In a nutshell
This trial was carried out to examine the effectiveness and safety of selpercatinib (Retevmo) in treating RET-positive non-small-cell lung cancer (NSCLC). The authors concluded that selpercatinib had good effectiveness and low toxicity in these patients.
Some background
NSCLC is responsible for 85% of all lung cancer diagnoses. The standard treatment is surgical removal of tumors and a combination of radiation therapy and chemotherapy.
RET mutations are genetic abnormalities that can cause some types of cancer, including NSCLC. RET-positive NSCLC is difficult to treat and often spreads to the brain. RET mutations have been found in 1-2% of patients with NSCLC. Selpercatinib is a RET kinase inhibitor and has shown effective in treating RET-positive tumors. However, the safety and effectiveness of selpercatinib in previously treated or newly diagnosed NSCLC remain under investigation.
Methods & findings
105 patients who had been previously treated an 39 previously untreated patients were included. All patients received selpercatinib treatment. The average follow-up for this trial was 12.1 months.
In patients who had previously received platinum-based chemotherapy, there was a response rate of 64%. The average duration of response to selpercatinib was 17.5 months. At one-year follow 66% of patients were disease progression-free. The survival without spread of disease was 16.5 months on average.
In patients who were not previously treated, the response rate to selpercatinib was 85%. At 6-month follow-up 90% of responses were still ongoing in previously untreated patients. 11 patients had cancer spread to the brain when the study begun. 91% of these patients experienced a response within the brain.
The most common side effects were high blood pressure (14% of patients), increased liver enzymes called ALT (10-13%), and low blood salt content (6%s). A total of 12 (2%) patients stopped selpercatinib because of side effects occurring.
The bottom line
The authors found that selpercatinib had good effectiveness and low toxicity in patients with RET-positive NSCLC.
The fine print
Selpercatinib is manufactured by Eli Lilly, a sponsor of this clinical trial. This trail did not have a placebo group for control.
Published By :
The New England Journal of Medicine
Date :
Aug 27, 2020