Efficacy

Vizimpro (dacomitinib) for Lung Cancer

Vizimpro (dacomitinib) is a kinase inhibitor specifically designed for the treatment of 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 primarily demonstrated in a randomized, multicenter, open-label, active-controlled trial. In this trial, patients treated with Vizimpro showed a significant improvement in progression-free survival (PFS) compared to those treated with gefitinib, another EGFR-targeted therapy. The median PFS for patients receiving Vizimpro was notably longer, indicating that Vizimpro is effective in delaying disease progression in this patient population.

Furthermore, while overall survival (OS) data were immature at the time of the final PFS analysis, subsequent updates suggest an OS benefit with Vizimpro treatment. The objective response rate (ORR), which measures the percentage of patients with tumor size reduction, was also higher in the Vizimpro arm compared to the control. These results support the efficacy of Vizimpro in improving key clinical outcomes for patients with EGFR-mutated NSCLC.

Exkivity (mobocertinib) for Lung Cancer

Exkivity (mobocertinib) is an oral kinase inhibitor indicated for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, who have received platinum-based chemotherapy. The efficacy of Exkivity was evaluated in a multicohort, multicenter, non-randomized, open-label clinical trial. In this trial, patients treated with Exkivity demonstrated a clinically meaningful ORR, with a substantial proportion of patients experiencing tumor shrinkage. This indicates that Exkivity is effective in inducing tumor responses in this specific patient population.

The duration of response (DOR) for patients treated with Exkivity was also noteworthy, with many patients maintaining their response for a significant period. This suggests that Exkivity not only induces tumor responses but also sustains these responses over time, which is an important aspect of treatment efficacy in NSCLC. Additionally, the safety profile of Exkivity was considered manageable, with treatment-related adverse events being consistent with those observed in other EGFR inhibitors. These findings underscore the potential of Exkivity as an effective treatment option for patients with EGFR exon 20 insertion mutation-positive NSCLC following prior platinum-based chemotherapy.