Ivonescimab

Merck's Keytruda, the world's best-selling drug, faces potential competition from Summit Therapeutics' ivonescimab and a patent cliff in 2028. Despite these challenges, Merck plans to mitigate losses with a subcutaneous version of Keytruda and new drug approvals, making its stock 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.

Lung cancer experts discuss practice-changing research and new agents at the 2024 IASLC World Conference, highlighting Ivonescimab's potential in NSCLC, rethinking immunotherapy approaches, emerging biomarker-driven therapies, promising HER2 TKIs, ADC developments in SCLC, novel drug delivery platforms, and patient-centered care.

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.

Bispecific antibodies, with two binding domains, offer targeted therapeutics and address co-administration challenges, gaining traction in biopharma. Initially approved for cancer, they now target various diseases, with 12 approved in the U.S. and more in development. Their dual action reduces patient burden and enhances treatment effects, potentially transforming therapeutic paradigms beyond oncology. The market is projected to grow significantly due to rising chronic disease incidence and technological advancements.

Summit Therapeutics presented ivonescimab data at ESMO 2024, showing efficacy in TNBC, HNSCC, and MSS CRC, with plans to expand clinical development beyond metastatic NSCLC.

Ivonescimab shows promising anti-tumor activity and safety in CRC, TNBC, and HNSCC, with encouraging Phase II data supporting its clinical development expansion beyond metastatic NSCLC, as presented at ESMO 2024.

Akeso presented efficacy data for its PD-1/VEGF bispecific antibody, ivonescimab, with or without ligufalimab, combined with FOLFOXIRI as a first-line treatment for metastatic colorectal cancer at the 2024 ESMO Conference. Both regimens showed high anti-tumor activity and effective disease control for MSS/pMMR mCRC, with ivonescimab plus ligufalimab demonstrating superior efficacy.