Lynparza performance in 1Q18
On July 27, Merck (MRK) and AstraZeneca (AZN) announced a strategic global collaboration for co-developing and co-commercializing the latter’s poly ADP ribose polymerase (or PARP) inhibitor, Lynparza. In 1Q18, Merck reported $33 million as its share of the Lynparza alliance revenues, of which $24 million were earned in US markets, while the remaining $9.0 million were reported from international markets. Lynparza is currently the leading PARP inhibitor in terms of new and total prescriptions for its approved label in ovarian cancer and breast cancer indications.
The above diagram shows the timeline of major data readouts from the Lynparza research program since 2016.
Lynparza in breast cancer indication
On January 12, the drug secured approval from the US Food and Drug Administration (or FDA) as a treatment option for patients suffering from human epidermal growth factor receptor 2 negative, metastatic breast cancer. These patients need to have been previously treated with chemotherapy in metastatic, adjuvant, or neoadjuvant settings. Patients who suffer from hormone receptor positive (or HR+) breast cancer must be ineligible for or have previously been treated with endocrine therapy.
This approval was based on positive results from the phase 3 OlympiAD trial, which compared Lynparza with chemotherapy agents such as capecitabine, eribulin, or vinorelbine in the germline BRCA-mutated HER2-negative metastatic breast cancer indication. Lynparza demonstrated statistically significant improvement in progression-free survival as compared to chemotherapy in these patients. To know more about Lynparza in breast cancer indications, read AstraZeneca Is Focused on Lynparza’s Label Expansion in 2017.
Lynparza, however, failed to demonstrate statistically significant improvement in overall survival as compared to chemotherapy in the OLYMPIAD trial.