AstraZeneca (AZN) recently presented data from a retrospective subgroup analysis of a phase II study (study 19, n = 265) on its oncology candidate, olaparib at the American Society of Clinical Oncology (TATD) meeting.
The randomized and double-blinded phase II study compared the efficacy and safety of olaparib versus placebo in patients suffering from platinum-sensitive, relapsed, high grade serous ovarian cancer. The patients had already been treated with two or more platinum-based regimens and exhibited a partial or complete response to the last platinum-based treatment regimen. Encouraging results from the study were presented in 2011.
An initial subgroup analysis revealed improved outcome in patients with BRCA mutation compared to the total study population. For better assessment further investigation was conducted. In the retrospective subgroup analysis it was found that olaparib significantly improved progression-free survival as compared to placebo.
AstraZeneca plans to conduct a phase III on olaparib for ovarian cancer patients with BRCA mutations. The company has already filed a Letter of Intent to submit marketing application with the European Medicines Agency for olaparib for BRCA mutated ovarian cancer.
AstraZeneca’s pipeline is currently under severe pressure with revenues plunging due to generic competition faced by several key drugs including Seroquel. The company will face additional pressure once Nexium (2014) and Crestor (2016) start facing generics.
AstraZeneca carries a Zacks Rank #3 (Hold). Companies that currently look attractive include Santarus, Inc. (SNTS), Jazz Pharmaceuticals (JAZZ) and Salix Pharmaceuticals (SLXP). All the three carry a Zacks Rank #1 (Strong Buy).
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