AstraZeneca upbeat on positive results from three drug trials
AstraZeneca announced a slew of positive drug trial results on Thursday, first reporting that the Phase III OLYMPUS and ROCKIES trials for roxadustat had each met their primary efficacy endpoints, for the treatment of patients with anaemia in chronic kidney disease (CKD) that were either non-dialysis-dependent or dialysis-dependent, respectively.
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The FTSE 100 pharmaceuticals giant also announced, alongside Merck, that positive results had been reported from the randomised, open-label, controlled, Phase III SOLO-3 trial of Lynparza (olaparib) tablets, in 266 patients with relapsed ovarian cancer after two or more lines of treatment.
On the OLYMPUS and ROCKIES trials, AstraZeneca described roxadustat as a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), and a potential first-in-class new medicine to treat anaemia in CKD, which was being jointly developed and commercialised by AstraZeneca and FibroGen.
It said OLYMPUS ws a Phase III, randomised, double-blinded, placebo-controlled trial designed to evaluate the efficacy and safety of roxadustat compared to placebo for the treatment of patients with anaemia in CKD stages three, four and five, whose disease progression was moderate to severe and who were non-dialysis dependent.
The trial met its primary efficacy endpoint by demonstrating a statistically-significant and clinically-meaningful improvement in mean change from baseline in haemoglobin (Hb) levels averaged over weeks 28 to 52 compared placebo.
AstraZeneca said the trial evaluated 2,781 patients in 26 countries.
ROCKIES, meanwhile, was a Phase III, randomised, open-label, active-controlled trial designed to assess the efficacy and safety of roxadustat compared to epoetin alfa, for the treatment of patients with anaemia in CKD who were dialysis dependent.
The trial also met its primary efficacy endpoint, the firm said, by demonstrating a statistically-significant improvement in mean change from baseline in Hb levels averaged over weeks 28 to 52, compared to epoetin alfa.
That trial evaluated 2,133 patients in 18 countries.
The global Phase III programme consisted of more than 9,000 patients in trials conducted by AstraZeneca, FibroGen and Astellas.
In September, Astellas announced high-level results from the Phase III ALPS trial.
FibroGen and Astellas anticipated reporting high-level results from their remaining trials in due course, with AstraZeneca explaining that the trials would contribute to the combined pooled safety analysis, including major adverse cardiovascular event (MACE) outcomes, anticipated during the first half of 2019.
“These results add to the growing body of evidence for roxadustat, which is part of the largest clinical programme worldwide in evaluating the novel class of HIF-PHI,” said AstraZeneca’s executive vice-president of global medicines development and chief medical officer, Sean Bohen.
“This is a significant milestone in the role roxadustat can play to help address a high unmet need in anaemia associated with chronic kidney disease, which today is under diagnosed and in many cases under treated.”
Data from the Phase III OLYMPUS and ROCKIES trials, together with the efficacy and pooled safety data from the global Phase III programme, would be part of the drug’s regulatory submission package in the US and other major countries.
Results from the trials would be presented at forthcoming medical meetings, the AstraZeneca board confirmed.
For the Phase III SOLO-3 trial of Lynparza (olaparib) tablets, AstraZeneca said the trial was conducted as a post-approval commitment in agreement with the US Food and Drug Administration (FDA).
It was the fourth Phase III trial to demonstrate a positive result for Lynparza, with AstraZeneca and Merck now planning to discuss the results with the FDA.
Results from the trial showed BRCA-mutated (BRCAm) advanced ovarian cancer patients treated with Lynparza following two or more prior lines of chemotherapy demonstrated a statistically-significant and clinically-meaningful improvement in the primary endpoint of objective response rate (ORR), and the key secondary endpoint of progression-free survival (PFS), compared to chemotherapy.
The safety and tolerability profile of Lynparza was consistent with previous trials.
“We are very excited about SOLO-3, which is the first Phase III trial for a PARP inhibitor to demonstrate a positive result versus chemotherapy in advanced ovarian cancer where effective options are needed,” said Sean Bohen.
“We look forward to sharing the full results at a forthcoming medical meeting.”