Following the news on March 19, 2019 that Merck KGaA and Pfizer have discontinued the ongoing Phase III JAVELIN Ovarian PARP 100 study for previously untreated advanced ovarian cancer,
Paul Jeng, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view on Talzenna (talazoparib) in ovarian cancer:
“The combination of Bavencio and Talzenna has seen a steady erosion of its prospects in ovarian cancer since the JAVELIN Ovarian PARP 100 study was initiated less than a year ago. Merck & Co. and AstraZeneca’s Lynparza has widened its lead over other PARP inhibitors in ovarian cancer with an approval as first-line maintenance therapy, while Pfizer’s Talzenna remains the only drug in its class that has yet to authorized for this indication.
“Merck KGaA and Pfizer have the option to initiate another Phase III Talzenna combination study using Lynparza as a new comparator. However, it may be more advantageous for the developers to cut their losses and reorient to other indications. Bavencio has already faced clinical failures in advanced ovarian cancer, missing the mark in two late-stage trials in late 2018.
“Talzenna is currently approved for treatment of patients with BRCA-mutated, HER2-negative breast cancer, and experts believe it has the potential to be a best-in-class breast cancer drug on the basis of its potent, single-pill oral regimen. Pfizer’s best chances for success will be to continue development of Talzenna in patients with breast cancer or gain a foothold in metastatic castration-resistant prostate cancer, where it is currently being assessed in combination with enzalutamide.”