AZ/Merck & Co's ovarian cancer drug gets wider US licence

AstraZeneca and Merck & Co have hit back at their rival GlaxoSmithKline after the FDA allowed Lynparza to be used in a wider group of ovarian cancer patients when combined with Roche’s Avastin. 

The FDA granted a licence extension covering use of Lynparza (olaparib) and Avastin (bevacizumab) in combination for the maintenance treatment of certain 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. 

Adding Avastin to the combination widens the patient group from just patients whose cancers have BRCA mutations, to include similar homologous recombination deficiency (HRD) mutations that lead to genomic instability. 

Around half of women with the disease will be eligible and can be identified with an FDA-approved test. 

Following this approval for Lynparza in the US, AstraZeneca will receive $100 million from Merck & Co, known as MSD outside the US, anticipated to be booked during the second quarter of 2020. 

Late last month, GlaxoSmithKline’s rival poly (ADP-ribose) polymerase (PARP) class drug Zejula (niraparib) was approved in the same first-line maintenance indication, but regardless of their biomarker status.

The new approval allows AZ to gain back some ground over its rival from GSK, which will still have the upper hand in this highly competitive slice of the market thanks to its wider label that does not mandate a genetic test.

Approval for the Lynparza and Avastin combination was based on PAOLA-1, a double-blind phase 3 trial testing the efficacy and safety of Lynparza in combination with Avastin compared with Avastin alone, in this patient group.

AstraZeneca and MSD announced in August 2019 that the trial met its primary endpoint of progression-free survival. 

In a separate development, AZ and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation in the US 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. 

Enhertu is an antibody-drug conjugate that was quickly approved following Breakthrough Designation in HER2-positive breast cancer at the end of last year. 

AstraZeneca has also completed a previously communicated agreement to recover the global rights to brazikumab (formerly MEDI2070), a monoclonal antibody targeting IL23, from Allergan.  

AstraZeneca and Allergan have terminated their previous licence agreement and all rights to brazikumab have returned to AstraZeneca. 

Allergan had to sell off brazikumab to satisfy competition regulators before its $63 billion merger with AbbVie, which went ahead last week.