Registrational Section III Research of APG-2449 Cleared by China CDE for the Remedy of Sufferers with NSCLC By Investing.com

ROCKVILLE, Md. and SUZHOU, China, Oct. 7, 2024 /PRNewswire/ — Ascentage Pharma (6855.HK), a world biopharmaceutical firm engaged in discovering, growing and commercializing therapies to deal with international unmet medical wants primarily for malignancies, at the moment introduced that APG-2449, a FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI), has been cleared by the Middle for Drug Analysis (CDE) of China’s Nationwide Medical Product Administration (NMPA) to enter two registrational Section III research that can individually consider APG-2449 in sufferers with non-small cell lung most cancers (NSCLC) who’re proof against or illiberal of second-generation anaplastic lymphoma kinase (ALK) TKIs; and treatment-naïve sufferers with ALK-positive superior or regionally superior NSCLC.

These two pivotal research will probably be multicenter, open-label, randomized, registrational Section III research: first one is to judge the efficacy and security of APG-2449 versus platinum-based chemotherapies in sufferers with NSCLC who’re proof against or illiberal of second-generation ALK TKIs. The second registrational Section III research is designed to judge the efficacy and security of APG-2449 versus crizotinib as frontline therapies for treatment-naïve sufferers with ALK-positive superior or regionally superior NSCLC. These two research are the research of an investigational drug not but authorized by the FDA within the US.

ALK-positive NSCLC is a sort of lung most cancers with a particular molecular profile characterised by the irregular association or the fusion of the ALK gene which happens in roughly 3%-5% of all lung most cancers instances. Most sufferers with ALK-positive NSCLC are comparatively younger, non-smoking or solely have a lightweight smoking historical past, and have the next threat of mind metastasis.

Regardless of that a number of ALK-targeted therapies have already been authorized, greater than half of sufferers with NSCLC handled with second-generation ALK TKIs would develop acquired resistance, thus the Chinese language Society of Medical Oncology (CSCO) tips’ advice of platinum-based chemotherapies as a therapy possibility for sufferers who had failed on second-generation ALK-targeted therapies. It’s extensively acknowledged that chemotherapies are generally related to sturdy unwanted effects and there’s a rising common choice for chemotherapy-free regimens for the therapy of superior tumors. Due to this fact, sufferers with resistance to second-generation ALK TKIs have an infinite unmet scientific want for brand spanking new therapies which can be efficient and protected.

APG-2449, developed by Ascentage Pharma, is an orally-active small molecule FAK inhibitor and a third-generation ALK/ROS1 TKI, and the primary FAK inhibitor cleared by the CDE to enter scientific research in China. Within the first-in-human trial, APG-2449 demonstrated preliminary scientific profit and favorable tolerability in sufferers with NSCLC who had been both second-generation ALK TKI resistant or treatment-naïve. APG-2449 additionally confirmed potential inhibitory impact on mind metastases, with its capability to cross the blood-brain barrier confirmed by pharmacokinetics (PK) evaluation on cerebrospinal fluid. Biomarker evaluation discovered that the phosphorylated FAK (pFAK) expression in tumor tissues at baseline in sufferers with NSCLC who had been second-generation ALK TKI-resistant, had been positively correlated with the progress-free survival (PFS) after therapy with APG-2449, indicating that elevated phosphorylated FAK could possibly be related to drug resistance to second-generation ALK TKIs.

Prof. Li Zhang, the principal investigator of those two registrational Section III research from Solar Yat-sen College Most cancers Middle, commented, “APG-2449 is an effective multitargeted inhibitor that acts on FAK/ALK/ROS1. In previously released clinical data, APG-2449 consistently showed manageable safety and favorable antitumor activity in patients with NSCLC. We are particularly encouraged by the preliminary efficacy observed in patients with resistance to second-generation ALK TKIs, as it suggests that multitargeted inhibition on FAK and ALK may offer a new strategy for the management of patients with NSCLC resistant to second-generation ALK TKIs. We look forward to initiating the two registrational Phase III studies of APG-2449 in order to further validate the drug candidate and allow more patients to benefit from this novel therapeutic agent as soon as possible.”

“There is considerable unmet clinical need in the field of NSCLC. APG-2449, a FAK/ALK/ROS1 TKI, has already showed its therapeutic potential in the released clinical data,” mentioned Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “The CDE’s approvals for the two registrational Phase III studies of APG-2449 are very encouraging as they mark a major milestone in the drug candidate’s clinical development. To fulfill our mission of addressing unmet clinical needs in China and around the world, we will expeditiously advance these clinical development programs for the benefit of more patients.”

References:

1. https://ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.9071
2. https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3124

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a world, built-in biopharmaceutical firm engaged in discovering, growing and commercializing therapies to deal with international unmet medical wants primarily in malignancies. On October 28, 2019, Ascentage Pharma was listed on the Foremost Board of the Inventory Change of Hong Kong Restricted with the inventory code 6855.HK.

The corporate has constructed a wealthy pipeline of progressive drug candidates that features novel, extremely potent Bcl-2 and twin Bcl-2/Bcl-xL inhibitors, in addition to candidates aimed toward IAP and MDM2-p53 pathways, and next-generation TKIs. Ascentage Pharma can also be the one firm on this planet with energetic scientific applications concentrating on all three identified courses of key apoptosis regulators. The corporate has performed greater than 40 scientific trials within the US, Australia, Europe, and China, together with 11 registrational research (accomplished/ ongoing/deliberate).

Olverembatinib, the corporate’s first lead asset developed for the therapy of drug-resistant persistent myeloid leukemia (CML) and the corporate’s first authorized product in China, has been granted Precedence Overview Designations and Breakthrough Remedy Designations by the Middle for Drug Analysis (CDE) of China Nationwide Medical Merchandise Administration (NMPA). To this point, the drug had been included into the China Nationwide Reimbursement Drug Listing (NRDL). Moreover, olverembatinib has been granted Orphan Drug Designations (ODDs) and a Quick Observe Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU.

To this point, Ascentage Pharma has obtained a complete of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the corporate’s investigational drug candidates. Leveraging its sturdy R&D capabilities, Ascentage Pharma has constructed a portfolio of worldwide mental property rights and entered into international partnerships and different relationships with quite a few main biotechnology and pharmaceutical firms resembling Takeda, AstraZeneca (NASDAQ:), Merck, Pfizer (NYSE:) and Innovent; and analysis and growth relationships with main analysis establishments resembling Dana-Farber Most cancers Institute, Mayo Clinic, MD Anderson Most cancers Middle, Nationwide Most cancers Institute and the College of Michigan.

The corporate has constructed a proficient workforce with a wealth of worldwide expertise within the discovery and growth of progressive medication and totally purposeful industrial manufacturing and Gross sales & Advertising and marketing groups. One pivotal intention of Ascentage Pharma is to repeatedly strengthen its R&D capabilities and speed up its scientific growth applications, in an effort to fulfil its mission of addressing unmet scientific wants in China and all over the world for the good thing about extra sufferers.

Ahead-Wanting Statements

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