Data from Phase 2 and 2/3 trials demonstrate continued efficacy and safety of vebreltinib for treating different tumor types carrying MET-driver alterations
FOSTER CITY, Calif., June 04, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, announced a poster presentation and an oral presentation by partner company, Avistone Biotechnology, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 31-June 4, 2024, in Chicago, Ill. and virtually. Copies of the poster and oral presentation are available on the Apollomics website at ir.apollomicsinc.com/news-events/presentations.
“Vebreltinib continues to display impressive selectivity and efficacy against multiple tumor types, demonstrating its high potential to treat a range of MET-altered tumors,” said Guo-Liang Yu, PhD, Chairman and Chief Executive Officer of Apollomics. “We believe this data highlights vebreltinib as a potential agent to treat both non-small cell lung cancer (NSCLC) patients and previously treated glioblastoma (GBM) patients and we remain excited about its continued clinical development.”
The poster presentation, titled “Efficacy and safety of vebreltinib in patients with advanced NSCLC harboring MET exon 14-skipping: Results of 2.5-year follow-up in KUNPENG”, demonstrated vebreltinib consistently showed promising efficacy and favorable safety in NSCLC patients with MET exon 14-skipping mutations. Patients in cohort 1 of the Phase 2, open-label, multi-cohort study, received 200 mg of vebreltinib twice daily. The primary endpoint was overall response rate (ORR) and was assessed by blinded independent review committee (BIRC). Per BIRC assessment, the ORR was at 75%, and subgroup analyses showed the ORR was 100.0%, 66.7%, 85.7% and 100.0% among patients with any baseline brain metastases (N=5), patients with any baseline liver metastases (N=6), patients aged 75 years and older (N=21) and patients with co-occurring of MET amplification (N=12), respectively. Other efficacy parameters included disease control rate (DCR) of 96.2%, the median duration of response (DoR) of 16.5 months, the median time to response (TTR) of 1.0 month and the median progression-free survival (PFS) of 14.3 months. Furthermore, the median overall survival (OS) was 20.3 months. The 3-year OS rate was 35.1%. No new safety signals were reported with long-term vebreltinib treatment.
The oral presentation, titled “Efficacy and safety of the vebreltinib in patients with previously treated, secondary glioblastoma/IDH mutant glioblastoma with PTPRZ1-METFUsion GENe (FUGEN): A randomised, multicentre, open-label, phase 2/3 trial”, demonstrated vebreltinib data in the first completed Phase 2/3 trial of previously treated sGBM / IDH mutant glioblastoma patients with PTPRZ1-MET Fusion gene. The primary endpoint was overall survival (OS) and, after a median follow-up of 4.44 months, the median OS in the vebreltinib group and chemotherapy group were statistically significant at 6.31 months and 3.38 months, respectively. The secondary endpoints were progression-free survival (PFS) and objective response rate (ORR); the median PFS in the vebreltinib group and chemotherapy group were also statistically significant at 1.87 months and 1.05 months, respectively. No significant differences were observed in ORR (9.5% vs. 2.6%) for the vebreltinib group and chemotherapy group. Treatment-related adverse events of grade 3 or 4 were reported in 7% of the patients in the vebreltinib group, as compared with 12.2% of those in the chemotherapy group and no treatment-related deaths were observed.
About vebreltinib (APL-101)
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 offers a potential breakthrough for patients with MET exon 14 skipping NSCLC and other cancers driven by c-MET alterations. Vebreltinib has demonstrated strong tumor inhibitory effect in a variety of preclinical c-MET dysregulated human gastric, hepatic, pancreatic and lung cancer xenograft animal models and patient-derived xenograft models (PDX).
Details on the Phase 1/2 SPARTA global clinical trial can be found on clinicaltrials.gov: NCT03175224. Apollomics is actively assessing the potential of vebreltinib in combination with novel therapies and in a variety of tumor types in addition to developing vebreltinib as single-agent cancer therapy. Vebreltinib recently received conditional approval from the National Medical Products Administration (NMPA) of China and is currently under clinical investigation and not approved for any use in any other regions in the world
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 its core product, 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, which is currently in a Phase 2 multicohort clinical trial in the United States, and developing an anti-cancer enhancer drug candidate, 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 and other hematologic cancers, which is currently in Phase 1 and Phase 3 clinical trials in China. For more information, please visit www.apollomicsinc.com.
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 the Company’s strategy, prospects, plans and objectives are forward-looking statements. When used in this press release, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Apollomics cautions you that these forward-looking statements are subject to numerous risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of Apollomics. 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; (vi) the risk that Apollomics may not be able to develop and maintain effective internal controls; (vii) unfavorable changes to the regulatory environment; and those risks and uncertainties discussed in the Annual Report on Form 20-F for the year ended December 31, 2023, filed by Apollomics Inc. with the U.S. Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” and the other documents filed, or to be filed, by the Company with the SEC. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that Apollomics has filed and will file from time to time with the SEC. These SEC filings are available publicly on the SEC’s website at www.sec.gov. Forward-looking statements speak only as of the date made by the Company. Apollomics undertakes no obligation to update publicly any of its 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 law.
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