) 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.
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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 (ASCO) 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
Gilead Sciences Inc.
) look well-positioned with all three being Zacks Rank #1 (Strong