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Lynparza scores against pancreatic cancer

AZ and MSD drug success in BRCA-mutated disease

Lynparza

AstraZeneca and partner Merck & Co/MSD may be able to add pancreatic cancer to the list of cancers targeted by PARP inhibitor Lynparza, after a positive phase 3 readout.

The POLO trial showed that Lynparza (olaparib) achieved a clinically and statistically significant extension in progression-free survival (PFS) compared to placebo when given as a maintenance treatment to germline BRCA1/2-mutated metastatic pancreatic cancer whose disease had not progressed after first-line platinum chemotherapy.

The partners are only revealing top-line results for the moment, and will now approach regulators around the world with the data. PFS is the primary endpoint of the study.

Lynparza is already approved to treat ovarian, fallopian tube and primary peritoneal cancers, as well as for BRCA-mutated HER2-negative breast cancer, and is one of a clutch of new cancer drugs that has been spearheading AZ’s return to revenue growth in the last couple of quarters. Last year, sales of the drug more than doubled to $647m.

The FDA has already given Lynparza an orphan drug designation for the treatment of patients with BRCA-mutated pancreatic cancer, which AZ says is a “devastating disease with critical unmet need” and accounts for around 5%-7% of all pancreatic cancer cases.

It also is the first drug PARP inhibitor to show efficacy in this form of cancer, and while the indication is fairly small in terms of the number of eligible patients approval would help AZ and MSD keep ahead of newer rivals in the class such as Tesaro's Zejula (niraparib) and Clovis' Rubraca (rucaparib).

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AstraZeneca's José Baselga

José Baselga, AstraZeneca's newly-appointed head of oncology R&D said: “This is the first positive phase 3 trial of any PARP inhibitor in germline BRCA-mutated metastatic pancreatic cancer, a devastating disease with critical unmet need. The results of POLO provide further evidence of the clinical benefit of Lynparza across a variety of BRCA-mutated tumour types. We will discuss these results with global health authorities as soon as possible.”

“The clinically-meaningful results of this trial potentially support the value of testing for germline BRCA mutations in patients with metastatic pancreatic cancer,” commented MSD’s head of global clinical development Roy Baynes.

Pancreatic cancer has lagged behind the treatment advances that have improved prospects for other common diseases, and still has a very low survival rate with less than 7% of patients still alive five years after diagnosis.

AZ and MSD agreed a global collaboration to develop and commercialise Lynparza, as well as the MEK inhibitor selumetinib, for multiple cancer types in 2017.

Article by
Phil Taylor

26th February 2019

From: Marketing

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