AstraZeneca and Merck & Co/MSD have caused a stir at the ASCO congress in Chicago with new data for their PARP inhibitor Lynparza in pancreatic cancer – a disease which is notoriously tough to treat.
The phase 3 POLO trial of Lynparza (olaparib) in advanced pancreatic cancer patients whose tumours carry BRCA mutations found that those on AZ’s drug had a progression-free survival of 7.4 months, almost twice the 3.8 months for a placebo group.
About 5% to 6% of pancreatic cancers are caused by mutations in one or both BRCA genes, which are more commonly associated with ovarian and breast cancer but are observed in a range of tumour types.
José Baselga
AZ’s head of oncology R&D José Baselga said the company will submit the results to regulators “as quickly as possible”, potentially opening up a third indication for its fast-growing cancer drug along with ovarian and breast cancer.
Lynparza 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.
In the trial, Lynparza or placebo was given to patients with cancer that had not progressed after completion of initial platinum-based chemotherapy and – after two years – 22.1% of those on the PARP inhibitor had no disease progression, compared to 9.6% of those treated with placebo.
Overall survival data aren’t available yet, but the results bode well for a positive readout on that important measure, particularly as the median survival of metastatic pancreatic cancer is currently below one year and less than 3% of metastatic pancreatic cancer patients survive more than five years after diagnosis.
“These unprecedented results raise new hope for patients that have seen little progress over a long period of time,” added Baselga.
POLO is the first phase 3 trial to support a biomarker-driven approach to pancreatic cancer, according to POLO lead investigator Hedy Kindler of University of Chicago Medicine, who presented the results at ASCO.
“For patients with BRCA-driven metastatic pancreatic cancer, we may be seeing a change in patients’ disease trajectory,” said Kindler, who suggested at a press conference that Lynparza could become a new standard-of-care in these patients.
Earlier this year, ASCO issued guidance recommending that people with pancreatic cancer undergo risk assessment for hereditary syndromes that increase pancreatic cancer risk, including testing for BRCA mutations.
While BRCA-mutated pancreatic cancer 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).