Apollomics' recent earnings call on March 28th, 2024, painted a picture of optimism and progress, especially regarding their lead drug candidate, Vebreltinib. However, a closer look reveals a curious omission, a silence that speaks volumes about the potential hurdles facing this once-heralded cancer treatment.

The company emphasized positive feedback received from the FDA regarding Vebreltinib's development for three indications: non-small cell lung cancer with MET exon 14 skipping mutation, non-small cell lung cancer with cMET amplification, and glioblastoma with PTPRZ-MET fusions. Encouraging response rates were highlighted, along with plans to continue enrollment in the SPARTA trial and potentially file an NDA as early as 2025.

But here's the catch – nowhere in the prepared remarks or the Q&A session was there any mention of overall survival (OS) data for Vebreltinib in any of these indications. This omission is particularly glaring considering the drug's potential as a best-in-class treatment and the significance placed on OS as a primary endpoint in oncology trials.

While response rates offer a glimpse into a drug's ability to shrink tumors, overall survival paints a much clearer picture of its ultimate impact on patients' lives. It's the gold standard, the metric that truly matters when evaluating the efficacy of a cancer treatment.

So why the deafening silence on this crucial data point?

One can speculate, but the most plausible explanation is that the OS data, at least at this stage, doesn't paint as rosy a picture as the response rates might suggest.

Here's why this hypothesis holds water:

Industry Standard: Oncology companies are acutely aware of the weight placed on OS data. Choosing not to disclose it, especially when positive response rates are readily available, raises red flags.

FDA Feedback: The FDA's emphasis on continued enrollment in the SPARTA trial hints at a desire for more robust data, particularly on long-term outcomes like OS.

Accelerated vs. Traditional Approval: Apollomics' plan to pursue traditional approval for Vebreltinib in the MET exon 14 skipping indication indicates that the available OS data may not be strong enough to warrant a quicker accelerated approval, which typically relies on surrogate endpoints like response rates.

Hypothetical Scenarios

Let's consider some hypothetical scenarios. Suppose the current median duration of response for Vebreltinib in the MET exon 14 skipping group is around 16 months. This figure, while promising, doesn't necessarily translate to a significant OS benefit.

Scenario 1: No OS Benefit: If the OS data shows no significant difference between Vebreltinib and existing treatments, the drug's commercial viability takes a considerable hit. It becomes just another option in an already crowded field, making it harder to justify its use, especially if priced at a premium.

Scenario 2: Marginal OS Benefit: A small improvement in OS, say a few months, would be positive but may not be enough to convince payers and clinicians to adopt Vebreltinib widely, especially if accompanied by a higher price tag or a less favorable safety profile compared to competitors.

The lack of OS data disclosure makes it impossible to ascertain the true potential of Vebreltinib. It's a gamble.

Cash Runway Concerns

Adding to the uncertainty surrounding Vebreltinib is Apollomics' limited cash runway. According to their financial reports, the company has enough cash to fund operations through the first quarter of 2025. This timeline puts significant pressure on them to achieve positive results from the SPARTA trial and secure additional funding.

Projected Cash Burn

Based on their current cash balance of $37.8 million and a runway through Q1 2025 (5 quarters), we can estimate their projected quarterly cash burn to be approximately $7.56 million.

Conclusion

While Apollomics focuses on its pipeline and upcoming milestones, investors and analysts must acknowledge the elephant in the room: the conspicuous absence of overall survival data. Until this critical piece of the puzzle is revealed, the future of Vebreltinib, and potentially Apollomics itself, hangs in the balance.

"Fun Fact: The MET gene, which Vebreltinib targets, plays a crucial role in cell growth and development. Its name comes from "Mesenchymal-Epithelial Transition," a process involved in tissue repair and embryonic development."