Akeso

Summit Therapeutics' stock has surged 1,000% on potential to rival Merck's Keytruda, but its market cap of $16 billion may be overvalued. CEO's recent stock purchase signals optimism, yet ivonescimab's success is uncertain and years away.

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

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.

Akeso's cadonilimab, a PD-1/CTLA-4 bispecific antibody, received NMPA approval for first-line treatment of locally advanced unresectable or metastatic gastric/G/GEJ adenocarcinoma in combination with fluoropyrimidine and platinum-based chemotherapy. The approval is based on the COMPASSION-15/AK104-302 study, which showed cadonilimab significantly reduced the risk of death across all PD-L1 expression levels, extending overall survival and demonstrating notable advantages in objective response and long-term survival.

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' 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.

The APOLLO trial at ESMO 2024 showed Chia Tai Tianqing's Focus V and Akeso's penpulimab significantly improved PFS and OS in advanced hepatocellular carcinoma (aHCC) compared to sorafenib, with a manageable safety profile. This contrasts with the failure of Merck & Co's Keytruda in the LEAP-002 trial. Competitive IO-TKIs like Elevar Therapeutics' camrelizumab and rivoceranib also showed benefits but with more TRAEs. Roche's Tecentriq with bevacizumab remains the first-line standard-of-care in aHCC, posing a challenge to new IO-TKI combinations.

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.

Akeso's Phase 2 results for ivonescimab, a PD-1/VEGF bispecific antibody, show significant tumor reduction in PD-L1-positive R/M HNSCC, with improved efficacy when combined with ligufalimab. A Phase 3 trial comparing ivonescimab plus ligufalimab to pembrolizumab has been initiated.