Apollomics Announces Positive Preliminary Data of Vebreltinib in Patients With Non-CNS MET Fusion Solid Tumors From its Phase 2 Trial

Apollomics Inc. recently announced positive preliminary clinical data for the cohort of patients with non-CNS MET fusion solid tumors from the Phase 2 SPARTA trial of vebreltinib.

“We are very pleased with the preliminary data showing 43% objective response rate in patients with non-CNS MET fusion solid tumors. The results in this specific cohort of patients adds to the accumulating evidence supporting the potential of vebreltinib as a highly selective and efficacious treatment against multiple tumor types harboring MET alterations. Alongside the Avistone data for vebreltinib in the treatment of gliblastoma with PTPRZ1 MET fusions, the clinical evidence for the efficacy of vebreltinib in MET fusions is very encouraging,” said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics. “Based on the overall occurrence of these fusions in 0.1-0.3% of solid tumors, we believe the incidence is several thousand per year in the United States. Given the increasing patient access to next-generation sequencing, we expect it will become increasingly practical to identify and treat these patients with a targeted therapy such as vebreltinb. We look forward to providing additional clinical updates from the SPARTA Phase 2 trial as they become available.”

The pivotal SPARTA trial is a global, multi-cohort, single-arm, open label Phase 2 Study evaluating the efficacy and safety of vebreltinib in a range of MET-altered tumors. As of data analysis cutoff date of July 31, 2024, 14 patients with non-CNS MET fusion solid tumors were included in the study: six with non-small cell lung cancer (NSCLC), one with lung sarcomatoid carcinoma, two with intrahepatic bile duct cancer, one with colon cancer, one with pancreatic cancer, one with breast cancer, one with head and neck cancer, and one with esophageal cancer. Two of the 14 were front-line patients without prior systemic therapy, and twelve were second-line or greater. The preliminary clinical efficacy results are based on independent central radiology review using RECIST v1.1 criteria.

Key preliminary clinical data highlights from 14 patients by RECIST v1.1

• 43% objective response rate (ORR): Six confirmed responses by RECIST 1.1 criteria, out of 14 evaluable patients including one complete response in third-line metastatic NSCLC and five partial responses (three patients with NSCLC, one patient in pancreatic cancer, and one patient with intrahepatic bile duct cancer).
• Median overall survival (OS) was 12.4 months and median progression free survival was 4.5 months.
• 5.6 months median duration of response and 3.7 months median time to response. The longest duration of response is 18 months, with that patient currently continuing treatment.

Based on these new data, Apollomics is evaluating opportunities for further development of vebreltinib in patients with MET fusions. Patients currently enrolled in the SPARTA MET fusion cohort will continue with treatment and study follow-up.

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 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 developing vebreltinib as single-agent cancer therapy in a variety of tumor types and actively assessing the potential of vebreltinib in combination with novel therapies. 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’ 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 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, visit www.apollomicsinc.com.