- |||||||||| Biomarker, Trial suspension, Metastases: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (clinicaltrials.gov) - Jan 5, 2022
P2, N=2316, Suspended, However, since there is little comparative evidence on the treatment options, there is need for relative trials to fully determine the best treatment options as well as the rapidly evolving treatment landscape. Recruiting --> Suspended
- |||||||||| Ensacove (ensartinib) / Xcovery
Trial completion date: Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK (clinicaltrials.gov) - Nov 24, 2021 P1, N=24, Recruiting, The implementation of a newer generation of ALK-TKIs in the first-line treatment of ALK-positive NSCLC into current clinical practice is evolving rapidly. Trial completion date: Dec 2020 --> Dec 2022
- |||||||||| ensartinib (X-396) / Xcovery
[VIRTUAL] Unique Efficacy of Ensartinib on Different ALK Fusion Subtypes Evaluated by Plasma ctDNA (ePoster Hall) - Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_1014; Ensartinib, a next generation ALK TKI approved by NMPA in China, showed comparable efficacy to other ALK TKIs in the post-crizotinib setting...Conclusion Consistent with previous reports, ensartinib showed high clinical efficacy. In particular, the similar efficacy of ensartinib between V1 and V3 subtypes and its non-inferior efficacy on the low-level ctDNA group differentiate ensartinib from other ALK-TKIs and provide directions for future clinical trial validation.
- |||||||||| Lorbrena (lorlatinib) / Pfizer
[VIRTUAL] Lorlatinib in First Line Treatment of Patients With ALK - Positive NSCLC: A Network Meta - Analysis (ePoster Hall) - Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_932; P3 Treatment comparison Lorlatinib vs: Studies PFS HR (95% CrI) Alectinib (600 mg) ALEX, ALESIA* 0.61 (0.38 to 0.99) Alectinib (300 mg) J-ALEX* 0.82 (0.36 to 1.85) Brigatinib ALTA-1L 0.57 (0.34 to 0.95) Ceritinib (750 mg) ASCEND-4, ASCEND-8 0.22 (0.13 to 0.37) Ceritinib (450 mg) ASCEND-8 0.31 (0.15 to 0.66) Ceritinib (600 mg) ASCEND-8 0.25 (0.12 to 0.54) Crizotinib CROWN, ALEX, ALESIA*, J-ALEX*, ALTA-1L, ASCEND-4, ASCEND-8, PROFILE 1014, PROFILE 1029*, eXalt3 0.28 (0.19 to 0.41) Ensartinib eXalt3 0.55 (0.32 to 0.93) Chemotherapy ASCEND-4, PROFILE 1014, PROFILE 1029* 0.12 (0.08 to 0.19) Key: CrI, credible interval; HR hazard ratio; PFS, progression-free survival Notes: *Study in Asian population only Conclusion For PFS, lorlatinib reduced the hazard of progression or death compared to all other treatments based on analyses conducted using all studies when comparing to all studies. This NMA suggest that lorlatinib is an effective first line treatment for ALK+ NSCLC patients when compared to other next-generation ALK TKIs.
- |||||||||| ensartinib (X-396) / Xcovery
Clinical, Journal: Pharmacology and Clinical Evaluation of Ensartinib Hydrochloride Capsule (Pubmed Central) - Jul 21, 2021 Several phase I to III clinical trials included both healthy volunteers and NSCLC patients have been conducted both in China and abroad. In this review, we briefly summarized the results of these trials, and preliminary efficacy, safety, pharmacology and pharmacokinetics/pharmacodynamics of ensartinib were discussed.
- |||||||||| Ensacove (ensartinib) / Xcovery
Trial completion date, Trial primary completion date: Treating Patients With Melanoma and ALK Alterations With Ensartinib (clinicaltrials.gov) - Jan 26, 2021 P2, N=18, Active, not recruiting, Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Mar 2021 --> Dec 2021 Trial completion date: Jan 2021 --> Jan 2022 | Trial primary completion date: Jan 2021 --> Jan 2022
- |||||||||| Review, Journal: How to select the best upfront therapy for metastatic disease? Focus on ALK-rearranged non-small cell lung cancer (NSCLC). (Pubmed Central) - Jan 26, 2021
Ceritinib, another second-generation ALK inhibitor has been shown to be superior to chemotherapy in ALK-rearranged disease with good CNS activity...Lorlatinib, a third-generation ALK inhibitor, has demonstrated activity in the treatment naïve setting and in resistance to crizotinib and second-generation ALK inhibitors...Another new ALK inhibitor, ensartinib, has demonstrated efficacy in the first-line setting and in alectinib refractory disease. Additional studies are underway examining mechanisms of resistance and best treatment options post resistance.
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