AstraZeneca ( NASDAQ: AZN ) and Daiichi Sankyo ( OTCPK:DSKYF ) ( OTCPK:DSNKY ) said their drug Enhertu showed clinically meaningful tumor responses in previously-treated patients with HER2-mutant (HER2m) unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC) in a phase 2 trial.
The company presented updated data from the study, dubbed DESTINY-Lung01, at the European Society for Medical Oncology (ESMO) Congress 2022.
Enhertu was evaluated in dose groups — 5.4mg/kg (n=52); (6.4mg/kg) (n=28).
A confirmed objective response rate (ORR) of 53.8% and 42.9% was seen in the Enhertu 5.4mg/kg and 6.4mg/kg groups, respectively, the company said in a Sept.11 press release.
One complete response (CR) was seen in each arm (5.4mg/kg: 1.9%, 6.4mg/kg: 3.6%), with 27 partial responses (PR) seen in the 5.4mg/kg group and 11 PRs seen in the 6.4mg/kg arm.
AstraZeneca added that as median duration of response (DoR) was not reached in the 5.4mg/kg group, an additional 90-day follow-up response analysis was carried out, where Enhertu showed a confirmed ORR of 57.7% and a median DoR of 8.7 months, with CRs seen in 1.9% of patients and PRs in 55.8% of patients.
The company said Grade 3 or higher treatment-related adverse events (TEAEs) occurring in 31.7% of patients in the 5.4mg/kg group while 58% of patients on 6.4mg/kg.
AstraZeneca noted that a favorable safety profile was seen in patients treated with 5.4mg/kg, with no new safety signals identified at either dose.
AZN +1.23% to $61.60 premarket Sept. 12
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AstraZeneca, Daiichi Sankyo's Enhertu shows response in lung cancer patients in trial