BARCELONA—Right now, Roche’s Avastin is the go-to therapy for keeping ovarian cancer from progressing in patients without a BRCA mutation who have received an initial round of chemo. But with their latest combo data, AstraZeneca and Merck are hoping to get Lynparza in on that market.
Saturday at the European Society for Medical Oncology annual meeting, the partners trumpeted data showing that adding Lynparza to Avastin cut the risk of disease progression or death by 41% among patients, regardless of whether they had a BRCA mutation. Lynparza patients went a median 22.1 months without seeing their disease worsen, versus 16.6 months for the group receiving Avastin plus placebo.
What “every woman wants to know is, ‘how long will I benefit from this therapy?’ To be able to say at the median, it was nearly two years, that is a milestone we haven’t been able to achieve before,” Dave Fredrickson, executive vice president and global head of AstraZeneca’s oncology business unit, said.
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As AZ execs said alongside their top-line data announcement in August, the company is racing to get the data in front of global regulators in hopes of snagging an approval. If it can, it’ll be the second for Lynparza in the first-line ovarian cancer maintenance setting, where it’s also approved solo for women with BRCA mutations. That’s an OK it picked up from U.S. regulators in December, and analysts at the time labeled the go-ahead a blockbuster new indication.
Indeed, that new indication helped Lynparza’s sales hit $520 million in the first half of 2019, an increase of 93% over the same period last year.
But Lynparza isn’t the only drug gunning for a first-line maintenance nod that goes beyond the BRCA group. Saturday at ESMO, GlaxoSmithKline unveiled positive results for its Zejula in the same setting, showing the drug cut patients' risk of disease worsening or death by 38%—only unlike Lynparza, which was paired with Avastin, Zejula produced the benefit on its own.
RELATED: ESMO: Glaxo's Zejula fends off ovarian cancer after first-line chemo, BRCA-positive or not
With both options ostensibly headed toward regulatory approvals, it’ll be up to doctors to look across trials and make their choice. But as Fredrickson pointed out, the addition of Avastin didn’t stop investigators from considering the Lynparza duo “to be well-tolerated.”
“I think one of the things that we’ve learned in oncology is that typically we get the best outcomes by finding drugs that we can combine together—drugs that have additive efficacy with non-overlapping toxicity,” he said, adding that having side effects that don’t overlap is “the thing that’s the most key.”
“Certainly there’s a different side effect profile than having Lynparza by itself, but we think the benefit-risk on this is clear” for the combo.