The drug out-performed two other antiandrogen drugs (testosterone blockers) currently treating specific types of metastatic prostate cancer.
Data from MRIs and other scans showed that the median progression free survival (PFS) was 7.4 months for Lynparza compared to the control group’s PFS of 3.6 months.
About the Phase III PROfound Trial
According to the results of the PROfound trial (Phase III) Lynparza reduced the risk of death or progression of the genetic disease by sixty-six percent over the two drugs in the control group.
Eligible study patients had metastatic castration-resistant prostate cancer (CRPC) and had been treated with Zytiga (Johnson & Johnson), Xtandi (Pfizer), or similar generics.
About ninety percent of CRPC patients will develop metastases, primarily located in their skeleton. CRPC is incurable with about a one to two-year survival time.
One other requirement was that study participants were to have certain genetic mutations.
People were screened and selected from twenty countries to qualify for the trial. Patients found to have homologous (same order of genes) recombination repair (HRR) gene mutations in their tumor tissue were accepted. In addition, the investigators also required that patients’ disease had progressed while being treated with novel hormonal therapies.
HRR is characterized as a repair process that involves a damaged molecule invading an undamaged DNA molecule of similar sequence. Recreation of the damaged area occurs by using the undamaged molecule as a guide.
PROfound trial patients were grouped into two cohorts:
The first group, Cohort A, was comprised of patients who had BRCA1, BRCA2 or ATM mutations. Inherited mutations in BRCA1 and BRCA2 have been noted quite often in medical news. ATM mutations however, also carry the risk of breast cancer.
The second group, Cohort B, consisted of twelve other types of homologous recombination repair genes.
Analysts anticipate definite FDA approval will be based on data from the trial. Lynparaza had been granted priority review which is an indication that the FDA’s decision should be made in the second quarter of 2020.
About Prostate Cancer
Approximately 1.3 million men worldwide were newly diagnosed with prostate cancer in 2018. It is ranked second in the most common cancers among men and has a high mortality rate.
The American Cancer Society estimates that prostate cancer will be responsible for 33,000 deaths in the US in 2020, and it anticipates approximately 192,000 new cases.
The Only Drug With Four Approvals
AstraZeneca, a global biopharmaceutical company and Merck & Co., a multinational pharmaceutical company, hope to be showcasing Lynparza which, when approved, would join its three other approved drugs for: breast cancer, ovarian cancer, and pancreatic cancer.
It is noteworthy that eighty-one percent of the study participants in either one of the control arms switched over to the Lynparza group when their treatment was no longer effective.