The approval is predicated on the pivotal TRIDENT-1 trial, wherein AUGTYRO achieved a excessive response price and sturdy responses, together with sturdy intracranial responses
SHANGHAI & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zai Lab Restricted (NASDAQ: ZLAB; HKEX: 9688) as we speak introduced that the Nationwide Medical Merchandise Administration (NMPA) in China has accepted the New Drug Software (NDA) for AUGTYRO™ (repotrectinib) for the remedy of grownup sufferers with domestically superior or metastatic ROS1-positive non-small-cell lung most cancers (NSCLC). The approval is predicated on the pivotal TRIDENT-1 examine, an open-label, single-arm, Section 1/2 trial that evaluated repotrectinib in TKI-naïve and TKI-pretreated sufferers with ROS1-optimistic NSCLC.
We’re happy with NMPA’s approval of AUGTYRO for the remedy of sufferers with ROS1-positive NSCLC in China. There’s a important unmet want for these sufferers given the restricted sturdiness of profit as a result of emergence of resistance with present therapies, finally resulting in tumor development, stated Rafael G. Amado, M.D., President, Head of World Oncology Analysis and Growth at Zai Lab (NASDAQ:). We admire the NMPA for his or her thorough evaluation of AUGTYRO, recognizing its potential to deal with the unmet medical want in China.
Regardless of present earlier technology TKIs for ROS1-positive NSCLC, there stays an unmet want for brand new remedy choices that assist necessary medical targets, resembling sturdy therapeutic response, stated Dr. Shun Lu, M.D., Ph.D., Chief of Lung Most cancers Heart, Shanghai Chest Hospital, Shanghai Jiaotong College. The TRIDENT-1 examine confirmed that remedy with repotrectinib leads to excessive response charges with promising sturdiness in sufferers with ROS1-positive NSCLC, throughout TKI-naïve and TKI-pretreated settings, together with within the presence of intracranial illness. Primarily based on this examine, repotrectinib has the potential to turn out to be a brand new commonplace of take care of these sufferers.
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In June 2023, China’s NMPA accepted the NDA for AUGTYRO for the remedy of grownup sufferers with domestically superior or metastatic ROS1-positive NSCLC, with precedence evaluate granted in Could 2023.
Zai Lab contributed to the pivotal TRIDENT-1 examine and dosed the primary affected person in Better China in Could 2021, and the outcomes had been printed within the New England Journal of Medication in January 2024. The topline efficacy and security knowledge of Chinese language subpopulation is according to that of worldwide inhabitants, demonstrating sturdy response charges and sturdy medical exercise in sufferers with ROS1-positive NSCLC. Remedy with AUGTYRO was typically effectively tolerated with a manageable security profile.
About AUGTYRO
AUGTYRO (repotrectinib) is a next-generation tyrosine kinase inhibitor focusing on the ROS1 and NTRK oncogenic drivers. Sufferers with stable tumors, together with NSCLC, harboring ROS1 and NTRK gene fusions handled with accepted focused therapies typically develop resistance mutations that restrict binding of those medicine to their goal. In the end, this results in shortened period of response and tumor development. AUGTYRO is the primary next-generation ROS1 and TRK TKI uniquely designed to enhance sturdiness of profit, together with within the mind.
In November 2023, AUGTYRO was accepted by the U.S. Meals and Drug Administration (FDA) for the remedy of grownup sufferers with domestically superior or metastatic ROS1-positive NSCLC.
AUGTYRO has been granted three Breakthrough Remedy Designations from the U.S. Meals and Drug Administration in: ROS1-positive metastatic NSCLC sufferers who haven’t been handled with a ROS1 TKI; ROS1-positive metastatic NSCLC sufferers who’ve beforehand been handled with one ROS1 TKI and who haven’t acquired prior platinum-based chemotherapy; and sufferers with superior stable tumors which have an NTRK gene fusion who’ve progressed following remedy with one or two prior TRK TKIs, with or with out prior chemotherapy, and haven’t had passable different remedies. Moreover, AUGTYRO was beforehand granted 4 Quick-Observe designations in sufferers with: ROS1-positive superior NSCLC who haven’t been handled with one ROS1 TKI; ROS1-positive superior NSCLC who’ve been beforehand handled with one prior line of platinum-based chemotherapy and one prior ROS1 TKI; ROS1-positive superior NSCLC pretreated with one prior ROS1 TKI with out prior platinum-based chemotherapy; and superior stable tumors which have an NTRK gene fusion who’ve progressed following remedy with at the very least one prior line of chemotherapy and one or two prior TRK TKIs and haven’t had passable different remedies. AUGTYRO was additionally granted an Orphan Drug designation in 2017.
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AUGTYRO has been granted 4 Breakthrough Remedy Designations by the CDE of China’s NMPA in ROS1-positive metastatic NSCLC sufferers who haven’t been handled with a ROS1 TKI; ROS1-positive metastatic NSCLC sufferers who’ve beforehand been handled with one prior ROS1 TKI and who haven’t acquired prior platinum-based chemotherapy or immunotherapy; and ROS1-positive metastatic NSCLC sufferers who’ve beforehand been handled with one prior ROS1 TKI and one platinum-based chemotherapy; and sufferers with superior stable tumors which have an NTRK gene fusion who’ve progressed following remedy with one or two prior TRK TKIs, with or with out prior chemotherapy, and haven’t had passable different remedies.
Zai Lab has an unique license settlement with Turning Level Therapeutics (NASDAQ:), Inc. (Turning Level Therapeutics, a Bristol Myers (NYSE:) Squibb firm) to develop and commercialize AUGTYRO in Better China (Mainland China, Hong Kong, Taiwan, and Macau).
About TRIDENT-1
TRIDENT-1 is a world, multicenter, single-arm, open-label, multi-cohort Section 1/2 medical trial evaluating the protection, tolerability, pharmacokinetics and anti-tumor exercise of AUGTYRO in sufferers with superior stable tumors, together with NSCLC.1,2 Section 1/2 consists of sufferers with domestically superior or metastatic stable tumors harboring ROS1 fusions.2 Further analyses of the trial are nonetheless being performed; asymptomatic central nervous system (CNS) metastases are allowed.1,2 The trial excludes sufferers with symptomatic mind metastases, amongst different exclusion standards.1 Section 1 of the trial included the dose escalation that decided the beneficial Section 2 dose.2
Section 2 of the trial has a main endpoint of total response price (ORR).1,2 Key secondary endpoints embody period of response (DOR) in line with Response Analysis Standards in Strong Tumors (RECIST v1.1) as assessed by Blinded Unbiased Central Evaluate (BICR), progression-free survival (PFS), and intracranial response in six distinct enlargement cohorts, together with TKI-naïve and TKI-pretreated sufferers with ROS1-positive domestically superior or metastatic NSCLC.1,2
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In TRIDENT-1, 79% (95% Confidence Interval [CI]: 68 to 88) of TKI-naïve sufferers (n=71) responded to remedy; 6% skilled full responses and 73% skilled partial responses.1 The median period of response (mDOR) was 34.1 months.1 Amongst TKI-pretreated sufferers, 38% (95% CI: 25 to 52) (n=56) responded to remedy; 5% skilled full responses and 32% skilled partial responses and the mDOR was 14.8 months.1 Amongst those that had measurable CNS metastases at baseline, responses in intracranial lesions had been noticed in 7 of 8 TKI-naïve sufferers and in 5 of 12 of those that had been TKI-pretreated.1
The FDA-approved dosing for AUGTYRO is 160 mg orally as soon as every day for 14 days, then elevated to 160 mg twice every day till illness development or unacceptable toxicity.1
About Non-Small Cell Lung Most cancers in China
Lung most cancers is essentially the most generally recognized most cancers sort and the main explanation for most cancers dying in China. There have been roughly 871,000 new instances and 767,000 deaths of lung most cancers in China in 2022, respectively.3 NSCLC accounts for roughly 85% of lung most cancers, and roughly 70% of NSCLC is domestically superior or metastatic at preliminary analysis. In China, ROS1 rearrangements happen in 2-3% of sufferers with superior NSCLC.4
1 Augtyro Prescribing Data. Augtyro U.S. Product Data. Final up to date: November 2023. Princeton, NJ: Bristol Myers Squibb Firm.
2 ClinicalTrials.gov: NCT03093116. A examine of repotrectinib (TPX-0005) in sufferers with superior stable tumors harboring ALK, ROS1, or NTRK1-3 rearrangements (TRIDENT-1). Obtainable at https://traditional.clinicaltrials.gov/ct2/present/NCT03093116. Accessed November 4, 2023.
3 Changfa Xia, et al. Most cancers statistics in China and United States, 2022: profiles, tendencies, and determinants.
4 Zhang, et al. Prevalence of ROS1 fusion in Chinese language sufferers with non-small cell lung most cancers, Thoracic Most cancers January 2019.
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About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an progressive, research-based, commercial-stage biopharmaceutical firm primarily based in China and the USA. We’re centered on discovering, creating, and commercializing progressive merchandise that handle medical circumstances with important unmet wants within the areas of oncology, autoimmune issues, infectious ailments, and neuroscience. Our purpose is to leverage our competencies and sources to positively impression human well being in China and worldwide.
For added details about Zai Lab, please go to www.zailaboratory.com or comply with us at www.twitter.com/ZaiLab_Global.
Zai Lab Ahead-Trying Statements
This press launch accommodates forward-looking statements about future expectations, plans, and prospects for Zai Lab, together with, with out limitation, statements referring to the prospects of repotrectinib and the potential remedy of ROS1-positive NSCLC and NTRK-positive stable tumors in Better China. These forward-looking statements could comprise phrases resembling goal, anticipate, imagine, might, estimate, anticipate, forecast, purpose, intend, could, plan, attainable, potential, will, would, and different related expressions. Such statements represent forward-looking statements throughout the that means of the Non-public Securities Litigation Reform Act of 1995. Ahead-looking statements will not be statements of historic truth or ensures or assurances of future efficiency. Ahead-looking statements are primarily based on our expectations and assumptions as of the date of this press launch and are topic to inherent uncertainties, dangers and adjustments in circumstances that will differ materially from these contemplated by the forward-looking statements. Precise outcomes could differ materially from these indicated by such forward-looking statements because of numerous necessary components, together with however not restricted to (1) our capacity to efficiently commercialize and generate income from our accepted merchandise; (2) our capacity to acquire funding for our operations and enterprise initiatives, (3) the outcomes of our medical and pre-clinical improvement of our product candidates, (4) the content material and timing of choices made by the related regulatory authorities concerning regulatory approvals of our product candidates, (5) dangers associated to doing enterprise in China, and (6) different components recognized in our most up-to-date annual and quarterly studies and in different studies we’ve got filed with the U.S. Securities and Change Fee. We anticipate that subsequent occasions and developments will trigger our expectations and assumptions to vary, and we undertake no obligation to replace or revise any forward-looking statements, whether or not because of new info, future occasions or in any other case, besides as could also be required by legislation. These forward-looking statements shouldn’t be relied upon as representing our views as of any date subsequent to the date of this press launch.
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