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TAGRISSOTM (osimertinib) DEMONSTRATED UNPRECEDENTED DISEASE-FREE SURVIVAL IN THE ADJUVANT TREATMENT OF STAGE IB-IIIA COMPLETELY RESECTED PATIENTS WITH EGFR MUTATION

AstraZeneca

Phase III ADAURA trial showed treatment with osimertinib after surgery with curative intent reduced the risk of disease recurrence or death by 83% vs. placebo in patients with Stage II/IIIA EGFRm NSCLC, meeting its primary endpoint


Luton, UK, 29th May 2020 - Detailed results from the Phase III ADAURA trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.

Results will be presented during the plenary session of the American Society of Clinical Oncology ASCO20 Virtual Scientific Program on 31 May (abstract #LBA5).

In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant treatment (after surgery) with osimertinib reduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12,0.23; p<0.0001). DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).

At two years, 89% of all patients in the trial treated with osimertinib remained alive and disease free versus 53% on placebo. Consistent DFS results were seen across all subgroups, including patients who were treated with surgery followed by chemotherapy and those who received surgery only, as well as in Asian and non-Asian patients. (1)

At the time of data cut-off, overall survival (OS) data were not mature (5% data maturity in the stage II/IIIA population). The trial will continue to assess OS as a secondary endpoint.

Osimertinib is not currently licensed as a treatment for patients with early stage EGFRm NSCLC anywhere in the world. In Europe, osimertinib as monotherapy is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations; and for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. (2)

Roy S. Herbst, MD, Ph.D., chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, CT and principal investigator in the Phase III ADAURA trial, said: “Osimertinib will provide a much-needed new treatment option that has the potential to change the practice of medicine and improve outcomes for patients in this setting.”Luton, UK, 29th May 2020 - Detailed results from the Phase III ADAURA trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.

Results will be presented during the plenary session of the American Society of Clinical Oncology ASCO20 Virtual Scientific Program on 31 May (abstract #LBA5).

In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant treatment (after surgery) with osimertinib reduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12,0.23; p<0.0001). DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).

At two years, 89% of all patients in the trial treated with osimertinib remained alive and disease free versus 53% on placebo. Consistent DFS results were seen across all subgroups, including patients who were treated with surgery followed by chemotherapy and those who received surgery only, as well as in Asian and non-Asian patients. (1)

At the time of data cut-off, overall survival (OS) data were not mature (5% data maturity in the stage II/IIIA population). The trial will continue to assess OS as a secondary endpoint.

Osimertinib is not currently licensed as a treatment for patients with early stage EGFRm NSCLC anywhere in the world. In Europe, osimertinib as monotherapy is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations; and for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. (2)

Roy S. Herbst, MD, Ph.D., chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, CT and principal investigator in the Phase III ADAURA trial, said: “Osimertinib will provide a much-needed new treatment option that has the potential to change the practice of medicine and improve outcomes for patients in this setting.”

José Baselga, Executive Vice President, AstraZeneca Oncology R&D, said: “Results of the Phase III ADAURA trial for osimertinib demonstrate for the first time in a global trial that an EGFR inhibitor can change the course of early-stage EGFR-mutated lung cancer and provide hope for a cure. We are discussing these outstanding data with regulatory authorities and look forward to bringing the benefits of osimertinib to patients with early-stage disease.”

In April 2020, an Independent Data Monitoring Committee recommended for the Phase III ADAURA trial to be unblinded two years early based on its determination of overwhelming efficacy.

José Baselga, Executive Vice President, AstraZeneca Oncology R&D, said: “Results of the Phase III ADAURA trial for osimertinib demonstrate for the first time in a global trial that an EGFR inhibitor can change the course of early-stage EGFR-mutated lung cancer and provide hope for a cure. We are discussing these outstanding data with regulatory authorities and look forward to bringing the benefits of osimertinib to patients with early-stage disease.”

In April 2020, an Independent Data Monitoring Committee recommended for the Phase III ADAURA trial to be unblinded two years early based on its determination of overwhelming efficacy.



The safety and tolerability of osimertinib in this trial was consistent with previous trials in the metastatic setting. Adverse events (AEs) at Grade 3 or higher from all causes occurred in 20% of patients in the osimertinib arm versus 14% in the placebo arm. All-causality AEs that occurred in >10% of patients taking osimertinib included: diarrhoea (46% all grades vs 19% in placebo group); paronychia (25% vs 1%); dry skin (23% vs 6%); pruritis (19% vs 9%); cough (18% vs 17%); stomatitis (17% vs 4%); nasopharyngitis (15% vs 10%); decreased appetite (13% vs 4%); upper respiratory tract infection (URTI) (13% vs 9%); dermatitis acneiform (11% vs 5%); and mouth ulceration (12% vs 2%). Grade 3/4 AEs in patients taking osimertinib included diarrhoea (2%), paronychia (1%), stomatitis (2%), decreased appetite (1%) and URTI (1%). (1)


References

1. Herbst RS et al. Osimertinib as adjuvant therapy in patients with stage IB–IIIA EGFR mutation positive NSCLC after complete tumor resection: ADAURA. Presented at the American Society of Clinical Oncology ASCO20 Virtual Scientific Program on 31 May 2020.

2. Tagrisso Summary of Product Characteristics. 2 April 2020. Available at: https://www.medicines.org.uk/emc/product/1985/smpc Accessed May 2020.

3. Cancer Research UK. Lung cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/lung-cancer#heading-Zero Accessed May 2020.

4. Cancer Research UK. Types of lung cancer. Available at: https://www.cancerresearchuk.org/about-cancer/lung-cancer/stages-types-grades/types Accessed May 2020.

5. Sasaki H, Suzuki A, Tatematsu T, et al. Prognosis of recurrent non‑small cell lung cancer following complete resection. Oncol Lett. 2014:7;1300-1304.

6. Royal College of Physicians. National Lung Cancer Audit 2017 information sheet. Published January 2018. Available at: https://www.rcplondon.ac.uk/file/8703/download?token=2UCmNec9 Accessed May 2020.

7. Midha A, Dearden S, McCormack R. EGFR mutation incidence in non-small cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity (mutMapII). Am J Cancer Res. 2015;5;2892-2911.

8. Cross DA, Ashton SE, Ghiorghiu S, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov. 2014;4:1046-1061.

9. Cagle PT, Allen TC, Olsen RJ..Lung cancer biomarkers: present status and future developments. Arch Pathol Lab Med. 2013;137:1191–1198.

10. Datta D, Lahiri B. . Preoperative evaluation of patients undergoing lung resection surgery. Chest. 2003;123:2096–2103.

11. Le Chevalier T. Adjuvant chemotherapy for resectable non-small-cell lung cancer: where is it going? Ann Oncol. 2010;21:196–198.
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