Efficacy

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). It is specifically indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Clinical trials have demonstrated the efficacy of Vizimpro in this setting. The ARCHER 1050 study, a phase III trial, compared dacomitinib to gefitinib, another EGFR TKI. Results showed a significant improvement in progression-free survival (PFS) with dacomitinib, with a median PFS of 14.7 months compared to 9.2 months with gefitinib.

Lumakras (Sotorasib) Efficacy in Lung Cancer

Lumakras (sotorasib) is a first-in-class KRASG12C inhibitor for the treatment of adults with locally advanced or metastatic NSCLC with a KRAS G12C mutation, as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on the overall response rate and duration of response. In a pivotal phase 2 study, sotorasib demonstrated a 37.1% response rate in patients with KRAS G12C-mutated NSCLC. The median duration of response was 11.1 months, showcasing the potential of sotorasib to provide clinical benefit in a previously difficult-to-treat patient population.

Both Vizimpro and Lumakras represent significant advancements in the targeted therapy landscape for lung cancer. The efficacy of these drugs underscores the importance of molecular profiling in NSCLC, as the presence of specific mutations can guide the selection of the most appropriate treatment. It is important to note that while Vizimpro is used as a first-line treatment in patients with EGFR mutations, Lumakras is used in patients who have progressed on other therapies and have the specific KRAS G12C mutation. As such, they address different patient populations within the lung cancer community.

The efficacy data for Vizimpro and Lumakras, while promising, also highlight the need for ongoing research and development of new treatments. The emergence of resistance to targeted therapies is a challenge in the management of NSCLC, and continuous efforts are being made to understand resistance mechanisms and develop next-generation therapies. Furthermore, the accelerated approval of Lumakras emphasizes the provisional nature of its current endorsement, pending further clinical trials to verify and describe the anticipated benefit.