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Overview of IBI363/TAK-928 Presentation at ESMO 2026

At the recent European Society for Medical Oncology (ESMO) Congress held on October 25, 2026, Innovent Biologics, Inc. shared multiple clinical updates regarding IBI363 (also known as TAK-928), a novel PD-1/alpha-biased IL-2 bispecific fusion protein. As a groundbreaking therapy under investigation, IBI363 is designed to target a variety of cancers, including non-small cell lung cancer (NSCLC) and gastroesophageal adenocarcinoma (G/GEJA). This presentation highlighted findings from three Phase 1b clinical trials involving IBI363 that underline its potential effectiveness across different treatment scenarios.

Clinical Trials Overview

1. IBI363 in Non-Small Cell Lung Cancer (NSCLC)

The first study focused on IBI363 in combination with chemotherapy for advanced NSCLC, particularly in patients with low or negative PD-L1 expression. Patients involved in the trial had not received prior treatments and demonstrated encouraging tumor response rates:

• - Confirmed Objective Response Rates (cORRs): 47.4%, 61.9%, and 86.4% across different dosage groups.
• - Disease Control Rates (DCRs): High DCRs of 94.7% to 100.0% were noted, demonstrating the treatment's ability to manage disease progression effectively.

As of the last update, 48.8% of treated patients remained on the therapy, showing promise for sustained treatment engagement and safety. The safety profile remained manageable, with hematologic-related side effects being the most frequently reported.

2. IBI363 in Gastroesophageal Adenocarcinoma (G/GEJA)

The second study evaluated the efficacy of IBI363 combined with capecitabine and oxaliplatin (XELOX) as a first-line treatment for HER2-negative advanced G/GEJA. Here, the results were just as compelling:

• - Cross-Patient cORR: Approached 78.6% across PD-L1 CPS subgroups, suggesting uniform effectiveness regardless of PD-L1 levels.
• - Disease Control Rate: Remarkably, the DCR reached 100% among patients on this combination.

Follow-up data revealed encouraging progression-free survival (PFS) and overall survival (OS) rates, with continued monitoring expected as further studies unfold.

3. Immunotherapy-Resistant Lung Adenocarcinoma

The final trial assessed the efficacy of IBI363/TAK-928 in patients with locally advanced or metastatic lung adenocarcinoma resistant to prior immunotherapy. In this randomized controlled trial, IBI363 demonstrated a significant reduction in disease progression risk compared with standard docetaxel treatment, with PFS improvements observed:

• - cORR: 20.0% in the IBI363 group compared to 7.1% for docetaxel, highlighting its potential as a new treatment alternative.
• - Safety Profile: The incidence of treatment-emergent adverse events remained manageable, underscoring IBI363's favorable safety landscape.

Future Perspectives and Collaborative Efforts

Dr. Hui Zhou, Chief RD Officer of Innovent, emphasized the importance of continuing this journey alongside Takeda, which is co-developing IBI363 on a global scale. The message conveyed is clear: IBI363/TAK-928 holds transformative potential in treating various cancer types, particularly among patients who have limited options available due to resistance to standard therapies. Furthermore, discussions about initiating a randomized controlled pivotal study are on the horizon, aimed at fully understanding the depths of IBI363's efficacy.

In summary, the data from ESMO 2026 reinforce IBI363/TAK-928's promising role in addressing the significant medical needs present in oncology, with ongoing trials set to unveil more about this innovative therapeutic approach. Innovent aims to provide new hope for patients grappling with these challenging malignancies whilst reiterating their commitment to drug development that centers around patient accessibility and safety.

About Innovent

Founded in 2011, Innovent Biologics is dedicated to developing high-quality biopharmaceutical products aimed at managing major health challenges. With over 20 marketed products, the company’s focus has led to strategic collaborations with industry leaders, all while maintaining the standard of excellence in biomedical advancements.