Alecensa (alectinib)

Crizotinib showed no significant difference in progression-free survival (PFS) or overall survival (OS) between first-line and post-chemotherapy use (PFS: p = 0.803; OS: p = 0.761). For second-generation ALK-TKIs, first-line treatment had numerically longer PFS compared to post-chemotherapy (alectinib: 41 vs 24 months; ceritinib: 30 vs 8 months), but these differences were not statistically significant after adjustment (p = 0.120 and 0.284, respectively)...Among patients treated with alectinib, there appears to be a trend toward shorter PFS and OS in those with MET overexpression. In a limited number of matched samples, PD-L1 expression did not change significantly after TKI resistance, although a slight increase was observed.

ALK inhibitors, including crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib has significantly improved clinical outcomes in ALK-rearranged NSCLC patients. To overcome these resistance mechanisms, the development of novel therapeutic strategies are required. By integrating structural biology, mutation evolution patterns, and emerging therapeutic approaches, this review underscores the need for next-generation inhibitors to overcome resistance and improve long-term outcomes in patients with ALK-positive NSCLC.

She received alectinib combined with CNS-directed chemotherapy and has remained in complete remission for 20 months on alectinib maintenance. These cases suggest that alectinib, combined with CNS-directed chemotherapy, is effective in both ALK-positive ALCL with CNS relapse and primary isolated CNS disease.

This multinational registry-based analysis highlights evolving global treatment patterns, supports newer TKIs' effectiveness, and identifies clinical and molecular factors associated with treatment duration.

P3, N=187, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed

These findings suggest that osimertinib crosses the placenta with a moderate tissue uptake, while alectinib and its metabolite M4 do not appear to be transferred to the fetus but accumulate significantly within the placental tissue. Further studies are needed to guide treatment selection for NSCLC in pregnant women.

Recent clinical trials have led to US Food and Drug Administration approval of osimertinib and alectinib as adjuvant treatments for resected pathologic stage II/III EGFR and ALK-mutated NSCLC; their use in the neoadjuvant setting remains subject to trials. These questions are the subject of two ongoing National Clinical Trials Network trials: CTIU2317-A082304-S2402-Perioperative versus Adjuvant Systemic Therapy in Patients with Resectable NSCLC (PROSPECT-Lung; ClinicalTrials.gov Identifier: NCT04267848)-and S2414-A Randomized Phase III Trial Incorporating Pathologic Response in Participants with Early-Stage NSCLC to Optimize Immunotherapy in the Adjuvant Setting (INSIGHT; ClinicalTrials.gov Identifier: NCT06498635). We discuss why there is sufficient equipoise to justify seeking answers to these two extremely important, patient-centered questions.

In this real-world Vietnamese cohort, first-line alectinib showed superior intracranial and systemic efficacy over ceritinib. In resource-limited settings, ceritinib combined with upfront brain RT is a reasonable clinical alternative. The differential benefit of brain RT between the two TKIs remains hypothesis-generating.

This case highlights the possibility that alectinib may impair postoperative wound repair. Comprehensive perioperative drug evaluation, multidisciplinary collaboration, and carefully monitored treatment interruption are recommended to maintain the balance between oncologic control and effective tissue healing.

While second- and third-generation ALKi (including alectinib, brigatinib, ensartinib, envonalkib, and lorlatinib) have demonstrated superior efficacy compared with the first-generation inhibitor crizotinib in randomized trials, the absence of direct head-to-head comparisons limits the definition of their relative clinical benefit. This indirect comparison indicates that lorlatinib provides the most durable PFS and the strongest intracranial disease control, although ALKis are characterized by distinct toxicity profiles. In the absence of clear OS differences at present, first-line treatment selection should integrate efficacy, intracranial activity, tolerability, and emerging molecular features within a personalized therapeutic framework.

One case harbored an ALK rearrangement, guiding effective targeted therapy with alectinib...Accurate histopathological assessment is essential to establish a correct diagnosis and guide appropriate therapy. A multidisciplinary approach remains the cornerstone of diagnostic precision in CUP cases.

The patient subsequently received palliative systemic chemotherapy with an alectinib-based targeted regimen starting in April 2025, but showed progressive disease on follow-up, even with additional second-line gemcitabine/cisplatin and third-line pembrolizumab therapy. This case highlights that even relatively subtle-appearing lesions require a high index of suspicion for malignancy, emphasizing the importance of early biopsy and comprehensive systemic evaluation. Carcinosarcoma, though rare, should be considered in the differential diagnosis of aggressive tumors arising in atypical locations.