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Molecular Profile ROS1 rearrange
Therapy Crizotinib
Indication/Tumor Type lung non-small cell carcinoma
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ROS1 rearrange lung non-small cell carcinoma sensitive Crizotinib Guideline Actionable Xalkori (crizotinib) is included in guidelines as first-line or subsequent therapy for patients with advanced or metastatic ROS1-rearranged non-small cell lung cancer (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma sensitive Crizotinib Phase II Actionable In a Phase II clinical trial, patients with non-small cell lung cancer harboring a ROS1 rearrangement demonstrated an objective response rate of 70% (21/30; all partial response), a median progression-free survival (PFS) of 20 months, a duration of response of 19 months, and a survival rate of 83% at 12 months and 63% at 24 months, when treated with Xalkori (crizotinib) (PMID: 30978502; NCT02183870). 30978502
ROS1 rearrange lung non-small cell carcinoma sensitive Crizotinib Phase I Actionable In a Phase I trial (PROFILE 1001), Xalkori (crizotinib) treatment resulted in an objective response rate of 72% (38/53), with 6 complete responses and 32 partial responses, a median duration of response of 24.7 months, a median progression-free survival of 19.3 months, and a median overall survival of 51.4 months in patients with POS1-positive non-small cell lung cancer (PMID: 30980071; NCT00585195). 30980071
ROS1 rearrange lung non-small cell carcinoma sensitive Crizotinib Guideline Actionable Xalkori (crizotinib) is included in the Pan-Asian Guidelines Adaptation (PAGA) as first-line therapy for advanced and metastatic non-small cell lung cancer patients with ROS1 rearrangements (PMID: 39615406; ESMO.org). 39615406 detail...
ROS1 rearrange lung non-small cell carcinoma sensitive Crizotinib Phase II Actionable In a Phase II trial (AcSe), treatment with Xalkori (crizotinib) resulted in a an overall response rate after 2 cycles of 47.2% (17/36; all partial responses), and after 4 cycles resulted in a best overall response rate of 69.4% (21/36; 20 partial responses and 1 complete response), and a median progression-free survival of 5.5 months and median overall survival of 17.2 months in patients with ROS1-translocated non-small cell lung cancer (PMID: 31584608; NCT02034981). 31584608
ROS1 rearrange lung non-small cell carcinoma sensitive Crizotinib Guideline Actionable Xalkori (crizotinib) is included in guidelines as first-line therapy for patients with metastatic non-small cell lung cancer harboring a ROS1 rearrangement, or as a next-line therapy in patients with ROS1-rearranged non-small cell lung cancer who have not received prior Xalkori (crizotinib) therapy (PMID: 30285222; ESMO.org). detail... 30285222
PubMed Id Reference Title Details
NCCN.org Full reference...
ESMO Clinical Practice Guidelines Full reference...
ESMO Clinical Practice Guidelines Full reference...
(30978502) Safety and Efficacy of Crizotinib in Patients With Advanced or Metastatic ROS1-Rearranged Lung Cancer (EUCROSS): A European Phase II Clinical Trial. Full reference...
(30980071) Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Full reference...
(31584608) Crizotinib in c-MET- or ROS1-positive NSCLC: results of the AcSé phase II trial. Full reference...
(30285222) Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Full reference...
(39615406) Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with oncogene-addicted metastatic non-small-cell lung cancer. Full reference...