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Data at WCLC showed patients in the practice-changing ADAURA Phase III trial maintained their quality of life based on patient-reported outcomes
New data reinforce the ability of TAGRISSO to penetrate the blood-brain barrier in patients with central nervous system metastases
Results from an exploratory analysis of the positive ADAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) extended disease-free survival (DFS) in patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) regardless of prior adjuvant chemotherapy treatment or stage of disease, building on the unprecedented primary DFS results for TAGRISSO in the adjuvant setting announced last year. Results from ADAURA were presented during the 2020 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC) and featured in the Press Program.
In this exploratory analysis of the overall trial population, adjuvant TAGRISSO reduced the risk of disease recurrence or death by 84% in patients who had been treated with prior adjuvant chemotherapy (based on a hazard ratio [HR] of 0.16, 95% confidence interval [CI] 0.10-0.26) and by 77% in patients who had not (HR 0.23; 95% CI 0.13-0.40). DFS benefits were similar across each stage of disease.
In addition, a separate exploratory post-hoc analysis of patient-reported outcomes in ADAURA showed that patients treated with TAGRISSO maintained their quality of life, with no clinically meaningful differences in physical or mental health measures in the TAGRISSO and placebo arms.
Yi-Long Wu, MD, FACS, Tenured Professor of the Lung Cancer Institute at Guangdong Provincial People's Hospital and Academy of Medical Sciences in Guangzhou, China, and a principal investigator in the ADAURA Phase III trial, said: “The overwhelming disease-free survival benefit in patients in ADAURA already supported the role of TAGRISSO as a pioneering therapy in the adjuvant treatment of EGFR-mutated non-small cell lung cancer. This latest analysis shows the magnitude of that benefit is consistent with or without prior adjuvant chemotherapy, and regardless of disease stage, reinforcing the critical role of TAGRISSO in this setting.”
Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “These new data show that TAGRISSO provides transformative benefits independent of prior chemotherapy treatment, preventing lung cancer from returning while allowing patients to sustain their quality of life. Following the recent approval of TAGRISSO in the US in the adjuvant setting, we continue to work urgently with regulatory authorities globally to bring this new standard of care to patients with early-stage lung cancer.”
Exploratory DFS analysis with and without chemotherapy (CTx) OSI: TAGRISSO; PBO: placebo
Stage IB
Stage II
Stage IIIA
Stage IB-IIIA
OSI
PBO
OSI
PBO
OSI
PBO
OSI
PBO
With CTx
n=28
n=30
n=81
n=85
n=94
n=92
n=203
n=207
DFS events patients (%)
4 (14)
11 (37)
6 (7)
36 (42)
12 (13)
56 (61)
22 (11)
103 (50)
DFS HR (95% CI)
NC (NC, NC)
0.15 (0.06, 0.32)
0.13 (0.06, 0.23)
0.16 (0.10, 0.26)
Without CTx
n=78
n=76
n=37
n=33
n=21
n=27
n=136
n=136
DFS events patients (%)
7 (9)
18 (24)
5 (14)
16 (48)
3 (14)
22 (81)
15 (11)
56 (41)
DFS HR (95% CI)
0.38 (0.15, 0.88)
0.20 (0.07, 0.52)
0.10 (0.02, 0.29)
0.23 (0.13, 0.40)
In the ADAURA Phase III trial, chemotherapy use was balanced across the two treatment arms, with 60% of patients receiving prior adjuvant chemotherapy. In line with uptake observed in prior studies and clinical practice, younger patients (<70 years) and those with more advanced disease were more likely to have prior adjuvant chemotherapy.1,2 Treatment with chemotherapy did not vary according to a patient’s performance status.
The safety and tolerability of TAGRISSO was consistent with previous trials in the metastatic EGFRm NSCLC setting. Adverse events at Grade 3 or higher from all causes occurred in 20% of patients in the TAGRISSO arm versus 13% in the placebo arm as assessed by investigators.
Primary results of ADAURA, which were published in The New England Journal of Medicine in September 2020, showed adjuvant treatment with TAGRISSO reduced the risk of disease recurrence or death by 83% (HR 0.17; 95% CI 0.12-0.23; p<0.0001) among patients with Stage II and IIIA EGFRm NSCLC and, as shown in a prespecified exploratory analysis, demonstrated a clinically meaningful improvement in central nervous system (CNS) DFS compared to placebo.
Additional TAGRISSO highlights at WCLC
In addition to these ADAURA analyses, several other presentations and posters for TAGRISSO across lung cancer settings and in novel combinations were featured during WCLC, including:
TAGRISSO was recently approved in the US for the adjuvant treatment of adult patients with early-stage EGFRm NSCLC after tumor resection with curative intent based on the ADAURA Phase III trial. This indication is under priority review in China and regulatory review in the EU; additional global submission discussions are ongoing. TAGRISSO is also approved for the 1st-line treatment of patients with metastatic EGFRm NSCLC and for the treatment of metastatic EGFR T790M mutation-positive NSCLC in the US, Japan, China, the EU and many other countries around the world.
TAGRISSO Important Safety Information
INDICATIONS
For additional information, please see the complete Prescribing Information, including Patient Information.
Lung cancer
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.4 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.5 The majority of all NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.6-8
For those with resectable tumors, the majority of patients eventually develop recurrence despite complete tumor resection and adjuvant chemotherapy.9 Early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition.10,11
Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.12-14 These patients are particularly sensitive to treatment with EGFR-tyrosine kinase inhibitors (TKIs) which block the cell-signaling pathways that drive the growth of tumor cells.15
About ADAURA
ADAURA is a randomized, double-blinded, global, placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated. Patients were treated with TAGRISSO 80 mg once-daily oral tablets or placebo for three years or until disease recurrence.
The trial enrolled in more than 200 centers across more than 20 countries, including the US, in Europe, South America, Asia and the Middle East. The primary endpoint was DFS in Stage II and IIIA patients and a key secondary endpoint was DFS in Stage IB, II and IIIA patients. The data readout was originally anticipated in 2022. The trial will continue to assess overall survival.
About TAGRISSO
TAGRISSO® (osimertinib) is a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system metastases. TAGRISSO 40 mg and 80 mg once-daily oral tablets have received approval in the US, Japan, China, the EU and many countries around the world for 1st-line EGFRm metastatic NSCLC and EGFR T790M mutation-positive metastatic NSCLC.
AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action.
AstraZeneca aims to address the unmet needs of patients with EGFRm tumors as a genetic driver of disease with the approved medicines gefitinib and TAGRISSO, and its ongoing LAURA, NeoADAURA, and FLAURA2 Phase III trials.
AstraZeneca is committed to addressing tumor mechanisms of resistance through the ongoing Phase II trials SAVANNAH and ORCHARD which test TAGRISSO in combination with savolitinib, a selective inhibitor of c-MET receptor tyrosine kinase, along with other potential new medicines.
AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.
By harnessing the power of six scientific platforms - Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies - and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit https://www.astrazeneca-us.com/ and follow us on Twitter @AstraZenecaUS.
References
US-49454 Last Updated 1/21
View source version on businesswire.com: https://www.businesswire.com/news/home/20210129005181/en/
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