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On January 28th, global biotech giant Amgen announced the clinical results of phase 2 of its high-profile KRAS G12C inhibitor Sotorasib (AMG 510) for patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation, showing a disease control rate (DCR) of 80.6% and an objective mitigation rate (ORR) of 37.1%! Details will be announced at a virtual meeting of the World Lung Cancer Congress.
KRAS gene, like a "switch" in the human body, generally inhibits tumor cell growth, and once a mutation occurs, it continues to stimulate cell growth, leading to tumors.
KRAS mutations are present in multiple solid tumors, accounting for 90% in pancreatic cancer, 10-15% in lung cancer (mainly NSCLC), and 30%-40% in colorectal cancer.
for decades, researchers have been exploring ways to suppress KRAS mutations, but because the gene has no obvious binding points, these explorations have almost failed, and the gene is considered a "non-drug" target.
turnaround came in 2019, when AmN presented phase 1 clinical data for the first KRAS-targeted drug, AMG510, at the annual meeting of the American Society of Clinical Oncology (ASCO 2019).
in 13 patients who received the highest dose of NSCLC, the objective remission rate reached 54% and the disease control rate was 100%.
sotorasib's performance is still commendable, based on clinical data released by AMS.
study involved 126 NSCLC patients with KRAS G12C mutations who had previously received at least three treatments but none of them were effective and the cancer became more severe.
These patients received 960 mg of Sotorasib treatment once a day, and after 12.2 months of medium follow-up time, more than 80 percent of patients achieved disease control, 43 patients had smaller tumors, 3 patients (2 percent) had all cancer symptoms eliminated, and the medium remission time was 10 months and the medium progression-free survival period was 6.8 months.
in adverse reactions, about two-thirds of patients reported side effects, mostly mild and moderate reactions.
Of these, 31% had diarrhea, 19% felt nauseous, 15% had elevated alanine transaminase, 15% had elevated winter arginase, and 7.1% had discontinued treatment due to adverse reactions. Dr. David M. Reese, Executive Vice President, research and development at
Amjin, said, "Suppressing kras mutations has been a 40-year-old undertaking for researchers around the world, and we are very happy that Sotorasib has successfully demonstrated rapid, deep and lasting effects in this record Phase 2 clinical study.
have reason to believe that Sotorasib could be the first targeted drug to be approved to treat these patients.
" To date, more than 700 patients with 13 cancer types have been treated with Sotorasib, and 10 different Sotorasib drug combinations are advancing around the world, and we expect this drug and related combinations to surprise us even more.
references: s1. WCLC: Amgen's KRAS drug pads its case for approval with global filings underway