313P - A pool analysis of MET TKI SCC244 in NSCLC patients with MET overexpression

Background

The prevalence of MET overexpression in NSCLC varied from 5%-75% and it may be concurrent with MET amplification. Several studies demonstrated that MET overexpression was an independent worse prognostic factor among EGFR wild-type NSCLC patients and may be a potential therapeutic target in NSCLC patients. SCC244, a highly selective and potent oral MET TKI, demonstrated high efficacy and acceptable safety profile in NSCLC patients with MET exon 14 skipping mutation. The purpose of the analysis was to evaluate the efficacy of SCC244 in MET overexpression NSCLC patients.

Methods

The pool analysis was performed on data from two ongoing single-arm phase Ib studies (Clinicaltrials.gov registration ID: NCT03457532 and NCT04270591) of SCC244, in which patients received SCC244 300 mg QD orally until progression or intolerable toxicity. Tumor was evaluated every 6-8 weeks. Only NSCLC patients with MET overexpression (IHC≥3+ determined by central laboratory) without MET exon 14 skipping mutation were included in the analysis.

Results

At data cut-off on May 25^th, 2022, a total of 32 patients enrolled from 22 cancer centers in China were included in the analysis, including 12 treatment naïve patients and 20 pre-treated patients who received 1-3 lines prior systemic anti-tumor therapies. The median follow up time was 8.8 months (IQR 3.7, 12.3). In the 32 patients, ORR was 37.5% (95% CI: 21.1%, 56.3%) overall, 41.7% (95% CI: 15.2%, 72.3%) and 35.0% (95% CI: 15.4%, 59.2%) in treatment naïve and pre-treated patients respectively. Median DoR was 8.3 months (95% CI: 2.8, NE) and median PFS was 6.9 months (95% CI: 3.6, 9.7). Tumor response in 6 of 12 responders was still ongoing. Median OS was 16.2 months (95% CI: 10.3, NE). 10 of the 32 patients had only MET overexpression without MET amplification which was defined as GCN≥4 or MET/CEP7≥2. The ORR was 30% (3 responders in 10 patients) for those patients and 40.9% (9 responders in 22 patients) for those patients with concurrent MET overexpression and amplification.

Conclusions

SCC244 demonstrated promising anti-tumor activity with durable response across treatment lines in NSCLC patients with MET overexpression. Further larger scale prospective studies are warranted to confirm these findings.

Clinical trial identification

NCT03457532, NCT04270591.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Haihe Biopharma Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.