AstraZeneca and MSD are closer to moving Lynparza into first line maintenance treatment of ovarian cancer after producing positive phase III data.
The SOLO-1 trial evaluated the drug as a first-line maintenance therapy in women with BRCA-mutated advanced ovarian cancer compared to placebo.
Topline results showed that Lynparza significantly delayed disease progression in this particular patient population, meeting the primary endpoint of progression-free survival (PFS). The companies say they will now begin discussions with regulators about filing for frontline use, helping Lynparza extend its lead over its PARP inhibitor rivals, Tesaro’s Zejula and Clovis’ recently EU-approved Rubraca.
Lynparza also recently won a maintenance approval for a new tablet formulation, receiving approvals of this in both Europe and the US.
Sean Bohen, executive vice president, global medicines development and chief medical officer, AstraZeneca, said: “For the first time, we see a significant and clinically-impactful improvement in progression-free survival in the first-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor.”
Lynparza is currently paving the way in this setting, and with the added boost of MSD’s marketing power, it can be safely said that competitors have a lot of catching up to do.
Roy Baynes, senior vice president and head of global clinical development, chief medical officer, MSD Research Laboratories (pictured) said: “Building on the strong data we’ve seen with Lynparza to date, the data from SOLO-1 reinforces Lynparza’s ability to provide meaningful disease control with a well-characterised safety and tolerability profile.
We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with regulatory authorities to bring Lynparza to women with ovarian cancer in the 1st-line maintenance setting as quickly as possible.”
AZ and MSD are expecting results of Lynparza in combination with bevacizumab as a first-line maintenance treatment in women with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status in 2019.
Tesaro is also expecting phase III results in the same setting for its PARP inhibitor Zejula (niraparib), but that data won’t be available until next year.