Up to 20% of prostate cancer cases are classified as castration-resistant
AstraZeneca (AZ) and Merck & Co – known as MSD outside the US and Canada – have announced that the Scottish Medicines Consortium (SMC) has approved Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC).
Affecting around one in ten men in Scotland, approximately 10% to 20% of prostate cancer cases are classified as castration resistant, evolving to resist androgen deprivation therapy, the standard of care.
mCRPC occurs when the cancer has spread to other parts of the body, which is challenging to treat and results in a poor prognosis.
The SMC’s decision was based on results from the phase 3 randomised, double-blind PROpel trial, which evaluated the efficacy, safety and tolerability of Lynparza versus placebo when given in addition to abiraterone in men with mCRPC who had not received prior chemotherapy or new hormonal agents (NHA).
Lynparza is a first-in-class PARP inhibitor that works by inhibiting PARP proteins to disrupt the DNA repair process in cells and tumours harbouring a homologous recombination repair deficiency, including BRCA1 and/or VRCA2, or NHAs.
The study demonstrated that the Lynparza combination therapy significantly reduced the risk of disease progression in comparison to placebo and abiraterone.
In addition, the combination therapy showed a 34% reduction in the risk of disease progression or death.
Tom Keith-Roach, president, AZ UK, said: “Extending access for Lynparza… to eligible patients in Scotland adds a much-needed new treatment option in an area with continued high unmet clinical need.”
David Long, head of oncology at Merck & Co UK, said: “We are delighted that patients with advanced prostate cancer can now access Lynparza without the need for a biomarker test, and we look forward to working with Scottish clinicians to offer this medicine to every eligible patient as fast as possible.”
In 2017, AZ and Merck & Co entered into a strategic global oncology collaboration to co-develop and co-commercialise Lynparza and Kselugo (selumetinib), a mitogen activated protein kinase inhibitor for multiple types of cancer.