AstraZeneca and Merck & Co. are looking at a $1 billion opportunity for Lynparza, thanks to new data that support using it to fight advanced ovarian cancer in certain women who have just been diagnosed, rather than after chemotherapy.
The PARP inhibitor, now approved for two later lines of therapy, showed it can hold off cancer’s advance when used upfront to treat BRCA-mutated ovarian cancer. Details of the SOLO-1 study data aren’t yet available, but they’re positive enough to prompt talks with the FDA about a new approval, AstraZeneca said in a Wednesday statement.
With the results, Lynparza becomes the first PARP inhibitor to deliver a success in newly diagnosed women, adding to a string of firsts for the drug. It was first to market in its class, ahead of Tesaro’s Zejula and Clovis Oncology’s Rubraca, and in January, it was the first in the field to win a breast cancer green light.
AstraZeneca is counting on big things from Lynparza, which CEO Pascal Soriot famously rescued from the castoff bin when he took the reins of the company and has grown to $297 million in 2017 sales. It won its initial FDA approval in December 2014. Starting last July, it’s sharing Lynparza revenue with Merck under an $8.5 billion licensing and development deal that includes a variety of combos—including with Merck’s superstar immunotherapy Keytruda—in a range of cancers. More than $1.2 billion of that hit AZ’s top line last year.
Evercore ISI analyst Steve Breazzano said Wednesday that the first-line market is now worth $1.4 billion in the U.S., and is expected to grow to $2.5 billion with time. That’s the entire market, which the PARP drugs will first have to capture—and will eventually be split among the players, he figures, with market share open to question.
How much Lynparza can grab will depend on the SOLO-1 details, Credit Suisse analysts wrote in a Wednesday note. And the progression-free survival bar is high, the firm figures, with pharma watchers looking for Lynparza to beat its PFS advantage in second-line patients.
“We would hope Lynparza in the first line setting demonstrates at least 23 months PFS benefit over placebo,” the note said. “We believe that if Lynparza in first-line matches the benefit of Lynparza in second-line, the data will be sufficient to push the regimen into first-line for BRCA-mutated patients.”
The details are likely to be on tap at the European Society of Medical Oncology meeting this October, Credit Suisse said. The firm isn’t raising its sales estimates for the drug yet. “The importance of this data is that it solidifies Lynparza’s lead in the competitive PARP space,” the note said.
Because the SOLO-1 trial focused on women with BRCA mutations, an approval would require doctors to test their patients before therapy, a potential hurdle to uptake. But AZ and Merck have been pushing routine BRCA testing already—including for patients with breast cancer, where Lynparza was approved early this year—and the companies are hoping that diagnostic becomes routine.
“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,” AstraZeneca EVP and CMO Sean Bohen said in Wednesday’s statement.
That said, the partners have snagged one approval—ovarian cancer maintenance therapy after chemo—in women regardless of their BRCA status. Plus, they’re testing Lynparza as a first-line treatment in that broader, BRCA-agnostic group, in a combination trial alongside Roche’s Avastin. That phase 3 trial, PAOLA-1, is expected to read out next year.
Meanwhile, the pair is looking beyond breast and ovarian cancer to prostate cancer. With positive phase 2 data presented at ASCO earlier this month—showing success alongside Johnson & Johnson’s own blockbuster, Zytiga—they’re on their way to another first approval in the PARP class.
And it would be a big approval to boot. The data are “really quite promising,” Dave Fredrickson, AstraZeneca VP and global head of oncology, told FiercePharma at the meeting, noting that prostate cancer “is the No. 1 cancer in terms of incidence across the globe.”