Trials and Treatments

ROS1-fusion positive cancer is a relatively rare subset of most cancers it is diagnosed in, typically accounting for 1-2% of most cancers. Therefore, historically there hasn’t been a lot of active research on just ROS1 cancers by themselves. However, fortunately for ROS1ers, things are changing and there is one new drug was recently approved for ROS1-positive lung cancer (Crizotinib, Xalkori) and there are several under development. We will keep updating this space with info on new clinical trials that you can participate in, if you have ROS1-fusion positive cancer, and any other news that might be of interest for you.

(brand name Xalkori, previously known as PF-02341066)

Currently FDA approved for ALK+ metastatic non-small cell lung cancer.

• Article: Benefit-Risk Summary of Crizotinib for the Treatment of Patients With ROS1 Alteration-Positive, Metastatic Non-Small Cell Lung Cancer
• Clinical Trial: Crizotinib in Pretreated Metastatic Non-small-cell Lung Cancer With MET Amplification or ROS1 Translocation (METROS)
• Clinical Trial: EUCROSS: European Trial on Crizotinib in ROS1 Translocated Lung Cancer
• Clinical Trial: Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1 (AcSé)
• Clinical Trial: A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC
• Article: Crizotinib in ROS1-Rearranged Non–Small-Cell Lung Cancer
• Article: Pfizer Receives U.S. FDA Breakthrough Therapy Designation For XALKORI® (crizotinib) For The Treatment Of Patients With ROS1-Positive Non-Small Cell Lung Cancer

• Article: Crizotinib-resistant ROS1 mutations reveal a predictive kinase inhibitor sensitivity model for ROS1- and ALK-rearranged lung cancers
• Article: An Activating KIT Mutation Induces Crizotinib Resistance in ROS1-Positive Lung Cancer

(previously known as PF-06463922)

• Clinical Trial: A Study of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations
• Article: PF-06463922 is a potent and selective next-generation ROS1/ALK inhibitor capable of blocking crizotinib-resistant ROS1 mutations

(previously known as RXDX-101)

• Clinical Trial: Entrectinib, an oral pan-Trk, ROS1, and ALK inhibitor in TKI-naïve patients with advanced solid tumors harboring gene rearrangements: Updated phase I results
• Clinical Trial: A Phase 1/2a Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer; Study Targeting ALK, ROS1, or TRKA/B/C (STARTRK-1)
• Article: Alka-372-001: First-in-human, phase I study of entrectinib – an oral pan-trk, ROS1, and ALK inhibitor – in patients with advanced solid tumors with relevant molecular alterations.

(brand name Cometriq)

Currently FDA approved for metastatic medullary thyroid cancer.

• Article: Identification of existing drugs that effectively target NTRK1- and ROS1-rearrangements in lung cancer
• Clinical Trial: Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity
• Article: Cabozantinib overcomes crizotinib resistance in ROS1 fusion-positive cancer.
• Article: A Novel Crizotinib-Resistant Solvent-Front Mutation Responsive to Cabozantinib Therapy in a Patient with ROS1-Rearranged Lung Cancer

(previously known as AP26113)

• Clinical Trial: currently no clinical trials for ROS1
• Article: ARIAD Presents New Preclinical Data Showing AP26113 Inhibits Clinically Relevant Mutants of ALK and ROS1
• Article: Abstract 3644: Identification of existing targeted agents that inhibit NTRK and ROS1 in lung cancer

(brand name Zykadia, previously known as LDK378)

Currently FDA approved for ALK+ metastatic non-small cell lung cancer.

• Clinical Trial: Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
• Clinical Trial: An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement

• Clinical Trial: First-in-human phase 1 dose-escalation study of DS-6051b, an oral ROS1 and NTRK inhibitor, in subjects with advanced solid tumors

• Article: Ending the endless acquired tyrosine kinase resistance mutations — Design of TPX-0005, a multi-target ALK/ROS1/TRK inhibitor with broad spectrum activity against wild-type and mutants including ALK G1202R, ROS1 G2032R and TRKA G595

• Article: TPD52L1-ROS1, a new ROS1 fusion variant in lung adenosquamous cell carcinoma identified by comprehensive genomic profiling