Apollomics Announces Two New Cohorts in Global Phase 2 SPARTA Study of Vebreltinib in Non-Small Cell Lung Cancer and Other Solid Tumors with MET Dysregulation
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FOSTER CITY, Calif., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced the addition of two new cohorts in its ongoing global multi-cohort Phase 2 SPARTA study (NCT03175224), which is evaluating vebreltinib (APL-101) in patients with non-small cell lung cancer (NSCLC) and other solid tumors (i.e., brain, esophageal, colon, pancreatic cancer) with MET dysregulations, including exon14 skipping mutation, c-MET amplification and MET fusion.
The first new cohort, labeled C-2, is evaluating the addition of vebreltinib to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, such as osimertinib, for patients with EGFR-mutated NSCLC progressing on first line EGFR inhibitor therapy to address acquired resistance due to c-MET amplification. The second new cohort, labeled F, will evaluate vebreltinib monotherapy in histology-agnostic solid tumors with wild type MET gene that have high expression of c-MET and hepatocyte growth factor (HGF).
“We are pleased to further expand the potential target indications in our Phase 2 SPARTA study by the addition of two new cohorts to include patients for whom there are no approved target therapy for addressing the tumor proliferation and/or treatment resistance resulting from dysregulations in the HGF/c-MET axis,” said Peony Yu, M.D., Chief Medical Officer of Apollomics.
A separate, ongoing Phase 1/2 investigator sponsored trial (IST), being conducted at the Washington University School of Medicine in St. Louis, Mo., is exploring the safety and efficacy of combining vebreltinib with frontline osimertinib in patients with EGFR-mutated NSCLC. Dr. Bindiya Patel and Dr. Siddhartha Devarakonda presented this study during a poster session on September 11, 2023, at the World Conference on Lung Cancer (WCLC) in Singapore. A link to the WCLC poster is available under the Investors tab of the Apollomics website at https://www.apollomicsinc.com.
Dr. Devarakonda who designed and led this IST study stated, “Combination therapy with vebreltinib and osimertinib features dual MET and EGFR inhibition, and has the potential to induce deep and durable responses in patients with EGFR-mutated lung cancer.”
Vebreltinib is a potent, small molecule, orally bioavailable and highly selective c-MET inhibitor. It 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 such as osimertinib. By targeting c-MET dysregulation, vebreltinib is potentially a new treatment for patients with cancers driven by c-MET alterations for which there are no approved targeted treatment, such as solid tumors with MET amplification or solid tumors with MET fusion inclusive of glioblastoma multiforme (GBM) with PTPRZ1-MET fusion, and histology-agnostic solid tumors with HGF and MET over-expression, as well as its potential for better serving the needs of patients with NSCLC harboring MET exon 14 skipping mutations than currently available treatments.
About SPARTA
Apollomics is conducting a multi-cohort Phase 2 study of vebreltinib, SPARTA, at over 90 centers in 13 countries investigating the efficacy and safety of vebreltinib in NSCLC and other solid tumors with MET dysregulation. Cohort A-1 includes first line, c-MET naive MET exon 14 skipping NSCLC subjects and Cohort A-2 includes pretreated (≤ 3L), c-MET naive MET exon 14 skipping NSCLC subjects. Cohort B includes MET exon 14 skipping NSCLC subjects who are c-MET experienced. In addition, Cohort C includes histology-agnostic c-MET amplified cancers excluding primary CNS tumors and Cohort C-1 includes NSCLC harboring MET amplification and wild-type epidermal growth factor receptor (EGFR). Cohort D includes histology-agnostic cancers harboring MET gene fusions excluding primary CNS tumors. Cohort E features primary CNS tumors with MET alterations.
Recently, two new cohorts, C-2 and F, were added to the Phase 2 study. Cohort C-2 evaluates the addition of vebreltinib to an EGFR inhibitor, such as osimertinib, in subjects with EGFR mutated NSCLC with an acquired c-MET amplification. Cohort F is histology-agnostic with high expression of c-MET and hepatocyte growth factor (HGF) in NSCLC tumors with wild type MET gene. Currently, there are over 240 subjects enrolled in the ongoing SPARTA study across all cohorts.
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.
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) the impact of any current or new government regulations in the United States and China affecting Apollomics’ operations and the continued listing of Apollomics’ securities; (ii) the inability to achieve successful clinical results or to obtain licensing of third-party intellectual property rights for future discovery and development of Apollomics’ oncology projects; (iii) the failure to commercialize product candidates and achieve market acceptance of such product candidates; (iv) 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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