Efficacy

Xalkori (Crizotinib) Efficacy in Lung Cancer

Xalkori, known generically as crizotinib, is a targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of non-small cell lung cancer (NSCLC) in patients whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The efficacy of crizotinib in the treatment of ALK-positive NSCLC has been demonstrated in a number of clinical trials. These studies have shown that crizotinib can significantly prolong progression-free survival (PFS) compared to chemotherapy in previously treated and untreated advanced ALK-positive NSCLC patients.

In one of the pivotal trials, PROFILE 1014, patients with advanced ALK-positive NSCLC who had not received prior systemic treatment for metastatic disease were randomized to receive crizotinib or standard chemotherapy. The results indicated that crizotinib significantly improved PFS, with a median PFS of 10.9 months compared to 7.0 months for those on chemotherapy. Additionally, the objective response rate (ORR) was higher in the crizotinib arm, demonstrating its efficacy in shrinking tumors.

Exkivity (Mobocertinib) Efficacy in Lung Cancer

Exkivity, with the generic name mobocertinib, is another targeted therapy specifically designed for the treatment of adult patients with locally advanced or metastatic NSCLC harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, who have received prior platinum-based chemotherapy. This indication is approved under accelerated approval based on the tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The efficacy of mobocertinib was evaluated in a multicenter, non-randomized, open-label, multi-cohort clinical trial. In patients with EGFR exon 20 insertion mutation-positive NSCLC who had been previously treated with platinum-based chemotherapy, mobocertinib demonstrated a significant ORR. The median duration of response was also notable, indicating that the responses to mobocertinib were durable. As mobocertinib targets a specific mutation within the EGFR gene, it is a valuable treatment option for patients with this particular genetic alteration in their lung cancer.