Diagnosis of adenocarcinoma of the lung, a major subtype of non-small lung cancer (NSCLC), nowadays triggers mandatory testing of tumor tissue for alterations in four genes: EGFR, ALK, ROS1, and more recently, BRAF. If present, these alterations predict sensitivity to specific targeted drugs approved by the U.S. Food and Drug Administration (FDA) that work better and often longer than standard chemotherapy, and are better tolerated.
However, there are many more targetable/actionable genomic alterations (also known as “drivers”) in NSCLC. This blog post will briefly discuss most of them, with the goal of promoting molecular testing for more than the four “usual suspects” mentioned above. Some patients with these alterations may benefit from FDA-approved drugs or from enrollment in clinical trials that are testing additional drugs and drug combinations. Continue reading…
“Ignyta, Inc. (RXDX),a precision oncology biotechnology company, today announced that updated results of its Phase 1 clinical trials of entrectinib, the company’s proprietary oral tyrosine kinase inhibitor targeting solid tumors harboring activating alterations to NTRK1, NTRK2, NTRK3, ROS1 or ALK, were presented in an oral plenary session at the 2016 Annual Meeting of the American Association for Cancer Research (AACR) in New Orleans, Louisiana.
“ ‘We continue to be excited by entrectinib’s ability to help patients with advanced cancer,’ said Jonathan Lim, M.D., Chairman and CEO of Ignyta. ‘With respect to efficacy, in the 25 patients in the Phase 1 trials who would meet the eligibility criteria for our Phase 2 clinical trial, we saw tumor regression in 20 patients, or 80%. Nineteen out of 24 patients with extracranial solid tumors had a confirmed RECIST response, representing a 79% overall response rate; and one patient with an astrocytoma had evidence of substantial tumor regression by volumetric measurement. These responses were observed in patients with each of NTRK, ROS1 and ALK rearrangements, and across six tumor histologies, including complete and/or durable responses in both primary and metastatic tumors of the central nervous system.’ ”
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The gist: Researchers are conducting a clinical trial with volunteer patients to test a new cancer treatment called RXDX-101. RXDX-101 is meant to treat cancer patients whose solid tumors have mutations in the genes TrkA, ROS1, or ALK. The clinical trial is enrolling adults with locally advanced or metastatic cancer with those mutations.
“Ignyta, Inc. (Nasdaq: RXDX), an oncology precision medicine biotechnology company, today announced the multicenter initiation of the company’s global Phase I/II clinical trial of RXDX-101, its proprietary oral tyrosine kinase inhibitor targeting multiple solid tumor indications. This clinical trial is called STARTRK-1, which stands for Study Targeting ALK, ROS1 or TRKA/B/C, and is a Phase I/IIa, multicenter, single-arm, open-label clinical trial of continuous daily dosing of oral RXDX-101 in adult patients with locally advanced or metastatic cancer confirmed to be positive for relevant molecular alterations.
” ‘We are excited to be able to expand the clinical dosing of this product candidate to patients at leading cancer centers in the U.S., Europe and Asia,’ said Jonathan Lim, M.D., Chairman and CEO of Ignyta. ‘The initiation of the STARTRK-1 trial builds on the momentum of our presentation of interim data from the ongoing RXDX-101 Phase I clinical trial at the ASCO annual meeting, where we reported partial responses in patients with each of TrkA, ROS1 and ALK alterations, as well as in three different tumor types.’ “
“Ignyta, Inc. (Nasdaq: RXDX),an oncology precision medicine biotechnology company, announced today that interim results from the first-in-human ALKA-372-001 Phase I clinical trial of RXDX-101, the company’s proprietary oral tyrosine kinase inhibitor targeting solid tumor indications, were presented in an oral presentation at the 2014 Annual Meeting of the American Society of Clinical Oncology(ASCO) in Chicago, Illinois.”
Editor’s note: This story is about a new drug called RXDX-101. In a clinical trial testing it in volunteer patients, it showed promise for patients with non-small cell lung cancer (NSCLC) whose tumors had mutations in the ALK gene, and another patient with NSCLC whose tumor had a mutation in the ROS1 gene (these mutations can be detected by molecular testing).