Efficacy

Efficacy of Gavreto (pralsetinib) in Lung Cancer

Gavreto (pralsetinib) is a targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) associated with rearranged during transfection (RET) gene fusions. RET gene fusions are a rare driver in NSCLC, occurring in approximately 1-2% of patients. Clinical trials have demonstrated that pralsetinib has significant efficacy in this patient population. In a pivotal phase 1/2 trial, pralsetinib showed a high response rate, with a majority of patients experiencing tumor shrinkage. The treatment was also associated with durable responses, meaning that the effect was long-lasting in a number of cases.

The efficacy of Gavreto was evaluated in a multi-cohort clinical study, where the overall response rate (ORR) was the primary endpoint. In patients with RET fusion-positive metastatic NSCLC, Gavreto demonstrated an ORR of around 70%, with many patients achieving a complete response or partial response to the therapy. The median duration of response (DoR) was also notable, extending beyond a year for many patients. These results suggest that Gavreto is a highly effective treatment option for patients with RET fusion-positive NSCLC.

Efficacy of Lumakras (sotorasib) in Lung Cancer

Lumakras (sotorasib) represents another advancement in the personalized treatment of lung cancer. It is the first therapy approved specifically for patients with NSCLC harboring the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C mutation, which accounts for approximately 13% of cases in NSCLC. The approval of sotorasib was based on the results of a phase 2 clinical trial that evaluated its efficacy in patients with advanced NSCLC who had received at least one prior systemic therapy.

In this clinical trial, Lumakras demonstrated a significant ORR, with a subset of patients achieving complete or partial shrinkage of their tumors. The median DoR was also promising, indicating that the responses to sotorasib can be sustained over time. The approval of Lumakras marked a significant milestone in the treatment of KRAS G12C-mutated NSCLC, as it was the first targeted therapy for this specific mutation, which had been considered "undruggable" for decades.