Lung Cancer Dispatch
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Clovis Launches TIGER2 Trial for CO-1686 in Previously Treated T790M-Positive NSCLC Patients

Clovis Launches TIGER2 Trial for CO-1686 in Previously Treated T790M-Positive NSCLC Patients | Lung Cancer Dispatch | Scoop.it

"Clovis Oncology has launched the TIGER2 study for its non-small cell lung cancer drug CO-1686, an agent the company is studying as a treatment for advanced patients with tumors characterized by EGFR mutations and the T790M resistance mutation.


"CO-1686 is an irreversible EGFR inhibitor. Clovis this week said it has dosed the first patient in the TIGER2 Phase I/II trial, which is focused on gauging the efficacy of CO-1686 in NSCLC patients who have progressed on their first and only anti-EGFR treatment."

Editor's note: Some people with advanced non-small cell lung cancer (NSCLC) have tumor cells with mutations in the EGFR gene (oncologists often use a tumor biopsy to check for this mutation in a patient). These patients can be treated with targeted drugs known as EGFR inhibitors. EGFR inhibitors can shrink tumors at first, but over time, tumors may become resistant to the drugs and start growing again. Often, this is because of a new, additional mutation that occurs in the EGFR gene called T790M. A new clinical trial is enrolling volunteer patients with the T790M mutation to test a new drug meant to overcome EGFR inhibitor resistance. The drug is called CO1-686.
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Pharmacogenomics Reporter  |  Jun 25, 2014

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Researchers Report Double Dose of Promising Lung Cancer Findings

Researchers Report Double Dose of Promising Lung Cancer Findings | Lung Cancer Dispatch | Scoop.it

"Researchers with UCLA's Jonsson Comprehensive Cancer Centerreport that two new experimental drugs have shown great promise in the treatment of patients with non–small-cell lung cancer, which accounts for about 85 percent of all lung cancers. Lung cancer is the leading cause of cancer death in the United States.


"The drugs—ramucirumab and CO-1868—were shown in separate clinical trials to increase survival times with fewer toxic side effects than standard treatments. The findings were presented this week at the American Society of Clinical Oncology annual meeting in Chicago."


Editor's note: For more on the ramucirumab findings, see our previous news post. To learn more about targeted therapies like CO-1686 and ramucirumab, visit our lung cancer Basics.

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Medical Xpress  |  Jun 5, 2014

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Clovis Oncology’s CO-1686 Demonstrates Compelling Clinical Activity and Progression-free Survival (PFS) in Updated Phase 1 Study Results in Patients with Non-small Cell Lung Cancer (NSCLC)

"Clovis Oncology (NASDAQ:CLVS) announced today updated findings from the Phase 1 portion of its ongoing Phase 1/2 clinical study of CO-1686, the Company’s novel, oral, targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) for the treatment of non-small cell lung cancer in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M. Interim results from the Phase 1 dose-escalation portion of this Phase 1/2 study are being presented today in an oral presentation by Dr. Heather Wakelee at the 4th European Lung Cancer Conference (ELCC) in Geneva."


Editor's note: CO-1686 is a targeted therapy drug that is meant to treat patients whose tumors have mutations in the EGFR gene, as detected by molecular testing. Some tumors with EGFR mutations become resistant to treatment and develop a new mutation called T790M. Researchers are particularly interested in whether patients with T790M can benefit from CO-1686.

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Reuters  |  Mar 27, 2014

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Patients with Drug-Resistant Lung Cancer Might Benefit from New Drug CO-1686

Patients with non-small cell lung cancer (NSCLC) who have mutations in the EGFR gene often improve significantly when treated with EGFR inhibitors like erlotinib (Tarceva) or gefitinib (Iressa). However, in virtually all cases, patients eventually develop resistance to these drugs. Resistance to EGFR inhibitors is frequently associated with patients developing an additional mutation in the EGFR gene called T790M. Hope for these patients may come from a new EGFR inhibitor designed to target the T790M mutation, called CO-1686. Preliminary results from an ongoing early clinical trial of CO-1686 show that the drug shrank tumors in at least a subset of patients with EGFR-mutant advanced NSCLC who were resistant to EGFR inhibitors and carried the T790M mutation.

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Reuters | June 3, 2013

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At ASCO, Next-Gen EGFR Inhibitors Show Early Promise in Lung Cancer Patients with T790M Mutations

"Next-generation EGFR inhibitors for treating metastatic non-small cell lung cancer patients who have acquired resistance to first-generation drugs in this class accurately hit mutant EGFR tumor cells and caused fewer serious side effects, early data presented at a major cancer conference showed.


"Researchers at the American Society of Clinical Oncology's annual meeting here this week, presented preliminary data from human studies on three next-generation EGFR inhibitors: AstraZeneca's AZD9291, Clovis Oncology's CO-1686, and Hanmi Pharmaceutical's HM61713. All three agents showed promising activity against patients who had EGFR mutations, had received prior treatment with a first-generation tyrosine kinase inhibitor – such as Roche's Tarceva (erlotinib) and AstraZeneca's Iressa (gefinitib) – and had T790M mutations."


Editor's note: For a more reader-friendly explanation of these new drugs, check out the "Drug resistance" section of our Chief Scientist's latest blog post.

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GenomeWeb  |  Jun 4, 2014

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Clovis Oncology Receives Breakthrough Therapy Designation for CO-1686
for the Treatment of Second-line EGFR Mutant Non-small Cell Lung Cancer
(NSCLC) in Patients with the T790M Mutation

Clovis Oncology Receives Breakthrough Therapy Designation for CO-1686 <br/>      for the Treatment of Second-line EGFR Mutant Non-small Cell Lung Cancer <br/>      (NSCLC) in Patients with the T790M Mutation | Lung Cancer Dispatch | Scoop.it

"Clovis Oncology, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Company’s investigational agent CO-1686 as monotherapy for the treatment of second-line EGFR mutant NSCLC in patients with the T790M mutation. The Breakthrough Therapy designation was granted based on interim efficacy and safety results from an ongoing Phase 1/2 study of CO-1686. CO-1686 is the Company’s novel, oral, targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) for the treatment of non-small cell lung cancer in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M."


Editor's note: CO-1686 is a targeted therapy drug that is meant to treat patients whose tumors have mutations in the EGFR gene, as detected by molecular testing. Some tumors with EGFR mutations become resistant to first-line treatment and develop a new mutation called T790M. Evidence shows that non-small cell lung cancer (NSCLC) patients with T790M may benefit from second-line treatment with CO-1686.The drug has received a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA). This means that the FDA finds CO-1686 to be very promising compared to currently available treatments for T790M-mutated NSCLC, and will accelerate the approval process that would ultimately permit oncologists to prescribe the drug outside of a clinical trial.

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MarketWatch  |  May 19, 2014

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Early Evidence Supports CO-1686 as a Treatment Option in Drug-Resistant EGFR-Mutant Lung Cancer

Early Evidence Supports CO-1686 as a Treatment Option in Drug-Resistant EGFR-Mutant Lung Cancer | Lung Cancer Dispatch | Scoop.it

Drugs known as EGFR inhibitors—such as erlotinib (Tarceva), gefitinib (Iressa), and afatinib (Gilotrif)—are very effective in treating non-small cell lung cancer (NSCLC) with mutations in the EGFR gene. However, patients eventually develop drug resistance, usually caused by new EGFR mutations. T790M is the most common EGFR drug resistance mutation. CO-1686 is a novel drug that inhibits EGFR with the T790M mutation, as well as other mutant EGFR. A small study showed that eight of nine patients who had the T790M resistance mutation experienced more than 10% tumor shrinkage when treated with CO-1686. And, a new formulation of CO-1686 has been found to produce higher, more consistent, well-tolerated drug concentrations in patients.

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Yahoo! Finance | Oct 27, 2013

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