Efficacy

Efficacy of Portrazza (Necitumumab) in Lung Cancer

Portrazza (necitumumab) is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), a protein found on the surface of some cancer cells. It is approved by the U.S. Food and Drug Administration (FDA) for use in combination with gemcitabine and cisplatin for first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). Clinical trials have demonstrated that necitumumab, when added to chemotherapy, can improve overall survival in patients with advanced squamous NSCLC compared to chemotherapy alone. However, it's important to note that its efficacy is limited to patients with squamous cell histology and it is not indicated for patients with non-squamous NSCLC.

The approval of Portrazza was based on a Phase III clinical trial, which showed a median overall survival of 11.5 months for patients treated with necitumumab plus chemotherapy compared to 9.9 months for those receiving chemotherapy alone. While the improvement in survival is modest, it represents a significant clinical development for a subtype of lung cancer that has fewer treatment options compared to non-squamous NSCLC.

Efficacy of Exkivity (Mobocertinib) in Lung Cancer

Exkivity (mobocertinib) is an oral tyrosine kinase inhibitor specifically designed to target EGFR exon 20 insertion mutations, which are a form of mutation that can drive cancer growth. It has been granted accelerated approval by the FDA for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, who have received prior platinum-based chemotherapy. This approval is contingent upon the verification of clinical benefit in a confirmatory trial.

The efficacy of Exkivity was evaluated in a multicenter, non-randomized, open-label clinical trial, which showed a response rate of approximately 28% in patients with EGFR exon 20 insertion-positive NSCLC. The median duration of response was also notable, with some responses lasting more than a year. These results are particularly meaningful given the limited treatment options for patients with this specific and rare genetic mutation in NSCLC. Mobocertinib provides a targeted therapy option for a patient population with a high unmet medical need.