New Lung Cancer Drug ivonescimab Significantly Extends Survival
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 hours ago
0mins
Source: CNBC
- Clinical Trial Results: The experimental drug ivonescimab from Akeso and Summit Therapeutics demonstrated a 34% reduction in death risk in late-stage trials, extending median survival by four months for patients with squamous non-small-cell lung cancer when combined with chemotherapy, indicating its potential in difficult-to-treat populations.
- Global Research Plans: The results from the Phase 3 trial conducted in China have garnered attention, and while a global Phase 3 study is ongoing, the applicability of the Chinese data to other populations remains uncertain, highlighting implications for future market dynamics.
- Market Reaction: Since Summit Therapeutics announced ivonescimab's superiority over Keytruda in a separate trial, its stock has surged nearly 600%, yet recent declines due to concerns over global efficacy reflect investor divisions regarding the drug's prospects.
- Safety Considerations: The trial revealed a bleeding incidence of nearly 25% in the ivonescimab group, double that of the control group, raising safety concerns despite fewer severe cases, which may impact market acceptance.
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Analyst Views on SMMT
Wall Street analysts forecast SMMT stock price to rise
12 Analyst Rating
8 Buy
3 Hold
1 Sell
Moderate Buy
Current: 17.410
Low
18.00
Averages
42.49
High
131.90
Current: 17.410
Low
18.00
Averages
42.49
High
131.90
About SMMT
Summit Therapeutics Inc. is a biopharmaceutical company focused on the discovery, development, and commercialization of patient, physician, caregiver and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Its lead development candidate is ivonescimab, a novel, potential first-in-class bispecific antibody intending to combine the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects of an anti-VEGF compound into a single molecule. Ivonescimab is being developed by both Akeso and the Company in multiple Phase III clinical trials. It is also developing ivonescimab in non-small cell lung cancer and other solid tumor settings. Ivonescimab is approved in China in combination with chemotherapy for patients with EGFR-mutated non-small cell lung cancer whose tumors have progressed following an EGFR-TKI based on the results of the HARMONi-A clinical trial.
About the author

Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
- Significant Survival Improvement: In the HARMONi-6 clinical trial, patients receiving Ivonescimab plus chemotherapy had a 24-month overall survival rate of 64.7%, compared to 48.6% for those on Tislelizumab plus chemotherapy, indicating a 34% reduction in the risk of death and marking a crucial breakthrough in first-line NSCLC treatment.
- Statistical Significance: The trial reported a hazard ratio of 0.66 (95% CI: 0.50, 0.87; p=0.0017), demonstrating for the first time that Ivonescimab significantly improves overall survival compared to PD-1 inhibitors in first-line therapy, which could redefine treatment standards.
- Acceptable Safety Profile: Ivonescimab exhibited a safety profile consistent with previous trials, with treatment-related serious adverse events occurring in 41.4% of patients, compared to 34.3% for Tislelizumab, indicating its potential for clinical application.
- Future Outlook: Summit plans to hold a conference call on June 1, 2026, to discuss the latest data on Ivonescimab, further advancing its global clinical development and potentially offering new treatment options for patients.
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- Clinical Trial Results: The experimental drug ivonescimab from Akeso and Summit Therapeutics demonstrated a 34% reduction in death risk in late-stage trials, extending median survival by four months for patients with squamous non-small-cell lung cancer when combined with chemotherapy, indicating its potential in difficult-to-treat populations.
- Global Research Plans: The results from the Phase 3 trial conducted in China have garnered attention, and while a global Phase 3 study is ongoing, the applicability of the Chinese data to other populations remains uncertain, highlighting implications for future market dynamics.
- Market Reaction: Since Summit Therapeutics announced ivonescimab's superiority over Keytruda in a separate trial, its stock has surged nearly 600%, yet recent declines due to concerns over global efficacy reflect investor divisions regarding the drug's prospects.
- Safety Considerations: The trial revealed a bleeding incidence of nearly 25% in the ivonescimab group, double that of the control group, raising safety concerns despite fewer severe cases, which may impact market acceptance.
See More

- Survival Rate Improvement: The experimental drug ivonescimab from Akeso and Summit Therapeutics demonstrated a 34% reduction in death risk in the Harmoni-6 Phase 3 trial conducted in China, extending the median survival of squamous non-small-cell lung cancer patients to 27.9 months, which is four months longer than standard treatment, highlighting its potential in difficult-to-treat populations.
- Global Research Outlook: While the trial was conducted exclusively in China, future global Phase 3 studies will further validate ivonescimab's efficacy across diverse populations, with experts noting that Chinese patients historically respond better to PD-1 and VEGF drugs, necessitating cautious interpretation of the data's applicability.
- Market Competition Landscape: The success of ivonescimab could position it as a successor to Merck's Keytruda; however, market analysts warn that its widespread adoption remains uncertain due to competition from emerging therapies, particularly antibody-drug conjugates that are gaining traction.
- Investment Surge: Licensing deals for PD-1 drugs reached $30 billion last year, nearly doubling the previous peak of $16 billion in 2017, reflecting strong market interest in new therapies, although ivonescimab's future requires more clinical data to support its market position.
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- Clinical Trial Results: In the recent AK112-206 trial, patients receiving ivonescimab combined with mFOLFOX6 chemotherapy achieved an objective response rate (ORR) of 70.8%, indicating the drug's potential in treating metastatic colorectal cancer (mCRC) and surpassing historical benchmarks for standard therapies.
- Tolerability and Safety: The safety profile of ivonescimab aligns with historical data, with 20.4% of patients experiencing serious treatment-related adverse events (TRAEs) but no new safety signals observed, suggesting good tolerability and suitability for further development.
- Durability of Efficacy: In the ivonescimab 20 mg/kg group, the duration of response landmark estimate at 9 months was 79.1%, compared to 41.5% in the 10 mg/kg group, indicating that the higher dose may offer better long-term survival prospects for patients.
- Future Research Directions: Summit is conducting the HARMONi-GI3 trial to evaluate the combined efficacy of ivonescimab with mFOLFOX6 chemotherapy, which is expected to provide new treatment options for patients with metastatic colorectal cancer and further advance the clinical development of this drug.
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- Financing Agreement Secured: VERAXA Biotech AG has entered into a securities purchase agreement with an institutional investor for $27.5 million, in addition to a $50 million share purchase agreement with Lincoln Park Capital Fund, significantly enhancing the company's liquidity.
- NASDAQ Listing Application: The company has applied for a NASDAQ listing under the ticker symbol “VRXA” through a merger with Voyager Acquisition Corp., aiming to accelerate the advancement of its cancer therapies pipeline, reflecting confidence in future growth prospects.
- Management Statement: CFO Torsten Bürgermeister stated that securing these financings marks a significant step in the ongoing business combination with Voyager Acquisition Corp., indicating a disciplined and flexible approach to capital management.
- Investor Support Acknowledged: The company expressed gratitude for the financial support from investors, emphasizing the importance of maintaining prudent financial management during ongoing capital acquisition efforts to ensure long-term growth and market competitiveness.
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- Market Recovery: The S&P 500 rose by 0.37% and the Nasdaq 100 by 0.42%, with the Dow Jones Industrial Average hitting an all-time high, reflecting optimism about a potential US-Iran peace deal that could boost investor confidence.
- Consumer Sentiment Decline: The University of Michigan's consumer sentiment index was revised down to a record low of 44.8, below the expected 48.2, indicating growing concerns among consumers about the economic outlook, which may impact future spending.
- Rising Inflation Expectations: The 1-year inflation expectations for May were revised upward to 4.8%, exceeding the expected 4.6%, potentially prompting the Federal Reserve to consider interest rate hikes in upcoming meetings, which could pressure the stock market.
- Tech Stocks Lead Gains: Workday's stock surged over 5% after reporting Q1 adjusted EPS of $2.66, surpassing expectations, highlighting strong performance in the software sector and potentially attracting more investor interest in tech stocks.
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