Innovent Biologics, Inc., a biopharmaceutical company based in China, has unveiled promising Phase 1 clinical data for its novel drug IBI3001 at the 2026 European Society for Medical Oncology (ESMO) Congress in San Francisco. This first-in-class EGFR/B7H3 bispecific antibody-drug conjugate (ADC) is designed to treat advanced solid tumors, and the results suggest significant potential in addressing difficult-to-treat cancers.
The international study, conducted across China, Australia, and the United States, involved 57 patients with advanced solid tumors. These patients, including those with non-small cell lung cancer (NSCLC), pancreatic cancer, and small cell lung cancer (SCLC), received IBI3001 monotherapy at doses ranging from 1 mg/kg to 10 mg/kg. Notably, 78.9% of participants had undergone at least two prior treatments, highlighting the refractory nature of their conditions.
IBI3001 demonstrated a manageable safety profile throughout the study. Dose-limiting toxicities were rare, with only one event observed in each of the 8 mg/kg and 10 mg/kg cohorts. The most common treatment-related adverse events were hematologic toxicities, yet these were clinically manageable. Importantly, only one patient discontinued treatment due to adverse effects, and no deaths related to treatment were reported.
The efficacy of IBI3001 was particularly notable. Among 53 patients evaluated for efficacy, the overall objective response rate (ORR) was 30.2%, while the disease control rate (DCR) reached 88.7%. In the 8 mg/kg cohort, the ORR climbed to 45.0%, with a DCR of 100%. By tumor type, patients with EGFR-mutant NSCLC showed an ORR of 31.3% and a DCR of 93.8%, with a median progression-free survival (PFS) of 7.7 months. Pancreatic cancer patients, many of whom had previously received irinotecan, exhibited an ORR of 15.4% and a DCR of 92.3%, with a median PFS of 6.9 months. SCLC patients had an ORR of 62.5% and a DCR of 100%, while those with head and neck or esophageal squamous cell carcinoma saw an ORR of 60.0% and a DCR of 100%.
Professor Yi Hu from the Chinese PLA General Hospital emphasized the significance of these findings, particularly for patients with limited treatment options after multiple lines of therapy. He highlighted the dual-targeting mechanism of IBI3001, which enhances tumor recognition and delivers a potent antitumor payload, resulting in impressive efficacy across various refractory tumor types.
Dr. Hui Zhou, Chief R&D Officer for Innovent's Oncology Pipeline, noted that IBI3001 represents a leading program in their oncology portfolio. The Phase 1 data supports the potential of Innovent's bispecific ADC platform, which aims to improve tumor-targeting specificity while minimizing off-target toxicity. The company plans to advance IBI3001 to a Phase 1b dose-optimization study and expand cohort studies to further explore its efficacy and safety.
Innovent's ADC Technology
IBI3001 is a groundbreaking bispecific ADC targeting EGFR and B7H3, two proteins associated with tumor growth and immune evasion. The drug carries a topoisomerase I inhibitor payload, designed to enhance its antitumor activity. Preclinical studies have shown that IBI3001 has a potent bystander effect and excellent antitumor activity in various tumor models, with a favorable safety profile.
Innovent, founded in 2011, has established itself as a leader in the biopharmaceutical industry, focusing on affordable, high-quality medicines for challenging diseases. The company has launched 20 products and has numerous strategic partnerships with global pharmaceutical giants, reflecting its commitment to advancing the biopharmaceutical industry.
As IBI3001 progresses through clinical trials, Innovent aims to offer a next-generation ADC treatment option for tumor types such as EGFR-mutant NSCLC, pancreatic cancer, and esophageal cancer. The ongoing Phase 1b study will further validate its potential to address unmet clinical needs in refractory cancer patient populations.
