US nod for Lynparza in HRD-positive advanced ovarian cancer

AstraZeneca and MSD's Lynparza (olaparib) has been cleared in the US for use as a first-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer.

The decision allows physicians to prescribe the drug for the maintenance treatment of adults 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.

Clearance was based on a biomarker subgroup analysis of the Phase III PAOLA-1 trial, which showed that Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67%.

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, the firms said.

“Ovarian cancer is a devastating disease. The magnitude of benefit in HRD-positive patients in the PAOLA-1 trial is impactful. The combination of Lynparza and bevacizumab now provides women with HRD-positive advanced ovarian cancer with a new standard of care and I look forward to seeing this translate into clinical practice,” noted Isabelle Ray-Coquard, principal investigator of the PAOLA-1 trial and medical oncologist, Centre Léon Bérard and President of the GINECO group.

Regulatory reviews are currently underway in the EU, Japan and other countries for Lynparza based on results from the PAOLA-1 trial.

Second US breakthrough status for Enhertu

Meanwhile, AZ also announced the second US breakthrough therapy designation for Enhertu (trastuzumab deruxtecan), for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.

“Current therapy options are limited for patients with HER2-positive metastatic gastric cancer and for those who relapse, there are no approved HER2-targeted medicines. We look forward to working with the FDA to further explore the potential of Enhertu to become an important new treatment and the first antibody drug conjugate for this devastating disease,” said José Baselga, executive vice president, R&D Oncology.

AZ and Daiichi Sankyo are jointly developing and commercialising Enhertu worldwide, except in Japan where the latter maintains exclusive rights.

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