Apollomics Announces Approval of Vebreltinib in China as a First-in-Class Treatment for Gliomas with MET Fusion Gene
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Insights
The approval of vebreltinib in China for gliomas with MET fusion gene is a noteworthy development in the oncology treatment landscape. Targeted therapies like vebreltinib, which inhibits the c-Met receptor tyrosine kinase, offer a personalized approach to cancer treatment, potentially addressing unmet medical needs. As gliomas are aggressive brain tumors, the prognosis for patients is often poor and the introduction of new treatment options can significantly affect survival rates.
From a medical research perspective, the approval was predicated on positive trial results, indicating a successful inhibition of the c-Met pathway, essential for tumor growth and survival in certain gliomas. This implies that vebreltinib may become a standard-of-care for patients with this specific genetic mutation who have limited treatment options after first-line therapy fails.
Furthermore, the drug's ability to penetrate the Central Nervous System (CNS) is a critical advantage for treating brain tumors, a challenge for many compounds due to the blood-brain barrier. It is essential for investors to monitor subsequent post-marketing studies and real-world data that will shed light on vebreltinib's long-term efficacy and safety profile.
Apollomics' announcement of NMPA approval for vebreltinib serves as a potential catalyst for the company's financial performance in the Chinese market. The drug's designation as a first-in-class c-Met inhibitor for CNS tumors represents a new revenue stream and could translate into a competitive advantage in the oncology drug market. The approval might also lead to increased interest from investors in Apollomics' broader drug pipeline.
For Apollomics, a critical aspect to consider is how this approval affects their earnings forecast and market share, especially since China represents a significant pharmaceutical market. The collaboration with Avistone is likely to provide strategic benefits, including local expertise and potential cost savings in production and distribution, which can positively influence profit margins.
It is important to analyze the upcoming quarterly financial reports to gauge the impact of this approval on Apollomics’ financial health. Any guidance updates by the company regarding revenue projections from vebreltinib sales would also be an essential factor in assessing the stock's potential.
The oncology sector in China is rapidly expanding, with increased emphasis on novel therapies for hard-to-treat cancers like gliomas. The approval of vebreltinib may signify a shift towards precision medicine in the treatment of such tumors. As a market research analyst, observing the uptake of vebreltinib in the Chinese market will provide insights into the demand for targeted therapies.
Understanding the competitive landscape is vital, as other c-Met inhibitors are being developed globally. The extent to which vebreltinib gains traction compared to these potential competitors will depend on the drug's efficacy, cost and the establishment of meaningful partnerships. Monitoring how Apollomics positions vebreltinib in China, both in marketing strategies and in price setting, will be important in predicting market performance.
Furthermore, the potential expansion to other markets, contingent on global trials such as the ongoing SPARTA trial, could have significant implications for the company's global market share and long-term growth potential. Insight into policy changes that may affect drug approval processes in other regions would also be valuable for investors to consider.
Apollomics’ partner in China, Avistone, received approval from National Medical Products Administration of China to expand the use of vebreltinib to the treatment of gliomas with PTPRZ1-MET fusion gene
Approval based on results from a randomized Phase 2/3 trial
FOSTER CITY, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced that its partner in China, Avistone Biotechnology Co. Ltd. (Avistone), received approval from the National Medical Products Administration (NMPA) of China for vebreltinib (APL-101) for the treatment of adult patients with isocitrate dehydrogenase (IDH) mutant astrocytoma (WHO Grade 4) or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion (ZM fusion) gene and have failed previous treatments. This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration, and follows the NMPA’s November 2023 approval of vebreltinib for the treatment of patients with Met Exon 14 skipping non-small cell lung cancer (NSCLC).
"The NMPA’s approval of vebreltinib in gliomas is an important, first-in-class approval as it demonstrates vebreltinib’s CNS penetration ability and c-Met inhibitory activity in the tumors there," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics. "Our collaboration with Avistone, which includes data-sharing, and our ongoing global SPARTA trial with vebreltinib underscores our commitment and the potential to develop vebreltinib for treating patients with solid tumors with c-Met alterations globally, outside of China.”
Gliomas are difficult-to-treat primary malignant intracranial tumors accounting for about
Vebreltinib, Apollomics’ most advanced product candidate in the U.S., is a potent, small molecule, orally bioavailable and highly selective c-Met inhibitor that works by inhibiting the aberrant activation of the HGF/c-Met axis, a key pathway involved in tumor growth, proliferation, and the development of resistance to certain targeted therapies.
The approval of vebreltinib for the ZM fusion-positive glioma indication in China is based on the positive results of Avistone’s FUGEN study (NCT06105619), a randomized, two-arm, multicenter Phase 2/3 clinical study that was conducted in China. This 84-patient study compared the efficacy and safety of vebreltinib with the dose-dense regimen of temozolomide or the combination of etoposide and cisplatin, with OS as the primary endpoint. The median OS for the vebreltinib monotherapy regimen was 6.31 months, compared to 3.38 months for the control group, reducing the risk of death by
In the ongoing global SPARTA study being conducted by Apollomics that includes U.S. and European patients, similar to the vebreltinib treated patients in the FUGEN study in China, a median survival of 6.5 months has been observed to date in the 25 patients with recurrent relapsing CNS tumors with c-Met alterations treated with vebreltinib. Eight of these 25 patients with recurrent relapsing glioma had centrally confirmed ZM fusion glioma, where the median OS was also 6.5 months. These preliminary data support cross-region similarity of patient response to treatment with vebreltinib.
Under the partnership agreement, Avistone holds the exclusive rights to vebreltinib in China, Hong Kong and Macau, while Apollomics retains the exclusive rights in the rest of the world, including the U.S, and the partners have access to each other’s data. This collaboration enables both companies to leverage their strengths and maximize the benefit of vebreltinib worldwide.
About SPARTA
Apollomics is conducting a multi-cohort Phase 2 study of vebreltinib, SPARTA, at over 90 centers in 12 countries investigating the efficacy and safety of vebreltinib in Met Exon 14 skipping NSCLC. Cohorts A-1 is recruiting in first line Met Exon 14 skipping NSCLC subjects and Cohort A-2 is recruiting in pretreated (> 2L) Met Exon 14 skipping NSCLC subjects. In addition, Cohort C includes histology agnostic c-Met amplified cancers (excluding primary CNS tumors) and Cohort C-1 includes NSCLC harboring c-Met amplification and wild-type epidermal growth factor receptor (EGFR).
About Apollomics Inc.
Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics currently has a pipeline of nine drug candidates across multiple programs, six of which are currently in the clinical stage of development. Apollomics’ lead programs include vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, and uproleselan (APL-106), a specific E-Selectin antagonist that has the potential to be used adjunctively with standard chemotherapy to treat acute myeloid leukemia. For more information, please visit www.apollomicsinc.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes statements that constitute “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of present or historical fact included in this press release, regarding clinical trials and results, as well as the Company’s strategy, business plans and objectives of management are forward-looking statements. In addition, Apollomics cautions you that the forward-looking statements contained in this press release are subject to unknown risks, uncertainties and other factors, including: (i) Apollomics’ ability to raise additional capital to meet its operating cash requirements and expectations regarding incurring net losses and net operating cash outflows; (ii) the ability of Apollomics to maintain the listing of its Class A ordinary shares on Nasdaq (iii) Apollomics’ ability to achieve successful clinical results; (iv) Apollomics’ ability to commercialize its product candidates; (v) Apollomics’ ability to develop and maintain effective internal controls over financial reporting; (vi) the impact of any current or new government regulations in the United States and China affecting Apollomics’ operations; (vii) Apollomics’ ability to obtain licensing of third-party intellectual property rights for future discovery and development of Apollomics’ oncology projects; (viii) the failure to protect Apollomics’ intellectual property; (v) breaches in data security; and other risks included in the Annual Report on Form 20-F filed with the SEC and other SEC filings that are available publicly on the SEC’s website at www.sec.gov. Apollomics undertakes no obligation to update publicly any of these forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable laws.
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FAQ
What is the significance of the approval of Vebreltinib in China by the NMPA?
What type of gliomas is Vebreltinib approved to treat?
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