AstraZeneca and its partner Merck have published positive results from SOLO-3 phase III trial of Lynparza, which is indicated for BRCA-mutated (BRCAm) advanced ovarian cancer.

This was the fourth phase III trial into the drug and is part of AstraZeneca and Merck’s post- approval commitment to the US Food and Drug Administration (FDA); the regulator granted Lynparza priority review in November this year.

In the SOLO-3 trial, Lynparza demonstrated statistically significant and clinically meaningful improvement in objective response rate and progression free survival after two or more lines of chemotherapy compared to chemotherapy alone.

The safety and tolerability profile was the same previous trials.

AstraZeneca executive vice-president of global medicines development and chief medical officer Sean Bohen said: “We are very excited about SOLO-3, which is the first Phase III trial for a PARP inhibitor to demonstrate a positive result versus chemotherapy in advanced ovarian cancer where effective options are needed.”

Merck’s chief medical officer, senior vice-president and head of global clinical development Roy Barnes said: “Following on the US approval of Lynparza as first-line maintenance therapy for certain patients with BRCAm advanced ovarian cancer, the results of SOLO-3 further reinforce the efficacy of Lynparza in relapsed patients with BRCAm advanced ovarian cancer following multiple lines of chemotherapy.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

AstraZeneca also announced positive results from two phase III trials of anaemia drug roxadustat indicated for patients with chronic kidney disease (CKD), which was recently approved in China.

Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) AstraZeneca has commercialised in collaboration with FibroGen.

The phase III Olympus trial evaluated the efficacy and safety of roxadustat compared to placebo in 2,781 patients in 26 countries with stage three, four or five CKD with moderate to severe disease progression.

The anaemia drug showed statistically significant and clinically meaningful improvement in mean change from baseline in haemoglobin (Hb) levels between weeks 28 and 52.

In the second ROCKIES trial, which compared roxadustat to epoetin alfa in 2,133 patients with dialysis dependent CKD, there was also a statistically-significant improvement in mean change from baseline in Hb levels over weeks 28 to 52.

These results will be combined with those from a phase III ALPS trial completed in September to formulate safety analysis for regulatory submission.

Bohen said: “This is a significant milestone in the role roxadustat can play to help address a high unmet need in anaemia associated with chronic kidney disease, which today is under diagnosed and in many cases under treated.”