SMMT Shares Updated Ivonescimab Survival Data From NSCLC Study

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.

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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 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. 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.

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