LUMAKRAS (sotorasib, sotorasib, AMG510) launched by Amgen is a RAS GTPase inhibitor for the treatment of adult non-small cell lung cancer (NSCLC) patients, including spread to other parts of the body or unable to Adult patients with non-small cell lung cancer (NSCLC) that have been surgically removed, as well as patients whose tumors have abnormal KRAS G12C genes and have received at least one cancer treatment. According to the post-analysis data of the ongoing Phase 1/2 CodeBreaK 100 trial (NCT03600883) announced during the World Lung Cancer Congress in 2021, KRAS G12C mutant non-small cell lung cancer (NSCLC) and patients with stable brain metastases (previously received radiotherapy) Or surgery), after treatment with Lumakras, strong anti-cancer activity was observed (complete intracranial remission and sustained intracranial stability). On May 28, 2021, AMGEN announced that the U.S. FDA has accelerated the approval of the KRAS G12C inhibitor Lumakras for the treatment of locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation that has received at least one systemic treatment in the past ( NSCLC) patients. After Lumakras was approved by the FDA, on September 10, 2021, officials from the British drug and health care product regulatory agency approved the drug to enter the ORBIS project, which allows different regulatory agencies to cooperate in cancer drug review. On September 16, 2021, Amgen announced the results of the first joint study of the Phase 1b/2 CodeBreaK 101 study, which is the most comprehensive global clinical development project for patients with KRAS G12C mutant advanced colorectal cancer (CRC). These new data show that the combination therapy of Lumakras and Vectibix® (panitumumab, panitumumab) monoclonal antibody epidermal growth factor receptor (EGFR) inhibitors has shown encouraging efficacy and safety. On October 7, 2021, Amgen announced the results of the new joint study of the Phase 1b CodeBreaK 101 study. This is a comprehensive global protocol trial that evaluated Lumakras in more than 10 different research combinations in the treatment of KRAS G12C. The safety and effectiveness of mutant cancers.
The study evaluated the efficacy of Lumakras and afatinib in the treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutations. Among them, 20mg afatinib/960mg Lumakras achieved an objective response rate (ORR) of 20%. And a 70% disease control rate. The ORR of 30mg afatinib/960mg Lumakras was 35%, and the disease control rate was 74%.
In the CodeBreaK 101 study, the combination of Lumakras and trametinib showed anti-tumor activity in patients with KRAS G12C mutant solid tumors (including patients treated with KRAS G12C inhibitors) after extensive pretreatment. Lumakras is one of the most exciting breakthroughs in the field of lung cancer treatment in 20 years. It has expanded the list of effective and precise treatments for lung cancer and will improve the survival rate of patients with limited options. Scientists continue to conduct research on Lumakras and prove the drug's good efficacy in diseases such as lung cancer, colorectal cancer, primary hypercholesterolemia or mixed dyslipidemia.
