MEDSIR is delighted to announce the end of another successful study which was coordinated by Dr. Rafael Rosell and Dr. Manuel Fernandez- Bruno from the H. Dexeus, Barcelona: A phase IIa clinical trial to evaluate the safety and efficacy of osimertinib (AZD9291) in first-line patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer and concomitant EGFR T790M mutation at time of diagnosis (AZENT study).
AZENT is a multicenter, single-arm, open-label, non-controlled phase IIa clinical study with the objective to evaluate the efficacy of Osimertinib (AZD9291), in terms of the objective response rate in patients with advanced non- squamous NSCLC with EGFR mutations and the EGFR T790M mutation at diagnosis.
A total of 23 patients were enrolled in 7 Spanish hospitals during 24 months of planned recruitment period, with the first patient beginning treatment August 2016 at Hospital Dexeus in Barcelona.
10 patients were successfully on treatment with Osimertinib until the 24th of April 2020, defined by 78 weeks as the final dose administered to the last patient in the Cruces Hospital in Bilbao. The Data Base Lock ended in July 2020.
Osimertib is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against CNS metastases.
The primary objective was to explore the efficacy of AZD9291, in terms of the objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and the EGFR T790M mutation at diagnosis as defined by RECIST 1.1 criteria.
The secondary objectives were to determine the safety and tolerability profile of AZD9291, measured using the number and severity of AEs entered into the Case Report Form (CRF); chemistry, blood count, vital signs, physical examination, weight, ECG and performance status (S) and other efficacy parameters such as progression-free survival (PFS), overall survival (OS), time to treatment failure (TTF), duration of response (DOR), disease control rate (DCR),and tumor shrinkage (TS).
On April 18, 2018 The FDA approved Osimertib (Tagrisso, AstraZeneca Pharmaceuticals LP) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
We highly appreciate the entire investigator team’s involvement, especially during the recruitment phase, and the enthusiasm showed regarding the effectiveness of treatment of their patients.
Author: Chiara Tiberto