#China #Suzhou #EGFR #IBI3001 #B7H3

Innovent Biologics Unveils Phase 1 Study Data for IBI3001 at ESMO 2026

At the 2026 European Society for Medical Oncology (ESMO) Congress, held in San Francisco, Innovent Biologics, Inc. showcased compelling Phase 1 clinical trial data for IBI3001, a groundbreaking bispecific antibody-drug conjugate (ADC) targeting both EGFR and B7H3. This study represents a significant step in the development of treatment options for patients battling advanced solid tumors, particularly those who have exhausted other therapies.

Breakthrough Data Presentation

During this prestigious event, Innovent presented findings from an international, multicenter Phase 1 clinical trial, which included over 57 patients suffering from complex cases of advanced solid tumors. The trial was conducted across China, Australia, and the United States, assessing both the safety and preliminary efficacy of IBI3001.

The participants were primarily individuals who had previously undergone multiple lines of treatment, evidencing an essential need for new therapies in such challenging clinical scenarios. Among the cohort, notable cancer types included non-small cell lung cancer (NSCLC), pancreatic cancer, and small cell lung cancer (SCLC).

Safety Profile and Tolerability

With regards to safety, IBI3001 presented a manageable profile. Throughout the dose-escalation phases (dosing between 1 mg/kg and 10 mg/kg), only two instances of dose-limiting toxicity (DLT) were observed, with effective management in both cases. Approximately 47.4% of patients experienced treatment-related adverse events (TRAEs), however, the majority were classified as hematologic toxicities that were deemed clinically manageable. Remarkably, only one patient discontinued treatment due to a TRAE, highlighting the overall favorable safety picture of the bispecific ADC.

Efficacy Results

The efficacy results were promising, illustrating encouraging activity across various solid tumor types. The objective response rate (ORR) across the efficacy-evaluable patient population was reported at 30.2%, with an impressive disease control rate (DCR) of 88.7%. In the 8 mg/kg dosing cohort, the ORR reached an impressive 45%. Such findings are particularly notable given the patient group’s prior treatments and advanced disease stage.

• - In patients with EGFR-mutant NSCLC, the ORR was 31.3%, with a DCR of 93.8% and a median progression-free survival (PFS) of 7.7 months.
• - Patients diagnosed with pancreatic cancer exhibited an ORR of 15.4% and a DCR of 92.3%, achieving a median PFS of 6.9 months.
• - Remarkably, 62.5% of patients with SCLC demonstrated positive responses, and both head and neck squamous cell carcinoma patients showed a striking 60% ORR with a DCR of 100%.

Future Directions: Phase 1b Study

The findings support further exploration of IBI3001 as an innovative treatment option, particularly for patients with resistant or advanced solid tumors. Innovent is moving forward with a Phase 1b proof-of-concept study, which focuses on dose optimization and aims to validate the efficacy and safety across more specific patient populations.

Professor Yi Hu from the Chinese PLA General Hospital remarked on the significance of this therapy: “Patients facing advanced solid tumors frequently reach a critical junction where conventional therapies lack effectiveness. IBI3001’s dual targeting strategy potentially enhances specificity in tumor recognition and facilitates better patient outcomes.”

Dr. Hui Zhou, Chief R&D Officer of Innovent, emphasized the company’s commitment to developing differentiated ADCs through studying IBI3001 rigorously and ensuring thorough understanding of its properties and applications. He reaffirmed that targeting the dual mechanisms holds promise in addressing significant unmet clinical needs.

About Innovent and IBI3001

Founded in 2011, Innovent Biologics is recognized for pioneering high-quality biopharmaceutical developments aimed at tackling major diseases. The introduction of IBI3001 marks a milestone in the company's vision of making effective medications accessible to patients worldwide. As the drug progresses through clinical trials, it offers new hope to those with limited treatment options, particularly in the realms of oncology.

To learn more about Innovent and the developments surrounding IBI3001, visit Innovent's official website.