Efficacy

Alunbrig (brigatinib) Efficacy in Lung Cancer

Alunbrig (brigatinib) is a targeted therapy approved for the treatment of non-small cell lung cancer (NSCLC) with a specific genetic alteration known as anaplastic lymphoma kinase (ALK) positive. The efficacy of Alunbrig in this patient population has been demonstrated in several clinical trials. For instance, the phase 2 ALTA trial reported that patients with ALK-positive NSCLC who had progressed on crizotinib, an earlier ALK inhibitor, achieved a confirmed objective response rate (ORR) of 45% with the 90 mg once-daily regimen and 54% with the 180 mg once-daily regimen following a 7-day lead-in at 90 mg. Progression-free survival (PFS) was also significantly extended in patients treated with Alunbrig, indicating its effectiveness in this setting.

Furthermore, the phase 3 ALTA-1L trial evaluated the efficacy of Alunbrig as a first-line treatment in patients with ALK-positive NSCLC. The results showed that Alunbrig significantly improved PFS compared to crizotinib, with a hazard ratio of 0.49, indicating a 51% reduction in the risk of disease progression or death. The ORR was also higher in the Alunbrig group compared to the crizotinib group. These findings suggest that Alunbrig is a highly effective treatment option for patients with ALK-positive NSCLC, both as a first-line and subsequent therapy.

Zepzelca (lurbinectedin) Efficacy in Lung Cancer

Zepzelca (lurbinectedin) is a newer chemotherapeutic agent that has shown efficacy in the treatment of small cell lung cancer (SCLC). It functions by binding to DNA and inhibiting oncogenic transcription, leading to cell death. The approval of lurbinectedin for the treatment of SCLC was based on the results of a multicenter, single-arm, open-label phase 2 study. In this study, patients with SCLC who had progressed after platinum-based chemotherapy received lurbinectedin, resulting in a reported ORR of 35% as assessed by an Independent Review Committee (IRC). The median duration of response was 5.3 months, indicating that lurbinectedin provides a meaningful clinical benefit in this patient population.

While the data on lurbinectedin is promising, it is important to note that the approval was granted under the FDA's accelerated approval program based on ORR and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. However, the current evidence positions Zepzelca as a valuable treatment option for patients with SCLC who have limited options after first-line therapy.