Summit Therapeutics has reported that its leading pipeline candidate, ivonescimab, has demonstrated superior clinical results compared to Merck's Keytruda in a Phase 3 clinical trial for non-small cell lung cancer (NSCLC). This development has significantly boosted Summit's stock performance, overshadowing even Nvidia's gains this year.
Phase 3 Trial Results
The Phase 3 trial pitted ivonescimab against Keytruda, the current standard of care and a top-selling drug for NSCLC. Ivonescimab achieved a median progression-free survival of 11.14 months, compared to Keytruda's 5.82 months. The study also indicated a 49% reduction in the risk of disease progression or death with ivonescimab compared to Keytruda. According to Summit Therapeutics, ivonescimab is the first drug to outperform Keytruda in a Phase 3 NSCLC study.
Ivonescimab's Market Potential
NSCLC accounts for approximately 85% of all lung cancer cases, with lung cancer being the second most common cancer globally and the leading cause of cancer-related deaths. Keytruda's sales from NSCLC indications were estimated to be between $7 billion and $10 billion of its $25 billion total sales last year. If approved in the U.S., Canada, Japan, and other regions where Summit holds licensing rights, ivonescimab could potentially capture a significant portion of this market.
Additional Indications
Beyond NSCLC, ivonescimab is also under investigation for other cancer types, including colorectal cancer, the second leading cause of cancer death worldwide. This broadens the potential applicability and market reach of the drug.
Financial Considerations and Risks
Despite the promising clinical results, Summit Therapeutics, valued at $17 billion, faces the risk of a stock downturn if ivonescimab encounters developmental issues. However, the company's financial position is stable, with $325.8 million in cash and equivalents reported at the end of the second quarter, sufficient to fund operations until the fourth quarter of 2025. The company has also raised additional capital following ivonescimab's recent successes.
