![]() ![]() As part of a broad development program, LYNPARZA is being assessed as a monotherapy and in combination across multiple tumor types. Regulatory reviews are currently underway in the European Union, Japan and other countries for LYNPARZA in combination with bevacizumab as a first-line maintenance treatment for patients with advanced ovarian cancer. #Hrd positive full#The full results from the Phase 3 PAOLA-1 trial were published in The New England Journal of Medicine. Today’s approval based on the PAOLA-1 trial highlights the importance of HRD testing at diagnosis to identify those who may benefit from LYNPARZA in combination with bevacizumab as a first-line maintenance treatment.” Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “Advances in understanding the role of biomarkers and PARP inhibition have fundamentally changed how physicians treat this aggressive type of cancer. These results further establish that HRD-positive is a distinct subset of ovarian cancer and HRD testing is now a critical component of diagnosis and tailoring of treatment for women with advanced ovarian cancer.”ĭr. The median progression-free survival of more than three years offers new hope for women to delay relapse in this difficult-to-treat disease. I look forward to seeing this translate into clinical practice.”ĭave Frederickson, executive vice president, head of the oncology business unit, AstraZeneca, said, “This approval represents another milestone for LYNPARZA in patients with ovarian cancer. The magnitude of benefit in HRD-positive patients in the PAOLA-1 trial is impactful. Isabelle Ray-Coquard, principal investigator of the PAOLA-1 trial and medical oncologist, Centre Léon Bérard and President of the GINECO group, said, “Ovarian cancer is a devastating disease. For patients with advanced ovarian cancer, the primary aim of first-line maintenance treatment is to delay disease progression for as long as possible. ![]() Discontinuation of treatment due to ARs occurred in 20% of patients on LYNPARZA in combination with bevacizumab.Īpproximately one in two women with advanced ovarian cancer has an HRD-positive tumor. ARs led to dose interruption in 54% of patients on LYNPARZA in combination with bevacizumab, while 41% of patients on LYNPARZA in combination with bevacizumab had a dose reduction. In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA in combination with bevacizumab (5%) than in those receiving bevacizumab alone (1.9%). 5% of patients included hypertension (19%) and anemia (17%). Grade 3 or above ARs were anemia (17% vs. The most common adverse reactions (ARs) ≥10% in the overall trial population for PAOLA-1 when treated with LYNPARZA in combination with bevacizumab (N=535) and at a ≥5% frequency compared to bevacizumab alone (N=267) were fatigue (53% vs. 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer. It improved progression-free survival (PFS) to a median of 37.2 months vs. The approval was based on a biomarker subgroup analysis of 387 patients with HRD-positive tumors from the Phase 3 PAOLA-1 trial, which showed that LYNPARZA in combination with bevacizumab reduced the risk of disease progression or death by 67% (HR 0.33 ). ![]() Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. Food and Drug Administration (FDA) has approved LYNPARZA in combination with bevacizumab as a first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Bevacizumab Alone (17.7 months) Following Response to Platinum-Based Chemotherapy with BevacizumabĪpproximately One in Two Women with Advanced Ovarian Cancer Has an HRD-Positive TumorĪstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Improved the Median Time to Disease Progression (37.2 months) vs. ![]()
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