Sotorasib may provide a long-term clinical benefit in patients with KRASG12C-mutated non-small cell lung cancer (NSCLC), according to results of the CodeBreaK100 trial.1
The 2-year overall survival (OS) rate was 32.5% in these patients. This compares favorably with OS rates for historical treatments in NSCLC, according to Grace K. Dy, MD, of Roswell Park Comprehensive Cancer Center in Buffalo, New York.
Dr Dy presented these results at the AACR Annual Meeting 2022.
The phase 1/2 CodeBreaK100 trial (ClinicalTrials.gov Identifier: NCT03600883) was designed to test sotorasib in patients with KRASG12C-mutated solid tumors.
Dr Dy presented long-term data on 174 NSCLC patients in this trial. At baseline, the patients’ mean age was 64.1 years, 52.3% were women, and 6.3% were never smokers. Sites of metastasis included bone (46.6%), brain (23.0%), and liver (21.8%).
Patients had received a median of 2 prior lines of therapy. Most had received prior anti-PD-1/PD-L1 therapy (90.2%) and platinum-based chemotherapy (92.5%).
Patients received sotorasib at 960 mg daily. The objective response rate was 40.7%, and the disease control rate was 83.7%. The median duration of response was 12.5 months, and the median progression-free survival was 6.3 months.
Prolonged response was observed across PD-L1 expression categories, including in tumors with low PD-L1 expression and STK11 co-mutation.
The median follow-up for OS was 24.9 months, which is the longest reported follow-up for a KRASG12C inhibitor.
The median OS was 12.5 months. The OS rate was 50.8% at 1 year and 32.5% at 2 years. In comparison, the 2-year OS rate in patients with non-squamous NSCLC treated with docetaxel as second-line therapy is less than 20%.2
Sotorasib was considered well tolerated, with no new safety signals after 12 months. There were no toxicity-related discontinuations after 12 months and no fatal treatment-related adverse events.
“In the longest follow-up of patients on any KRASG12C inhibitor, sotorasib demonstrated meaningful durable efficacy and a safety profile that was consistent with what was earlier reported,” Dr Dy said. “[N]early a quarter of patients achieved long-term benefit, as defined by progression-free survival of at least 12 months.”
Disclosures: This research was supported by Amgen. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
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1. Dy GK, Govindan R, Velcheti V, et al. Long-term outcomes with sotorasib in pretreated KRASp.G12C-mutated NSCLC: 2-year analysis of CodeBreaK100. Presented at AACR 2022, April 8-13, 2022. Abstract CT008.
2. Horn L, Spigel DR, Vokes EE, et al. Nivolumab versus docetaxel in previously treated patients with advanced non-small-cell lung cancer: Two-year outcomes from two randomized, open-label, phase III trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017;35(35):3924-3933. doi:10.1200/JCO.2017.74.3062