Innovent Delivers Oral Presentation of Updated Results from a Pivotal Phase 2 Study of Dupert® (Fulzerasib) in Patients with Advanced Non-Small Cell Lung Cancer Harboring KRAS G12C Mutation

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SAN FRANCISCO and SUZHOU, China, Sept. 9, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces an oral presentation of updated results from a pivotal Phase 2 clinical trial of Dupert^®（fulzerasib）for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation at the 2024 World Conference on Lung Cancer (WCLC).

Fulzerasib is a novel, orally active, potent KRAS G12C inhibitor. Based on the results from this single-arm registrational Phase 2 clinical study (NCT05005234).

Dupert^® (fulzerasib) received approval by the NMPA in August 2024 for the treatment of adult patients with advanced NSCLC harboring the KRAS G12C mutation who have received at least one systemic therapy.

As of the data cutoff date (Dec 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable.

• Fulzerasib showed encouraging antitumor activity. The confirmed objective response rate (ORR) assessed by the Independent Radiology Review Committee (IRRC) was 49.1% (95% CI: 39.7-58.6). The disease control rate (DCR) was 90.5% (95%CI: 83.7, 95.2). The median duration of response (DoR) has not yet been reached, while the median progression-free survival (PFS) was 9.7 months (95%CI: 5.6-11.0). Median overall survival (OS) has not been reached.
• Fulzerasib was generally well-tolerated, with no additional safety signals observed. Treatment-related adverse events (TRAEs) occurred in 92.2% of patients (107 individuals), mostly Grade 1-2. The most common TRAEs included anemia, increased alanine aminotransferase, increased aspartate aminotransferase, asthenia and proteinuria.

Professor Yi-Long Wu from Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, stated: "As a potent KRAS G12C inhibitor, Dupert^® monotherapy has demonstrated encouraging efficacy in advanced lung cancer with KRAS G12C mutations, with the pivotal registry study meeting the prespecified primary endpoints and overall favorable safety profile. As the first KRAS G12C inhibitor approved in China, Dupert^® provides a new treatment option for cancer patients harboring this gene mutation in China. We look forward to seeing more KRAS G12C-mutated patients with advanced lung cancer benefit from this drug soon."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to share the latest clinical data from the registration study of Dupert^® at the WCLC. Thanks to the exceptional efficacy and good tolerability demonstrated in this study, Dupert^® was recently approved as the first KRAS G12C inhibitor in China. Moving forward, we remain committed to advancing Dupert^® as both a monotherapy and in combination treatments, aiming to maximize the clinical value of this innovative targeted drug and benefit more patients."

About Dupert^® (Fulzerasib, KRAS G12C Inhibitor)

The RAS protein family is categorized into KRAS, HRAS and NRAS categories. KRAS mutation are detected in nearly 90% of pancreatic cancers, 30-40% of colon cancers, and 15-20% lung cancers. The KRAS G12C mutation is more prevalent than the combined occurrence of ALK, ROS1, RET and NTRK 1/2/3 mutations.

Fulzerasib is a novel, orally active and potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange—an essential step in pathway activation—by covalently and irreversibly modifying the cysteine residue of KRAS G12C protein. Preclinical cysteine selectivity studies demonstrated high selectivity of fulzerasib towards G12C, leading to inhibition of downstream signaling, resulting in tumor cells apoptosis and cell cycle arrest.

In September 2021, Innovent and GenFleet Therapeutics entered an exclusive license agreement for the development and commercialization of fulzerasib (Innovent R&D code: IBI351, GenFleet R&D code: GFH925) in China, including mainland China, Hong Kong, Macau and Taiwan.

In January 2023, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation (BTD) to fulzerasib for the treatment of patients with advanced NSCLC harboring KRAS G12C mutation who have received at least one prior systemic therapy. In May 2023, another BTD was granted for the treatment of advanced CRC patients with KRAS G12C mutation who had undergone at least two systemic therapies.

As of August 2024, the CDE of NMPA has approved fulzerasib for the treatment of adult patients with advanced NSCLC harboring the KRAS G12C mutation who have received at least one systemic therapy.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. 

For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

SOURCE Innovent Biologics