AstraZeneca's Lynparza scores limited NICE backing for new first-line maintenance use

With competitors racking up new indications and data wins, AstraZeneca’s Lynparza is looking to keep its lead in the PARP inhibitor field. England’s cost watchdog delivered a leg up Friday with a new recommendation—a couple of caveats notwithstanding.

The National Institute for Health and Care Excellence (NICE) recommended Lynparza’s use via the Cancer Drugs Fund (CDF), with a confidential discount for maintenance treatment of advanced BRCA mutation-positive ovarian cancer after chemotherapy. To win coverage, patients will need to apply for CDF approval.

Lynparza is already covered for routine National Health Service use after three lines of chemo and later, so the newest nod represents a major step for the patient population. However, NICE is still holding out on a routine recommendation because long-term patient survival data isn't available yet.

"It is not known whether people having (Lynparza) live longer, because people in the trial have not been followed up for long enough," the final appraisal read. "The currently available clinical trial evidence does not show a significant difference in overall survival between (Lynparza) and placebo."

The newest NICE recommendation is a positive—if qualified—boost in the drug’s quest for its first-ever blockbuster sales year, driving AstraZeneca’s strong oncology portfolio.

In the second quarter, Lynparza cleared $283 million, ranking third in the company's portfolio behind EGFR inhibitor Tagrisso’s $784 million and anti-PD-L1 newcomer Imfinzi’s $338 million. On the whole, AZ’s oncology franchise raked in $2.17 billion, up 51% from the previous quarter.

With an FDA approval to treat first-line BRCA-mutated ovarian cancer, Lynparza is capitalizing on its lead in the PARP field. But it's also looking at GlaxoSmithKline competitor Zejula, which recently put up positive results in treating first-line ovarian cancer patients in the maintenance setting, with or without the BRCA mutation.

Zejula only posted £57 million in the second quarter. But in this particular slice of the market, AstraZeneca is a bit behind—it's testing Lynparza in tandem with Roche’s Avastin in first-line ovarian cancer maintenance regardless of BRCA status, but those results aren't due till later this year.

In tandem with its ovarian cancer hopes, AstraZeneca is pushing Lynparza in BRCA-positive pancreatic cancer with phase 3 trial data showing promise in cutting patient progression risk as a maintenance treatment.

At the American Society of Clinical Oncology (ASCO) annual meeting in early June, AstraZeneca released new data showing Lynparza cut the risk of disease worsening or death by 47% in patients with germline BRCA-mutated pancreatic cancer that hadn’t progressed after an initial round of chemo.

Lynparza also stifled disease progression over placebo in patients at the one- and two-year marks, and patients went a median 7.4 months without their cancer advancing compared with just 3.8 months for placebo patients.