On December 18, 2024, the Food and Drug Administration sanctioned ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously been treated with an ALK inhibitor.
Efficacy and Safety
The efficacy was assessed in eXALT3 (NCT02767804), an open-label, randomized, active-controlled, multicenter trial involving 290 patients with locally progressed or metastatic ALK-positive NSCLC who had not previously undergone ALK-targeted treatment. Patients were randomized in a 1:1 ratio to receive either ensartinib or crizotinib.
The primary effectiveness endpoint was progression-free survival (PFS) assessed by blinded independent central review. The primary secondary efficacy outcome measure was overall survival (OS). Ensartinib exhibited a statistically significant enhancement in progression-free survival (PFS) vs to crizotinib, with a hazard ratio (HR) of 0.56 (95% CI: 0.40, 0.79; p-value 0.0007).
The median progression-free survival (PFS) was 25.8 months (95% confidence interval: 21.8, not estimable) in the ensartinib group and 12.7 months (95% confidence interval: 9.2, 16.6) in the crizotinib group. No statistically significant change in overall survival was observed (HR 0.88 [95% CI: 0.63, 1.23], p-value 0.4570).
The predominant adverse responses (≥20%) included rash, musculoskeletal pain, constipation, cough, pruritus, nausea, edema, pyrexia, and exhaustion.
Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.
Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.
Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.
Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.
These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.
Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.
