#China #Suzhou #Innovent Biologics #Lung Cancer #IBI363

Innovent Biologics Unveils IBI363 Data at ASCO 2025

Innovent Biologics, Inc. has made a significant impact at the American Society of Clinical Oncology (ASCO) 2025 conference with the presentation of updated clinical data for its groundbreaking bispecific antibody, IBI363. This first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein is being evaluated for its effectiveness in treating advanced non-small cell lung cancer (NSCLC), a leading cause of cancer mortality worldwide.

At the conference, Innovent announced that this marks the third oral presentation of IBI363's clinical data, following previous presentations concerning its effects in colorectal cancer and melanoma. The drug showed promising efficacy and a manageable safety profile, specifically in patients with immunotherapy-resistant squamous NSCLC and wild-type lung adenocarcinoma. Notably, Innovent highlighted that they secured a total of eight oral presentations at the ASCO conference, comprising about 2% of the total presentations for the event.

Clinical Trial Overview

Clinical studies for IBI363 are being conducted in multiple countries, including China, the USA, and Australia. This extensive research aims to explore the drug's efficacy in various tumor types, particularly in addressing immune resistance, cold tumors, and first-line treatment settings. During this year’s ASCO meeting, the data presented for IBI363 emphasized outcomes from its Phase 1/2 studies targeting NSCLC, CRC, and melanoma, which focus on resistant tumor types, yielding significant clinical benefits.

Detailed Findings

The updated results provided insights into the drug's potential as an innovative treatment approach. Among the 136 patients with advanced NSCLC who participated in the study as of April 7, 2025, IBI363 demonstrated a robust therapeutic potential. The breakdown of patient cohorts includes 67 with squamous cell carcinoma and 58 with EGFR wild-type adenocarcinoma.

In patients with squamous NSCLC, notable improvements were observed depending on the dosing regimen. Patients who received targeted doses at either 1 mg/kg or 1.5 mg/kg displayed an impressive overall response rate (ORR) of 25.9%, while those at the 3 mg/kg dose achieved a higher ORR of 36.7%. The durability of therapeutic responses was similarly promising, with a median overall survival (OS) of 15.3 months for the lower dose and a statistically significant survival trend for the higher dose.

For patients with advanced EGFR wild-type lung adenocarcinoma, the findings were equally significant. Those treated with lower doses noted a median OS of 17.5 months compared to the higher regimen cohort, which experienced improved response rates, confirming the drug's robust profile in patients exhibiting a history of smoking.

Safety Profile

Importantly, the safety profile of IBI363 was deemed manageable. Adverse events were reported primarily as grade 3 or above, notably arthralgia and rash, with a small percentage leading to treatment discontinuation. Overall, this data supports the drug's well-tolerated nature in a challenging patient population often with limited options.

Next Steps for Innovent

Encouraged by these results, Innovent Biologics plans to advance into a Phase 3 registration trial specifically for patients with locally advanced or metastatic squamous NSCLC who have shown resistance to platinum-based chemotherapy and anti-PD-1/PD-L1 therapies. The drug has also received Breakthrough Therapy Designation from China’s CDE and Fast Track Designation from the US FDA.

Professor Jianya Zhou from Zhejiang University commented on the unmet clinical needs in lung cancer treatment, referring to the limitations of current therapies that yield low ORR and OS rates for patients who have undergone prior treatments.

Dr. Hui Zhou, the Senior Vice President of Innovent, expressed optimism regarding the significant efficacy observed in patients with immune-resistant tumors. The company is committed to enhancing clinical exploration for IBI363 for NSCLC and other cancers, aiming for advancement in treatments that have historically showcased minimal progress.

Conclusion

The presentation of IBI363 at ASCO 2025 represents a critical point in immunotherapy development for advanced NSCLC, showcasing the potential for better patient survival and new therapeutic options in a domain where limitations remain significant. Innovent Biologics is steadily working towards delivering innovative solutions that meet the needs of those battling complex and resilient cancers.

For more information on Innovent Biologics and their groundbreaking work, visit Innovent's Official Website.