Efficacy

Vizimpro (dacomitinib) for Lung Cancer

Vizimpro (dacomitinib) is an oral, once-daily, irreversible pan-human epidermal growth factor receptor (HER) tyrosine kinase inhibitor (TKI). It is specifically indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. The efficacy of Vizimpro was demonstrated in a randomized, multicenter, open-label, active-controlled trial (ARCHER 1050) where it showed a significant improvement in progression-free survival compared to gefitinib, another EGFR TKI. Patients treated with Vizimpro had a median progression-free survival of 14.7 months compared to 9.2 months in patients treated with gefitinib.

Furthermore, Vizimpro also showed an overall survival benefit. In the updated analysis of the ARCHER 1050 study, the median overall survival for patients treated with Vizimpro was 34.1 months, compared to 26.8 months for those who received gefitinib. This demonstrates a clear advantage in the use of Vizimpro for patients with the specified EGFR mutations in the context of metastatic NSCLC. However, it is important to note that Vizimpro's efficacy is contingent upon the presence of EGFR exon 19 deletions or exon 21 L858R substitution mutations, and it is not indicated for patients whose tumors harbor other types of EGFR mutations or those with wild-type EGFR NSCLC.

Enhertu (fam-trastuzumab deruxtecan-nxki) for Lung Cancer

Enhertu (fam-trastuzumab deruxtecan-nxki) is an antibody-drug conjugate (ADC) consisting of a humanized anti-HER2 antibody, a cleavable linker, and a cytotoxic topoisomerase I inhibitor payload. Enhertu is approved for the treatment of adult patients with unresectable or metastatic HER2-positive NSCLC who have received a prior systemic therapy. The efficacy of Enhertu in lung cancer was evaluated in a multicenter, single-arm, open-label clinical trial. In this trial, patients with HER2-mutant metastatic NSCLC who had received one or more prior systemic therapies demonstrated a confirmed objective response rate (ORR) of 61.9%, with a median duration of response (DoR) of 14.8 months. This data suggests that Enhertu provides a potent therapeutic option for patients with HER2-mutant NSCLC, especially considering the limited treatment options for this subgroup of lung cancer patients.

It is noteworthy that the use of Enhertu comes with the need for diligent patient selection, as its efficacy is specific to HER2-positive lung cancers. Additionally, the safety profile of Enhertu should be carefully considered, as it can cause interstitial lung disease, which is a potentially fatal adverse reaction. The promising efficacy data for Enhertu in lung cancer highlights the importance of molecular profiling in the management of NSCLC, allowing for more personalized and targeted treatment approaches that can significantly improve patient outcomes.