Efficacy

Lumakras (Sotorasib) Efficacy in Lung Cancer

Lumakras, also known by its generic name sotorasib, is a medication specifically designed to treat non-small cell lung cancer (NSCLC) with a particular genetic mutation known as KRAS G12C. This mutation is present in a subset of patients with NSCLC and has been historically difficult to target with existing therapies. The efficacy of Lumakras was demonstrated in a clinical trial that included patients with advanced NSCLC who had previously received treatment with an immune checkpoint inhibitor and/or platinum-based chemotherapy. The primary endpoint of the trial was objective response rate (ORR), and results showed that Lumakras produced a significant ORR, leading to its approval by the U.S. Food and Drug Administration (FDA) for this indication.

The clinical trial data indicated that Lumakras had a median duration of response that was noteworthy for patients with the KRAS G12C mutation. The treatment was associated with a reduction in tumor size in a significant proportion of patients. While the overall survival data were still maturing at the time of the initial analysis, the progression-free survival provided by Lumakras suggested a clinical benefit for patients who had limited treatment options due to their specific genetic profile.

Exkivity (Mobocertinib) Efficacy in Lung Cancer

Exkivity, with the generic name mobocertinib, is another targeted therapy for NSCLC, specifically designed for patients whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations. These mutations are responsible for a small percentage of NSCLC cases and are not effectively treated by the first and second-generation EGFR inhibitors. Exkivity's efficacy was evaluated in a multicenter, non-randomized, open-label clinical trial that included patients with metastatic NSCLC harboring these mutations who had previously undergone platinum-based chemotherapy.

The trial's findings showed that Exkivity led to a significant ORR, with many patients experiencing partial responses. The median duration of response indicated that the benefits of Exkivity could be sustained over time for responders. Similar to Lumakras, while overall survival data were still immature at the time of the FDA approval, the progression-free survival data suggested that Exkivity could provide a meaningful clinical benefit for patients with EGFR exon 20 insertion mutations. The approval of Exkivity provided a new treatment option for a group of lung cancer patients with previously unmet medical needs.