A trio of approvals by health chiefs in Japan has boosted AstraZeneca’s strategy to deliver new drugs to treat types of breast and lung cancer and also autoimmune neurodegenerative disease.
The Cambridge-born drug Lynparza (olaparib), being commercialised globally by AstraZeneca and MSD, has been approved in Japan for the adjuvant treatment of patients with BRCA-mutated (BRCAm), HER2-negative early breast cancer at high risk of recurrence.
Backing from the Japanese Ministry of Health, Labour, and Welfare was based on results from the OlympiA Phase III trial published in The New England Journal of Medicine in June 2021.
In the trial, Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42 per cent versus placebo.
Lynparza also demonstrated a statistically significant and clinically meaningful improvement in overall survival, reducing the risk of death by 32 per cent.
Breast cancer is the most diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed in 2020. In Japan, an estimated 95,000 people will be diagnosed with breast cancer in 2022 and over 15,000 will die from the disease. Out of the approximately 80 per cent of patients with HER2-negative breast cancer, some 11 per cent have BRCA mutations.
Dave Fredrickson, Executive VP, Oncology Business Unit, AstraZeneca, said: “The approval marks a significant leap forward for breast cancer patients in Japan where it is the most commonly diagnosed cancer among women.
“Patients with BRCA mutations have high rates of disease recurrence and lower survival, and Lynparza has been shown to significantly reduce both the risk of recurrence and death. We hope this approval sets a new, much-needed standard of care for these early breast cancer patients in Japan.”
In a second success, AstraZeneca reveals that Tagrisso (osimertinib) has been approved in Japan for the adjuvant treatment of patients with epidermal growth factor receptor-mutated non-small cell lung cancer (NSCLC) after surgery. This follows positive results from the global ADAURA Phase III trial.
While up to 30 per cent of all patients with NSCLC may be diagnosed early enough to have surgery with curative intent, recurrence is still common in early-stage disease.
Historically, over half of patients diagnosed in Stage II and around three-quarters of patients diagnosed in Stage III have experienced recurrence within five years of resection.
In Japan, lung cancer is the leading cause of cancer death and among patients with NSCLC, more than 35 per cent have tumours with an EGFR mutation.
Fredrickson said: “Patients diagnosed with lung cancer in Japan are more likely than patients anywhere else in the world to be alive five years after their diagnosis. Yet lung cancer remains the country's leading cause of cancer death.
“With this approval of Tagrisso, early-stage lung cancer patients in Japan now have a targeted treatment option available after surgery that can dramatically change the course of their disease, potentially helping them live cancer-free even longer.”
The trial enrolled in more than 200 centres across more than 20 countries, including the US, in Europe, South America, Asia and the Middle East.
Success No.3 came with the approval of Ultomiris in Japan for the treatment of adults with generalised myasthenia gravis who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy or plasmaphaeresis.
The CHAMPION-MG Phase III trial showed that Ultomiris was superior to placebo.
gMG is a rare, debilitating, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness. The diagnosed prevalence of gMG in Japan is estimated at approximately 22,000.
Ultomiris was approved in the US for adults with anti-AChR antibody-positive gMG in April and regulatory reviews are ongoing in additional countries. It was recently recommended for marketing authorisation in the European Union as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-AChR antibody-positive.