ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated a median progression-free survival of 14.3 months as 1st-line therapy in patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial
AstraZeneca and Daiichi Sankyo's ENHERTU met the primary endpoint of the Phase III DESTINY-Lung04 trial, reducing the risk of disease progression or death by 37.0% (HR 0.63, 95% CI 0.50-0.79, p<0.0001) versus pembrolizumab plus chemotherapy in first-line HER2-mutant advanced non-small cell lung cancer. Median progression-free survival was 14.3 months with ENHERTU versus 8.3 months for standard of care — a six-month improvement — and it is the first HER2-directed therapy to beat standard of care in a Phase III trial in this setting. Objective response rate was 70.0% versus 44.5%, with median duration of response of 13.4 months.
Key figures
- Drug Name
- ENHERTU (fam-trastuzumab deruxtecan-nxki)
- Phase Of Trial
- Phase III
- Dose
- 5.4 mg/kg
- Trial
- DESTINY-Lung04
- Indication
- 1st-line HER2-mutant unresectable, locally advanced or metastatic non-squamous NSCLC
- Data cutoff
- 9 June 2026
- Orr control
- 44.5%
- Orr enhertu
- 70.0%
- Pfs p value
- p<0.0001
- Risk reduction
- 37.0%
- Os hazard ratio
- 1.15
- Os data maturity
- 46.9%
- Pfs hazard ratio
- 0.63
- Patients enrolled
- 454
- Pfs hazard ratio ci
- 0.50-0.79
- Grade3plus ae enhertu
- 34.1%
- Median os control months
- 33.1
- Median os enhertu months
- 29.3
- Ild grade5 events enhertu
- 4
- Ild pneumonitis incidence
- 20.8%
- Median dor control months
- 9.7
- Median dor enhertu months
- 13.4
- Median pfs control months
- 8.3
- Median pfs enhertu months
- 14.3
- Median pfs2 control months
- 17.3
- Median pfs2 enhertu months
- 22.7
AI analysis
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