Cecilia Brown

DocwireNews

Osimertinib (Tagrisso) plus pemetrexed and platinum-based chemotherapy has been approved in the European Union (EU) as a first-line treatment for adults with advanced EGFR-mutated non-small cell lung cancer (NSCLC) that has exon 19 deletions or exon 21 (L858R) mutations, according to an announcement from the drug manufacturer, AstraZeneca.The European Commission&rsquo;s approval of the combination comes after the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the phase 3 FLAURA2 trial, which were published in the New England Journal of Medicine.The trial showed osimertinib plus chemotherapy extended median progression-free survival (PFS) by 8.8 months compared with osimertinib monotherapy, which is the &ldquo;first-line global standard of care,&rdquo; according to AstraZeneca.&ldquo;Today&rsquo;s news marks a significant advance for patients with EGFR-mutated lung cancer in Europe, providing a new first-line treatment option with osimertinib now in combination with chemotherapy,&rdquo; David Planchard, MD, PhD, a thoracic oncologist at Gustave Roussy Institute of Oncology and the principal investigator for the trial, said in a statement. &ldquo;The FLAURA2 results build on the established efficacy of osimertinib monotherapy, showing a meaningful 9-month improvement in [PFS] and offering physicians the option to tailor treatment to a patient&rsquo;s specific needs.&rdquo;The FLAURA2 trial showed the combination reduced the risk of disease progression or death by 38% compared with osimertinib monotherapy, per investigator assessment (hazard ratio [HR], 0.62; 95% CI, 0.49-0.79; P&lt;.0001). The PFS results from blinded independent central review (BICR) were &ldquo;consistent with the results by investigator assessment,&rdquo; showing a median PFS of 29.4 months with the combination, a 9.5-month improvement over the monotherapy (19.9 months; HR, 0.62; 95% CI, 0.48-0.80; nominal P=.0002), according to the announcement.Among patients with brain metastases at baseline, the combination also reduced the risk of central nervous system (CNS) disease progression or death by 42% compared with monotherapy (HR, 0.58; 95% CI, 0.33-1.01), as assessed by BICR. The 2-year follow-up data showed 74% of patients who received the combination had not experienced CNS disease progression or death, compared with 54% of patients who received the monotherapy.The overall survival (OS) results &ldquo;remained immature&rdquo; at the second interim analysis, there was a &ldquo;trend towards an OS benefit&rdquo; with the combination compared to the monotherapy (HR, 0.75; 95% CI, 0.57-0.97), company officials said in the announcement. The safety profile of osimertinib plus chemotherapy &ldquo;was consistent with the established profiles of the individual medicines,&rdquo; as adverse event (AE) rates were higher in those receiving the combination and were &ldquo;driven by well-characterized chemotherapy-related AEs,&rdquo; according to the announcement. The discontinuation rate due to AEs was 11% for the combination therapy and 6% for the monotherapy.Osimertinib is approved as monotherapy in more than 110 countries, including the United States, the European Union, China, and Japan. Osimertinib plus chemotherapy is also approved as first-line treatment for locally advanced or metastatic EGFR-mutated NSCLC in some countries, including the United States, China, and Japan.Source: <a href="https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-with-the-addition-of-chemotherapy-approved-in-the-eu-as-new-1st-line-treatment-for-patients-with-egfr-mutated-advanced-lung-cancer.html" target="_blank" rel="noopener">AstraZeneca</a>

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Osimertinib Plus Chemotherapy Approved in EU as First-Line Therapy for EGFR-Mutated Advanced NSCLC

Non-Small Cell Lung Cancer

Osimertinib (Tagrisso) plus pemetrexed and platinum-based chemotherapy has been approved in the European Union (EU) as a first-line treatment for advanced EGFR-mutated NSCLC.

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