651P - Efficacy and safety outcomes of Phase II study of SCC244 in NSCLC patients harboring MET exon 14 skipping (METex14) mutations (GLORY study): Long-term follow-up analysis

Background

Gumarontinib (SCC244) is an oral, potent and highly selective small molecule MET inhibitor, and has been approved by NMPA in China on March 7, 2023, and by PMDA in Japan on June 24,2024, which is based on the efficacy and safety data at data cut-off on Apr 28^th 2022 from GLORY study (PMID: 37096188). Here, we report the updated clinical data from Glory study after 18 months of additional follow-up.

Methods

GLORY study (NCT04270591) is an open-label, multinational, multicenter phase II pivotal study. Patients (Pts) with locally advanced or metastatic NSCLC harboring METex14 skipping mutations who without systemic therapy or had failed 1 or 2 prior lines of systemic therapies. SCC244 was taken orally at a dose of 300 mg once daily. The primary endpoint was objective response rate (ORR) assessed by blinded independent review committee (BIRC) per RECIST 1.1.

Results

As of Oct 28^th 2023, a total of 84 pts (46 treatment-naïve and 38 pre-treated pts) with locally advanced or metastatic NSCLC harboring METex14 mutation were enrolled. 5 pts were excluded from efficiency analysis set due to absence of METex14 skipping mutation test results as determined by central lab. The ORR assessed by BIRC was 65.8% (95% CI: 54.3%, 76.1%), and the ORR of treatment-naïve and pre-treated populations was 70.5% (95% CI: 54.8%, 83.2%) and 60.0% (95% CI: 42.1%, 76.1%), respectively. The median follow up duration was 35.0 months (95% CI: 32.7, 36.8). Median OS was 19.4 months (95% CI: 12.1, 30.1), and median OS of treatment-naïve and pre-treated populations was 25.4 months (95%CI: 11.7, NA) and 16.3 months (95%CI: 8.7, NA) respectively. The most common (≥30%) treatment-related adverse events were peripheral edema, hypoalbuminaemia, decreased appetite, headache, hyperglycaemia, hyponatraemia, blood bilirubin increased, hypokalaemia, nausea.

Conclusions

Gumarontinib provided significant clinical benefits for pts with exon 14 skipping locally advanced or metastatic NSCLC, which can translate into long-term survival benefits. The latest data shows that the median OS of treatment-naïve population reached 25.4 months, and Gumarontinib had acceptable and manageable safety profiles.

Clinical trial identification

NCT04270591.

Editorial acknowledgement

Legal entity responsible for the study

Haihe Biopharma Co., Ltd, Shanghai, China.

Funding

Haihe Biopharma Co., Ltd, Shanghai, China.

Disclosure

K. Goto: Financial Interests, Personal, Other, Honoraria: Amgen K.K., Amoy Diagnosties Co., Ltd., AstraZeneca K.K. J. Sakakibara-Konishi: Financial Interests, Personal, Other, Scholarship grant: Eli Lilly Japan K.K., Nippon Boehringer Ingelheim Co ., Ltd. F. Li, M. Qin, M. Li: Financial Interests, Personal, Other, Employee: Haihe Biopharma Co., Ltd. All other authors have declared no conflicts of interest.