We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
SMMT Shares Updated Ivonescimab Survival Data From NSCLC Study
Read MoreHide Full Article
Key Takeaways
Summit reported updated overall survival data from the phase III HARMONi study with longer follow-up.
SMMT submitted updated HARMONi data to the FDA while ivonescimab's BLA review continues.
Summit partnered with Arcus to study ivonescimab plus casdatifan in clear cell kidney cancer.
Summit Therapeutics (SMMT - Free Report) announced updated overall survival ("OS") data from the phase III HARMONi study evaluating its investigational antibody ivonescimab in certain patients with non-small cell lung cancer ("NSCLC").
The company reported more favorable OS data in the latest June 2026 analysis, driven by more mature follow-up and a strengthening survival benefit, particularly among Western patients. In the Western subgroup, the OS hazard ratio improved to 0.76 from 0.84 in the September 2025 analysis. The latest data suggests a 24% reduction in the risk of death compared with placebo plus chemotherapy. The median follow-up for Western patients increased to 23.2 months, up from 13.7 months in the September 2025 analysis, providing a more mature assessment of the treatment's long-term survival benefit.
With the extended follow-up, the magnitude of the OS benefit observed in Western patients is now consistent with that previously reported in Asian patients, who had a longer follow-up duration at the time of the primary OS analysis.
The OS benefit strengthened in the overall intention-to-treat population, with the hazard ratio improving to 0.76 from 0.78 in the September 2025 analysis. Collectively, the updated findings reinforce the durability and consistency of ivonescimab's survival benefit across both Western and Asian patient populations.
The HARMONi study enrolled patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC whose disease had progressed following treatment with an EGFR tyrosine kinase inhibitor (EGFR-TKI).
Year to date, SMMT's shares have lost 15.7% compared with the industry’s 2.6% decline.
Image Source: Zacks Investment Research
Updated Data Could Delay FDA Decision on SMMT’s Ivonescimab Filing
To remind investors, Summit reported encouraging data from the HARMONi study last year. The study met one of its primary endpoints by demonstrating a statistically significant improvement in progression-free survival. Although it narrowly missed statistical significance for OS at the primary analysis, the data showed a favorable survival trend.
Based on the September 2025 analysis, Summit had submitted a biologics license application ("BLA") to the FDA. The agency had originally assigned a PDUFA action date of Nov. 14, 2026.
The updated data, which has been submitted to the FDA as part of the ongoing BLA review, could extend the FDA’s review timeline.
Summit Inks New Clinical Collaboration
In a separate press release, Summit announced a clinical study collaboration with Arcus Biosciences (RCUS - Free Report) to evaluate Ivonescimab in combination with Arcus' experimental drug, casdatifan in kidney cancer.
Arcus and Summit have entered a clinical study collaboration to evaluate the former's investigational HIF-2α inhibitor, casdatifan, in combination with the latter's ivonescimab for the treatment of clear cell renal cell carcinoma (ccRCC), including first-line metastatic disease. The combination will be studied as a new cohort in Arcus' ongoing ARC-20 platform study to assess its safety and efficacy as a chemotherapy and TKI-sparing first-line treatment. Arcus will sponsor and conduct the study, while both companies will share development costs and retain commercial rights to their respective therapies. Initial study data are expected by mid-2027.
To expand ivonescimab’s development across multiple disease areas, Summit has entered into multiple similar partnership deals with several global institutions and pharma companies. Earlier this year, Summit signed a similar deal with GSK plc (GSK - Free Report) . Per the terms, the companies will evaluate ivonescimab in combination with risvutatug rezetecan, GSK’s novel investigational B7-H3-targeting antibody-drug conjugate, across multiple solid tumor settings, including small cell lung cancer.
Ivonescimab is a dual PD-1/VEGF inhibitor being evaluated in multiple late-stage studies across different settings in NSCLC and colorectal cancer ("CRC"). Unlike currently marketed immuno-oncology therapies that target only the PD-1 pathway, ivonescimab simultaneously targets both PD-1 and VEGF, a differentiated mechanism that management believes could redefine the treatment landscape and emerge as the next standard of care in NSCLC. Summit in-licensed the rights to develop and commercialize ivonescimab in most major global markets outside China from China-based Akeso in 2022.
The company is enrolling patients in three late-stage ivonescimab studies, two in NSCLC (HARMONi-3 and HARMONi-7) and one in CRC (HARMONi-GI3).
View the Zacks #1 Rank List
Image: Bigstock
SMMT Shares Updated Ivonescimab Survival Data From NSCLC Study
Key Takeaways
Summit Therapeutics (SMMT - Free Report) announced updated overall survival ("OS") data from the phase III HARMONi study evaluating its investigational antibody ivonescimab in certain patients with non-small cell lung cancer ("NSCLC").
The company reported more favorable OS data in the latest June 2026 analysis, driven by more mature follow-up and a strengthening survival benefit, particularly among Western patients. In the Western subgroup, the OS hazard ratio improved to 0.76 from 0.84 in the September 2025 analysis. The latest data suggests a 24% reduction in the risk of death compared with placebo plus chemotherapy. The median follow-up for Western patients increased to 23.2 months, up from 13.7 months in the September 2025 analysis, providing a more mature assessment of the treatment's long-term survival benefit.
With the extended follow-up, the magnitude of the OS benefit observed in Western patients is now consistent with that previously reported in Asian patients, who had a longer follow-up duration at the time of the primary OS analysis.
The OS benefit strengthened in the overall intention-to-treat population, with the hazard ratio improving to 0.76 from 0.78 in the September 2025 analysis. Collectively, the updated findings reinforce the durability and consistency of ivonescimab's survival benefit across both Western and Asian patient populations.
The HARMONi study enrolled patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC whose disease had progressed following treatment with an EGFR tyrosine kinase inhibitor (EGFR-TKI).
Year to date, SMMT's shares have lost 15.7% compared with the industry’s 2.6% decline.
Image Source: Zacks Investment Research
Updated Data Could Delay FDA Decision on SMMT’s Ivonescimab Filing
To remind investors, Summit reported encouraging data from the HARMONi study last year. The study met one of its primary endpoints by demonstrating a statistically significant improvement in progression-free survival. Although it narrowly missed statistical significance for OS at the primary analysis, the data showed a favorable survival trend.
Based on the September 2025 analysis, Summit had submitted a biologics license application ("BLA") to the FDA. The agency had originally assigned a PDUFA action date of Nov. 14, 2026.
The updated data, which has been submitted to the FDA as part of the ongoing BLA review, could extend the FDA’s review timeline.
Summit Inks New Clinical Collaboration
In a separate press release, Summit announced a clinical study collaboration with Arcus Biosciences (RCUS - Free Report) to evaluate Ivonescimab in combination with Arcus' experimental drug, casdatifan in kidney cancer.
Arcus and Summit have entered a clinical study collaboration to evaluate the former's investigational HIF-2α inhibitor, casdatifan, in combination with the latter's ivonescimab for the treatment of clear cell renal cell carcinoma (ccRCC), including first-line metastatic disease. The combination will be studied as a new cohort in Arcus' ongoing ARC-20 platform study to assess its safety and efficacy as a chemotherapy and TKI-sparing first-line treatment. Arcus will sponsor and conduct the study, while both companies will share development costs and retain commercial rights to their respective therapies. Initial study data are expected by mid-2027.
To expand ivonescimab’s development across multiple disease areas, Summit has entered into multiple similar partnership deals with several global institutions and pharma companies. Earlier this year, Summit signed a similar deal with GSK plc (GSK - Free Report) . Per the terms, the companies will evaluate ivonescimab in combination with risvutatug rezetecan, GSK’s novel investigational B7-H3-targeting antibody-drug conjugate, across multiple solid tumor settings, including small cell lung cancer.
Ivonescimab is a dual PD-1/VEGF inhibitor being evaluated in multiple late-stage studies across different settings in NSCLC and colorectal cancer ("CRC"). Unlike currently marketed immuno-oncology therapies that target only the PD-1 pathway, ivonescimab simultaneously targets both PD-1 and VEGF, a differentiated mechanism that management believes could redefine the treatment landscape and emerge as the next standard of care in NSCLC. Summit in-licensed the rights to develop and commercialize ivonescimab in most major global markets outside China from China-based Akeso in 2022.
The company is enrolling patients in three late-stage ivonescimab studies, two in NSCLC (HARMONi-3 and HARMONi-7) and one in CRC (HARMONi-GI3).
SMMT’s Zacks Rank
Summit currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.