Efficacy

Portrazza (Necitumumab) Efficacy in Lung Cancer

Portrazza (necitumumab) is a monoclonal antibody designed to target and block the activity of the epidermal growth factor receptor (EGFR), a protein that is often found in high amounts on the surface of cancer cells and helps them grow. In the context of lung cancer, Portrazza has been specifically approved for use in combination with gemcitabine and cisplatin for first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). The approval of Portrazza was based on a Phase III clinical trial, which demonstrated an improvement in overall survival when necitumumab was added to the chemotherapy regimen of gemcitabine and cisplatin compared to chemotherapy alone.

The efficacy of Portrazza in this setting was highlighted in the SQUIRE study, which showed that patients receiving necitumumab in addition to chemotherapy had a median overall survival of 11.5 months, compared to 9.9 months for those receiving chemotherapy alone. This improvement in survival was statistically significant, indicating that Portrazza can provide a meaningful benefit for patients with advanced squamous NSCLC when used as part of a first-line treatment regimen.

Gavreto (Pralsetinib) Efficacy in Lung Cancer

Gavreto (pralsetinib) is a targeted therapy designed to inhibit RET (rearranged during transfection) kinases, which can be oncogenic drivers in non-small cell lung cancer (NSCLC) when altered. Gavreto has been granted accelerated approval by the FDA for the treatment of adults with metastatic RET fusion-positive NSCLC. The efficacy of Gavreto was evaluated in a multi-cohort clinical trial, which included patients with RET fusion-positive metastatic NSCLC who had received prior treatment and those who were treatment-naïve.

In the trial, Gavreto demonstrated a high response rate in patients with RET fusion-positive NSCLC. The overall response rate (ORR) was reported to be around 57% among previously treated patients and 70% among treatment-naïve patients. The duration of response (DOR) also supported the efficacy of Gavreto, with many patients experiencing a sustained response. These findings suggest that Gavreto is an effective treatment option for patients with RET fusion-positive metastatic NSCLC, offering a targeted approach that can lead to significant tumor shrinkage and durable responses.