The Food and Drug Administration (FDA) has approved Lynparza® (olaparib; AstraZeneca and Merck) for use in combination with bevacizumab as 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.

The approval was based on data from the PAOLA-1 trial, a double-blind, placebo-controlled study that compared the efficacy of olaparib in combination with bevacizumab to placebo plus bevacizumab. In a subgroup analysis of patients with HRD-positive tumors (n=387), the combination of olaparib plus bevacizumab resulted in a median progression-free survival (PFS; primary end point) of 37.2 months compared with 17.7 months with placebo/bevacizumab (hazard ratio 0.33 [95% CI, 0.25-0.45]).   

“The magnitude of benefit in HRD-positive patients in the PAOLA-1 trial is impactful,” said Isabelle Ray-Coquard, principal investigator of the PAOLA-1 trial and medical oncologist, Centre Léon Bérard and President of the GINECO group. “I look forward to seeing this translate into clinical practice.”

With regard to safety, the most common adverse reactions associated with the combination therapy included nausea, fatigue (including asthenia), anemia, lymphopenia, vomiting, diarrhea, neutropenia, leukopenia, urinary tract infection, and headache.

Patients should be selected for treatment based on an FDA-approved companion diagnostic for Lynparza. The Agency approved the use of Myriad’s myChoice CDx® diagnostic to identify advanced ovarian cancer patients with positive HDR status. The test was used to identify patients with HRD positive tumors post-randomization in the PAOLA-1 trial.

“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,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

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Lynparza, a poly (ADP-ribose) polymerase (PARP) inhibitor, is also approved for the first-line maintenance treatment of BRCA-mutated advanced ovarian cancer, for the maintenance treatment of recurrent ovarian cancer, for the treatment of advanced germline BRCA-mutated ovarian cancer after 3 or more lines of chemotherapy, for the treatment of germline BRCA-mutated HER2-negative metastatic breast cancer, and for the first-line maintenance treatment of germline BRCA-mutated metastatic pancreatic adenocarcinoma.

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