Innovent presents clinical data for bispecific fusion protein IBI363

SAN FRANCISCO and SUZHOU, China, Oct. 26, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (HKEX Stock Code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases including oncology, autoimmune, metabolic, and ophthalmic diseases, announced multiple clinical data updates for IBI363 (Takeda R&D code: TAK-928), at the 2026 European Society for Medical Oncology (ESMO) Congress. IBI363/TAK-928 is a potential first-in-class PD-1/alpha-biased IL-2 bispecific fusion protein being jointly developed by Innovent and Takeda globally.

Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent, said: "The latest IBI363/TAK-928 data presented at 2026 ESMO across lung and gastric cancer studies further demonstrate its broad antitumor potential. Encouraging efficacy signals were observed in both first-line and later-line/immunotherapy-resistant cancers. Together with Takeda, we will continue to advance the global development of IBI363/TAK-928 and seek to provide new treatment options for more patients."

First-Line NSCLC: IBI363/TAK-928 Continues to Show Encouraging Efficacy Trend

Title: IBI363 (TAK-928) plus chemotherapy as first line (1L) treatment for advanced non-small cell lung cancer (NSCLC): Update of a phase 1b study

Abstract number: 1044P

• This study represents the first stage of a proof-of-concept (PoC) clinical study evaluating IBI363/TAK-928 in combination with platinum-based doublet chemotherapy (PDC) in patients with previously untreated locally advanced or metastatic NSCLC. The study is designed to evaluate the safety and efficacy of IBI363 plus chemotherapy in the first-line treatment of NSCLC and to explore dose-optimization strategies. Initial data from the study were first presented at the 2026 ASCO Annual Meeting [link]. Updated results with a longer follow-up period were presented at the 2026 ESMO Annual Meeting.
• As of April 7, 2026, a total of 80 patients had been enrolled, including 11 patients in the safety run-in phase and 69 patients in the dose-optimization phase. The median follow-up was 8.9 months, with a range of 0.6 to 12.3 months. Patients enrolled in the dose-optimization phase had PD-L1 tumor proportion scores (TPS) of less than 50%, including patients with TPS of 1–49% and TPS of less than 1%. They were randomized in a 1:1:1 ratio to three dose groups, with generally balanced baseline characteristics across the groups. As of the data cutoff date, 48.8% of patients remained on IBI363 treatment.

IBI363/TAK-928 Continued to Demonstrate Encouraging Efficacy Signals

• IBI363/TAK-928 continued to demonstrate encouraging antitumor activity. In the first-line treatment of patients with PD-L1-negative or PD-L1-low NSCLC, the confirmed objective response rates (cORRs) in the IBI363 1.5 mg/kg, 3 mg/kg and 3→1.5 mg/kg dose groups were 47.4%, 61.9% and 86.4%, respectively. The corresponding disease control rates (DCRs) were 94.7%, 100.0% and 100.0%.
• Overall progression-free survival (PFS) data remained immature.

Manageable Safety Profile with No New Safety Signals with Longer Follow-up

• The overall safety profile of IBI363/TAK-928 in combination with chemotherapy remained manageable across dose groups. With longer follow-up, the safety profile remained generally consistent, and no new safety signals were identified.
• The most frequently reported TEAEs were hematologic — anemia (82.5%), neutrophil count decreased (76.3%), WBC count decreased (66.3%), and platelet count decreased (46.3%) — consistent with the known toxicity profile of the individual agents.

Conclusions and Next Steps

• IBI363/TAK-928 in combination with platinum-based doublet chemotherapy continued to demonstrate encouraging clinical activity in patients with PD-L1 TPS <50% NSCLC in the first-line setting, further supporting its potent antitumor activity as a potential first-in-class PD-1/alpha-biased IL-2 bispecific fusion protein. The second stage of this PoC study, a randomized controlled study evaluating IBI363/TAK-928 plus chemotherapy versus pembrolizumab plus chemotherapy as first-line treatment for advanced NSCLC, is currently ongoing.

Professor Haiyan Tu of Guangdong Provincial People's Hospital said:

"Following the initial efficacy and safety data presented at the 2026 ASCO Annual Meeting, longer-term follow-up presented at ESMO continued to demonstrate encouraging antitumor immune response with IBI363 in combination with chemotherapy in patients with PD-L1-negative or PD-L1-low advanced NSCLC in the first-line setting, with the potential for durable clinical benefit. As the randomized controlled phase of the study progresses, we look forward to further evaluating its clinical potential as a new treatment option for these patients."

First-Line G/GEJA: IBI363/TAK-928 Demonstrated Encouraging Efficacy Observed Across PD-L1 CPS Subgroups

Title: IBI363 (TAK-928) plus XELOX as the first line (1L) treatment for advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA)

Abstract number: 1008RO

• This is the investigator-initiated Phase 1b clinical study evaluating IBI363/TAK-928 in combination with capecitabine and oxaliplatin (XELOX) as first-line treatment for HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA; NCT06610799).
• As of July 9, 2026, a total of 46 patients had been enrolled, including seven patients in the dose-escalation phase and 39 patients in the dose-expansion phase. The median follow-up duration was 9.2 months, with a range of 7.9 to 10.8 months. Distant metastases were present in 97.8% of patients, including liver metastases in 45.7% and peritoneal metastases in 28.3%. 34.8% of patients have PD-L1 CPS<5 and 60.9% of patients have PD-L1 CPS≥5.

IBI363/TAK-928 Demonstrated Encouraging Response Signals in 1L G/GEJA Regardless of PD-L1 CPS Level

• Among patients who had undergone at least one post-baseline tumor assessment, the cORR was 78.6% and the DCR was 100.0% in the overall population (n=42). In the dose-expansion cohort receiving IBI363 at 1.5 mg/kg (n=35), the cORR was 80.0% and the DCR was 100.0%; and the cORRs were 90.0% and 76.9% in patients with PD-L1 CPS ≥5 and CPS <5, respectively.

12-Month PFS and OS Remained Immature, with Potential Signals of Survival Benefit

• In the overall population (n=42), the 12-month PFS and overall survival (OS) rates were 52.8% and 84.5%, respectively. In the dose-expansion cohort receiving IBI363 at 1.5 mg/kg (n=35), the 12-month PFS and OS rates were 55.2% and 84.5%, respectively. Follow-up is ongoing.

Manageable Safety Profile with No New Safety Signals

• The incidence of Grade 3 or higher treatment-emergent adverse events (≥Grade 3 TEAEs) was 45.7% in the overall population and 46.2% in the dose-expansion cohort. No treatment-related deaths were reported.
• The most common TEAEs were anemia (69.6%; ≥Grade 3, 13.0%), decreased platelet count (60.9%; ≥Grade 3, 8.7%) and decreased neutrophil count (43.5%; ≥Grade 3, 13.0%). Most events were mild to moderate and manageable with standard clinical management.
• The safety profile was generally consistent with the known safety profile of the individual agents.

Conclusions and Next Steps

• The first Phase 1b clinical study of IBI363/TAK-928 in first-line HER2-negative G/GEJA demonstrated encouraging efficacy and safety signals. Potential clinical benefit was observed in patients across different PD-L1 CPS expression levels, consistent with the differentiated mechanism of action of IBI363 and findings from previous clinical studies.
• A randomized controlled PoC study is planned to initiate to further evaluate the potential of IBI363 plus chemotherapy in the first-line treatment of G/GEJA.

Professor Pengfei Yu of Zhejiang Cancer Hospital said:

"Since the establishment of PD-1 antibody plus chemotherapy as the standard first-line treatment for HER2-negative G/GEJA, improvements in efficacy have gradually reached a plateau. In this study, IBI363 plus chemotherapy demonstrated encouraging efficacy and a manageable safety profile, with positive signals observed across different PD-L1 CPS expression levels. These findings provide a new opportunity to address the current treatment challenges. We look forward to further exploring IBI363 in the first-line treatment of advanced HER2-negative G/GEJA to potentially provide patients with more comprehensive and effective treatment options."

Immunotherapy-Resistant Lung Adenocarcinoma: IBI363/TAK-928 Significantly Reduced the Risk of Disease Progression

Title: IBI363 (TAK-928) plus bevacizumab (Bev) vs docetaxel (DTX) in patients with locally advanced or metastatic immunotherapy (IO)-resistant lung adenocarcinoma without actionable genomic alterations: a randomized phase Ib study

Abstract number: 1952RO

• Previous studies have demonstrated a favorable long-term safety profile and promising survival data with IBI363/TAK-928 monotherapy in patients with immunotherapy-resistant NSCLC [link]. A global Phase 3 study MarsLight-11 is currently underway to further evaluate IBI363 monotherapy in this patient population(NCT07217301).
• This study is the first randomized controlled Phase 1b study of IBI363/TAK-928 in immunotherapy-resistant NSCLC (NCT06468098). It evaluated IBI363/TAK-928 plus bevacizumab versus docetaxel in patients with locally advanced, unresectable or metastatic lung adenocarcinoma without actionable genomic alterations whose disease had progressed following prior immunotherapy. Baseline characteristics were generally balanced between the two treatment groups. Notably, the docetaxel group had higher proportions of patients with a history of smoking and patients with PD-L1 expression of ≥1%.

IBI363/TAK-928 Demonstrated Efficacy Benefit Compared with Standard of Care Therapy

• As of July 6, 2026, the median follow-up time was 8.48 months in the IBI363/TAK-928 treatment group, with a range of 2.1 to 15.1 months, and 7.59 months in the docetaxel group, with a range of 0.2 to 14.8 months.
• The cORR was 20.0% in the IBI363/TAK-928 treatment group, compared with 7.1% in the docetaxel group. Median PFS was significantly prolonged with IBI363/TAK-928, with a hazard ratio of 0.40 (p=0.0006), corresponding to a 60% reduction in the risk of disease progression or death. In the subgroup analysis, the IBI363/TAK-928 treatment group demonstrated a PFS benefit regardless of PD-L1 expression level. OS data remained immature, and follow-up is ongoing.

Manageable Safety Profile with No New Safety Signals

• The incidence of ≥Grade 3 TEAEs was 62.2% in the IBI363/TAK-928 treatment group and 78.0% in the docetaxel group. The most common TEAEs in the IBI363/TAK-928 treatment group were arthralgia (53.3%; ≥Grade 3, 4.4%), anemia (48.9%; ≥Grade 3, 2.2%) and rash (46.7%; ≥Grade 3, 11.1%). Most events were mild to moderate and manageable with standard clinical management.
• No treatment-related deaths occurred in the IBI363/TAK-928 treatment group. One treatment-related death occurred in the docetaxel group.

Professor Jianya Zhou of The First Affiliated Hospital of Zhejiang University School of Medicine said:

"Immunotherapy resistance remains a major challenge in NSCLC, and treatment options after immunotherapy failure remain limited. The results from this first randomized controlled study of IBI363/TAK-928 are highly encouraging. Compared with docetaxel, IBI363/TAK-928 plus bevacizumab significantly reduced the risk of disease progression, with benefits observed regardless of PD-L1 expression level. These findings, consistent with the long-term follow-up data presented at this year's ASCO Annual Meeting, further support the differentiated clinical profile of IBI363/TAK-928 and its evaluation in immunotherapy-resistant nonsquamous NSCLC in the global multicenter Phase 3 MarsLight-11 study. We look forward to IBI363/TAK-928 potentially offering a new treatment option for these patients."

About IBI363/TAK-928 (PD-1/alpha-biased IL-2 Bispecific Fusion Protein)

IBI363/TAK-928 is a potential first-in-class PD-1/alpha-biased IL-2 bispecific fusion protein being co-developed by Innovent and Takeda. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363/TAK-928 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, with the aim of minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2 to the tumor.

IBI363/TAK-928 is being evaluated in a series of clinical trials globally, including

• a pivotal Phase II study in China in previously untreated acral and mucosal melanoma
• a global multi-center Phase III trial in immunotherapy-resistant squamous and non-squamous NSCLC
• a pivotal Phase III study in China in advanced CRC refractory or intolerant to standard therapy.
• In parallel, multiple Phase Ib/II trials are evaluating IBI363/TAK-928 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types.

IBI363/TAK-928 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/TAK-928 in the U.S., and Takeda will exclusively commercialize IBI363/TAK-928 worldwide other than the U.S. and greater China. Takeda will lead global co-development efforts under joint governance and aligned development plan, sharing development costs (60/40 - Takeda/Innovent).