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AstraZeneca/Merck's Lynparza Improves PFS in Frontline Study
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AstraZeneca (AZN - Free Report) presented detailed data from a phase III study evaluating the company’s and Merck’s (MRK - Free Report) PARP inhibitor, Lynparza, for a broader advanced ovarian cancer patient population at the European Society of Medical Oncology (ESMO) congress in Barcelona, Spain
The PAOLA-1 study evaluated Lynpazra as a first-line maintenance treatment in combination with Roche’s (RHHBY - Free Report) Avastin (bevacizumab) versus Avastin alone in women suffering from advanced ovarian cancer regardless of their biomarker status or surgical outcome.
Data from the study showed that Lynparza improved progression-free-survival (PFS), or the time the abovementioned women lived without disease progression, to a median of 22.1 months versus 16.6 months in the Avastin arm in the broad population. Lynparza added to bevacizumab reduced the risk of disease progression or death by 41% in the overall patient population.
Meanwhile, in a sub-group of patients — homologous recombination deficiency (HRD) positive newly-diagnosed advanced ovarian cancer patients — treatment with Lynparza plus bevacizumab reduced the risk of disease progression or death by 67%. Please note that HRD positive patients represent about half of ovarian cancer cases.
Shares of AstraZeneca have rallied 19.2% this year so far against the industry’s decrease of 0.6%.
In August, the companies had announced top-line data from the same study. Back then, the company had said that treatment with Lynparza plus Avastin led to a statistically-significant and clinically-meaningful improvement in PFS in the intent-to-treat population versus Avastin alone.
Lynparza is presently approved as first-line maintenance treatment for BRCAm advanced ovarian cancer, following response to platinum-based chemotherapy based on data from the phase III SOLO-1 study. If approved for first-line maintenance indication based on PAOLA-1 study, Lynparza can be prescribed to a much wider population including those who do not have the BRCA mutation. This can significantly increase the market for the drug.
Lynparza, presently marketed for advanced ovarian cancer and breast cancer, is also in different studies for a range of tumor types including prostate, pancreatic and gastric cancers as well as earlier-line settings for ovarian and breast cancers.
Lynparza is part of AstraZeneca’s strong oncology portfolio. Oncology sales now comprise around 35% of AstraZeneca’s total product sales, surging 50% in 2018 and 58% in the first half of 2019. In the same period, Lynparza generated sales of $520 million, up 93% year over year.
Glaxo (GSK - Free Report) also presented positive detailed data from the phase III PRIMA study evaluating its PARP inhibitor, Zejula (niraparib), as monotherapy for maintenance therapy of women with first-line ovarian cancer, who had received platinum-based chemotherapy. Data demonstrated that Zejula significantly reduced the risk of disease progression or death by 38%, irrespective of biomarker status.
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AstraZeneca/Merck's Lynparza Improves PFS in Frontline Study
AstraZeneca (AZN - Free Report) presented detailed data from a phase III study evaluating the company’s and Merck’s (MRK - Free Report) PARP inhibitor, Lynparza, for a broader advanced ovarian cancer patient population at the European Society of Medical Oncology (ESMO) congress in Barcelona, Spain
The PAOLA-1 study evaluated Lynpazra as a first-line maintenance treatment in combination with Roche’s (RHHBY - Free Report) Avastin (bevacizumab) versus Avastin alone in women suffering from advanced ovarian cancer regardless of their biomarker status or surgical outcome.
Data from the study showed that Lynparza improved progression-free-survival (PFS), or the time the abovementioned women lived without disease progression, to a median of 22.1 months versus 16.6 months in the Avastin arm in the broad population. Lynparza added to bevacizumab reduced the risk of disease progression or death by 41% in the overall patient population.
Meanwhile, in a sub-group of patients — homologous recombination deficiency (HRD) positive newly-diagnosed advanced ovarian cancer patients — treatment with Lynparza plus bevacizumab reduced the risk of disease progression or death by 67%. Please note that HRD positive patients represent about half of ovarian cancer cases.
Shares of AstraZeneca have rallied 19.2% this year so far against the industry’s decrease of 0.6%.
In August, the companies had announced top-line data from the same study. Back then, the company had said that treatment with Lynparza plus Avastin led to a statistically-significant and clinically-meaningful improvement in PFS in the intent-to-treat population versus Avastin alone.
Lynparza is presently approved as first-line maintenance treatment for BRCAm advanced ovarian cancer, following response to platinum-based chemotherapy based on data from the phase III SOLO-1 study. If approved for first-line maintenance indication based on PAOLA-1 study, Lynparza can be prescribed to a much wider population including those who do not have the BRCA mutation. This can significantly increase the market for the drug.
Lynparza, presently marketed for advanced ovarian cancer and breast cancer, is also in different studies for a range of tumor types including prostate, pancreatic and gastric cancers as well as earlier-line settings for ovarian and breast cancers.
Lynparza is part of AstraZeneca’s strong oncology portfolio. Oncology sales now comprise around 35% of AstraZeneca’s total product sales, surging 50% in 2018 and 58% in the first half of 2019. In the same period, Lynparza generated sales of $520 million, up 93% year over year.
Glaxo (GSK - Free Report) also presented positive detailed data from the phase III PRIMA study evaluating its PARP inhibitor, Zejula (niraparib), as monotherapy for maintenance therapy of women with first-line ovarian cancer, who had received platinum-based chemotherapy. Data demonstrated that Zejula significantly reduced the risk of disease progression or death by 38%, irrespective of biomarker status.
Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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This outperformance has not just been a recent phenomenon. From 2000 – 2018, while the S&P averaged +4.8% per year, our top strategies averaged up to +56.2% per year.
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