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23 January, 2020 - 21:53 By Kate Sweeney

AstraZeneca hails US cancer drugs progress

Cambridge anchored Big Biotech AstraZeneca has enjoyed fresh success as it progresses cancer treatments, notably in the US.

AstraZeneca’s Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, have both been granted Orphan Drug Designation (ODD) in the US for the treatment of hepatocellular carcinoma (HCC), the most common type of liver cancer.

The US Food and Drug Administration (FDA) grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

Liver cancer is the third leading cause of cancer death worldwide and for patients with unresectable or advanced disease, only 13 per cent are alive five years after diagnosis.

José Baselga, Executive VP, Oncology R & D at AZ, said: “Many patients with liver cancer are diagnosed and treated only after the disease is advanced, and there is an urgent need for new effective and tolerable treatments.We are eager to bring new potential options to these patients and look forward to the results of our ongoing Phase III HIMALAYA trial later this year.”

The Phase III HIMALAYA trial is testing Imfinzi and the combination of Imfinzi plus tremelimumab in patients with unresectable, advanced HCC who have not been treated with prior systemic therapy and are not eligible for locoregional therapy (treatment localised to the liver). 

HIMALAYA is the first trial to test dual immune checkpoint blockade in the 1st-line advanced HCC setting. HCC represents about 80 per cent of all primary liver cancers. Approximately 700,000 people were diagnosed with HCC around the world in 2018, and an estimated 42,000 people were diagnosed in the US last year. Between 80-90 per cent of all patients with HCC also have chronic liver disease, which is primarily caused by infection with the hepatitis B or C viruses.

Chronic liver disease is associated with inflammation that, over time, results in immunosuppression and can lead to the development of HCC.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer and other solid tumours.

Immuno-oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. AstrZeneca’s IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. 

AstraZeneca believes that IO-based therapies offer the potential for life-changing cancer treatments for the clear majority of patients. AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the company’s future. 

With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

In a prior development, AstraZeneca and Merck revealed that a supplemental New Drug Application for Lynparza (olaparib) had also been accepted and granted priority review in the US for patients with metastatic castration-resistant prostate cancer (mCRPC) and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, that have progressed following prior treatment with a new hormonal agent.

A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020.

The Priority Review by the FDA is based on results from the Phase III PROfound trial, which were presented during the Presidential Symposium at the 2019 European Society of Medical Oncology congress. Results of the PROfound trial showed Lynparza significantly reduced the risk of disease progression or death by 66 per cent.

Lynparza is currently approved in 65 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status. 

It is approved in the US, the EU, Japan, China and several other countries as first-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in 44 countries, including the US and Japan, for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer. 

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