Innovent's IBI363 Gets Second FDA Fast Track for Squamous NSCLC

SAN FRANCISCO and SUZHOU, China, Feb. 16, 2025 -- Innovent Biologics, Inc., a prominent player in the biopharmaceutical arena, has announced a significant milestone for its groundbreaking PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363. The U.S. Food and Drug Administration (FDA) has granted this innovative drug its second Fast Track Designation (FTD). This latest recognition is for its application in treating unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC), particularly in cases that have deteriorated following anti-PD-(L)1 immune checkpoint inhibitor therapy and platinum-based chemotherapy. IBI363 has shown promising results in terms of both safety and efficacy across multiple solid tumor types. Presently, Innovent is spearheading Phase 1/2 clinical trials of IBI363, primarily in China and the U.S.

At the World Conference on Lung Cancer in September 2024, IBI363 showcased its potential as a treatment for sqNSCLC patients who previously underwent immunotherapy. Within the 3 mg/kg dosage group, for patients monitored for at least 12 weeks or upon study completion, impressive outcomes were observed: an objective response rate of 50.0% and a disease control rate of 88.9%. The median progression-free survival (PFS) has yet to be determined and remains under review.

In a separate 1/1.5 mg/kg dosage group, the median PFS was recorded at 5.5 months, with a 12-month PFS rate of 30.7%, underscoring the potential long-term benefits of this therapy. Across various dosage groups (1/1.5/3 mg/kg), patients with different PD-L1 expression levels achieved encouraging objective response rates, suggesting IBI363's promise in populations with low PD-L1 expression.

Dr. Hui Zhou, Innovent's Senior Vice President, expressed satisfaction with the FDA's Fast Track Designation for sqNSCLC. This follows a previous designation for melanoma. Dr. Zhou highlighted the drug’s ability to improve objective response rates and disease control rates at higher doses, along with a manageable safety profile. Recent data from the 3 mg/kg dose group further bolsters confidence in IBI363’s potential as a long-term immunotherapy solution. The drug has exhibited potent anti-tumor activity irrespective of PD-L1 expression levels, indicating its potential use for immunotherapy-resistant and low PD-L1 expression tumors. Furthermore, promising efficacy signals have been observed in cold tumors, like colorectal cancer and mucosal melanoma, the latter already advancing to pivotal clinical stages. Future plans include exploring early-line treatment opportunities and combination therapies involving IBI363.

The Fast Track Designation is an FDA process designed to expedite the development and review of drugs targeting serious conditions and addressing unmet medical needs. Drugs with this designation enjoy increased FDA communication throughout development, potentially accelerating their path to approval.

IBI363, a first-in-class drug independently developed by Innovent Biologics, is a PD-1/IL-2 bispecific antibody fusion protein. It aims to enhance therapeutic efficacy while minimizing toxicity. The drug's design facilitates efficient targeting and activation of tumor-specific T cells by concurrently inhibiting the PD-1/PD-L1 pathway and activating the IL-2 pathway. Preclinical studies indicate strong anti-tumor activity across various models, including those resistant to PD-1 inhibitors. Clinical trials in China, the United States, and Australia are assessing its safety, tolerability, and preliminary efficacy in advanced malignancies.

Lung cancer remains the world's leading cause of cancer-related deaths, with non-small cell lung cancer (NSCLC) making up over 80% of cases. Currently, there is an urgent need for effective treatments for NSCLC patients who have not responded to immunotherapy and lack driver gene mutations. While immune checkpoint inhibitors have revolutionized NSCLC treatment, options for subsequent lines of therapy remain limited.