Apollomics, a pioneering clinical-stage biopharmaceutical company, unveiled compelling efficacy and safety data for its groundbreaking drug, vebreltinib, derived from the KUNPENG clinical trial, during the European Society of Medical Oncology Congress (ESMO) 2023. The esteemed event, which commenced on October 20 and concludes on October 24, is currently underway in Madrid, Spain. However, this revelation was accompanied by a noticeable downturn in Apollomics’ stock value.
At the time of this publication, Apollomics Inc stock (APLM) has witnessed a decline.
Apollomics Inc
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Guo-Liang Yu, Ph.D., the co-founder, Chairman, and Chief Executive Officer of Apollomics, commented on the findings of the clinical trial, stating, “The clinical results demonstrate the potential of Vebreltinib as a new treatment for patients with cancers driven by MET alterations, particularly in Non-Small Cell Lung Cancer (NSCLC) with MetEx14 skipping mutation. We are also pleased to see that vebreltinib is making progress in clinical programs for patients with various MET alterations.”
In the Phase 2 KUNPENG clinical trial, conducted in collaboration with Apollomics’ Chinese partner, Avistone Biotechnology Ltd. (Beijing Pearl Biotechnology Ltd.), vebreltinib displayed notable efficacy in patients afflicted with locally advanced or metastatic NSCLC harboring Exon-14 skipping mutations, boasting an Overall Response Rate (ORR) of 75%. The study further revealed noteworthy outcomes, including a 100% ORR and Disease Control Rate (DCR) in patients with brain metastases (n=5) and a 66.7% ORR in patients with liver metastases (n=6).
The preliminary efficacy and safety data from the Phase 2 KUNPENG clinical trial (NCT04258033) is elucidated in poster 1378P, which is available for perusal on the Apollomics website at https://ir.apollomicsinc.com/news-events/presentations.
Specifically focusing on NSCLC patients with MetEx14 skipping mutation, the following efficacy results were observed:
– Out of 52 patients, 39 achieved either a complete or partial response, culminating in an impressive ORR of 75% (95% CI, 61.1-86.0). The median duration of response (DOR) stood at 15.9 months (95% CI, 9.2-17.8), and a commendably high Disease Control Rate (DCR) of 96.2% (95% CI, 86.8 to 99.5%) was recorded. Notably, there was a rapid onset of response, with a median time to response of merely 1 month (95% CI, 1, 2.8).
– In the cohort of 35 treatment-naïve patients, the ORR was reported at an impressive 77.1% (95% CI, 59.9-89.6%), with a median DOR of 16.5 months (95% CI, 9.2-NE).
– Among the 17 patients who had received prior systemic treatment, the ORR registered at 70.6% (95% CI, 44.0-89.7%), with a median DOR of 15.3 months (95% CI, 3.7-17.8).
This groundbreaking data from the KUNPENG clinical trial underscores vebreltinib’s potential as a transformative treatment for patients afflicted with MET-driven cancers, specifically in the realm of Non-Small Cell Lung Cancer with MetEx14 skipping mutation. The exceptional efficacy observed across diverse patient profiles presents a significant stride toward advancing cancer therapeutics.
Apollomics’ revelatory findings at ESMO 2023 hold great promise for the future of oncological treatment, heralding a potential paradigm shift in the fight against MET-driven cancers.