AstraZeneca has reported detailed findings from the Phase III POLO clinical trial that assessed Lynparza (olaparib) tablets as first-line maintenance monotherapy for metastatic adenocarcinoma of the pancreas.
The trial recruited 154 germline BRCA-mutated (gBRCAm) patients that saw no disease progression after receiving standard-of-care platinum-based first-line chemotherapy.
Lynparza is a poly adenosine diphosphate ribose polymerase (PARP) inhibitor being jointly developed and commercialised by AstraZeneca and MSD, which is known as Merck in the US and Canada.
According to findings from the POLO trial, the drug demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), compared to placebo.
A median improvement of 7.4 months in time without disease progression was observed in the study drug arm versus 3.8 months with placebo.
In addition, 34% and 22% of patients treated with Lynparza showed no disease progression at one and two years, respectively, compared to 15% and 10% in the placebo arm.
AstraZeneca oncology research and development (R&D) executive vice-president José Baselga said: “These unprecedented results raise new hope for patients that have seen little progress over a long period of time.
“From as early as six months after initiation, more than twice as many patients taking Lynparza lived without progression of their disease compared to those on placebo and we are now working with regulatory authorities to bring Lynparza to patients as quickly as possible.”
The drug’s safety and tolerability profile during the Phase III trial was found to be consistent with that observed in previous clinical trials.
According to the data, the most common adverse events (AE) were fatigue, asthenia, nausea, abdominal pain, diarrhoea, anaemia, decreased appetite and constipation.
MSD Research Laboratories chief medical officer Roy Baynes said: “We are encouraged by the results of the POLO trial, which showed a considerable reduction in risk of disease progression or death with Lynparza for germline BRCA-mutated metastatic pancreatic cancer patients who did not progress on chemotherapy.
“Currently, less than 3% of metastatic pancreatic cancer patients survive more than five years after diagnosis.”
Lynparza holds approval for various indications across advanced ovarian and metastatic breast cancers.