AstraZeneca gets new approvals in Japan on three drugs

AstraZeneca announced on Wednesday that its immunotherapies ‘Imfinzi’, or durvalumab, and ‘Imjudo’, or tremelimumab, have been approved in Japan for the treatment of three cancer types - advanced liver, biliary tract and lung.

It also said ‘Calquence’, or acalabrutinib, a selective Bruton's tyrosine kinase (BTK) inhibitor, had been approved in Japan for the treatment of adult patients with treatment-naïve chronic lymphocytic leukaemia.

The FTSE 100 pharmaceuticals giant said the approvals of Imfinzi and Imjudo authorise the combination for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), and for the treatment of adult patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC), in combination with chemotherapy.

Imfinzi was also authorised for the treatment of adult patients with unresectable HCC as monotherapy and for the treatment of adult patients with curatively unresectable biliary tract cancer (BTC) in combination with chemotherapy - gemcitabine plus cisplatin.

The company said the concurrent approvals by the Japanese Ministry of Health, Labour, and Welfare were based on positive results from the ‘HIMALAYA’ and ‘TOPAZ-1’ phase 3 trials, each published in the New England Journal of Medicine Evidence, and the ‘POSEIDON’ phase 3 trial, published in the Journal of Clinical Oncology.

“Japan has one of the highest rates of diagnosis for liver and biliary tract cancers in the world, and lung cancer remains the country's leading cause of cancer death,” said Dave Fredrickson, executive vice-president of the company’s oncology business unit.

“With these approvals for Imfinzi and Imjudo, patients in Japan can now be treated with novel immunotherapy-based treatment regimens that have demonstrated significant survival benefits across three complex cancers with poor prognoses.”

Calquence, meanwhile, was previously approved in Japan for the treatment of adults with relapsed or refractory CLL.

The company said the new approval from the Japanese Ministry of Health, Labour and Welfare was based on positive results from two clinical trials, including the ‘ELEVATE-TN’ phase 3 trial in adults with treatment-naive CLL.

That trial showed that Calquence combined with obinutuzumab or as monotherapy demonstrated a “significantly improved” progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab.

Data from the interim analysis of ELEVATE-TN was published in the Lancet in 2020.

Additionally, a phase 1 trial in treatment-naive Japanese patients with CLL was also submitted to the ministry supporting the approval, with the trial showing an overall response rate of 88.9% for Calquence alone and 100% for Calquence combined with obinutuzumab.

CLL is the most prevalent type of adult leukaemia globally, but is considered a rare disease in Japan and East Asia, with fewer than one person newly diagnosed per 100,000 people each year across Japan.

“The approval of Calquence in Japan for those with treatment-naïve chronic lymphocytic leukaemia now offers more patients a next-generation Bruton's tyrosine kinase inhibitor that has proven longer-term efficacy and tolerability compared to standards of care,” Dave Fredrickson added.

“With this approval, people living with chronic lymphocytic leukaemia in Japan can now potentially benefit from our medicine in an earlier setting.”

Reporting by Josh White for Sharecast.com.