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Gene ROS1
Variant fusion
Impact List fusion
Protein Effect unknown
Gene Variant Descriptions ROS1 fusion indicates a fusion of the ROS1 gene, but the fusion partner is unknown.
Associated Drug Resistance
Category Variants Paths

ROS1 mutant ROS1 rearrange ROS1 fusion

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No Variant Reference Transcript is Available.
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Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
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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 no benefit Erlotinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ROS1 rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma no benefit Osimertinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ROS1 rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma sensitive Iruplinalkib Phase I Actionable In a Phase I trial, Iruplinalkib (WX-0593) demonstrated safety and resulted in an objective response rate (ORR) of 56.6% (56/99; all partial responses) and a disease control rate (DCR) of 83.8% (83/99), and median duration of response and median progression-free survival were not reached in non-small cell lung cancer patients with an ALK or ROS1-rearrangement, with an ORR of 44.4% (4/9) and DCR of 66.7% (6/9) in patients with a ROS1 rearrangement (PMID: 35087031). 35087031
ROS1 rearrange Advanced Solid Tumor predicted - sensitive TQ-B3101 Case Reports/Case Series Actionable In a Phase I trial, TQ-B3101 treatment was well tolerated and resulted in an objective response rate (ORR) of 62.5% (15/24) in patients with ALK-positive, ROS1-positive, or MET-amplified advanced solid tumors, with an ORR of 62.5% (5/8) in patients with brain metastases (J Clin Oncol 38, 2020 (suppl 15; abstr e21705); NCT03019276). detail...
ROS1 rearrange lung adenocarcinoma sensitive Crizotinib Phase I Actionable In a retrospective analysis of Phase I clinical data, Xalkori (crizotinib) resulted in an objective response rate of 80% (24/30) and a median PFS of 9.1 months in patients with ROS1 rearranged lung adenocarcinoma (PMID: 25667280). 25667280
ROS1 rearrange lung non-small cell carcinoma sensitive Foritinib Phase II Actionable In a Phase II trial, Foritinib treatment led to an 89% (65/73, 65 partial responses (PR)) objective response rate (ORR), median duration of response (mDOR) of 20.7 mo, and median progression-free survival (mPFS) of 22.1 mo in ROS1 inhibitor-naive non-small cell lung cancer patients harboring a ROS1 rearrangement, including a 92.3% (24/26) ORR in patients with CNS lesions, and a 40% (10/25, 10 PR) ORR, mDOR of 7.0 mo, and mPFS of 5.5 mo in patients who received prior crizotinib (PMID: 39059398; NCT04237805). 39059398
ROS1 rearrange lung non-small cell carcinoma sensitive Ceritinib Phase II Actionable In a Phase II trial, treatment with Zykadia (ceritinib) resulted in an overall response rate of 62% (20/32, including 1 complete response), a disease control rate of 81% (26/32), and a progression-free survival of 9.3 months in all patients and 19.3 months in Xalkori (crizotinib)-naive patients with non-small cell lung cancer harboring a ROS1 rearrangement (PMID: 28520527; NCT01964157). 28520527
ROS1 rearrange lung non-small cell carcinoma sensitive Ceritinib Guideline Actionable Zykadia (ceritinib) is included in guidelines as first-line therapy for ROS1-rearranged non-small cell lung cancer, but is not indicated after patients become resistant to Xalkori (crizotinib) (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma sensitive Ceritinib Guideline Actionable Zykadia (ceritinib) is included in guidelines for patients with metastatic non-small cell lung cancer harboring a ROS1 rearrangement who have not received prior Xalkori (crizotinib) therapy (PMID: 30285222; ESMO.org). 30285222 detail...
ROS1 rearrange lung non-small cell carcinoma no benefit Afatinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ROS1 rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma predicted - sensitive Carboplatin + Pembrolizumab + Pemetrexed Disodium Clinical Study - Cohort Actionable In a retrospective analysis, immune checkpoint inhibitor plus chemotherapy (including Keytruda (pembrolizumab) plus pemetrexed and carboplatin, n=11) in ROS1-rearranged non-small cell lung cancer patients led to an overall response rate (ORR) of 83% (5/6), disease control rate (DCR) of 100%, and duration of response (DOR) of 24.3 mo as first-line, an ORR of 28.6% (4/14), DCR of 92.9%, and DOR of 4.8 mo as subsequent-line, and an intracranial ORR of 40% (4/10) and intracranial DCR of 90% (PMID: 36952645). 36952645
ROS1 rearrange Advanced Solid Tumor predicted - sensitive Entrectinib Clinical Study Actionable In a combined analysis of 2 Phase I trials (ALKA-372-001, STARTRK-1), Rozlytrek (entrectinib) treatment resulted in an objective response rate of 86% (12/14) in patients with ROS-1 rearranged advanced solid tumors that were treatment-naive, but no response (0/6) in patients who received prior Xalkori (crizotinib) (PMID: 28183697; NCT02097810). 28183697
ROS1 rearrange lung non-small cell carcinoma predicted - sensitive Taletrectinib Phase I Actionable In a Phase I trial, Taletrectinib (DS6051b) demonstrated manageable toxicity, resulted in an objective response rate of 33.3% (2/6) in patients with advanced non-small cell lung cancer harboring ROS1 rearrangements (PMID: 32591465). 32591465
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 the preferred first-line therapy for ROS1 rearranged non-small cell lung cancer (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma sensitive Crizotinib FDA approved - On Companion Diagnostic Actionable In a Phase I trial (PROFILE 1001) that supported FDA approval, 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 non-small cell lung cancer harboring ROS1 rearrangements as detected by an FDA-approved test (PMID: 30980071; NCT00585195). detail... detail... 30980071
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 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
ROS1 rearrange lung non-small cell carcinoma no benefit Brigatinib Guideline Actionable Alunbrig (brigatinib) is not indicated for use in ROS1 rearranged non-small cell lung cancer patients whose disease became resistant to Xalkori (crizotinib) (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma no benefit Brigatinib Case Reports/Case Series Actionable In a retrospective analysis, Alunbrig (brigatinib) treatment resulted in a partial response in a patient with Xalkori (crizotinib)-naive non-small cell lung cancer (NSCLC) harboring ROS1 rearrangement, and resulted in 1 partial response and 1 stable disease in 7 patients with Xalkori (crizotinib)-resistant NSCLC harboring ROS1 rearrangements (PMID: 32462394). 32462394
ROS1 rearrange Cancer of Unknown Primary sensitive Crizotinib Guideline Actionable Xalkori (crizotinib) is included in guidelines for patients with cancer of unknown primary harboring ROS1 rearrangements (PMID: 36563965, PMID: 30285222; ESMO.org). detail... 30285222 36563965
ROS1 rearrange lung non-small cell carcinoma sensitive Entrectinib Clinical Study Actionable In a combined analysis of 2 Phase I trials (ALKA-372-001, STARTRK-1), Rozlytrek (entrectinib) treatment resulted in a complete response in 15% (2/13) and partial response in 77% (10/13) patients with ROS-1 rearranged non-small cell lung carcinoma that were treatment-naive (PMID: 28183697; NCT02097810). 28183697
ROS1 rearrange lung non-small cell carcinoma sensitive Entrectinib Guideline Actionable Rozlytrek (entrectinib) is included in guidelines as a first-line or subsequent therapy for patients with advanced or metastatic ROS1 rearrangement-positive non-small cell lung cancer (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma sensitive Entrectinib Guideline Actionable Rozlytrek (entrectinib) 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 ROS1 inhibitor therapy (PMID: 30285222, Version Update 15 Sept 2020; ESMO.org). 30285222 detail...
ROS1 rearrange lung non-small cell carcinoma no benefit Gefitinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ROS1 rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma predicted - sensitive Carboplatin + Paclitaxel + Pembrolizumab Clinical Study - Cohort Actionable In a retrospective analysis, immune checkpoint inhibitor plus chemotherapy (including Keytruda (pembrolizumab) plus paclitaxel and carboplatin, n=7) in ROS1-rearranged non-small cell lung cancer patients led to an overall response rate (ORR) of 83% (5/6), disease control rate (DCR) of 100%, and duration of response (DOR) of 24.3 mo as first-line, an ORR of 28.6% (4/14), DCR of 92.9%, and DOR of 4.8 mo as subsequent-line, and an intracranial ORR of 40% (4/10) and intracranial DCR of 90% (PMID: 36952645). 36952645
ROS1 rearrange lung non-small cell carcinoma sensitive Repotrectinib Guideline Actionable Augtyro (repotrectinib) is included in guidelines as first-line or subsequent therapy for patients with advanced or metastatic non-small cell lung cancer harboring a ROS1 rearrangement (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma sensitive Repotrectinib Guideline Actionable Augtyro (repotrectinib) 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 ROS1 inhibitor therapy (PMID: 30285222, Version Update 15 Sept 2020; ESMO.org). detail... 30285222
ROS1 rearrange lung non-small cell carcinoma sensitive NPS-1034 Preclinical - Cell culture Actionable In a preclinical study, NPS-1034 inhibited ROS1 activity and proliferation of a non-small cell lung cancer cell line harboring a ROS1 rearrangement in culture (PMID: 24165158). 24165158
ROS1 rearrange lung non-small cell carcinoma sensitive Lorlatinib Guideline Actionable Lorbrena (lorlatinib) is included in guidelines as subsequent therapy in patients with advanced or metastatic ROS1-rearranged non-small lung cancer (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma sensitive Lorlatinib Phase Ib/II Actionable In a Phase I/II trial, Lorbrena (lorlatinib) treatment resulted in an objective response rate of 62% (13/21) in tyrosine kinase inhibitor (TKI)-naive and 35% (14/40) in previous Xalkori (crizotinib)-treated patients with non-small cell lung cancer harboring ROS1 rearrangements, intracranial responses were observed in 64% (7/11) of TKI-naive patients and 50% (12/24) of previous Xalkori (crizotinib)-treated patients (PMID: 31669155; NCT01970865). 31669155
ROS1 rearrange lung non-small cell carcinoma sensitive Lorlatinib Phase I Actionable In a Phase I trial, Lorbrena (lorlatinib) treatment resulted in an objective response in 50% (6/12) of patients with non-small cell lung carcinoma harboring a ROS1 rearrangement (PMID: 29074098; NCT03052608). 29074098
ROS1 rearrange lung non-small cell carcinoma sensitive Lorlatinib Guideline Actionable Lorbrena (lorlatinib) 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 ROS1 inhibitor therapy (PMID: 30285222, Version Update 15 Sept 2020; ESMO.org). 30285222 detail...
ROS1 rearrange lung non-small cell carcinoma no benefit Alectinib Guideline Actionable Alecensa (alectinib) is not indicated for use in ROS1 rearranged non-small cell lung cancer patients whose disease became resistant to Xalkori (crizotinib) (NCCN.org). detail...
ROS1 rearrange lung non-small cell carcinoma sensitive TQ-B3101 Phase Ib/II Actionable In a Phase I/II trial, TQ-B3101 treatment demonstrated safety and resulted in an objective response rate (ORR) of 80.2% (89/111, 1 complete response (CR), 88 partial (PR)), disease control rate (DCR) of 88.3%, median duration of response of 20.3 mo, median progression-free survival of 16.5 mo, and intracranial ORR of 72.7% (8/11, 1 CR, 7 PR) and DCR of 90.9% in patients with non-small cell lung cancer harboring ROS1 rearrangements (PMID: 37385995; NCT03019276, NCT03972189). 37385995