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AZ’s Tagrisso approved for EGFR-positive NSCLC in the EU

European Commission approved Tagrisso in this setting based on positive results from the ADAURA phase 3 study

AstraZeneca’s (AZ) third-generation EGFR tyrosine kinase inhibitor (TKI) Tagrisso has been approved to treat early-stage EGFR mutated non-small cell lung cancer (NSCLC) in the EU.

The European Commission has approved Tagrisso (osimertinib) in this setting based on positive results from the ADAURA phase 3 study.

In this trial, adjuvant Tagrisso treatment was found to reduce the risk of disease recurrence or death by 80% in the overall patient population, including EGFR-mutated NSCLC patients with stage IB-IIIA disease.

“We know the earlier a patient’s cancer is detected and treated, the greater chance they may have of being cured, which is why this approval is significant. For the first time, patients in the EU with EGFR-mutated lung cancer have a targeted, biomarker-driven treatment option available in the early stages of their disease that can help them live cancer-free longer,” said Dave Fredrickson, executive vice president, oncology business unit, AZ.

New data, revealed in September 2020, also showed that fewer patients treated with Tagrisso in the adjuvant setting had a recurrence event or death compared to placebo – 11% and 46% respectively.

For those patients whose cancer did recur, 38% had a metastatic recurrence, compared to 61% of patients on the placebo arm. In addition, Tagrisso treatment also reduced the risk of central nervous system (CNS) recurrence or death by 82%, although median CNS DFS was not reached yet in either arm of the study.

In a statement, AZ said that approximately a fifth of global lung cancer patients live in the EU – among those with NSCLC around 15% have tumours with EGFR mutations.

Although the EGFR-mutated NSCLC market is niche, Tagrisso could be rivalled by Janssen’s bispecific antibody amivantamab, following the announcement of positive early results in this patient population.

Amivantamab is being investigated as a treatment for NSCLC patients with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R mutations, which account for 8% of all EGFR mutations in NSCLC.

Janssen assessed the investigational drug in combination with EGFR tyrosine kinase inhibitor (TKI) lazertinib, which the company licensed from South Korean pharma firm Yuhan in 2018.

The results, presented at the 2020 European Society for Medical Oncology (ESMO) virtual congress, showed promise in this patient population, with patients in the treatment-naïve group achieving a 100% overall response rate (ORR).

In a group of 45 patients who had relapsed following treatment with Tagrisso, Janssen’s combination treatment produced a 36% ORR, with one complete response and 15 partial response, representing a clinical benefit rate of 60%.

Article by
Lucy Parsons

28th May 2021

From: Regulatory



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