AstraZeneca and MSD have announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Lynparza. The therapy – also known as olaparib – will be for use in the UK with both abiraterone and prednisone or prednisolone.

The combination therapy treats adult patients with metastatic castration-resistant prostate cancer (mCRPC) when chemotherapy is not clinically indicated.

The verdict from the MHRA followed results from the PROpel phase 3 trial, which showed that AstraZeneca and MSD’s olaparib in combination with abiraterone clearly improved radiographic progression-free survival in contrast to abiraterone alone as a first-line treatment for patients with mCRPC. This would be irrespective of their biomarker status.

Data also demonstrated that the combination therapy cut the risk of disease progression or death by 34% against abiraterone alone. At the time of the results cut-off point, analysis of overall survival (OS) was at 40% maturity. The study will continue to assess OS as a key secondary endpoint.

David Long, head of oncology at MSD UK, was optimistic about the results: “Prostate cancer is the most common cancer in men in the UK and advanced prostate cancer is associated with a significant mortality rate. This approval from the MHRA marks important progress in advancing a new treatment option to address the significant unmet need of patients with mCRPC.”

Professor Noel Clarke, professor of urological oncology at The Christie and Salford Royal Hospitals, concluded: “This data from the PROpel phase 3 trial underlines the therapeutic potential of new first-line treatment options for patients with mCRPC, especially given that many have a much-shortened lifespan when their disease becomes castrate resistant.”

Prostate cancer is a significant cause of disease and mortality among men and has become fifth most common cause of cancer death across the world. In the UK alone, more than 52,000 men are diagnosed with prostate cancer every year – accounting for more than 140 cases every day.

Immutep – a company that concentrates on developing novel LAG-3 immunotherapies for cancer and autoimmune diseases – has announced the initiation of its AIPAC-003 (Active Immunotherapy, Eftilagimod Alpha and PAClitaxel) study.

The research is an integrated phase 2/3 trial to evaluate eftilagimod alpha – also known as efti – in combination with paclitaxel for the treatment of metastatic HER2-neg/low breast cancer (MBC).

Regulatory approval has already been received in the US, while Institutional Review Board approval has been received in Spain. Meanwhile, approvals in several additional countries are expected to follow imminently. The first patient is due to be enrolled later this year.

Efti is regarded as well positioned to improve clinical outcomes from standard-of-care chemotherapy. Its stimulation of antigen-presenting cells, such as dendritic cells and monocytes, instigates a broad immune response that includes increases in cytotoxic CD8+ T cells, combined with chemo-induced tumour antigens to target cancer.

This interaction was shown by the AIPAC phase 2b trial’s encouraging safety and efficacy, including a better median overall survival (mOS) improvement, statistically significant mOS improvements across three prespecified subgroups and a statistically significant boost in cytotoxic CD8 T cells that correlated with improved OS.

Immutep chief executive officer, Marc Voigt, was encouraged by the results: “With its novel mechanism of action to activate antigen-presenting cells, efti has to date safely improved clinical outcomes from anti-PD-(L)1 therapies and standard-of-care chemotherapy.”

He added: “We look forward to AIPAC-003 building upon the encouraging synergy seen in our previous phase 2b trial in metastatic breast cancer, especially with its three key adaptations: same day administration of efti plus paclitaxel, this dual IO-chemotherapy treatment continuing until disease progression, and a new primary endpoint of overall survival.”

Depending on the phase 2 results, potential regulatory actions and resources, a randomised, double-blinded, placebo-controlled phase 3 element will follow in due course.