Efficacy

Alunbrig (brigatinib) for Lung Cancer

Alunbrig (brigatinib) is an anaplastic lymphoma kinase (ALK) inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of non-small cell lung cancer (NSCLC) in patients who have an ALK gene mutation. The efficacy of Alunbrig in lung cancer was demonstrated in clinical trials where it was shown to be effective in patients who had progressed on or were intolerant to crizotinib, which is another ALK inhibitor. In these trials, Alunbrig showed a high objective response rate and a significant progression-free survival benefit compared to chemotherapy in patients with ALK-positive metastatic NSCLC.

Specifically, the ALTA-1L trial, a pivotal phase 3 study, compared the efficacy of Alunbrig to crizotinib in ALK-positive NSCLC patients who had not previously been treated with an ALK inhibitor. The results indicated that Alunbrig significantly prolonged progression-free survival, suggesting a robust clinical benefit for patients with this specific genetic profile of lung cancer. The overall response rate and duration of response also favored Alunbrig over crizotinib, underlining its efficacy as a first-line treatment option for ALK-positive NSCLC.

Rybrevant (amivantamab-vmjw) for Lung Cancer

Rybrevant (amivantamab-vmjw) is a bispecific antibody targeting epidermal growth factor receptor (EGFR) and MET receptor pathways, approved for the treatment of adults with NSCLC with EGFR exon 20 insertion mutations. The approval of Rybrevant was based on the results of the CHRYSALIS study, a multicenter, open-label, multicohort clinical trial. The study demonstrated that Rybrevant provided a meaningful objective response rate in patients with NSCLC harboring these specific mutations, who had progressed on or after platinum-based chemotherapy.

The CHRYSALIS study showed that treatment with Rybrevant led to a significant percentage of patients achieving partial response, with a median duration of response that was clinically meaningful. These findings highlight the potential of Rybrevant as an important treatment option for patients with NSCLC that have EGFR exon 20 insertion mutations, a group that historically has had limited effective treatment options. The efficacy data from the trial support the use of Rybrevant in this subset of lung cancer patients, offering a new avenue for targeted therapy where there is a significant unmet medical need.