AstraZeneca announced that its Lynparza drug has been recommended for marketing authorization in the European Union (EU) for patients with metastatic prostate cancer (mCRPC) and breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, as well as for advanced ovarian cancer.
AstraZeneca (AZN) said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its recommendation on a subgroup analysis of patients with BRCA1/2 mutations from the Phase 3 trial.
Prostate cancer is the second-most common type of cancer in men, with an estimated 1.3 million new patients diagnosed worldwide in 2018. About 12% of men with mCRPC have a BRCA mutation. Ovarian cancer is the 5th most common cause of cancer death in Europe and the 5-year survival rate is approximately 45%.
Lynparza, which AstraZeneca has developed with Merck (MRK) is a first-in-class PARP inhibitor, which is a targeted treatment to potentially block DNA damage response (DDR) pathway deficiencies, such as BRCA mutations to kill cancer cells.
“Patients diagnosed with metastatic castration-resistant prostate cancer unfortunately have few treatment options and historically a poor prognosis,” said AstraZeneca’s José Baselga. “This recommendation for Lynparza brings us closer to making the only PARP inhibitor to improve overall survival in this setting available to men in the EU. BRCA testing should now become a critical step in the diagnosis and determination of treatment for men with advanced prostate cancer in the EU.”
Baselga added that for advanced ovarian cancer patients, Lynparzatogether with bevacizumab has demonstrated a median progression-free survival benefit of more than 3 years.
The recommendation for Lynparza is for the treatment of adult patients with mCRPC and BRCA1/2 mutations who have progressed following prior therapy that included a new hormonal agent. In May this year, Lynparza was approved in the US for men with gene-mutated mCRPC based on the Phase 3 trial. Regulatory reviews are ongoing in other countries around the world, the British drugmaker said.
AstraZeneca and Merck are exploring additional trials in metastatic prostate cancer including the ongoing Phase 3 trial testing Lynparza as a 1st-line treatment for patients with mCRPC in combination with abiraterone versus abiraterone alone. Data are anticipated to be released in the second half of 2021.
AZN shares have gained 13% this year as the drugmaker joined the list of companies engaged in the development of a potential coronavirus vaccine. The Phase 2/3 study of the AstraZeneca/Oxford vaccine candidate was this month put on hold after an adverse event in a single participant from the UK. The trial has now restarted in the UK but is still on hold in the US. (See AstraZeneca stock analysis on TipRanks)
In reaction, SVB Leerink analyst Andrew Berens reiterated a Buy rating on the stock suggesting that the adverse event could have a broader impact and could cause near-term volatility in AstraZeneca’s shares as well as in the stock of other companies with COVID vaccine programs until the exact nature of the event is clear.
As a result, Berens cautions that the overall speed of many of the programs could be affected as the investigation progresses and sponsors become more vigilant, as well as public sentiment regarding the safety of the vaccines once approved.
Overall, the stock scores a Strong Buy consensus from the analyst community with 3 unanimous Buy ratings. Looking ahead, the $91.76 average analyst price target puts the upside potential at a promising 63% in the coming 12 months.
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