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FDA starts speedy review of Lynparza plus Avastin in ovarian cancer

AZ/Merck look set to consolidate dominance in this indication

Lynparza bottle

AstraZeneca and Merck & Co/MSD’s PARP inhibitor looks set to consolidate its grip on the ovarian cancer market, after being granted a priority review by the FDA for a combination regimen for first-line maintenance therapy.

The US regulator is expected to deliver a verdict on the new indication – which combines Lynparza (olaparib) with Roche’s cancer antibody Avastin (bevacizumab) – in the second quarter of this year.

The new regimen is based on the results of the PAOLA-1 study, which involved advanced ovarian cancer patients who have responded to first-line treatment with platinum-based chemotherapy and Avastin.

The results showed there was a 41% lower risk of their disease progressing or death for Lynparza plus Avastin maintenance therapy compared to Avastin alone. Progression-free survival (PFS) was extended to 22.1 months from 16.6 months with the addition of AZ and Merck’s drug.

Two years after the trial started, 46% of patients treated with Lynparza added to Avastin showed no disease progression, compared to 28% of patients treated with Avastin alone.

Crucially, the benefits of the PARP inhibitor were apparent regardless of BRCA biomarker status of the patient or the outcome of surgery to remove the tumour, suggesting that Lynparza could be added to treatment on an ‘all-comer’ basis for eligible patients.

Lynparza has been the dominant drug in the PARP inhibitor category since AZ and Merck began co-developing the drug in 2017 in a deal worth $1.6bn upfront, and is on course to become a blockbuster product with sales of $847m in the first nine months of 2019.

It is already approved as a monotherapy for first-line maintenance of BRCA-mutated ovarian cancer based on the results of the SOLO-1 trial, as well as for later lines of ovarian cancer therapy and BRCA-mutated breast and pancreatic cancer.

If the FDA backs the new indication it will help AZ and Merck to maintain their lead over newer rivals in the PARP inhibitor class, including GlaxoSmithKline’s Zejula (niraparib), Clovis Oncology’s Rubraca (rucaparib) and Pfizer’s Talzenna (talazoparib).

Epanova trial disappoints

There was disappointing news as well for AZ at the start of this week however, after it announced it had decided to abandon the STRENGTH trial of Epanova – its formulation of fish oil-derived omega-3 carboxylic acids – in mixed dyslipidaemia because it was unlikely to show a clinical benefit on cardiovascular outcomes.

Epanova was acquired by AZ in its $443m takeover of Omthera in 2013, and was approved in 2014 as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia.

The STRENGTH trial was viewed as being critical to expanding the market for the drug, whose sales hasn’t taken off as AZ had hoped since approval.

Article by
Phil Taylor

13th January 2020

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