 injection (Xinbimin®), mazdutide injection (Xinermei®), picankibart injection (Xinmeiyue®), and ipilimumab N01 injection (Daboxin®). Currently, 5 new drug molecules are in Phase III or pivotal clinical studies, and another 14 new drug candidates have entered clinical research.
The company has established over 30 strategic collaborations with international partners such as Eli Lilly, Roche, Takeda, Sanofi, Incyte, and MD Anderson Cancer Center. While continuously innovating and developing its own drugs, Innovent adheres to the people-centered development philosophy in economic construction. Over the years, it has always been guided by scientific goodwill, adhered to a “patient-centered” approach, cared for patients and their families, and actively fulfilled its social responsibilities. The company has initiated and participated in multiple drug assistance programs, enabling more and more patients to benefit from advances in life sciences and to afford and access high-quality biologics. To date, Innovent’s patient assistance programs have benefited over 200,000 ordinary patients, with a total drug donation value of RMB 4 billion. Innovent hopes to work together with everyone to improve the development level of China’s biopharmaceutical industry, to meet the public’s need for drug accessibility and the people’s aspirations for life and health.
For more information, please visit the company’s website: www.innoventbio.com or the company’s LinkedIn page: www.linkedin.com/
Disclaimer: 1. Innovent does not recommend the use of unapproved drugs/indications.
2. Ramucirumab injection (Cyramza®), selpercatinib capsules (Retevmo®), and pirtobrutinib tablets (Jaypirca®) are developed by Eli Lilly.
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