Efficacy

Imfinzi (Durvalumab) Efficacy in Lung Cancer

Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma and for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. In the context of lung cancer, the efficacy of Imfinzi has been demonstrated in the PACIFIC trial, a Phase 3, randomized, double-blind, placebo-controlled, multi-center study. Patients treated with Imfinzi showed a significant improvement in median progression-free survival compared to those receiving placebo. This benefit was observed across all pre-specified subgroups, including varying levels of PD-L1 expression.

Furthermore, the PACIFIC trial results also indicated an improvement in overall survival for patients treated with Imfinzi. The drug has been shown to reduce the risk of death compared to placebo, marking a significant advancement in the treatment of Stage III NSCLC. The safety profile of durvalumab in this trial was consistent with its known adverse effects, which include, but are not limited to, immune-mediated pneumonitis, hepatitis, colitis, endocrinopathies, and nephritis.

Vizimpro (Dacomitinib) Efficacy in Lung Cancer

Vizimpro (dacomitinib) is an oral, once-daily, irreversible pan-human epidermal growth factor receptor (HER) tyrosine kinase inhibitor (TKI) that is indicated for the first-line treatment of patients with metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. The efficacy of Vizimpro was established in a randomized, multicenter, open-label, active-controlled trial (ARCHER 1050) comparing it to gefitinib, another EGFR TKI, in patients with previously untreated metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.

In the ARCHER 1050 study, Vizimpro demonstrated a statistically significant improvement in progression-free survival compared to gefitinib. Additionally, an improvement in overall survival was also observed. The trial results showed that patients receiving Vizimpro had a longer duration of response than those receiving gefitinib. It is important to note that the adverse effects associated with Vizimpro can be severe and may include diarrhea, rash, stomatitis, nail toxicity, decreased appetite, and dry skin, among others. The treatment decision should be based on a thorough assessment of the patient's overall health and the presence of EGFR mutations.