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Gene Symbol ROS1
Synonyms c-ros-1 | MCF3 | ROS
Gene Description ROS1, ROS proto-oncogene 1, receptor tyrosine kinase, is an orphan receptor tyrosine kinase that may activates multiple pathways involved in cell survival and transformation (PMID: 23719267, PMID: 32327173). ROS1 fusion proteins frequently lead to constitutive activation of Ros1 signaling and have been identified in glioblastoma, non-small cell lung cancer, cholangiocarcinoma, ovarian cancer, gastric adenocarcinoma, colorectal cancer, inflammatory myofibroblastic tumor, angiosarcoma, glioma, and epithelioid hemangioendothelioma (PMID: 23719267, PMID: 30262706, PMID: 30171048, PMID: 3004937), and ROS1 mutations are often associated with acquired resistance to inhibition (PMID: 31256210).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ROS1 positive pancreatic cancer predicted - sensitive Entrectinib Case Reports/Case Series Actionable In a Phase I trial, Rozlytrek (entrectinib) treatment resulted in stable disease in a patient with ROS1-positive pancreatic cancer (J Clin Oncol 32:5s, 2014 (suppl; abstr 2502)). detail...
ROS1 G2032R Advanced Solid Tumor predicted - resistant Crizotinib Preclinical - Biochemical Actionable In a preclinical study, Xalkori (crizotinib) treatment did not inhibit kinase activity of a transformed cell line expressing ROS1 G2032R in culture (PMID: 32918045). 32918045
ROS1 G2032R Advanced Solid Tumor predicted - resistant Ceritinib Preclinical - Biochemical Actionable In a preclinical study, Zykadia (ceritinib) treatment did not inhibit kinase activity of a transformed cell line expressing ROS1 G2032R in culture (PMID: 32918045). 32918045
ROS1 G2032R Advanced Solid Tumor predicted - sensitive Lorlatinib Preclinical - Biochemical Actionable In a preclinical study, Lorbrena (lorlatinib) inhibited kinase activity of a transformed cell line expressing ROS1 G2032R in culture (PMID: 32918045). 32918045
ROS1 G2032R Advanced Solid Tumor predicted - sensitive Foritinib Preclinical - Biochemical Actionable In a preclinical study, Foritinib inhibited kinase activity of a transformed cell line expressing ROS1 G2032R in culture (PMID: 32918045). 32918045
ROS1 fusion ROS1 G2032R lung non-small cell carcinoma predicted - sensitive Repotrectinib Phase I Actionable In a Phase I/II trial (TRIDENT-1), Augtyro (repotrectinib) treatment resulted in a confirmed objective response rate of 59% (10/17) in patients with TKI-pretreated, ROS1 fusion-positive non-small cell lung cancer harboring ROS1 G2032R (PMID: 38197815; NCT03093116). 38197815
ROS1 fusion ROS1 G2032R Advanced Solid Tumor predicted - sensitive Repotrectinib Phase I Actionable In a Phase I (TRIDENT-1) trial, Augtyro (repotrectinib) treatment resulted in partial response in a patient with advanced solid tumor harboring ROS1 G2032R in the context of ROS1 fusion (J Clin Oncol 36, 2018 (suppl; abstr 2513); NCT03093116). detail...
ROS1 fusion ROS1 G2032R lung non-small cell carcinoma predicted - sensitive Taletrectinib Case Reports/Case Series Actionable In a Phase II trial (TRUST-I), Taletrectinib (DS6051b) treatment resulted in an objective response rate of 66.7% (8/12, all partial responses) in patients with non-small cell lung cancer harboring ROS1 fusions with secondary ROS1 G2032R mutations (PMID: 38822758; NCT04395677). 38822758
ROS1 fusion ROS1 G2032R lung non-small cell carcinoma predicted - sensitive NUV-520 Phase I Actionable In a Phase I trial (ARROS-1), NUV-520 treatment resulted in 6 partial responses among 12 patients with non-small cell lung cancer harboring a ROS1 fusion including a partial response in 5 of 7 patients harboring a ROS1 fusion with ROS1 G2032R (Eu J Cancer 2022 Vol 174, Supp 1:S6-S7; NCT05118789). detail...
ROS1 fusion Advanced Solid Tumor sensitive Brigatinib Preclinical - Cell culture Actionable In a preclinical study, Alunbrig (brigatinib) inhibited growth of transformed cells expressing ROS1 fusion proteins in culture (PMID: 27780853). 27780853
ROS1 fusion lung non-small cell carcinoma sensitive Crizotinib FDA approved - On Companion Diagnostic Actionable In a Phase I trial that supported FDA approval, Xalkori (crizotinib) treatment resulted in an objective response rate of 72% (36/50), with 3 complete responses and 33 partial responses, a median duration of response of 17.6 months, and a median progression-free survival of 19.2 months in patients with non-small cell lung cancer harboring ROS1 rearrangements as detected by an FDA-approved test (PMID: 25264305; NCT00585195). detail... 25264305 detail...
ROS1 fusion lung non-small cell carcinoma sensitive Crizotinib Clinical Study - Cohort Actionable In a Phase II trial (NLMT), Xalkori (crizotinib) treatment resulted in an observed objective response rate (ORR) of 71% (5/7), durable clinical benefit rate (DCBR) of 75% (6/8), and medial progression-free survival (PFS) of 44.6 months in patients with non-small cell lung cancer harboring ROS1 fusions, with Bayesian estimated OR and DCBR of 68% and 71%, respectively, and Bayesian posterior probability for OR and DCBR of 0.99 and >0.99, respectively (PMID: 32669708, NCT02664935). 32669708
ROS1 fusion skin melanoma sensitive Crizotinib Guideline Actionable Xalkori (crizotinib) is included in guidelines as second-line therapy for metastatic or unresectable cutaneous melanoma patients with ROS1 fusions (NCCN.org). detail...
ROS1 fusion lung non-small cell carcinoma sensitive Lorlatinib Phase I Actionable In a Phase I clinical trial, Lorlatinib (PF-06463922) demonstrated safety and resulted in a 50% (26/52) overall response rate in patients with ALK-positive or ROS1-positive non-small cell lung cancer, including intracranial responses in patients with CNS metastasis (J Clin Oncol 34, 2016 (suppl; abstr 9009)). detail...
ROS1 fusion lung non-small cell carcinoma sensitive Entrectinib FDA approved - On Companion Diagnostic Actionable In a combined analysis of 3 clinical trials (ALKA-372-001, STARTRK-1, STARTRK-2) that supported FDA approval, Rozlytrek (entrectinib) treatment resulted in an objective response rate of 77% (41/53), a median duration of response of 25 months in patients with ROS1 fusion positive non-small cell lung cancer, with median progression-free survival of 26 and 14 months for patients without (n=30) and with (n=23) CNS disease, respectively (PMID: 31838015; NCT02097810, NCT02568267). detail... 31838015
ROS1 fusion lung non-small cell carcinoma sensitive Entrectinib Phase II Actionable In a Phase II/III trial (BFAST), Rozlytrek (entrectinib) treatment demonstrated safety and efficacy in treatment-naive advanced non-small cell lung cancer patients with ROS1 fusions detected by liquid biopsy, resulting in an investigator-assessed objective response rate of 81.5% (44/54, 2 complete and 42 partial responses), clinical benefit rate of 87% (47/54), stable disease in 7 patients, median duration of response of 13 mo, and median progression-free survival of 12.9 mo (PMID: 38898120; NCT03178552). 38898120
ROS1 fusion skin melanoma sensitive Entrectinib Guideline Actionable Rozlytrek (entrectinib) is included in guidelines as second-line therapy for metastatic or unresectable cutaneous melanoma patients with ROS1 fusions (NCCN.org). detail...
ROS1 fusion Advanced Solid Tumor predicted - sensitive Entrectinib Case Reports/Case Series Actionable In a Phase I/II trial (STARTRK-NG), Rozlytrek (entrectinib) treatment was safe and resulted in an overall response rate (ORR) of 57.7% (15/26, 7 complete responses) with median duration of response and progression-free survival no reached in pediatric patients with CNS or extracranial solid tumors harboring fusions in NTRK1, NTRK2, NTRK3, ROS1, or ALK, ORR was 62.5% (5/8) in patients harboring ROS1 fusions (PMID: 35395680; NCT02650401). 35395680
ROS1 fusion lung non-small cell carcinoma sensitive Repotrectinib FDA approved Actionable In a Phase I/II trial (TRIDENT-1) that supported FDA approval, Augtyro (repotrectinib) resulted in an objective response rate of 79% (56/71, 7 complete and 49 partial responses) and 38% (21/56, 3 complete and 18 partial responses), median duration of response of 34.1 and 14.8 months, and a median progression-free survival of 35.7 and 9.0 months in patients with TKI-naive and TKI-treated, ROS1 fusion-positive non-small cell lung cancer, respectively (PMID: 38197815; NCT03093116). 38197815 detail...
ROS1 fusion lung non-small cell carcinoma sensitive Repotrectinib Phase Ib/II Actionable In a Phase I/II trial (TRIDENT-1), Augtyro (repotrectinib) treatment resulted in an intracranial objective response rate (icORR) of 88% (7/8) with intracranial duration of response (DOR) ranging from 1.9-14.8 months in non-small cell lung cancer patients harboring ROS1 fusions who were TKI-naive, and an icORR of 42% (5/12) with intracranial DOR ranging from 3.0-11.1 months in those with 1 prior TKI and no chemo (J Clin Oncol 41, 2023 (suppl 16; abstr 9017); NCT03093116). detail...
ROS1 fusion Advanced Solid Tumor predicted - sensitive Repotrectinib Phase I Actionable In a Phase I (TRIDENT-1) trial, Augtyro (repotrectinib) treatment resulted in partial response in 21.6% (8/37) of patients with advanced solid tumors harboring ROS1 or NTRK fusions (J Clin Oncol 36, 2018 (suppl; abstr 2513); NCT03093116). detail...
ROS1 fusion lung non-small cell carcinoma predicted - sensitive Taletrectinib Phase I Actionable In a Phase I trial, Taletrectinib (DS6051b) was well-tolerated and demonstrated some preliminary efficacy in patients with advanced solid tumors, including a partial response in a patient with non-small cell lung cancer liver metastases harboring a ROS1 fusion (Cancer Res 2016;76(14 Suppl):Abstract nr CT024; NCT02279433). detail...
ROS1 fusion lung non-small cell carcinoma predicted - sensitive Taletrectinib Phase II Actionable In a Phase II trial (TRUST-I), Taletrectinib (DS6051b) treatment in non-small cell lung cancer patients with ROS1 fusions resulted in a 90.6% (96/106) overall response rate (ORR) and 95.3% disease control rate (DCR) in TKI-naive patients and 51.5% (34/66) ORR and 83.3% DCR in crizotinib-pretreated patients, intracranial ORR of 87.5% (7/8) and DCR of 100% in patients with baseline brain lesions, and partial responses in 8 of 12 patients with secondary ROS1 G2032R mutations (PMID: 38822758; NCT04395677). 38822758
ROS1 fusion lung non-small cell carcinoma predicted - sensitive Taletrectinib Phase II Actionable In a Phase II trial (TRUST-II), Taletrectinib (DS6051b) treatment demonstrated safety in ROS1 fusion-positive non-small cell lung cancer patients and resulted in a confirmed investigator-assessed objective response rate (cORRinv) of 94% (17/18) and a disease control rate (DCR) of 100% in the treatment-naive cohort and a cORRinv of 55% (12/22) and DCR of 91% in the previously treated cohort (Ann Oncol (2023) 34 (suppl_2):S788-S789; NCT04919811). detail...
ROS1 fusion lung non-small cell carcinoma unknown unspecified immune checkpoint inhibitor Clinical Study - Cohort Actionable In a retrospective clinical study, patients with non-small cell lung cancer harboring rare targetable drivers (RTD) (BRAF, ERBB2/3, RET, MET, ROS1, NTRK) who received immune checkpoint inhibitors (ICI) achieved longer median overall survival (mOS) (32 vs 13 mo, p=0.01) compared to those who did not receive ICI, mOS was not reached in a patient harboring ROS1 fusion, although RTD type was not associated with OS in a univariate analysis (PMID: 30268448). 30268448
ROS1 fusion lung non-small cell carcinoma predicted - sensitive NUV-520 Phase I Actionable In a Phase I trial (ARROS-1), NUV-520 treatment resulted in 6 partial responses among 12 patients with non-small cell lung cancer harboring a ROS1 fusion including a partial response in 5 of 7 patients harboring a ROS1 fusion with ROS1 G2032R (Eu J Cancer 2022 Vol 174, Supp 1:S6-S7; NCT05118789). detail...
ROS1 fusion lung non-small cell carcinoma predicted - sensitive TQ-B3139 Case Reports/Case Series Actionable In a Phase I trial, TQ-B3139 (CT-711) treatment demonstrated safety and resulted in an overall response rate (ORR) of 61.9% (39/63), intracranial ORR of 70% (7/10), disease control rate of 84.1% (53/63), and median progression-free survival (mPFS) of 19.0 mo in non-small cell lung cancer patients harboring an ALK or ROS1 fusion, with longer mPFS in TKI-naive patients (25.2 mo vs 5.4 mo), and an ORR of 66.7% (2/3), including 1 complete response, in patients with ROS1 fusions (PMID: 35940055; NCT03099330). 35940055
ROS1 fusion ROS1 L1951R ROS1 L2026M lung non-small cell carcinoma predicted - resistant Crizotinib Case Reports/Case Series Actionable In a clinical study, a non-small cell lung carcinoma patient harboring a ROS1 fusion progressed after 17 months of treatment with Xalkori (crizotinib), and was found to have acquired two additional mutations in trans, ROS1 L2026M and ROS1 L1951R, and cells derived from this patient showed partially decreased SHP2 and ERK1/2 signaling and ROS1 activation (PMID: 29636358). 29636358
ROS1 fusion ROS1 L1951R ROS1 L2026M lung non-small cell carcinoma resistant Ceritinib Case Reports/Case Series Actionable In a clinical study, a non-small cell lung carcinoma patient co-harboring a ROS1 fusion, and two other mutations in trans, ROS1 L2026M, and ROS1 L1951R demonstrated resistance to treatment with Zykadia (ceritinib), and cells derived from this patient showed partially decreased SHP2 and ERK1/2 signaling and ROS1 activation (PMID: 29636358). 29636358
ROS1 fusion KIT D816G lung non-small cell carcinoma predicted - resistant Crizotinib Case Reports/Case Series Actionable In a clinical study, a non-small cell lung carcinoma patient harboring a ROS1 fusion developed resistance to treatment with Xalkori (crizotinib) and was subsequently found to have acquired KIT D816G (PMID: 29636358). 29636358
ROS1 fusion ROS1 S1986F ROS1 L2000V lung non-small cell carcinoma predicted - resistant Lorlatinib Case Reports/Case Series Actionable In a clinical case study, a patient with non-small cell lung cancer harboring a ROS1 fusion who had progressed on Xalkori (crizotinib) was subsequently treated with Lorbrena (lorlatinib) but progression ensued and post treatment biopsy revealed acquisition of ROS1 S1986F and ROS1 L2000V (PMID: 33685866). 33685866
ROS1 L2026M Advanced Solid Tumor predicted - sensitive Lorlatinib Preclinical - Biochemical Actionable In a preclinical study, Lorbrena (lorlatinib) inhibited kinase activity of a transformed cell line expressing ROS1 L2026M in culture (PMID: 32918045). 32918045
ROS1 L2026M Advanced Solid Tumor predicted - sensitive Foritinib Preclinical - Biochemical Actionable In a preclinical study, Foritinib inhibited kinase activity of a transformed cell line expressing ROS1 L2026M in culture (PMID: 32918045). 32918045
ROS1 rearrange ROS1 L2026M TP53 P278H lung non-small cell carcinoma predicted - resistant Crizotinib Case Reports/Case Series Actionable In a Phase II clinical trial, a patient with non-small cell lung cancer harboring a ROS1 rearrangement demonstrated progression while being treated with Xalkori (crizotinib), and was found to have acquired two mutations, ROS1 L2026M and TP53 P278H (PMID: 30978502; NCT02183870). 30978502
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 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 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 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 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 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 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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
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 TP53 mut lung non-small cell carcinoma predicted - sensitive Crizotinib Clinical Study - Cohort Actionable In a Phase II clinical trial, treatment with Xalkori (crizotinib) demonstrated a shorter median progression-free survival in patients with non-small cell lung cancer co-harboring a ROS1 rearrangement and TP53 mutation compared to patients with a ROS1 rearrangement and wild-type TP53 (7 vs. 24.1 months; p=0.022) (PMID: 30978502; NCT02183870). 30978502
ROS1 rearrange PIK3CA E545K lung non-small cell carcinoma predicted - resistant Crizotinib Case Reports/Case Series Actionable In a Phase II clinical trial, a patient with non-small cell lung cancer harboring a ROS1 rearrangement demonstrated progression while being treated with Xalkori (crizotinib), and was found to have acquired a PIK3CA E545K mutation (PMID: 30978502; NCT02183870). 30978502
ROS1 rearrange ALK neg lung non-small cell carcinoma sensitive Crizotinib Phase II Actionable In a Phase II trial, Xalkori (crizotinib) treatment resulted in an objective response rate of 69% (89/129), and a median duration of treatment of 7.8 months in ALK negative, ROS1 rearranged non-small cell lung carcinoma patients (J Clin Oncol 34, 2016 (suppl; abstr 9022); NCT01945021). detail...
ALK rearrange ROS1 rearrange lung non-small cell carcinoma predicted - sensitive Crizotinib Case Reports/Case Series Actionable In a clinical case study, Xalkori (crizotinib) treatment resulted in a near complete response and progression-free survival for at least 55 months in a patient with non-small cell lung cancer harboring rearrangements in ALK and ROS1 (PMID: 34459458). 34459458
ALK rearrange ROS1 rearrange lung adenocarcinoma predicted - sensitive Crizotinib Case Reports/Case Series Actionable In a clinical case study, Xalkori (crizotinib) treatment resulted in decreased tumor size and metabolism in a patient with lung adenocarcinoma harboring rearrangements in ROS1 and ALK (PMID: 28532565). 28532565
ALK rearrange ROS1 rearrange lung adenocarcinoma predicted - sensitive Crizotinib Case Reports/Case Series Actionable In a clinical case study, Xalkori (crizotinib) treatment resulted in decreased tumor size at 3 months in a patient with lung adenocarcinoma harboring rearrangements in ROS1 and ALK (PMID: 30327151). 30327151
ALK rearrange ROS1 rearrange lung adenocarcinoma predicted - sensitive Crizotinib Case Reports/Case Series Actionable In a clinical case study, Xalkori (crizotinib) treatment resulted in lymph node response and progression-free survival greater than 1 year in a patient with EGFR wild-type lung adenocarcinoma harboring rearrangements in ALK and ROS1 (PMID: 29268402). 29268402
ROS1 rearrange ROS1 L2086F lung adenocarcinoma predicted - sensitive Cabozantinib Case Reports/Case Series Actionable In a clinical case study, Cometriq (Cabometyx, cabozantinib) treatment resulted in a partial response in a heavily pretreated patient with metastatic lung adenocarcinoma harboring a ROS1 rearrangement with ROS1 L2086F (PMID: 39091594). 39091594
ROS1 D2033N Advanced Solid Tumor predicted - sensitive Lorlatinib Preclinical - Biochemical Actionable In a preclinical study, Lorbrena (lorlatinib) inhibited kinase activity of a transformed cell line expressing ROS1 D2033N in culture (PMID: 32918045). 32918045
ROS1 D2033N Advanced Solid Tumor predicted - sensitive Foritinib Preclinical - Biochemical Actionable In a preclinical study, Foritinib inhibited the kinase activity of a transformed cell line expressing ROS1 D2033N in culture (PMID: 32918045). 32918045
ROS1 S1986Y Advanced Solid Tumor predicted - sensitive Lorlatinib Preclinical - Biochemical Actionable In a preclinical study, Lorbrena (lorlatinib) inhibited kinase activity of a transformed cell line expressing ROS1 S1986Y in culture (PMID: 32918045). 32918045
ROS1 S1986Y Advanced Solid Tumor predicted - sensitive Foritinib Preclinical - Biochemical Actionable In a preclinical study, Foritinib inhibited kinase activity of a transformed cell line expressing ROS1 S1986Y in culture (PMID: 32918045). 32918045
ROS1 S1986F Advanced Solid Tumor predicted - sensitive Lorlatinib Preclinical - Biochemical Actionable In a preclinical study, Lorbrena (lorlatinib) inhibited kinase activity of a transformed cell line expressing ROS1 S1986F in culture (PMID: 32918045). 32918045
ROS1 S1986F Advanced Solid Tumor predicted - sensitive Foritinib Preclinical - Biochemical Actionable In a preclinical study, Foritinib inhibited kinase activity of a transformed cell line expressing ROS1 S1986F in culture (PMID: 32918045). 32918045
ROS1 D2113G Advanced Solid Tumor sensitive Crizotinib Preclinical - Cell culture Actionable In a preclinical study, Xalkori (crizotinib) inhibited proliferation of transformed cells expressing ROS1 D2113G in culture (PMID: 37587872). 37587872
ROS1 D2113G Advanced Solid Tumor sensitive Lorlatinib Preclinical - Cell culture Actionable In a preclinical study, Lorbrena (lorlatinib) inhibited proliferation of transformed cells expressing ROS1 D2113G in culture (PMID: 37587872). 37587872
ROS1 D2113G Advanced Solid Tumor sensitive Selumetinib Preclinical - Cell culture Actionable In a preclinical study, Koselugo (selumetinib) inhibited proliferation of transformed cells expressing ROS1 D2113G in culture (PMID: 37587872). 37587872
ROS1 D2113G Advanced Solid Tumor sensitive Repotrectinib Preclinical - Cell culture Actionable In a preclinical study, Augtyro (repotrectinib) inhibited proliferation of transformed cells expressing ROS1 D2113G in culture (PMID: 37587872). 37587872
ROS1 D2113G Advanced Solid Tumor sensitive TNO155 Preclinical - Cell culture Actionable In a preclinical study, TNO155 inhibited proliferation of transformed cells expressing ROS1 D2113G in culture (PMID: 37587872). 37587872
ROS1 D2113G Advanced Solid Tumor sensitive RMC-4550 Preclinical - Cell culture Actionable In a preclinical study, RMC-4550 inhibited proliferation of transformed cells expressing ROS1 D2113G in culture (PMID: 37587872). 37587872
ROS1 D2113G Advanced Solid Tumor sensitive NUV-520 Preclinical - Cell culture Actionable In a preclinical study, NUV-520 inhibited proliferation of transformed cells expressing ROS1 D2113G in culture (PMID: 37587872). 37587872
ROS1 D2113N Advanced Solid Tumor sensitive Crizotinib Preclinical - Cell line xenograft Actionable In a preclinical study, Xalkori (crizotinib) inhibited proliferation of transformed cells expressing ROS1 D2113N in culture and inhibited tumor growth and increased survival in a cell line xenograft model (PMID: 37587872). 37587872
ROS1 D2113N Advanced Solid Tumor sensitive Lorlatinib Preclinical - Cell line xenograft Actionable In a preclinical study, Lorbrena (lorlatinib) inhibited proliferation of transformed cells expressing ROS1 D2113N in culture and inhibited tumor growth and increased survival in a cell line xenograft model (PMID: 37587872). 37587872
ROS1 D2113N Advanced Solid Tumor sensitive Selumetinib Preclinical - Cell culture Actionable In a preclinical study, Koselugo (selumetinib) inhibited proliferation of transformed cells expressing ROS1 D2113N in culture (PMID: 37587872). 37587872
ROS1 D2113N Advanced Solid Tumor sensitive Repotrectinib Preclinical - Cell culture Actionable In a preclinical study, Augtyro (repotrectinib) inhibited proliferation of transformed cells expressing ROS1 D2113N in culture (PMID: 37587872). 37587872
ROS1 D2113N Advanced Solid Tumor sensitive TNO155 Preclinical - Cell culture Actionable In a preclinical study, TNO155 inhibited proliferation of transformed cells expressing ROS1 D2113N in culture (PMID: 37587872). 37587872
ROS1 D2113N Advanced Solid Tumor sensitive RMC-4550 Preclinical - Cell culture Actionable In a preclinical study, RMC-4550 inhibited proliferation of transformed cells expressing ROS1 D2113N in culture (PMID: 37587872). 37587872
ROS1 D2113N Advanced Solid Tumor sensitive NUV-520 Preclinical - Cell culture Actionable In a preclinical study, NUV-520 inhibited proliferation of transformed cells expressing ROS1 D2113N in culture (PMID: 37587872). 37587872