HARMONi-A
Trial question
What is the role of addition of ivonescimab to chemotherapy in patients with relapsed advanced or metastatic non-small cell lung cancer with EGFR variant?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 322
322 patients (166 female, 156 male).
Inclusion criteria: patients with relapsed advanced or metastatic non-small cell lung cancer with EGFR variant.
Key exclusion criteria: small cell or squamous cell histology; receipt of systemic anticancer therapy except EGFR-TKIs; receipt of immunotherapy antibodies or agents that act on T-cell co-stimulation or other immune checkpoint pathways.
Interventions
N=161 ivonescimab (ivonescimab 20 mg/kg plus pemetrexed and carboplatin once every 3 weeks for 4 cycles, followed by ivonescimab plus pemetrexed maintenance).
N=161 placebo (placebo plus pemetrexed and carboplatin once every 3 weeks for 4 cycles, followed by placebo plus pemetrexed maintenance).
Primary outcome
Progression-free survival
7.1 months
4.8 months
7.1 months
5.3 months
3.5 months
1.8 months
0.0 months
Ivonescimab
Placebo
Significant
increase ▲
Significant increase in progression-free survival (7.1 months vs. 4.8 months; HR 2.17, 95% CI 1.61 to 2.94).
Secondary outcomes
Significant increase in overall response rate (50.6% vs. 35.4%; AD 15.6%, 95% CI 5.3 to 26).
Safety outcomes
No significant difference in treatment-emergent adverse events.
Conclusion
In patients with relapsed advanced or metastatic non-small cell lung cancer with EGFR variant, ivonescimab was superior to placebo with respect to a progression-free survival.
Reference
HARMONi-A Study Investigators, Wenfeng Fang, Yuanyuan Zhao et al. Ivonescimab Plus Chemotherapy in Non-Small Cell Lung Cancer With EGFR Variant: A Randomized Clinical Trial. JAMA. 2024 Aug 20;332(7):561-570.
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