Apollomics presents interim data from ongoing Phase 2 trials with vebreltinib

Apollomics announced the presentation of vebreltinib efficacy and safety data from the ongoing multi-cohort Phase 2 KUNPENG trial and the ongoing global multi-cohort Phase 2 SPARTA trial at the 2023 IASLC North America Conference on Lung Cancer, that was held December 1-3, 2023, in Chicago, Illinois. Vebreltinib appears efficacious in non-small cell lung cancer patients with MetExon14 skipping mutation with or without co-occurring MET amplification. Of the 83 NSCLC patients with MetExon14 skipping mutation with available gene copy number data from the Phase 2 KUNPENG and SPARTA trials, 91.6% did not have co-occurring MET amplifications, reflecting the real-world distribution of the NSCLC patients with MetExon14 skipping mutation from two large public databases. NSCLC patients with MetExon14 skipping mutation without co-occurring MET amplification from the KUNPENG and SPARTA trials showed an overall response rate of 64.5% and a median duration of response of 15.9 months, and those with overlapping MET amplification achieved ORR of 85.7%. To date, more than 500 patients and 170 healthy volunteers have been dosed with vebreltinib. The safety profile is generally acceptable. Preliminary efficacy and safety data from the Phase 2 KUNPENG and SPARTA trials in patients with MetExon14 skipping mutation is presented in poster PP01.104 titled, “Vebreltinib Efficacy In MetEx14 Mutant NSCLC With or Without Concurrent MET Amplification, MET GCN Status Distributions Compared With Public Databases.” The preliminary data from NSCLC patients with MetExon14 skipping mutation from the KUNPENG and SPARTA trials showed the following efficacy and safety results: ORR in patients without co-occurring MET amplification was 64.5%, with median DOR of 15.9 months and Disease Control Rate of 88%. ORR in patients with MET amplification was 85.7%, with DCR of 100%. mDOR was not reached. There were only 2 patients with GCNgreater than or equal to6, and both achieved partial response. Treatment-related adverse events of grade 3 or higher were reported in 42.2% of patients, with the most common being edema and ALT increase. Of NSCLC patients with MetExon14 skipping mutation with available GCN data included in this analysis, 91.6% had no co-occurring MET amplification, similar to 83.6% and 91.9% in two public databases.