AACR 2022: Sotorasib shows stunning 2-year survival in KRAS G12C+ NSCLC

The American Association for Cancer Research (AACR) annual meeting is one of the most influential academic events in the field of oncology in the world

RAS is the most frequently mutated oncogene in human cancers, and KRAS is one of the most frequently occurring subtypes in the RAS family, with KRAS mutations accounting for 86% of the total RAS mutations

Presented at the AACR meeting this year are 2-year follow-up data

Research design

For locally advanced or metastatic NSCLC with KRAS p.

In the trial, study participants took sotorasib orally at an FDA-approved dose (960 mg once daily) until disease progression

In the combined analysis of the Phase I and Phase II studies (n=174), the number of prior lines of therapy was 2.

Table efficacy analysis

Main results: The 2-year overall survival (OS) rate of sotorasib (Lumakras) in patients with KRAS G12C-mutant non-small cell lung cancer (NSCLC) was 32.

The updated results showed that the overall response rate (ORR) of sotorasib was 40.

The median progression-free survival (PFS) was 6.

OS results

Sotorasib was well tolerated in the long term, with mild and manageable adverse events and no new safety events

Tumor and plasma samples were further analyzed to determine the biomarker profile associated with durable clinical benefit

Among patients with PD-L1 expression less than 1% (n=31), 51.

Exploratory Analysis Results

Among STK11 mutated/KEAP1 wt patients (n=13), 46.

In terms of safety, overall, the severity of most toxicities was grade 1/2; the nature of the main AEs were gastrointestinal nausea, diarrhea, and abnormal liver function tests, and 22% of patients required dose adjustment or interruption; Six percent required drug discontinuation, and about a quarter of patients were still on treatment after 1 year

Analysis conclusion

This is the longest follow-up study of KRAS G12C inhibitors including all KRAS G12C inhibitors, sotorasib still showed good safety and durable efficacy, sotorasib (Lumakras) in KRAS G12C mutant non-small cell lung cancer ( The 2-year overall survival (OS) rate in patients with NSCLC) was 32.

Dr.

References:

Long-term outcomes with sotorasib in pretreated KRASp.
G12C-mutated NSCLC: 2-year analysis of CodeBreaK100.
2022 AACR.

CodeBreak 100: Phase I study of AMG 510, a novel KRASG12C inhibitor, in patients (pts) with advanced solid tumors other than non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
 

CodeBreaK 100 Study Factsheet

Sotorasib for Lung Cancers with KRAS p.
G12C Mutation | NEJM

Lumakras CODEBREAK 100 study shows two year overall survival of 32.
5% in KRAS G12C mutated NSCLC.
| medthority.
com