AstraZeneca’s oncology R&D team has successfully hit another landmark milestone.
The pharma giant along with its partners at Merck are drumming up new, blockbuster-sized market expectations for its PARP inhibitor Lynparza as a first-line maintenance treatment in ovarian cancer with a quick, top-level announcement of their late-stage success today.
In a Phase III trial dubbed SOLO-1, Lynparza “significantly” delayed disease progression in women with BRCA-mutated advanced ovarian cancer — the primary endpoint. There’s no word on the data just yet, which will be carefully studied as analysts assess market impact. Investigators generally hold on to the details for an upcoming conference — in this case quite possibly ESMO in October.
“For the first time, we see a significant and clinically-impactful improvement in progression-free survival in the 1st-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor,” said AstraZeneca CMO Sean Cohen. “The SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive Lynparza earlier.”
Lynparza was the first of three PARP inhibitors to make it to the market, setting the stage for a big alliance with Merck and staying well ahead of a small pack of rivals from Clovis and Tesaro. Pfizer will soon join that crowd, without distinguishing its PARP so far. Now AstraZeneca and Merck plan to push hard for regulatory approval to go after the added market here, which some analysts believe will likely add $1 billion-plus in new revenue.
That’s particularly crucial for AstraZeneca, which has been making significant advances in oncology, including recent successes for its PD-L1 inhibitor Imfinzi. These successes are key to CEO Pascal Soriot’s promise of a turnaround at AstraZeneca, and won’t go unnoticed.
Failure was not an option, according to Leerink, which several months ago noted:
AZN/MRK’s SOLO–1 (Lynparza) study in the 1L maintenance setting for BRCA-mutated ovarian cancer expected in 1H18 is a high expectations “must succeed” catalyst to validate the assumed expansion to 1L maintenance for the PARP class.
More data are to come, according to AstraZeneca and Merck, which paid $1.6 billion upfront last year to co-develop and co-commercialize the drug. They added that a separate Phase III study testing a combo of Lynparza and Avastin in women with newly-diagnosed advanced ovarian cancer regardless of their BRCA status is expected to produce results in 2019. That would potentially set up a case for Lynparza to be a first-line maintenance therapy after chemo, which is the standard companion with Avastin in this setting.
With contribution by John Carroll.
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