ENHERTU reaches 14.3-month PFS in Phase III lung cancer trial

• AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo said ENHERTU delivered median progression-free survival of 14.3 months versus 8.3 months with pembrolizumab plus chemotherapy.
• ENHERTU reduced the risk of disease progression or death by 37% and produced a 70.0% objective response rate in the Phase III DESTINY-Lung04 trial.
• The companies said the results support ENHERTU’s potential as a first-line treatment for advanced HER2-mutant non-squamous non-small cell lung cancer.

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo reported that ENHERTU achieved median progression-free survival of 14.3 months in the Phase III DESTINY-Lung04 lung cancer trial.

ENHERTU extended median PFS by six months compared with 8.3 months for pembrolizumab plus platinum-pemetrexed chemotherapy and reduced the risk of progression or death by 37%, with a hazard ratio of 0.63.

“HER2-mutant non-small cell lung cancer is an aggressive disease with limited responses to current 1st-line standard of care,” said DESTINY-Lung04 lead investigator Julia Rotow.

The objective response rate was 70% with ENHERTU versus 44.5% with pembrolizumab plus chemotherapy, while median duration of response was 13.4 months versus 9.7 months.

The progression-free survival difference was statistically significant at p<0.0001, while favorable PFS trends for ENHERTU were reported across key subgroups including patients with brain or liver metastases.

AstraZeneca said DESTINY-Lung04 is the first Phase III trial to demonstrate superior PFS against the global first-line standard of care in patients with advanced HER2-mutant non-small cell lung cancer.

Daiichi Sankyo said the six-month PFS improvement and response rates support ENHERTU’s potential use in the first-line setting, extending its role beyond its established second-line use in HER2-mutant NSCLC.