SAN FRANCISCO and SUZHOU, China, January 3, 2025 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and markets high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmic and other major diseases, today announced that China The National Medical Products Administration (NMPA) approved the second New Drug Application (NDA) for DOVBLERON® (taletrectinib adipate capsule), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of patients adults with locally advanced or metastatic ROS1. -Positive NSCLC.
Approval is based on positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a single-arm, open-label, multicenter trial that evaluated the safety, tolerability, and efficacy of taletrectinib in patients Chinese patients with ROS1-positive advanced NSCLC. . The results, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology (JCO), demonstrated that taletrectinib continued to exhibit high and durable overall responses as well as robust activity against intracranial injury. In ROS1 TKI-naïve patients (n=106), the confirmed objective response rate (cORR, as assessed by an independent review committee, IRC) and intracranial cORR reached 91% and 88%, respectively. After a median follow-up of 23.5 months in TKI-naïve patients, the median duration of response (assessed by IRC) and median progression-free survival (assessed by IRC) were not reached. [Link]
In December 2024DOVBLERON® was approved by the NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs. DOVBLERON® is the 13thth in addition to Innovent’s commercial portfolio, representing an innovative precision therapy that is expected to benefit more lung cancer patients alongside our strong ITK franchise.
Caicun Zhou, MD, Ph.D., Director of the Department of Oncology, Shanghai East Hospital, Tongji Universitycommented: “We are pleased to see that DOVBLERON® has been approved at a rapid pace for ROS1-positive NSCLC across all treatment lines. DOVBLERON® demonstrated superior efficacy compared to first generation TKIs. These TRUST-I results reinforce the high overall efficacy of taletrectinib. response and prolonged PFS. The efficacy and safety profile of DOVBLERON® provides a more effective first-line treatment option and I look forward to its benefits in patients with ROS1-positive NSCLC. China“.
Dr. Hui ZhouSenior Vice President of Innovent, said: “The approval of both DOVBLERON® NDAs reflects its potential best-in-class efficacy to address the urgent needs of patients with ROS1-positive NSCLC. We just recently launched the first batch of DOVBLERON® to the market, quickly bringing this precision therapy product to NSCLC patients who need new treatment options. Innovent’s strong ITK product portfolio, including RETSEMOV®, PEMAZYRE®, DUPERT® and DOVBLERON®, highlights our leadership and leadership. synergistic forces in precision oncology. We strive to advance more innovative medicines to improve patients’ quality of life.
About ROS1-positive non-small cell lung cancer
Lung cancer continues to have one of the highest incidence and mortality rates in the world, with NSCLC accounting for approximately 85% of all cases. In Chinaapproximately 2.6% of NSCLC patients are estimated to be ROS1-positive[i]. Despite recent advances in patients with ROS1-positive NSCLC, there remains a need for more effective and tolerable therapeutic options. In patients with metastatic ROS1-positive NSCLC who progressed after initial treatment, many have tumors that have spread to the brain (up to 55%) or have acquired resistance mutations, including G2032R. Next-generation ROS1 TKIs demonstrated robust intracranial and G2032R activity. In the clinical management of patients with ROS1-positive NSCLC, first-line application of next-generation ROS1 TKIs may provide prolonged progression-free survival and provide patients with greater survival benefits.
About DOVBLERON ® (taletrectinib adipate capsule)
DOVBLERON® is an oral, powerful, central nervous system active, selective, new generation ROS1 inhibitor. Taletrectinib, the active ingredient in DOVBLERON®, is being evaluated for the treatment of patients with ROS1-positive advanced NSCLC in two pivotal single-arm Phase 2 studies: TRUST-I ( NCT04395677) in Chinaand TRUST-II (NCT04919811), a global study.
DOVBLERON® has been approved by China National Medical Products Administration (NMPA): 1) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who have been previously treated with ROS1 TKIs; 2) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.
Taletrectinib has been granted Orphan Drug Designation by the US FDA for the treatment of patients with ROS1-positive NSCLC and other NSCLC indications, as well as Breakthrough Therapy Designation by the US FDA and China NMPA for the treatment of patients with locally advanced or metastatic ROS1-positive NSCLC. Based on pooled results from the TRUST-I and TRUST-II clinical studies, Nuvation Bio Inc. (NYSE: NUVB) submitted an NDA for taletrectinib to the U.S. FDA for the treatment of patients with ROS1- advanced NSCLC. positive (lineage independent, full approval). This NDA has been accepted by the US FDA for priority review in December 2024.
In June 2021Innovent and AnHeart Therapeutics (Hangzhou) Co. Ltd., a Nuvation Bio Inc. company, has entered into an exclusive licensing agreement for the co-development and commercialization of taletrectinib in Greater Chinaincluding the continent China, Hong Kong, Macau And Taiwan.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission of providing affordable, high-quality biopharmaceutical products to patients around the world. The company discovers, develops, manufactures and markets innovative medicines targeting some of the most incurable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and ocular diseases. Innovent has launched 13 products on the market. It has 4 new drug applications currently under regulatory review, 3 assets in phase III or pivotal clinical trials and 17 other molecules in early clinical phase. Innovent partners with more than 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 with Action”, Innovent maintains the highest standards of industry practices and works collaboratively to advance the biopharmaceutical industry so that best-in-class pharmaceutical drugs can become widely available. accessible. For more information, visit www.innoventbio.comor follow Innovent on Facebook and LinkedIn.
Forward-looking statements
This press release may contain certain forward-looking statements which, by their nature, are 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 these statements prospective. Innovent does not intend to regularly update these forward-looking statements.
These forward-looking statements are based on Innovent’s management’s existing beliefs, assumptions, expectations, estimates, projections and understandings regarding future events at the time such 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. Therefore, actual results may differ materially from the information contained in the forward-looking statements due to future changes or developments in our business, Innovent’s competitive environment and political, economic, legal and social conditions.
References
[i] Zhang et al. Prevalence of ROS1 fusion in Chinese non-small cell lung cancer patients. Thoracic cancer. January 2019; 10(1):47-53.
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