Apollomics to Present Vebreltinib Data at 2024 ASCO Annual Meeting

Foster City, Calif., June 4, 2024 - Apollomics, a clinical-stage biopharmaceutical company, recently showcased compelling data on its oncology drug candidate, vebreltinib, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The data, presented through both a poster and an oral presentation by Avistone Biotechnology, highlights vebreltinib's potential in treating various cancers with MET-driver alterations.

In 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,” the drug demonstrated strong efficacy and safety in non-small cell lung cancer (NSCLC) patients with MET exon 14-skipping mutations. The study included patients treated with 200 mg of vebreltinib twice daily. The primary measure of success was the overall response rate (ORR), assessed by a blinded independent review committee (BIRC), which was found to be 75%.

Subgroup analyses revealed the ORR varied among different patient groups: 100% in those with baseline brain metastases, 66.7% in those with liver metastases, 85.7% in patients aged 75 and older, and 100% in patients with co-occurring MET amplification. Additional efficacy metrics showed a disease control rate (DCR) of 96.2%, a median duration of response (DoR) of 16.5 months, a median time to response (TTR) of 1.0 month, and a median progression-free survival (PFS) of 14.3 months. The median overall survival (OS) was 20.3 months, with a 3-year OS rate of 35.1%. Importantly, no new safety concerns were identified 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-MET Fusion Gene (FUGEN): A randomized, multicenter, open-label, phase 2/3 trial,” focused on data from the first completed Phase 2/3 trial in glioblastoma patients. This study compared vebreltinib with chemotherapy, showing significant differences in primary and secondary endpoints - overall survival (OS) and progression-free survival (PFS).

The median OS was 6.31 months in the vebreltinib group compared to 3.38 months in the chemotherapy group. Furthermore, the median PFS was 1.87 months for the vebreltinib group versus 1.05 months for the chemotherapy group. The objective response rate (ORR) was slightly better in the vebreltinib group at 9.5%, compared to 2.6% in the chemotherapy group. Treatment-related adverse events of grade 3 or 4 were lower in the vebreltinib group (7%) versus the chemotherapy group (12.2%), with no treatment-related deaths reported.

Vebreltinib (APL-101) is an orally administered, highly selective c-MET inhibitor that targets aberrant activation of the HGF/c-MET pathway, a critical driver of tumor growth and resistance to certain therapies. This agent has shown strong tumor-inhibitory effects in preclinical models of various cancers, including NSCLC, gastric, hepatic, and pancreatic tumors.

Currently, Apollomics is conducting the Phase 1/2 SPARTA clinical trial to further explore vebreltinib's potential in combination with novel therapies and as a stand-alone treatment for different tumor types. Vebreltinib has received conditional approval from China's National Medical Products Administration (NMPA) but remains under clinical investigation elsewhere.

Apollomics focuses on developing innovative oncology therapies that can be combined with other treatments to harness the immune system and target specific molecular pathways. The company's pipeline includes nine drug candidates, six of which are in clinical stages. Alongside vebreltinib, Apollomics is progressing with uproleselan (APL-106), an E-Selectin antagonist for treating acute myeloid leukemia and other hematologic cancers.

The ASCO presentations underscore vebreltinib’s potential as a promising therapy for patients with MET-altered tumors, marking a significant step in Apollomics’ mission to develop effective treatments for challenging cancers.

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