AstraZeneca/Merck hope for expanded ovarian cancer drug use
AstraZeneca and partner Merck & Co are to apply for an expanded use for their ovarian cancer drug Lynparza, after phase 3 trial data supported its use in patients with early-stage disease.
Lynparza was the first poly (ADP-ribose) polymerase (PARP) class drug approved and is one of AstraZeneca’s fastest growing sales prospects.
In Q1 sales more than doubled compared with the same period last year – but the revenues of around $119m mean it’s still a niche drug compared with some of the multi-billion dollar blockbusters on the market.
Since its first approval back in 2014, rival PARP drugs from Tesaro and Clovis have also been approved.
The results from the SOLO-1 trial, which showed a statistically significant improvement in progression-free survival compared with placebo, mean the firms could add first line maintenance therapy in women with BRCA-mutated ovarian cancer to Lynparza’s label
SOLO-1 involved 391 patients with deleterious or suspected deleterious BRCA1 or BRCA2 mutation who were in complete clinical response following platinum-based chemotherapy.
Patients were randomly selected to receive either Lynparza 300mg tablets twice daily or placebo.
Primary endpoint was progression-free survival and key secondary endpoints included time to second disease progression or death and overall survival.
The companies gave no further details about the results, save that they were “clinically meaningful” and will file details with regulators as soon as possible to try and get the expanded use.
They will also announce full details at a forthcoming scientific conference.
Roy Baynes, head of global clinical development at Merck Research Laboratories, said: “We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with regulatory authorities to bring Lynparza to women with ovarian cancer in the 1st-line maintenance setting as quickly as possible.”
AZ is also testing Lynparza in combination with Roche’s Avastin (bevacizumab) as a first-line maintenance treatment in women with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status. Results are expected in 2019.
AZ originally developed Lynparza, and in July last year established a collaboration with Merck to develop the drug as a monotherapy and as a component in combination therapies.
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