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2020-04-12| Trials & Approvals

Overwhelming Efficacy Allows AstraZeneca to End Cancer Drug Trial Sooner

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

Following outstanding performance in the ADAURA trial conducted in patients with a type of non-small cell lung cancer (NSCLC), AstraZeneca’s blockbuster drug Tagrisso is recommended for early unblinding.

Lung cancer, the most common type of cancer is the leading cause of cancer-related deaths worldwide. NSCLC is the predominant type of lung cancer with approximately 2 million cases diagnosed annually. Among the several drugs targeting this group, AstraZeneca’s tyrosine kinase inhibitor (TKI), Tagrisso (Osimertinib) is a prominent one. It is currently approved in approximately 80 countries for 1st-line treatment of advanced NSCLC with tumors harboring an epidermal growth factor receptor mutation (EGFRm). It is also approved for 2nd-line treatment of advanced NSCLC in patients who acquire a TKI resistant EGFR T790M mutation following first-line treatments such as gefitinib and afatinib.

Tagrisso is a third-generation TKI that selectively targets and binds irreversibly to EGFR T790M mutants. Identified specifically for this purpose through a drug discovery program in 2012, the drug advanced quickly through the ranks. Following a strong showing in clinical trials, It went on to receive approvals by the FDA and EMA in 2017, lapping up breakthrough therapy and priority review designations along the way. Today, Tagrisso is one of Astra Zeneca’s top-selling drugs yielding expanding revenues that doubled to US$ 784 million in 2019.

 

Tagrisso, a ‘Trial’ blazer

Statistics reveal that approximately 10-15% of patients in the US and Europe, and 30-40% in Asia have EGFRm positive NSCLC. Last year, the company announced that Tagrisso demonstrated a statistically-significant overall survival benefit in Phase III, FLAURA trial involving previously-untreated patients with EGFRm positive locally-advanced or metastatic NSCLC. Through a Phase III, placebo-controlled, ADAURA trial the drug was also being developed in the adjuvant setting for the treatment of stage IB, II and IIIA EGFRm positive NSCLC with complete tumor resection. The primary endpoint of the 3-year long trial is disease-free survival (DFS).

On 10th April, the British drugmaker announced that due to the “overwhelming efficacy” of the drug, the ADAURA trial comprising 682 patients will be unblinded early, following a recommendation from an Independent Data Monitoring Committee (IDMC) which also did not find any new safety concerns. The trial would still proceed to evaluate the secondary endpoint of overall survival.

“We are thrilled by the recommendation to unblind the Phase III ADAURA trial much earlier than expected and are incredibly excited with these unprecedented results in patients with early-stage EGFR-mutated non-small cell lung cancer. Lung cancer is a devastating diagnosis and for the first time an EGFR-targeted medicine can now provide the hope of cure” said José Baselga, Executive Vice President of Oncology R&D. The data is said to be revealed at a medical meeting in the future. With a strong oncology pipeline comprising of Tagrisso, Lynparza, Imfinzi among others, the pharma giant is looking ahead to another profitable year.

Related Article: Japan Approves World’s First Therapy for Metastatic Non–Small Cell Lung Cancer with METex14

References
  1. https://www.astrazeneca.com/media-centre/press-releases/2020/tagrisso-phase-iii-adaura-trial-will-be-unblinded-early-after-overwhelming-efficacy-in-the-adjuvant-treatment-of-patients-with-egfr-mutated-lung-cancer.html
  2. https://www.astrazeneca.com/media-centre/press-releases/2019/tagrisso-significantly-improves-overall-survival-in-the-phase-iii-flaura-trial-for-1st-line-egfr-mutated-non-small-cell-lung-cancer-09082019.html
  3. https://www.reuters.com/article/us-astrazeneca-study/astrazenecas-tagrisso-helps-lung-cancer-patients-live-longer-study-idUSKCN1UZ0L3

 

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