Encouraging phase III trial results for AstraZeneca for lung cancer and prostate cancer drugs
AstraZeneca has confirmed two encouraging phase III trial results.
It announced significant overall survival results from FLAURA trial of Tagrisso (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer, whose tumours have epidermal growth factor receptor (EGFR) mutations.
The drug - already approved in 64 countries - also increased the time patients with central nervous system metastases lived without disease progression.
It found a significant improvement in radiographic progression-free survival compared to new hormonal anti-cancer treatments for men with metastatic castration-resistant prostate cancer who had specific gene mutations.
José Baselga, AstraZeneca’s executive vice president, oncology R&D, said: “For men with metastatic castration-resistant prostate cancer the disease remains deadly, especially in those who have failed on a new hormonal anticancer treatment.
“This trial is the only positive phase III trial of any PARP inhibitor in metastatic castration-resistant prostate cancer, where the need for new, effective therapies is high. The PROfound trial also demonstrates the potential value of genomic testing in this at-risk patient population. We look forward to discussing these results with global health authorities soon.”
The trial compared Lynparza (olaparib) with enzalutamide or abiraterone in men with this cancer selected for BRCA1/2 or ATM gene mutations.
The companies are also exploring additional trials in prostate cancer.
Lynparza is the only PARP inhibitor with positive phase III results in four cancer types - ovarian, breast, pancreatic and prostate.
Meanwhile, AstraZeneca has also had approval from the European Commission for an update to the marketing authorisation for Forxiga (dapagliflozin) to include positive cardiovascular outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type-2 diabetes. The trial enrolled a majority of patients with no existing cardiovascular disease.
Mene Pangalos, executive vice president, biopharmaceuticals R&D, said: “For patients with type-2 diabetes, heart failure is one of the earliest cardiovascular complications before heart attack or stroke.
“In the Phase III DECLARE-TIMI 58 trial, Forxiga reduced the composite endpoint of hospitalisation for heart failure or cardiovascular death in patients with type-2 diabetes, and we look forward to bringing these additional benefits of the medicine to people with type-2 diabetes in the EU.”