EU backs AstraZeneca drug for prostate and ovarian cancer
A blockbuster drug candidate whose IP originated in Cambridge has earned two key approvals from the European Union for treatment in prostate and ovarian cancers.
AstraZeneca, based at Cambridge Biomedical Campus, and international partner MSD have secured the dual endorsement for Lynparza (olaparib).
The seeds of the technology were sown in Professor Steve Jackson’s Cambridge lab and principally at one of his spin-out companies KuDOS Pharmaceuticals, which AstraZeneca acquired.
It is the only PARP inhibitor to date to improve overall survival versus new
hormonal agent treatments in advanced prostate cancer.
AstraZeneca and MSD’s iteration of the now highly advanced drug has been recommended for marketing authorisation in the EU for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.
Prostate cancer is the second-most common type of cancer in men, with an estimated 1.3 million new patients diagnosed worldwide in 2018. Approximately 12 per cent of men with mCRPC have a BRCA mutation.
José Baselga, AstraZeneca’s executive VP for oncology R & D, said: “Patients diagnosed with metastatic castration-resistant prostate cancer unfortunately have few treatment options and historically a poor prognosis. 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.”
AstraZeneca and MSD are exploring additional trials in metastatic prostate cancer including the ongoing PROpel Phase III trial testing Lynparza as a 1st-line treatment for patients with mCRPC in combination with abiraterone versus abiraterone alone. Data are anticipated in the second half of 2021.
Lynparza has also been recommended for marketing authorisation in the EU for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer.
The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on a biomarker subgroup analysis of the PAOLA-1 Phase III trial, which was published in The New England Journal of Medicine.
The trial showed that Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67 per cent.
Ovarian cancer is the fifth most common cause of cancer death in Europe and the five-year survival rate is approximately 45 per cent, due in part because women are often diagnosed with advanced disease (Stage III or IV).
Baselga said: “Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumours. Lynparza together with bevacizumab has demonstrated a median progression-free survival benefit of more than three years, offering new hope for women in this setting.
“This recommendation is a vital step toward addressing a significant unmet need and could bring a new treatment option that delays relapse in this devastating disease.”