Efficacy

Cyramza (Ramucirumab) Efficacy in Lung Cancer

Cyramza (ramucirumab) is a monoclonal antibody that targets the vascular endothelial growth factor receptor 2 (VEGFR2), which is implicated in the growth and spread of cancer cells. In the context of lung cancer, specifically non-small cell lung cancer (NSCLC), Cyramza has been evaluated for its efficacy. It is usually considered for use in combination with docetaxel in patients who have experienced disease progression during or after platinum-based chemotherapy. Clinical trials have demonstrated that this combination can lead to an improvement in overall survival compared to chemotherapy alone. The improvement in survival, although statistically significant, might be modest, and the benefits should be weighed against the potential risks and side effects of the treatment.

One of the pivotal studies for Cyramza's approval in lung cancer was the Phase III REVEL trial, which included patients with advanced NSCLC who had progressed after initial chemotherapy. The trial showed an increase in median overall survival by 1.4 months for patients treated with Cyramza plus docetaxel compared to those who received placebo plus docetaxel. Progression-free survival was also modestly improved. These results supported the FDA's decision to approve Cyramza for use in this patient population.

Exkivity (Mobocertinib) Efficacy in Lung Cancer

Exkivity (mobocertinib) is an oral tyrosine kinase inhibitor specifically designed to target EGFR exon 20 insertion mutations in NSCLC. This mutation is a less common form of EGFR mutation that has been historically difficult to treat with the first and second-generation EGFR inhibitors. Exkivity has shown promising efficacy in patients with metastatic NSCLC harboring these specific mutations, who have received prior platinum-based chemotherapy.

The efficacy of Exkivity was evaluated in a multicenter, open-label, non-randomized, phase 1/2 trial. The results demonstrated a substantial response rate, with a significant proportion of patients exhibiting tumor shrinkage. Additionally, the duration of response and progression-free survival were clinically meaningful, indicating that Exkivity provides a new treatment option for this subset of NSCLC patients. The FDA granted accelerated approval to Exkivity based on these results, although continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.