Today, Amgen announced the latest results from a critical Phase 2 clinical trial in patients with advanced non-small cell lung cancer (NSCLC) who studied the KRAS G12C inhibitor sotorasib (AMG 510).
this is the first time the company has published the results of this clinical trial after more than a year of follow-up.
results will be presented at the International Lung Cancer Research Association (IASLC) 2020 World Lung Cancer Congress (WCLC) Presidential Symposium.
NSCLC accounts for 80%-85% of all lung cancers, and most patients (66%) are terminal or metastasis at the time of initial diagnosis.
KRAS G12C is one of the most common driver mutations in NSCLC.
options for patients with KRAS G12C mutation NSCLC who failed in first-line treatment are limited, and the outcome of treatment is not ideal at present.
the remission rate of second-line treatment in these patients was about 9-18%, and the medium non-progression survival period was about 4 months. orasib, developed by
Amjin, is the first KRAS G12C inhibitor to enter clinical development and is currently being studied in a wide range of clinical projects, with a deep clinical data set in place in just over two years for more than 13 types of cancer, and has been used to treat more than 600 patients in 13 tumor types.
, which has been awarded a breakthrough treatment by the FDA, submitted a new drug application (NDA) to the FDA late last year.
in a critical Phase 2 clinical trial called CodeBreaK 100, patients with advanced non-small cell lung cancer with KRAS G12C mutation received oral treatment at a dose of 960 mg of sotorasib once a day.
81% of these patients had been treated with platinum-containing chemotherapy and PD-1/PD-L1 inhibitors before the disease continued to progress.
test results showed that at a medium follow-up time of 12.2 months, sotorasib achieved a confirmed objective mitigation rate (ORR) of 37.1% and a disease control rate of 80.6%, including 3 cases of complete remission and 43 cases of partial remission.
the medium mitigation duration was 10 months and the medium non-progression lifetime was 6.8 months.
" first-line treatment failed patients with advanced non-small cell lung cancer have a poor prognostication, they have limited options for treatment, Anding has been working to change this situation.
. David M. Reese, Executive Vice President of Research and Development at Amtrane, said, "We are very pleased that Sotorasib has produced a fast, deep and lasting response in this registered Phase 2 clinical trial.
is expected to be the first targeted drug approved to treat these patients.