AstraZeneca has presented late-stage data showing that patients taking its ovarian cancer therapy Lynparza not only benefitted from improved progression-free survival but also reported similar quality of life to those taking a placebo.
On three separate rating scales - functional, physical well-being and symptoms - women with germline BRCA-mutated, platinum-sensitive, relapsed serous ovarian cancer receiving Lynparza (olaparib) maintenance treatment reported similar QoL to those taking placebo, according to data presented at the 2017 ASCO Annual Meeting in Chicago.
Significant ‘patient-centred benefits’ of Lynparza vs placebo in quality-adjusted progression-free survival (QAPFS) and time without symptoms of disease or toxicity (TWiST) were observed up to 27 months after randomisation, AZ said.
The results showed: no appreciable detrimental effect on quality of life for patients receiving maintenance treatment with Lynparza versus patients on placebo, thereby meeting the QoL primary endpoint; mean quality-adjusted progression-free survival (QAPFS) of 13.96 vs 7.28 months, respectively; and significant improvement on time without symptoms of disease or toxicity (TWiST) with 13.5 vs 7.21 months, respectively.
The data add to previously reported results of the SOLO-2 trial, in which the group taking Lynparza showed median progression free survival of 19.1 months vs 5.5 months for the placebo arm.
“This is very good news for patients because it suggests that olaparib not only has the potential to significantly prolong the amount of time they have before their disease progresses, but that additional time does not come at the cost of their quality of life,” said Eric Pujade-Lauraine, head of the Women Cancers and Clinical Research Department at Hôpitaux Universitaires Paris Centre, site Hôtel-Dieu, AP-HP and principal investigator of SOLO-2.
“This may mean patients feel more able to adhere to maintenance treatment. This contrasts with what we have seen in the past with chemotherapy where the price of longer progression-free survival is often reduced quality of life leading to poor adheence to treatment.”
Ovarian cancer is a serious and life-threatening condition causing more than 4,000 deaths in the UK each year. Up to 21 percent with the most aggressive form of ovarian cancer have the genetic BRCA mutation.
Lynparza, a first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells, is already approved in the EU and US for the treatment of women with BRCAm ovarian cancer.
“The olaparib quality of life data further support the potential benefit of this first-in-class PARP inhibitor as maintenance therapy for women with BRCA-mutated relapsed serous ovarian cancer,” noted Sean Bohen, AZ’ chief medical officer. “They strengthen our confidence in targeting DNA damage response (DDR) mechanisms to selectively kill cancer cells while minimising damage to healthy tissue which may cause adverse effects that impact negatively on quality of life for patients.”