When combined with frequently used cancer drug Avastin, Lynparza was shown to slow the progression of advanced ovarian cancer.
The patient group that had been examined in the PAOLA-1 trial had previously been successfully given chemotherapy and Avastin as an initial treatment following diagnosis.
Normally, they would then receive Avastin as a maintenance therapy to reinforce the earlier treatments, but AstraZeneca wanted to show the advantage of adding Lynparza in the maintenance setting.
The results follow on from a similar phase III study last year, and AstraZeneca said it would be discussing the latest outcome with regulators around the world “as soon as possible”.
“The positive results from the PAOLA-1 trial demonstrate a clear potential benefit of adding Lynparza to the standard-treatment bevacizumab for women with advanced ovarian cancer,” said José Baselga, Executive Vice President, Oncology R&D.
“Following positive results from the SOLO-1 trial for women with a BRCA gene mutation, the PAOLA-1 trial marks yet another positive phase III trial for Lynparza as a 1st-line maintenance treatment for women with advanced ovarian cancer.”
Battling with GSK
Lynparza, which had been dumped by AstraZeneca at one stage before being revived by current chief executive Pascal Soriot, is part of a class of treatments called PARP inhibitors.
PARP – or poly-ADP ribose polymerase – is a protein which helps damaged cells to recover. Taking a PARP inhibitor stops it from repairing cancer cells which then eventually die.
Calquence secures Breakthrough Therapy Designation
In a separate statement, Astra confirmed its Calquence leukaemia drug has been granted a Breakthrough Therapy Designation by US regulators.
The move from the US Food and Drug Administration effectively fast-tracks the regulatory review of the medicine, which has been shown to increase the time patients lived without progression or death.
“This is an important regulatory milestone for our work in haematology and for patients living with chronic lymphocytic leukaemia, a life-threatening disease,” added Baselga.
“The Breakthrough Therapy Designation acknowledges the growing body of evidence that supports Calquence as a highly-selective Bruton tyrosine kinase inhibitor with the potential to offer patients a new, differentiated, chemotherapy-free treatment option with a favourable safety profile.”