(NIH.gov)
9 Sept. 2019. Results of a clinical trial show a treatment targeting specific genetic aberrations produces a therapeutic response in most patients with lung cancer from that condition. Findings from the trial were presented today at the 2019 World Conference on Lung Cancer in Barcelona, Spain.
The clinical trial is testing a therapy for non-small cell lung cancer, the most common form of lung cancer accounting for 80 to 85 percent of cases. The treatment aims at a specific genetic abnormality causing REarranged during Transfection or RET kinase enzymes linked to non-small cell lung cancer. In this case, the aberration is a fusion gene resulting from DNA of different genes joining together. Enzymes from RET-fusion genes produce overactive cell signaling and proliferation, and are believed to be responsible for about 2 percent of all non-small cell lung cancers.
The trial is assessing a therapy called selpercatinib, code-named LOXO-292 by drug maker Eli Lilly and Company. In January 2018, Lilly acquired Loxo Oncology Inc. in Stamford, Connecticut for $8 billion, as reported by Science & Enterprise, with the company continuing operations as subsidiary of Lilly. Loxo designs cancer therapies, such as selpercatinib, to address specific genetic conditions. The therapy limits the signaling activity of enzymes from RET-fusion genes and blocks expected resistance mechanisms in the tumor, helping treatments to succeed.
The early- and mid-stage clinical trial is enrolling 970 participants with solid tumor cancers, including non-small cell lung cancer, expressing RET-fusion genes. The first part of the trial tests dosage levels of selpercatinib among solid tumor cancer patients, who are not responding to chemo- or immunotherapies. A second phase expands the trial to other solid tumor cancer types. As of the cut-off date, 17 June 2019, 253 patients with non-small cell lung cancer from RET-fusion genes were treated.
At the meeting, Alexander Drilon, research director for early drug development at Memorial Sloan Kettering Cancer Center in New York and the study’s principal investigator, reported on results from the first 105 patients of this non-small cell lung cancer or NSCLC group. These participants already received platinum-based chemotherapy treatments, and more than half (58 of 105) also received checkpoint-inhibitor immunotherapies, with the group tracked for 26 months following their selpercatinib therapies.
The results show a solid majority of participants receiving selpercatinib responded to the drug. About two-thirds of recipients (68%) show an objective response, indicating a reduction in tumor burdens, independent of previous treatments. Since RET-fusion lung cancers can also spread to the brain and central nervous system or CNS, the researchers found 91 percent of participants with these metastatic tumors responded to selpercatinib. Plus, in half or more of participants these responses to treatment continued for at least 20.3 months, with progression-free survival, or their cancer not worsening, for at least 18.4 months.
The researchers report few serious adverse effects among participants. Among all 531 participants enrolled in the trial so far, most adverse effects — such as dry mouth, diarrhea, and hypertension — were rated mild or moderate. Only 9 patients, or 1.7 percent, discontinued their participation because of adverse effects from the treatments.
“In this large cohort, selpercatinib’s response rate, durability, robust CNS activity, and safety show promise,” says Drilon in an Eli Lilly statement. Drilon adds, “We are encouraged by these data as there is currently an unmet need to provide genomically-tailored therapy to patients with RET fusion-positive NSCLCs.”
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