Ensacove (ensartinib)

A 63-year-old female underwent radical resection for stage IA lung adenocarcinoma (ALK-positive) and received adjuvant ensartinib...The patient was subsequently treated with lorlatinib combined with stereotactic radiotherapy...This case highlights that during long-term follow-up of patients with malignancies, a new intracranial lesions may warrant consideration of a second primary cancer (SPC), particularly when the treatment response is not consistent with the expected biology of the original tumor. Timely pathological confirmation and multidisciplinary review may help reduce diagnostic delay and improve treatment selection.

CT at 3 months showed marked regression, with sustained disease control at 12 months. This case illustrates an objective imaging response to ALK-directed therapy in RAIR thyroid carcinoma.

Long-term outcomes remain to be determined. This case expands the spectrum of ALK rearrangements and highlights the critical role of molecular profiling in guiding adjuvant treatment decisions for early-stage, high-risk non-small cell lung cancer (NSCLC).

According to current analyses, although treatment initiating with the third-generation ALK-TKI led in effectiveness, chemotherapy-dominated sequential treatment remained the most cost-effective option when costs were considered. Our study identified a strong physician-patient alignment on preference priorities for treatment pathway selection, placing greater weight on the efficacy dimension, which was reflected in the high preference for sequential second- and third-generation ALK-TKI strategies. These findings underscore the importance of strategic ALK-TKI sequencing and ​​advocate for​​ shared decision-making.

We report the case of a 50-year-old woman with advanced ALK-positive NSCLC who experienced rapid tumor regression after 1 month of treatment with ensartinib, complicated by mild bilateral interstitial pneumonitis...Following progression on second-line chemotherapy, she was rechallenged with lorlatinib, which induced severe cutaneous toxicity that responded to corticosteroids...These findings highlight the need for heightened vigilance, multidisciplinary management, and the development of predictive biomarkers for TKI-associated toxicities. Future prospective studies are essential to guide safe rechallenge strategies and personalize toxicity monitoring in ALK-positive NSCLC.

P2, N=10, Terminated, National Cancer Institute (NCI) | Trial completion date: Mar 2027 --> Mar 2026 | Active, not recruiting --> Terminated; Inadequate accrual rate

The HEATR5B-ALK fusion is targetable by ensartinib, producing durable disease control and excellent tolerability. Comprehensive NGS and ALK IHC are essential for detecting rare actionable ALK variants.

P1/2, N=20, Recruiting, Tang-Du Hospital | Not yet recruiting --> Recruiting

The patient recovered well and was discharged after four postoperative days. During more than four years of follow-up, long-term ensartinib therapy was associated with stable disease without recurrence, offering potential clinical insights for managing LUAD with rare ALK variants.

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..

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