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AZ, Merck’s Lynparza scores market-expanding clinical success

Positive phase 3 findings in ovarian cancer

Lynparza

Adding AstraZeneca and Merck’s Lynparza (olaparib) to Roche’s Avastin (bevacizumab) has improved outcomes in advanced ovarian cancer patients in a phase 3 trial.

Thephase 3Paola-1trial randomised women to receive Avastin with or without PARP inhibitor Lynparza in a first-line maintenance setting. PARP inhibitors came to market on the strength of data showing they destroy BRCA-mutated tumours through synthetic lethality,but the phase3trial enrolled women regardless of their genetic status.

Top-line findings from the trial suggest that the gamble has paid off. The addition of Lynparza to Avastin, the standard of care in first-line ovarian cancer, was associated with a statistically significant increase in progression-free survival, the primary endpoint of the trial.

AstraZeneca and Merck, which began co-developing Lynparza in 2017 through a deal worth $1.6bn upfront, are yet to share the data from the trial that will reveal a fuller picture of the efficacy of the combination, both in the overall population and specific subpopulations of patients.

The limited information that is available paints the trial as another win for Lynparza, which is already FDA approved for first-line maintenance use in ovarian cancer patients with germline or somatic BRCA mutations.

That approval and clearances in other indications have turned Lynparza into a significant product for AstraZeneca and Merck. AstraZeneca recorded Lynparza sales of $283m in its most recent results.

Approval in ovarian cancer patients regardless of BRCA status would significantly expand the market opportunity for Lynparza. Around 15% of ovarian cancer patients have germline BRCA mutations.

Many of the remaining 85% of patients start treatment on Avastin. AstraZeneca thinks Roche’s drug is used as a first-line treatment in around 50% of US patients and 60% of people in Europe, giving it and Merck a chance to piggyback on an existing care pathway to grow sales of Lynparza.

David fred

David Fredrickson, president of AstraZeneca’s oncology business

“If the data that comesout of Paola suggests that there’s a benefit of adding Lynparza onto an Avastin backbone in the maintenance setting, that risk-benefit is one that we will have every opportunity to bring to physicians. There’s enough behaviourand comfort with Avastin that exists across the globe that I don’t see that as a difficult barrier to adoption,” said David Fredrickson, president of AstraZeneca’s oncology business, on a conference call with investors last month.

However, AstraZeneca is likely to face competition. Last month, phase 3data linked Zejula, the PARP inhibitor GlaxoSmithKline acquired in its $5.1bn takeover of Tesaro, to improved progression-free survival in first-line ovarian cancer patients, regardless of their biomarker status.

Article by
Nick Taylor

15th August 2019

From: Research

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