[Slide 1]
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A BERKSHIRE HATHAWAY COMPANY
May 30, 2025 6:00 AM Eastern Daylight Time
Ivonescimab Plus
Chemotherapy
Demonstrates Statistically
Significant and Clinically
Meaningful Improvement in
Progression-Free Survival in
Patients with EGFR-Mutant
Non-Small Cell Lung Cancer
after EGFR TKI Therapy in
Global Study
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[Slide 1]
Approximately 38% of patients were randomized from western countries (ex-Asia), consistent with other recent
multiregional Phase III studies in patients with EGFR-mutated NSCLC.
At the prespecified primary data analysis, ivonescimab in combination with chemotherapy demonstrated a
statistically significant and clinically meaningful improvement in progression-free survival, with a hazard ratio of
0.52 (95% CI: 0.41 - 0.66; p<0.00001). PFS was measured by blinded independent central radiology review
committee (BICR) compared to placebo in combination with chemotherapy. A clinically meaningful hazard ratio
was observed in both Asia and ex-Asia sub-populations. The primary analysis demonstrated the consistency of
the magnitude of the PFS benefit between patients randomized in Asia and ex-Asia, as well as the consistency in
a single-region study (HARMONi-A) with this multiregional study.
HARMONi is a positive phase 3 of ivonescimab (PD-1xVEGF bispecific) + chemotherapy vs. chemotherapy in EGFR-mutant non-squamous NSCLC after progression on a 3rd-generation EGFR TKI (e.g., osimertinib). Summit Therapeutics submitted a BLA in Q4 2025; the FDA accepted the BLA for filing in January 2026 with a PDUFA goal action date of November 14, 2026. Ivonescimab holds FDA Fast Track designation. If approved, ivonescimab would be the first PD-1xVEGF bispecific antibody approved in the United States. Ivonescimab is approved in China (NMPA, initial approval May 2024).
Grade ≥3 adverse events: 54.3% (ivo_chemo) vs. 54.0% (chemo). Key AEs: neutropenia (G≥3: 41.8%), anemia, thrombocytopenia, bleeding events (all-grade 24.6% vs. 14.1%; G≥3 2.6% vs. 1.2%, including 1 fatal hemoptysis in combo arm). Bleeding is the key class-effect concern for PD-1xVEGF bispecific. Rates of hypertension comparable to chemo alone.
⚠️ BLA accepted for filing by FDA; PDUFA goal date November 14, 2026. HARMONi is a positive phase 3 of ivonescimab (PD-1xVEGF bispecific) + chemotherapy vs. chemotherapy in EGFR-mutant non-squamous NSCLC after progression on a 3rd-generation EGFR TKI (e.g., osimertinib). Summit Therapeutics submitted a BLA in Q4 2025; the FDA accepted the BLA for filing in January 2026 with a PDUFA goal action date of November 14, 2026. Ivonescimab holds FDA Fast Track designation. If approved, ivonescimab would be the first PD-1xVEGF bispecific antibody approved in the United States. Ivonescimab is approved in China (NMPA, initial approval May 2024).
