Explaining Summit's Fall Despite Positive Data In EGFR-Positive Lung Cancer

Summary

• SMMT's HARMONi trial showed strong PFS benefit for ivonescimab in EGFR-mutant NSCLC, but overall survival data missed statistical significance so far.
• FDA approval hinges on a significant overall survival benefit, which remains unproven, creating regulatory uncertainty despite positive PFS results.
• Concerns persist over trial reproducibility and reliance on Chinese patient data, with global results showing diminished benefit compared to China-only studies.
• SMMT's $13B valuation already prices in massive success, but high near-term risks and lack of commercial clarity are cause for me to remain cautious on the stock.

Klaus Vedfelt

Topline Summary and Update

Summit Therapeutics (NASDAQ:SMMT) has kicked off one of the most important and interesting developing stories in solid tumor oncology over the past two years. Few were paying attention when they reported the findings from HARMONi-A around

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.