AstraZeneca plc AZN presented detailed data from a phase III study evaluating the company’s and Merck’s MRK PARP inhibitor, Lynparza, as a precision medicine for an advanced prostate cancer patient population, at the European Society of Medical Oncology (ESMO) congress in Barcelona, Spain.
The phase III PROfound study (n=387) evaluated Lynparza in men with metastatic castration-resistant prostate cancer (mCRPC) who have a mutation in their homologous recombination repair (HRRm) genes. The disease of these men had progressed on prior treatment with new hormonal agent (NHA) treatments like J&J’s JNJ Zytiga and Pfizer PFE/Astellas’ Xtandi which makes it a difficult-to-treat disease.
Data from the study showed that Lynparza improved radiographic progression-free survival (rPFS), or the time men with BRCA1/2- or ATM-mutated mCRPC lived without disease progression or death, to a median of 7.4 months versus 3.6 months for those treated with Zytiga/Xtandi. It thus met the primary endpoint of the study. Treatment with Lynparza reduced the risk of disease progression or death by 66% in such men. However, in the overall HRRm population, Lynparza reduced the risk of disease progression or death by 51%, thereby meeting a key secondary endpoint. The clinical benefit seen in patients beyond just those with BRCA mutations was encouraging.
In August, the companies had announced top-line data from the same study. Back then, the company had said the study met the primary endpoint of significantly increasing the time patients live without radiographic disease progression versus standard of care treatment.
As ESMO, AstraZeneca and Merck earlier presented detailed data from another late-stage study evaluating Lynparza for a broader advanced ovarian cancer patient population. Lynparza, when added to bevacizumab, as a first-line maintenance treatment, reduced the risk of disease progression or death by 41% in women suffering from advanced ovarian cancer regardless of their biomarker status or surgical outcome.
Shares of AstraZeneca have rallied 17.3% this year so far against the industry’s decrease of 0.6%.
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.
Zacks Rank
AstraZeneca currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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