Summit Therapeutics

Summit Therapeutics completes enrollment in HARMONi trial evaluating ivonescimab for EGFR-mutated NSCLC, with topline data expected in mid-2025. The FDA grants Fast Track designation for ivonescimab in combination with platinum-based chemotherapy for advanced NSCLC patients who have progressed after EGFR-TKI therapy.

Cassava Sciences misled investors with falsified Alzheimer’s drug data; FDA action needed. Major biotech events this quarter include Amgen, Novo Nordisk, and AbbVie drug readouts. Triveni Bio raises $115 million for immunology treatments. Eli Lilly considers obesity drug testing for prevention, similar to Novo Nordisk. Lilly invests $4.5 billion in a research and manufacturing hub.

Bob Duggan's experimental cancer drug, ivonescimab, showcased at the World Conference on Lung Cancer, led to a 700% surge in Summit Therapeutics' stock, boosting Duggan's net worth to $16 billion. The drug outperformed Merck's Keytruda in trials, showing potential for future cancer treatments.

Merck's Keytruda, the world's best-selling drug, faces potential competition from Summit Therapeutics' ivonescimab, which outperformed Keytruda in a phase 3 study for first-line advanced lung cancer. Keytruda's patent expires in 2028, but Merck plans to mitigate losses with a subcutaneous version and new drug approvals. Despite these challenges, Merck's stock remains attractive for long-term investors.

Summit Therapeutics, a 21-year-old biotech with 130 employees and no revenue, saw its market cap surge due to positive data on its cancer drug candidate, ivonescimab, outperforming Merck's Keytruda. Co-CEO Maky Zanganeh's shares rose 17-fold, making her a billionaire. The drug, licensed from Akeso, requires a global Phase 3 trial for FDA approval. Zanganeh, born in Iran, followed an unconventional path to biotech leadership, collaborating with co-CEO Robert Duggan, who turned around Pharmacyclics.

Summit Therapeutics' stock has surged nearly 900% YTD, outperforming Nvidia's 137% gain, driven by clinical success of its cancer drug ivonescimab, which outperformed Merck's Keytruda in a phase 3 trial. Ivonescimab's potential in NSCLC and other cancers could redirect billions in revenue to Summit, but the stock's high valuation poses risk. Despite this, Summit's strong financial position and ivonescimab's potential make it a risky but potentially lucrative investment for biotech investors.

Summit Therapeutics and Akeso's Phase III HARMONi-2 trial results show ivonescimab, a bispecific monoclonal antibody, outperforming Merck's Keytruda in non-small cell lung cancer patients with PD-L1 TPS above 1%, with significant median progression-free survival and overall response rate advantages. However, safety concerns and the need for a multiregional trial may limit immediate FDA approval. GlobalData forecasts ivonescimab reaching $1.7bn in sales by 2030, challenging Keytruda's market dominance.

Brendan, a Stanford Ph.D. in organic synthesis, worked at Merck and co-founded 1200 Pharma at Caltech. He remains an investor in biotech stocks. Analyst's disclosure: beneficial long position in SMMT shares. Disclaimer: SMMT is a high-risk, speculative, pre-revenue company.

Summit Therapeutics' ivonescimab outperformed Merck's Keytruda in NSCLC treatment, with data from China trials showing significant PFS benefits. Analysts caution on data generalizability, and FDA approval may require U.S. data. Ivonescimab also showed promise in other cancers, but overall survival data is pending. Summit plans multi-regional trials in 2025.