SAN FRANCISCO and SUZHOU, China, May 21, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, first announced the preliminary PoC clinical study results for its global first-in-class PD-1/IL-2^α-bias bispecific fusion protein IBI363 (Takeda R&D code: TAK-928) in the first-line treatment of advanced non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. An overview of the abstract information is provided below, and the full abstract is available here. More detailed results will be presented during the conference.

This study is the first stage of a PoC clinical study conducted in China, to evaluate the safety, efficacy, and dose optimization strategy of IBI363 in combination with platinum-based doublet chemotherapy (PDC) in previously untreated patients with locally advanced or metastatic NSCLC. During dose optimization, patients with NSCLC expressing PD-L1 TPS < 50% (including TPS 1-49% and TPS < 1%) were enrolled to explore the potential of IBI363 in PD-L1 negative and low-expressing NSCLC, an area with significant unmet clinical need.

The preliminary results showed that IBI363 combined with PDC demonstrated encouraging efficacy signals in the first-line treatment of NSCLC with PD-L1 negative or low expression. The 3→ 1.5 mg/kg dosing regimen brought comprehensive benefits with strong objective response rate (ORR), disease control rate (DCR), and manageable safety and tolerability. Meanwhile, the approach supports continuous dosing, which has the potential to translate into durable efficacy benefits with ongoing follow-up. The second stage of this study is currently ongoing, designed as a randomized head-to-head trial comparing this dose regimen vs. pembrolizumab plus chemotherapy in the first-line treatment of advanced NSCLC (all PD-L1 expression levels).

1) Mechanistic Rationale for Dosing Regimen Design and Dose Selection in Immunotherapy-naïve Population

Multiple studies have indicated that in immunotherapy (IO)-naive populations, the tumor microenvironment exhibits lower immunosuppression, which allows an immune activation strategy that ignites immunity and then maintains stability. Meanwhile, combination with chemotherapy can facilitate antigen release and activate the immune system.

Therefore, the first cycle of 3 mg/kg IBI363 could initiate the immune system to expand effector T cells rapidly, enhance T cell infiltration, and form an IO-sensitive immune microenvironment. Subsequently, a 1.5 mg/kg every three weeks (Q3W) regimen is adopted for the maintenance treatment, which could maintain the IO-sensitive tumor microenvironment, prolong the possible treatment cycles, and further enhance the efficacy. This strategy is common in the study design of other immunological treatments.

Based on this mechanism, three IBI363 combination dosing regimens were compared in the study:

• 3→1.5 mg/kg dose group (3 mg/kg + PDC in cycle 1, followed by 1.5 mg/kg Q3W + PDC);
• 1.5 mg/kg dose group (1.5 mg/kg Q3W + PDC);
• 3 mg/kg dose group (3 mg/kg Q3W + PDC).

2) Study Design and Baseline Characteristics: Focusing on Dose Exploration in PD-L1 Negative or Low Expression NSCLC

Previously untreated patients with locally advanced or metastatic NSCLC, without sensitizing EGFR, ALK, or ROS1 alterations were enrolled in this study. The aim of the study is to evaluate the efficacy and safety of different doses of IBI363 combined with PDC in patients with PD-L1 negative or low expression NSCLC.

As of the data cutoff date, Dec 22, 2025, a total of 80 patients had been enrolled in this Phase 1 study, including 11 patients enrolled in the safety lead-in phase and 69 patients in the dose optimization phase. The median follow-up time was 5.8 months (range: 0.9–9.5 months).

• The median age was 64 years, 88.8% were male, 81.3% had an ECOG PS score of 1, and 66.3% were squamous NSCLC. The baseline characteristics of patients in the three dose groups were balanced and comparable.
• In the dose optimization part, NSCLC patients with PD-L1 TPS < 50% were enrolled, of which 65.2% had PD-L1 TPS < 1% and 34.8% had TPS 1–49%.

3) IBI363 Showed Encouraging Response in First-line Treatment of PD-L1 Negative or Low Expression NSCLC

In the dose optimization stage, the 3→ 1.5 mg/kg dose group (n=22) showed ORR of 86.4% and confirmed ORR (cORR) of 81.8% (95% CI: 59.7-94.8) and DCR of 100%. The efficacy was consistent in the 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 groups with ongoing follow-up. For the 1.5mg/kg (N = 19) and 3 mg/kg cohorts (N = 21), ORR was 57.9% (cORR: 42.1%) and 66.7% (cORR: 57.1%), respectively.

For NSCLC patients with negative or low PD ‑ L1 expression, the benefit from current immunotherapies is limited. In the Keynote ‑ 407 study, in first ‑ line squamous NSCLC patients treated with PD ‑ 1 combined with chemotherapy, the ORRs were 67.4% and 54.5% for the PD ‑ L1 1–49% and PD ‑ L1 <1% subgroups, respectively. In the Keynote ‑ 189 study, in first ‑ line non ‑ squamous NSCLC patients treated with PD ‑ 1 combined with chemotherapy, the ORRs were 50.0% and 33.1% for the PD ‑ L1 1–49% and PD ‑ L1 <1% subgroups, respectively.

Previous studies have shown that, regardless of PD ‑ L1 expression status, IBI363 demonstrates potent anti ‑ tumor activity in immunotherapy ‑ resistant NSCLC, suggesting that its unique mechanism of action may not depend on PD ‑ L1 expression. Preliminary efficacy data in this study showed impressive response rate of IBI363 in combination with PDC in first-line treatment of NSCLC with PD-L1 negative or low expression. This further validates IBI363 as a PD-1/IL-2 ^α-bias bispecific fusion protein capable of exerting potent anti-tumor effects regardless of PD-L1 expression status, underscoring the powerful immune-activating effects of IL-2.

4) Favorable Safety Supports Continuous Administration with Potential to Translate into Long-term Efficacy Benefits

Good safety and tolerability were observed in 3→1.5 mg/kg dose groups. Among all patients, grade ≥3 treatment-related adverse events (G3+ TEAEs) were occurred in 65.2% of patients in the 3→1.5 mg/kg dose group, which was lower than the 3 mg/kg dose group (93.1%) and the 1.5 mg/kg dose group (82.1%). This favorable safety supports 3→1.5 mg/kg as the recommended dose regimen for further clinical investigation of IBI363 in combination therapies as a first-line treatment of NSCLC, which has the potential to translate into durable efficacy benefits.

The most common treatment emergent adverse events (TEAEs) among all patients were anemia (any grade: 78.8%; grade ≥3: 18.8%), neutrophil count decrease (75.0%; 42.5%), white blood cell count decrease (63.8%; 20.0%), arthralgia (51.3%; 2.5%), and platelet count decrease (45.0%; 17.5%).

5) Conclusion and follow-up:

Based on the comprehensive evaluation of preliminary efficacy and safety data, dose regimen of 3→1.5 mg/kg is the recommended dose for further clinical investigation of IBI363 combined with chemotherapy as a first-line treatment for advanced NSCLC. Currently, as the second part of the PoC study, a randomized head-to-head study of 3→1.5 mg/kg IBI363 combined with chemotherapy vs. pembrolizumab combined with chemotherapy as first-line treatment for advanced NSCLC (all PD-L1 expression levels) is ongoing.

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, stated: "IBI363 is designed to break through the bottleneck of current immunotherapy. Data from this study demonstrate that by designing a dosing strategy consistent with its immune mechanism, IBI363 achieved an encouraging response rate, leveraging its strong advantages in effectively activating the IL-2 pathway in first-line NSCLC patients with PD-L1 negative or low expression. At the same time, its favorable safety and tolerability holds the potential to translate into long term efficacy benefits. This not only further validates the mechanism but also represents a significant step in its clinical application. We look forward to continued evaluation of IBI363 in first-line treatment of NSCLC and the accumulation of data from the ongoing head-to-head PoC study to provide further evidence for the development of IBI363."

About IBI363 (PD-1/IL-2 ^α-bias Bispecific Fusion Protein)

IBI363 is a first-in-class PD-1/IL-2^α-bias bispecific fusion protein developed by Innovent Biologics. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, thereby minimizing toxicity. The PD-1 binding arm blocks PD-1 and selectively delivers IL-2 to the tumor.

IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC. In parallel, multiple Phase Ib/II trials are evaluating IBI363 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types. IBI363 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.

In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363 in the U.S., and Takeda will exclusively commercialize IBI363 worldwide other than the U.S. and greater China.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 5 assets in Phase III or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

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