Dr Chiappori on the Integration of Ensartinib Into the NSCLC Treatment Arsenal

"Becoming familiar with all of those drugs [in the first-line treatment arsenal] is the first step. The second step would be to remember that we cannot scientifically claim that any of these drugs are superior to the others. Whether you choose one or another will depend on your experience and knowledge of the data corresponding to each of those drugs."

Alberto Chiappori, MD, a senior member of Oncology and Medicine for the Thoracic Oncology Program at the H. Lee Moffitt Cancer Center and Research Institute, outlines steps for incorporating ensartinib (Ensacove) into the first-line treatment armamentarium for patients with ALK-positive non–small cell lung cancer (NSCLC).

Ensartinib is now included in version 3 of the 2025 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for NSCLC as a preferred category 1 first-line therapy option for patients with ALK-positive disease; this inclusion in the NCCN guidelines follows the agent’s FDA approval in December 2024 for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have not previously received an ALK inhibitor. The agent joins alectinib (Alecensa), brigatinib (Alunbrig), and lorlatinib (Lorbrena) in this recommendation category.

The selection of first-line therapy for ALK-positive NSCLC requires familiarity with the available treatment arsenal, Chiappori begins. Oncologists must first understand the efficacy and toxicity profiles of alectinib, brigatinib, and lorlatinib, which serve as standard options, he says. With the introduction of ensartinib, oncologists must alsoassess this agent’s clinical data and safety profile to determine how it compares with those of existing therapies, Chiappori continues. However, there is currently no conclusive evidence to establish the superiority of one of these frontline agents over another, he notes. Treatment selection should therefore be guided by individual clinical experience and an understanding of the available data, Chiapporiemphasizes.

Integrating a new agent into clinical practice involves gaining firsthand experience, he says, adding that prescribing ensartinib to patients will provide an opportunity to compare its real-world performance with other ALK inhibitors. Although a direct, randomized phase 3 trial comparing all 4 agents is unlikely to occur, oncologists can develop their own insights to determine whether incorporating ensartinib into practice is beneficial in specific clinical scenarios, he states. Ultimately, treatment decisions should be tailored to individual patient needs, weighing the efficacy, safety, and practical considerations associated with each agent, Chiappori concludes.