AstraZeneca’s Tagrisso (osimertinib) with pemetrexed and platinum-based chemotherapy has been recommended for approval in the European Union (EU) for first-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). This recommendation follows the positive results from the FLAURA2 Phase III trial. The trial demonstrated that Tagrisso plus chemotherapy extended median progression-free survival by nearly nine months compared to the standard of care, which is Tagrisso monotherapy. The combination reduced the risk of disease progression or death by 38% (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001), with a median progression-free survival (PFS) of 25.5 months versus 16.7 months for Tagrisso alone.
Overall survival (OS) analysis remains ongoing, but early results indicate a trend towards improvement with the combination therapy (HR 0.75; 95% CI 0.57-0.97). This finding supports the potential benefit of combining Tagrisso with chemotherapy for patients with EGFR-mutated NSCLC. The trial continues to assess OS as a key secondary endpoint. The recommendation is a significant milestone, reflecting the evolving treatment landscape for EGFR-mutated non-small cell lung cancer and providing a new therapeutic option for patients in Europe.
The combination therapy aims to address the treatment needs of patients with advanced NSCLC, particularly those whose disease has spread to the brain or with specific EGFR mutations such as exon 19 deletions or exon 21 (L858R) mutations. The safety profile of Tagrisso plus chemotherapy was manageable and consistent with the known effects of the individual treatments. While adverse event (AE) rates were higher in the combination arm, they were in line with expectations for chemotherapy-related side effects. Discontinuation rates due to AEs were 11% for the combination therapy and 6% for monotherapy, indicating a relatively low impact on treatment adherence.
CHMP Recommends Tagrisso Plus Chemotherapy for Advanced NSCLC
The recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is based on robust clinical evidence, underscoring the efficacy and safety of Tagrisso plus chemotherapy. This approval would provide healthcare professionals with an additional tool to manage advanced NSCLC, potentially improving patient outcomes. It also reinforces the role of Tagrisso as a cornerstone in the treatment of EGFR-mutated lung cancer, offering a flexible approach that can be tailored to individual patient needs.
David Planchard, MD, PhD, thoracic oncologist and principal investigator for the FLAURA2 trial, highlighted the significance of the results, stating that the combination therapy builds on the established efficacy of osimertinib monotherapy. The nine-month improvement in progression-free survival is a meaningful advancement, providing patients with more time before disease progression. This recommendation represents a vital step towards expanding treatment options for patients in Europe, enhancing the ability of physicians to tailor therapies to specific disease characteristics.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, emphasized the importance of Tagrisso as a backbone therapy in EGFR-mutated lung cancer. She noted that the option to combine Tagrisso with chemotherapy is particularly valuable for patients with advanced disease, including those with brain metastases. The positive recommendation by the CHMP aligns with AstraZeneca’s commitment to advancing cancer treatment and improving patient outcomes through innovative therapies.
A Significant Advancement for EGFR-Mutated Lung Cancer Treatment
The approval of Tagrisso plus chemotherapy would mark an important development in the treatment of EGFR-mutated NSCLC, a condition affecting a significant proportion of lung cancer patients in Europe. Lung cancer remains the leading cause of cancer-related deaths globally, with non-small cell lung cancer being the most common subtype. The majority of NSCLC patients are diagnosed at an advanced stage, underscoring the need for effective first-line treatments. The ability to offer a combination therapy that extends progression-free survival provides a crucial option for these patients.
AstraZeneca’s continued research and development efforts in oncology aim to address the unmet needs of lung cancer patients. The company is exploring additional therapeutic strategies to overcome resistance mechanisms and improve long-term outcomes. Ongoing trials, such as the NeoADAURA and ADAURA2 studies, are investigating the use of Tagrisso in earlier stages of the disease, potentially extending its benefits to a broader patient population. The company’s comprehensive approach includes collaborations with other pharmaceutical companies to develop new combination therapies and explore novel treatment pathways.
In conclusion, the CHMP’s recommendation for Tagrisso plus chemotherapy represents a significant advancement in the treatment of EGFR-mutated NSCLC. This combination therapy offers a new option for patients, potentially extending their progression-free survival and providing a valuable tool for healthcare professionals. AstraZeneca’s commitment to innovation and patient care continues to drive progress in oncology, aiming to improve outcomes for lung cancer patients worldwide. The approval of this combination therapy would reinforce the role of Tagrisso as a key treatment in EGFR-mutated lung cancer and highlight the importance of ongoing research in addressing complex cancer challenges.
Resource:AstraZeneca, June 03, 2024
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