Apollomics shifts to a smaller niche

Back in April Apollomics was still hoping that first US approval for its cMet inhibitor vebreltinib would be in NSCLC with Met exon 14 skipping mutations, but yesterday it said it was putting all its NSCLC hopes on a slightly smaller niche, those with Met amplifications.

The move came against the backdrop of cost cuts that will see the departure of Apollomics’ president, Sanjeev Redkar, chief medical officer, Peony Yu, and an undisclosed number of other employees. The company reckons this will halve its expenses.

cMet

The receptor tyrosine kinase cMet is overexpressed in several cancers; this overexpression can result from abnormalities in the Met gene such as amplification and exon 14 mutations.

Apollomics estimates that 6,800 patients in the US have Met exon 14 skipping mutations, and around 5,800 have Met amplifications. There are already other cMet inhibitors approved for NSCLC patients with exon 14 skipping, but there's no approved targeted therapy for Met-amplified cancers.

Therefore Apollomics’ assertion, that it wants to focus on the area with the greatest unmet medical need, makes sense. But there appear to be other factors at play, too.

Originally, Apollomics had hoped to gain US approval in Met exon 14 skipping NSCLC based on pooled data from its global phase 2 study, Sparta, and the Chinese Kunpeng trial, sponsored by Beijing Pearl Biotechnology. In its April corporate presentation, the company said the FDA had accepted this plan and didn’t require a randomised, controlled phase 3 trial.

At that time, the group outlined its intent to file in Met exon 14 skipping disease in 2025/26, including more patients and longer follow-up in Sparta. A submission in Met-amplified patients was set to follow in 2026.

It is unclear what has changed to make Apollomics focus squarely on Met-amplified disease, but it’s possible that regulatory requirements became too onerous, especially given that pooled analysis of Sparta and Kungpeng in patients with exon 14 skipping produced respectable-looking efficacy.

The company didn't give any updated timeline yesterday for filing in Met-amplified NSCLC..

Competition

Others haven’t fared so well in Met-amplified disease. Novartis’s Tabrecta, approved in NSCLC patients with Met exon 14 skipping, has shown limited activity in patients with Met amplification.

However, Apollomics might not have this niche to itself: AbbVie is testing its cMet-targeted ADC telisotuzumab vedotin in first-line Met-amplified NSCLC in the phase 2 TeliMET NSCLC-02 trial. The company also has a phase 3 study ongoing in the broader cMet-overexpressing population, and reported results here at ASCO, from the phase 2 Luminosity study.

AbbVie reckons that around a quarter of advanced EGFR wild-type NSCLC patients overexpress cMet; however, so far teliso-V has shown the highest activity in the smaller subset of patients deemed cMet-high.

Apollomics, which went public last year via a SPAC, had just $38m in cash at the end of last year, so going up against AbbVie would be a daunting task. For now, though, the microcap will just hope that yesterday’s reorganisation will keep it going into the third quarter of 2025.

Approved and late-stage cMet inhibitors in NSCLC

Source: OncologyPipeline, product labels.