Ensacove (ensartinib)

P1/2, N=164, Recruiting, Betta Pharmaceuticals Co., Ltd.

The progression-free survival (PFS) exceeded 32 months, with no significant treatment-related adverse events observed. This study investigates the feasibility of combining targeted therapy with local radiotherapy, guided by genetic testing, to offer novel treatment strategies for patients with advanced primary pulmonary EIMS..

P2, N=10, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026

Among patients who received next-generation ALK TKIs as first-line therapy, continuation of next-generation ALK TKI with PT/Pem led to longer PFS and OS than PT/Pem alone, with no unanticipated toxicities. The modest efficacy of PT/Pem-based regimens overall underscores the need for more effective therapies for TKI-refractory ALK+ NSCLC.

Since the approval of crizotinib, several next-generation ALK inhibitors have been introduced, offering improved treatment outcomes. The phase III eXalt3 study, a global randomized open-label trial, compared the efficacy of ensartinib, a second-generation ALK inhibitor, with crizotinib in patients with advanced ALK-rearranged NSCLC who had not received prior ALK-targeted therapy. With superior systemic and intracranial efficacy, ensartinib stands as a promising option in precision oncology. Ongoing research into improved ALK inhibitors and novel therapeutic strategies, including immune-based approaches, is expected to further improve patient outcomes.

Among the three paradigms, MET-specific monitoring provided the most favorable diagnostic performance to identify long-term responders, with a specificity of 90% and a positive predictive value of 80%. These data demonstrate that early MET-specific ctDNA clearance is a robust on-treatment biomarker for ensartinib benefit in METex14 NSCLC, while broader ctDNA profiling remains valuable for uncovering emerging resistance mechanisms.

P2, N=18, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027

Specifically, lorlatinib demonstrated superior efficacy in the Non-Asian subgroup (86.8%), patients without brain metastasis (84.7%), those with Eastern Cooperative Oncology Group performance status (ECOG PS) 0/1 (78.5%), males (71.2%), females (83.9%), patients aged < 65 years (74.3%), and never-smoking patients (89.7%)...Ensartinib achieved the optimal PFS in the Asian subgroup (71.8%)...Alectinib had the lowest hepatic and gastrointestinal AEs risk, while iruplinalkib had the lowest hematological AEs risk. https://www.crd.york.ac.uk/prospero/, identifier CRD42023495527.

Limited CIR beyond 12 months existed for brigatinib and ensartinib. Results from the Asian group's CIR aligned with global trials. Due to lower BM CIR, lorlatinib showed higher BM management cost savings compared to crizotinib and alectinib in Chinese 1 L patients.

P4, N=598, Recruiting, Jiangsu Cancer Hospital; Jiangsu Cancer Hospital

P4, N=20, Not yet recruiting, The Second Affiliated Hospital of Air Force Medical University; The Second Affiliated Hospital of Air Force Medical University