30th Sep 2019 08:58
(Alliance News) - AstraZeneca PLC on Saturday said its drug Lynparza, added to bevacizumab, cut the risk of death or disease progression in newly diagnosed ovarian cancer patients by 41%.
The phase 3 Paola-1 trial compared Lynparza plus bevacizumab - bevacizumab being the standard of care - against bevacizumab alone. Lynparza is being developed jointly by the London-listed Astra and New York-listed Merck & Co Inc.
The result shows that "Lynparza added to bevacizumab reduced the risk of disease progression or death by 41%". Moreover, the combination treatment also improved progression-free-survival by a median of 22.1 months versus 16.6 months with bevacizumab alone.
Two years since starting the trial, 46% of women taking Lynparza added to bevacizumab had no progression, compared to 28% of women taking bevacizumab alone.
The trial included sub-group analysis of those with BRCA-mutated ovarian cancer or homologous recombination deficiency. BRCA mutations are associated with cancers such as ovarian cancer, while HRD is a genetic factor which causes ovarian cells to have difficulty repairing themselves.
The risk of disease progression or death fell 69% in patients with BRCA-mutated cancer and HRD positive patients risk of disease progression fell 67%.
Jose Baselga, executive vice president of Oncology Research & Development at Astra, said: "This trial was designed to reflect everyday clinical practice using a global standard-of-care treatment with Lynparza. The results showed at two years nearly half of women with advanced ovarian cancer were progression-free with Lynparza added to bevacizumab as a 1st-line maintenance treatment, regardless of their biomarker status or surgical outcome. We are working with regulatory authorities to bring Lynparza to these patients as quickly as possible."
Results also were published on Saturday from Astra's Flaura trial of Tagrisso in non-small cell lung cancer. The phase 3 trial assessed Tagrisso as a first-line treatment for "patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer".
The Flaura trial found "a statistically significant and clinically meaningful improvement" in overall survival, which was a key secondary endpoint for the trial, when compared to previous standard-of-care drugs gefitinib or erlotinib.
Tagrisso also produced a median overall survival of 38.6 months compared to 31.8 months with gefitinib or erlotinib.
Baselga commented on the Tagrisso result, saying: "Tagrisso has set a new benchmark in EGFR-mutated non-small cell lung cancer by demonstrating a median overall survival of more than three years. We have not before seen survival benefits of this magnitude in any global phase 3 trial with any such therapy. The ground-breaking data reaffirm the benefit of using Tagrisso first and further support its use as the 1st-line standard of care in this setting."
Shares in Astra were down 1.8% at 7,247.00 pence in London on Monday morning.
By Anna Farley; [email protected]
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