AstraZeneca (AZN) recently announced that it has started enrolling patients for the phase III SOLO (Study of OLaparib in Ovarian cancer) program for its oncology candidate, olaparib. The SOLO program comprises two studies – SOLO 1 and SOLO 2.
While SOLO 1 will evaluate the use of olaparib as a maintenance monotherapy in BRCA mutated ovarian cancer patients who are in complete or partial response following platinum-based chemotherapy in the first line setting, SOLO 2 will evaluate the candidate in the relapsed setting.
The SOLO program was initiated on the basis of data from a retrospective subgroup analysis of a phase II study (study 19, n = 265) on olaparib, presented at the American Society of Clinical Oncology (TATD) meeting.
The 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. 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.
We remind investors, in Dec 2011, AstraZeneca decided to stop developing pf olaparib as maintenance treatment of serous ovarian cancer following an interim analysis of a phase II study (study 19). The analysis indicated that the progression free survival benefit demonstrated earlier would most likely not translate into an overall survival benefit.
The company incurred a pre-tax impairment charge of $285 million due to the discontinuation of olaparib for the ovarian cancer indication. Now that the company has decided to evaluate the candidate further, the impairment charge will be reversed in the third quarter of 2013.
AstraZeneca’s pipeline is currently under severe pressure with revenues plunging due to generic competition faced by several key drugs including Seroquel.
AstraZeneca carries a Zacks Rank #3 (Hold). Currently, companies like Biogen Idec (BIIB), Gilead Sciences Inc. (GILD) and Actelion Ltd. (ALIOF) look well-positioned with all three being Zacks Rank #1 (Strong Buy) stocks.
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