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Get filing alertsSummit reports Phase III HARMONi OS data showing 24% mortality reduction in Western patients
Filed July 22, 2026 · Period ending July 22, 2026 · ~1 min read
Key Changes
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high
Updated OS analysis (June 2026 cutoff) showed hazard ratio of 0.76 in both full population and Western patient subgroup, indicating 24% reduction in death risk for ivonescimab plus chemo vs placebo plus chemo in EGFR-mutated NSCLC.
Item 8.01 verify on EDGAR → -
high
Western patient OS benefit improved sequentially across three analyses: HR 0.98 (April 2025, 9.2 months median follow-up), 0.84 (September 2025, 13.7 months), and 0.76 (June 2026, 23.2 months), now consistent with Asian patients.
Exhibit 99.1 view on EDGAR → -
high
Summit submitted updated OS results to FDA ahead of November 14, 2026 PDUFA goal date for pending BLA; detailed data to be presented at upcoming medical conference.
Item 8.01 verify on EDGAR → -
medium
Safety profile remained acceptable and manageable with no new safety signals identified, consistent with prior Phase III data.
Exhibit 99.1 view on EDGAR →
Summary
Summit disclosed updated overall survival results from the Phase III HARMONi trial evaluating ivonescimab plus chemotherapy in EGFR-mutated non-small cell lung cancer patients previously treated with third-generation EGFR inhibitors. The June 2026 analysis showed a hazard ratio of 0.76 in both the full intention-to-treat population and Western patient subgroup, representing a 24% reduction in mortality risk.
This marks meaningful improvement from the April 2025 primary analysis, which showed a positive trend (HR 0.79) but missed statistical significance (p=0.057). The sequential improvement in Western patient outcomes addresses a critical question for the drug's global applicability.
With 23.2 months median follow-up, Western patients now demonstrate survival benefit magnitude consistent with Asian patients (who had 32.7 months follow-up in the primary analysis). The company has submitted these results to the FDA ahead of the November 14, 2026 PDUFA goal date for the pending BLA. The strengthened Western patient data could support FDA approval and inform the agency's benefit-risk assessment for the U.S. market.
Section-by-Section Diff
Event · Item 8.01 — Other Events
Summit announced updated Phase III HARMONi trial results showing consistent overall survival benefit (HR 0.76) for ivonescimab in EGFR-mutated NSCLC.
Added in current filing · verify on EDGAR →
The updated analysis that was conducted with a data cutoff date of June 2026 analyzed OS when most western patients had discontinued treatment or completed two years of treatment. This analysis showed a consistent OS trend amongst western and Asian patients as western patients were followed for additional time on study reaching median follow-up of 23.2 months; Asian patients remained locked with a median follow-up time of 32.7 months from the primary analysis. A hazard ratio of 0.76 was observed for the full population; the 0.76 hazard ratio was also observed in western patient subgroups, respectively, in this analysis.
Summit disclosed updated overall survival data from the Phase III HARMONi trial evaluating ivonescimab plus chemotherapy in EGFR-mutated non-small cell lung cancer patients previously treated with third-generation EGFR inhibitors. The analysis showed a hazard ratio of 0.76 for both the full population and western patient subgroups, indicating a 24% reduction in risk of death. Western patients reached median follow-up of 23.2 months while Asian patients remained at 32.7 months from the primary analysis, demonstrating consistent survival trends across both populations.
Added in current filing · verify on EDGAR →
These OS results have been made available to the FDA, and more detailed data are intended to be presented at an upcoming medical conference.
Summit has submitted the overall survival results to the FDA and plans to present detailed data at an upcoming medical conference. This indicates progression toward potential regulatory approval and broader scientific dissemination of the trial results.
Event · Exhibit 99.1
Summit announced updated Phase III HARMONi trial results showing ivonescimab plus chemo achieved OS HR 0.76 in Western patients, consistent with Asian patients.
Added in current filing · view on EDGAR →
Summit’s Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) is based on the results from the HARMONi trial and has a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
Summit has a pending BLA with the FDA for ivonescimab based on the HARMONi trial results, with a PDUFA goal action date of November 14, 2026. The updated OS analysis results have been made available to the FDA as part of the ongoing review process.
Added in current filing · view on EDGAR →
In April 2025, the primary OS analysis was performed, whereby ivonescimab in combination with chemotherapy showed a positive trend without achieving a statistically significant benefit with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057). Median OS was 16.8 months for those patients administered ivonescimab plus chemotherapy vs. 14.0 months for those receiving placebo plus chemotherapy.
The primary OS analysis in April 2025 showed a positive trend but did not achieve statistical significance, with a hazard ratio of 0.79 and p-value of 0.057. Median OS was 16.8 months for ivonescimab plus chemotherapy versus 14.0 months for placebo plus chemotherapy. At that time, Western patients had only 9.2 months median follow-up, less than the median OS itself.
Added in current filing · view on EDGAR →
In this most recent analysis, ivonescimab continued to demonstrate an acceptable and manageable safety profile that was consistent with previous Phase III data of ivonescimab plus chemotherapy. No additional safety signals were noted in this current HARMONi data cut.
The updated analysis confirmed that ivonescimab maintained an acceptable and manageable safety profile consistent with prior Phase III data, with no new safety signals identified in the current data cut. This consistency supports the drug's tolerability profile as follow-up extends.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jul 23, 2026 · How we verify