Late-stage Clinical Biopharmaceutical Company Reports Positive Preliminary Data From Cancer Treatment Trial
Positive Preliminary Data from Apollomics' Phase 2 SPARTA Trial on Vebreltinib in Patients with Non-CNS MET Fusion Solid Tumors.
Disclaimer: The following article is based on preliminary clinical trial data and is intended for informational purposes only. It does not constitute medical advice or an endorsement of any specific treatment. Readers are encouraged to consult healthcare professionals for medical advice.
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Apollomics Inc., a late-stage clinical biopharmaceutical company, has recently announced encouraging preliminary data from its Phase 2 SPARTA trial of vebreltinib. This data pertains specifically to a cohort of patients with non-central nervous system (non-CNS) MET fusion solid tumors. This announcement is significant as it adds to the body of evidence supporting the potential effectiveness of vebreltinib, a highly selective c-MET inhibitor, in treating a variety of hard-to-treat cancers.
Overview of the SPARTA Trial
The SPARTA trial is a global, multi-cohort, single-arm, open-label Phase 2 study aimed at evaluating both the efficacy and safety of vebreltinib in various MET-altered tumors. As of the data cutoff date of July 31, 2024, 14 patients with non-CNS MET fusion solid tumors were included in the study. These patients presented a diverse range of cancers, including non-small cell lung cancer (NSCLC), lung sarcomatoid carcinoma, intrahepatic bile duct cancer, colon cancer, pancreatic cancer, breast cancer, head and neck cancer, and esophageal cancer. The preliminary clinical efficacy results for this cohort are based on an independent central radiology review using RECIST v1.1 criteria, which is a standard method for assessing tumor response to treatment. The following are the key highlights from the 14 patients included in this analysis:
Objective Response Rate (ORR): The trial reported a 43% ORR, which includes six confirmed responses by RECIST 1.1 criteria. Of these, one was a complete response in a third-line metastatic NSCLC patient, and five were partial responses (three in NSCLC, one in pancreatic cancer, and one in intrahepatic bile duct cancer).
Median Overall Survival (OS): The median OS was reported to be 12.4 months.
Median Progression-Free Survival (PFS): The median PFS was 4.5 months.
Duration and Time to Response: The median duration of response was 5.6 months, and the median time to response was 3.7 months. Notably, the longest duration of response observed was 18 months, with the patient continuing treatment at the time of this report.
Vebreltinib, also known as APL-101, is a small molecule that is orally bioavailable and highly selective in inhibiting the c-MET receptor. The c-MET receptor and its ligand, hepatocyte growth factor (HGF), play crucial roles in tumor growth, proliferation, and the development of resistance to certain targeted therapies. Vebreltinib works by inhibiting the aberrant activation of the HGF/c-MET axis, thereby exerting a strong tumor-inhibitory effect. This mechanism has been demonstrated in various preclinical models, including human gastric, hepatic, pancreatic, and lung cancer xenograft animal models and patient-derived xenograft models (PDX).
The Trial Results
The preliminary data from the SPARTA trial is significant for multuple reasons:
Efficacy Across Multiple Tumor Types: The trial's 43% ORR is encouraging, especially considering the diverse range of cancers included in the cohort. This suggests that vebreltinib may have broad applicability across various MET-altered tumors.
Potential for Targeted Therapy: The presence of MET fusions in 0.1-0.3% of solid tumors translates to several thousand cases per year in the United States alone. With increasing access to next-generation sequencing, identifying and treating these patients with targeted therapies like vebreltinib could become more practical.
Improved Patient Outcomes: The median OS of 12.4 months and PFS of 4.5 months are promising, particularly for patients with treatment-resistant cancers. The duration of response is also notable, with some patients benefiting from extended periods of disease control.
Based on the positive preliminary data, Apollomics is exploring further development opportunities for vebreltinib in patients with MET fusions. The company plans to continue treating patients currently enrolled in the SPARTA MET fusion cohort and will provide additional clinical updates as more data becomes available.
Vebreltinib has received conditional approval from the National Medical Products Administration (NMPA) of China and is under clinical investigation in several regions. Apollomics Inc. is focused on discovering and developing oncology therapies that can be combined with other treatments to harness the immune system and target specific molecular pathways. The lead programs include vebreltinib for treating non-small cell lung cancer and other tumors with c-MET alterations, and uproleselan, a specific E-Selectin antagonist for treating acute myeloid leukemia and other hematologic cancers.
The preliminary data from Apollomics' Phase 2 SPARTA trial of vebreltinib in patients with non-CNS MET fusion solid tumors is promising and adds to the growing body of evidence supporting the potential effectiveness of this targeted therapy. As the company continues to gather more data and explore further development opportunities, vebreltinib could become a valuable treatment option for patients with difficult-to-treat cancers.
Disclaimer: The information provided in this article is based on preliminary clinical trial data and is for informational purposes only. It does not constitute medical advice and should not be used as a substitute for professional healthcare consultation.
We are working endlessly to provide free insights on the stock market every day, and greatly appreciate those who are paid members supporting the development of the Stock Region mobile application. Stock Region offers daily stock and option signals, watchlists, earnings reports, technical and fundamental analysis reports, virtual meetings, learning opportunities, analyst upgrades and downgrades, catalyst reports, in-person events, and access to our private network of investors for paid members as an addition to being an early investor in Stock Region. We recommend all readers to urgently activate their membership before reaching full member capacity (500) to be eligible for the upcoming revenue distribution program. Memberships now available at https://stockregion.net