Trial data, however, raised doubt about Lynparza's benefit in metastatic castration-resistant prostate cancer patients with non-BRCA1/2 HRR gene mutations.
AstraZeneca's EGFR-inhibitor has now demonstrated an 'overwhelming' disease-free survival and CNS recurrence benefit, but overall survival benefit remains unknown.
After five years, nearly half the Lynparza-treated patients in the SOLO-1 trial remained disease-free, compared with one-fifth of those who received placebo.
Patients on the combo regimen had similar outcomes to those on monotherapy, but researchers said that the benefit seen in certain groups should be explored in randomized trials.
The companies will collaborate on a trial evaluating the HER3-targeted antibody drug conjugate patritumab deruxtecan in combiantion with AstraZeneca's Tagrisso.
The companies will jointly develop and commercialize DS-1062 worldwide, sharing in the development costs and the profits, but Daiichi Sankyo will maintain exclusive rights in Japan.
The approval will make Merck and AstraZeneca's Lynparza available to patients in the EU who have not progressed after 16 weeks on platinum-based chemotherapy.
