AstraZeneca’s core PARP inhibitor candidate Lynparza has produced impressive results in breast cancer, suggesting the drug could be filed in the near future.
Data from the phase 3 OLYMPIAD trial AZ showed an improvement in progression-free survival compared to either capecitabine, vinorelbine or eribulin chemotherapy in HER-2-negative, metastatic breast cancer patients with BRCA1 or BRCA2 mutations.
Lynparza inhibits the activity of a molecule called PARP – a protein responsible for the repair of single-strand DNA breaks. The drug’s action produces a ‘synthetic lethality‘ effect which takes advantage of a loss of DNA repair due to mutations in the BRCA gene.
By inhibiting single strand repair, the chances of a double-strand break – a powerful inducer of cell death – dramatically increase.
The OLYMPIAD trial assessed Lynparza (olaparib) as a twice-daily, 300mg tablet regimen compared to injections of chemotherapy at periodic cycles.
“These results are positive news for patients with BRCA-mutated metastatic breast cancer, a disease with a high unmet need, and are the first positive phase 3 data for a PARP inhibitor beyond ovarian cancer. This is highly encouraging for the development of our broad portfolio which aims to treat multiple cancers by targeting DNA damage response pathways,” said Sean Bohen, chief medical officer at AstraZeneca.
The news closes out a positive week for the company which saw it receive $130 million in milestone payments from Valeant Pharmaceuticals following FDA approval of its psoriasis drug Siliq (brodalumab) – a drug AZ licensed to Valeant in 2015.
Lynparza gained FDA approval in late 2014 for BRCA-mutated, advanced ovarian cancer that has received three or more prior lines of chemotherapy.
Its approval generated around $280 million in sales last year, and will go towards achieving AZ’s greater than $40 billion in annual revenue in 2023.