Section 3 of 6
Product information and disease description
58 evidence topics · 50 sources
Product description
Phase of product development
Regulatory submission: BLA submitted in the fourth quarter of 2025
Launch
No evidence found.
Authorization outside the United States
Product information
Generic, brand name and therapeutic class of product
Manufacturer: Summit Therapeutics
Companies and product names
| Field | Quoted record |
|---|---|
| Companies | “Summit Therapeutics Inc. has a definitive partnership with Akeso, Inc.” |
| Product names | “Ivonescimab is known as SMT112 in Summit’s license territories”“and as AK112” |
Product and Chinese trade name
Dosage forms and strengths
Chinese marketed presentation
Material safety data sheet
No evidence found.
Average sales price and wholesale acquisition cost
No evidence found.
American hospital formulary service (AHFS), or other drug classification
Other classification: bispecific antibody
Indication
Pharmacology
Mechanism of action
Pharmacodynamics
Pharmacokinetics
Contraindications/Warnings/Precautions/Adverse effects
Warnings and precautions
Summary
The Chinese prescribing information warns that immune-related adverse reactions may be severe, life-threatening, or fatal. The trial safety table below reports treatment-related adverse events; it is not U.S. prescribing information.
Chinese prescribing information: severity of immune-related adverse reactions
HARMONi: treatment-related adverse events
Special populations
Summary
The Chinese prescribing information states that older adults do not require a dose adjustment.
Chinese prescribing information: dosing in older adults
Drug/Drug, drug/disease interactions
Effects of other drugs on Ivonescimab
No evidence found.
Effects of Ivonescimab on other drugs
No evidence found.
Dosing and administration
Dosage
HARMONi dosing
| Treatment phase | Quoted regimen |
|---|---|
| Initial treatment | “Ivonescimab 20 mg/kg Q3W”“+Pemetrexed 500 mg/m² Q3W”“+Carboplatin AUC 5 Q3W”“4 cycles (3 weeks/cycle)” |
| Maintenance | “Ivonescimab 20 mg/kg Q3W”“+Pemetrexed 500 mg/m² Q3W” |
Administration
HARMONi: administration route and schedule
Access and distribution
Co-prescribed/Concomitant therapies
Chemotherapy partners in the Chinese indication
Effect of Ivonescimab on quality measures
No evidence found.
Product comparison
Systematic review: included studies and overall survival data
Treatment prioritization of chemotherapy-anchored regimens after EGFR-TKI failure
Place of product in therapy
Disease description
Definition and etiology
Epidemiology
Incidence of EGFR-mutated non-small-cell lung cancer
Population incidence specific to EGFR-mutated NSCLC
No evidence found.
Broader context: all lung cancers in the United States
Prevalence of EGFR-mutated non-small-cell lung cancer
Proportion of NSCLC cases with an EGFR mutation
Natural history, survival, and mortality
Broader NSCLC prognosis: stage IV disease
Pathophysiology
Diagnosis
Clinical presentation - signs and symptoms
Long-term morbidity
Case-based evidence: recurrent pleural effusion and atelectasis
Burden of EGFR-mutated non-small-cell lung cancer
Humanistic burden and health-related quality of life
Economic burden and healthcare resource utilization
Economic impact of EGFR-mutated non-small-cell lung cancer on families
Broader NSCLC evidence: reduced caregiver working hours
Economic impact of diagnostic testing
NGS versus single-gene testing: current-practice scenario, 2023–2024
Approaches to treatment
Current treatment options and standard of care
EGFR tyrosine kinase inhibitors
First-line therapy for classical activating EGFR mutations
Platinum-based chemotherapy
First-line targeted therapy plus chemotherapy
EGFR/MET bispecific antibodies
First-line combination option
Treatment alternatives: amivantamab with chemotherapy
Antibody-drug conjugates
Antiangiogenic combination therapy
EGFR-TKI and antiangiogenic combinations
CSCO guideline: post-resistance EGFR-mutant NSCLC
Surgical resection
Broader NSCLC standard of care: stage I disease
Radiotherapy
Broader NSCLC care: palliation of local symptoms
Supportive and palliative care
Integration throughout cancer treatment
Limitations of current therapies
Summary
Post-EGFR-TKI treatment options include amivantamab plus carboplatin and pemetrexed and, after prior EGFR-directed therapy and platinum chemotherapy, datopotamab deruxtecan. These options occupy different treatment positions. HARMONi compared ivonescimab plus chemotherapy with placebo plus chemotherapy, not with either of these active combination or antibody-drug conjugate strategies. Its results therefore do not establish superiority over those alternatives.
Place in treatment, anticipated use, and care setting
Summary
The U.S. development setting is ivonescimab plus chemotherapy after progression on a third-generation EGFR TKI in EGFR-mutated nonsquamous NSCLC. Treatment in HARMONi was intravenous every 3 weeks. Summit reports a November 14, 2026 FDA action date and estimates that more than 14,000 U.S. patients could be eligible annually. That estimate describes a potential treatment population, not the incidence of EGFR-mutated NSCLC.
Ivonescimab has been authorized in China since May 2024. Akeso reports a Class I CSCO recommendation for ivonescimab plus chemotherapy after EGFR-TKI resistance. In the United States and Canada, Summit describes exceptional single-patient expanded access rather than routine commercial access.
Anticipated U.S. population
Heterogeneity of treatment effect
Summary
The geographically stratified survival update and individual case reports describe possible variation in treatment outcomes. The case reports do not establish comparative treatment effects or validate predictive biomarkers. The reported geographic HRs should not be interpreted as proof that treatment effects are identical across regions.
HARMONi: updated survival by geographic population
Care management intervention strategies
Multidisciplinary palliative and oncology care coordination
Other product development or post-marketing obligations required by the FDA
No evidence found.
Ongoing post-approval monitoring
No evidence found.