Hrd ovarian cancer trial#

The CHMP recommendation is for Lynparza in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with HRD positive status defined by either a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation and/or genomic instability.Р”Р‡urther results from the PAOLA-1 trial recently presented during the 2020 European Society for Medical Oncology virtual congress showed that Lynparza in combination with bevacizumab maintenance treatment demonstrated a statistically significant improvement in the time to second disease progression (PFS2) versus bevacizumab alone in patients with HRD-positive advanced ovarian cancer, a key secondary endpoint. This recommendation and the results from the PAOLA-1 trial underscore the importance of HRD testing at diagnosis to determine the best course of treatment for women with advanced ovarian cancer.РІР‚Сњ Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: РІР‚СљHRD is an important biomarker of advanced ovarian cancer that can inform how physicians in the EU treat this aggressive type of cancer. 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.РІР‚Сњ

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. JosР“В© Baselga, Executive Vice President, Oncology R&D, said: РІР‚СљHalf of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumours. Ovarian cancer is the fifth most common cause of cancer death in Europe and the five-year survival rate is approximately 45%, due in part because women are often diagnosed with advanced disease (Stage III or IV). The addition of Lynparza improved progression-free survival (PFS) to a median of 37.2 months versus 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.Р”Р‡or patients with advanced ovarian cancer, the primary aim of 1st-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission. The trial showed that Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% (based on a hazard ratio of 0.33 95% confidence interval 0.25-0.45).

The Committee for Medicinal Products for Human Use (CHMP) 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. Partnerships, alliances and recognitionР”Р„straZeneca and MSDРІР‚в„ўs Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer.

Hrd ovarian cancer