MUNICH—AstraZeneca and Merck’s Lynparza is the first in its ultracompetitive class of PARP inhibitors to post positive data in BRCA-mutated ovarian cancer patients who've just wrapped up an initial round of chemo. And it’s entering with a bang.
In a study presented Sunday at the European Society for Medical Oncology annual meeting, Lynparza reduced the risk of disease progression or death by a whopping 70%. Patients receiving placebo went a median 13.8 months without their cancer worsening, while in the Lynparza group, the median still hadn’t been reached at 41 months and counting.
Another way to put it? 60% of women receiving the drug in the trial, dubbed SOLO-1, had logged three years without a relapse, according to Dave Fredrickson, EVP and global head of AZ’s oncology business unit. “We’ve doubled the number of women who are progression-free at three years versus what until today was standard of care,” he said, adding that “these data will be practice-changing.”
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The results exceed what analysts were hoping for, based on the advantage Lynparza had posted in second-line ovarian cancer patients. Heading into the weekend, Credit Suisse’s Vamil Divan wrote to clients that he was looking for Lynparza to demonstrate “at least 23 months PFS benefit over placebo.”
The data, "are superlative, in our view, with a 70% risk reduction vastly exceeding both our expectations and the minimum for clinical relevance indicated by the majority of physicians in our recent MEDACorp survey," Leerink Partners Andrew Berens wrote to clients Sunday.
They also put AstraZeneca and Merck in line for a blockbuster sales opportunity. Evercore ISI analyst Steve Breazzano has pegged the value of the first-line ovarian cancer maintenance market at $1.4 billion—and predicted that figure would grow to $2.5 billion over time.
Of course, Lynparza will eventually have to face down its PARP nemeses in ovarian cancer, Clovis Oncology’s Rubraca and Tesaro’s Zejula, for those sales, analysts say. But first, the Merck-AZ team intend to capitalize on the head start.
“We will be ready for our commercial launch the day we hear from our various health authorities,” Fredrickson said, adding that Merck and AstraZeneca spent part of ESMO “getting ourselves prepared for what Day 1” of the rollout will look like.
And if the companies’ first joint Lynparza launch, which came in breast cancer, is any indication, they can expect big things, Fredrickson said.
“That launch has gone very well,” and it’s provided “our roadmap for how we’re approaching this with the SOLO-1 opportunity,” he said. “The account-by-account level coordination is excellent. The coordination among functions and teams—so today, we really see that the medical teams, diagnostic teams, marketing teams, sales teams, are all working well together between the companies and across regions, so I’m really quite pleased with how the partnership is progressing on the commercial front.”