Efficacy

Tagrisso (Osimertinib) Efficacy in Lung Cancer

Tagrisso (osimertinib) is a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) designed to inhibit both EGFR-sensitizing and EGFR T790M resistance mutations, with clinical efficacy in the treatment of non-small cell lung cancer (NSCLC). In patients with metastatic EGFR T790M mutation-positive NSCLC, Tagrisso has shown a significant improvement in progression-free survival (PFS) compared to standard first-line EGFR TKIs. The FLAURA study, a pivotal phase III clinical trial, demonstrated that osimertinib significantly prolonged PFS in patients with previously untreated EGFR-mutated advanced NSCLC compared to standard EGFR TKIs, establishing it as a first-line treatment option for this patient population.

Moreover, Tagrisso has been associated with a higher objective response rate (ORR) and a longer duration of response (DoR) than earlier-generation EGFR TKIs. It has also shown central nervous system (CNS) activity, which is critical for patients with NSCLC, as brain metastases are common. The improved CNS efficacy helps in addressing a significant unmet need in lung cancer treatment. Osimertinib has become a standard of care for patients with EGFR-mutated advanced NSCLC both in the first-line setting and for those who develop T790M-mediated resistance after earlier EGFR TKI therapy.

Enhertu (Fam-trastuzumab Deruxtecan-nxki) Efficacy in Lung Cancer

Enhertu (fam-trastuzumab deruxtecan-nxki) is an antibody-drug conjugate (ADC) composed of a humanized anti-HER2 antibody, a cleavable linker, and a cytotoxic topoisomerase I inhibitor payload. It is designed to target and deliver chemotherapy directly to cancer cells that overexpress HER2. While initially approved for the treatment of HER2-positive breast cancer, Enhertu has shown promising efficacy in HER2-mutated or overexpressed non-small cell lung cancer (NSCLC).

Clinical trials, such as the DESTINY-Lung01 phase II study, have demonstrated that Enhertu has substantial antitumor activity in patients with HER2-mutant unresectable and/or metastatic NSCLC who have received prior systemic therapy. The study reported a notable ORR, indicating a significant proportion of patients experienced tumor shrinkage. Additionally, the duration of response and disease control rate observed in the study underscored the potential of Enhertu as a new treatment option for this subset of lung cancer patients. The results have led to further investigation of Enhertu in larger, confirmatory trials and its consideration for patients with HER2-driven NSCLC.