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New Indication: Crizotinib for ALK-positive inflammatory myofibroblastic tumor - Altai Oncology
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New Indication: Crizotinib for ALK-positive inflammatory myofibroblastic tumor

New Indication: Crizotinib for ALK-positive inflammatory myofibroblastic tumor
Study:
  • Multicenter, single‐arm, open‐label phase 1b study (PROFILE 1013)
  • ALK‐positive advanced malignancies other NSCLC (N:44)
  • Crizotinib 250 mg x 2 /day
Efficacy:
  • ORR: 53% (95% CI, 28-77), CR:8/18 and PR:1/18 patients for lymphoma
  • ORR: 67% (95% CI, 30-93), CR:8/9 and PR:1/9 patients for IMT
  • 2 year PFS: 63% and 67% (lymphoma and IMT)
Safety:
  • Treatment related AEs: 88.6%
  • Any grade AEs: Diarrhea: 45.5%, vision disorder: 45.5%, nausea:%38.6%
  • Serious AEs:20.5%  CPK increase: 6.8%

Am J Hematol. 2018 May;93(5):607-614.

Gambacorti-Passerini C, Orlov S, Zhang L, et al. Long-term effects of crizotinib in ALK-positive tumors (excluding NSCLC): A phase 1b open-label study.

https://doi.org/10.1002/ajh.25043

Reviewed by Hasan Çağrı Yıldırım, MD on Aug 16, 2022

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