Efficacy

Tagrisso (Osimertinib) Efficacy in Lung Cancer

Tagrisso (osimertinib) is a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) specifically designed for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific types of EGFR mutations. Clinical trials have demonstrated that osimertinib is effective in treating patients with NSCLC harboring EGFR T790M mutation, which is associated with resistance to earlier-generation EGFR inhibitors. The FLAURA study, a pivotal phase III clinical trial, showed that osimertinib significantly improved progression-free survival compared to standard EGFR TKIs (erlotinib or gefitinib) in the first-line treatment of EGFR-mutated advanced NSCLC.

Osimertinib has also shown efficacy in the central nervous system (CNS), which is particularly relevant since lung cancer patients are at risk of developing brain metastases. The drug's ability to penetrate the blood-brain barrier means it can be effective in treating and preventing CNS metastases, a common site of progression in EGFR-mutated NSCLC. This has been an area of unmet medical need, and osimertinib's efficacy in the CNS is a significant advancement in the treatment of this patient population.

Vegzelma (Bevacizumab-adcd) Efficacy in Lung Cancer

Vegzelma (bevacizumab-adcd) is a biosimilar to the original monoclonal antibody bevacizumab, which targets the vascular endothelial growth factor (VEGF) and is used in combination with chemotherapy for the treatment of non-squamous NSCLC. The efficacy of bevacizumab in lung cancer has been established through various studies, including the pivotal ECOG 4599 trial, which demonstrated that adding bevacizumab to carboplatin and paclitaxel chemotherapy significantly improved overall survival and progression-free survival in patients with advanced non-squamous NSCLC compared to chemotherapy alone.

As a biosimilar, Vegzelma is highly similar to the reference product bevacizumab and has no clinically meaningful differences in terms of safety, purity, and potency. Clinical studies conducted to support the approval of Vegzelma would have demonstrated that it is as effective and safe as the original bevacizumab in treating lung cancer. By providing a more cost-effective alternative to the reference product, Vegzelma may help to increase accessibility to this important biological therapy for lung cancer patients.