Long-term follow-up results from the GLORY study: phase II study of gumarontinib in East Asian patients with MET exon 14 skipping mutated non-small cell lung cancer
Later report from the trial registered as NCT04270591, in Translational lung cancer research (2025); its title describes an updated or longer-term analysis.
Overview
Background: Gumarontinib has previously shown activity in patients with non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutation ( MET ex14). We hereby report the updated results from the phase II stage of GLORY study after additional 18-month follow-up.
Methods: The single-arm, multicenter, open-label, phase II of the GLORY study was conducted at 42 centers across China and Japan. Patients with locally advanced or metastatic MET ex14-positive NSCLC received gumarontinib 300 mg orally once daily until disease progression or intolerable toxicity. Eligible patients had failed one or two prior lines of therapy (not including a MET inhibitor) and had no genetic alterations targetable with standard therapies. The primary endpoint was the objective response rate (ORR) by the blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors version 1.1. The study was registered at ClinicalTrials.gov (NCT04270591).
Results: The phase II stage of GLORY study included 84 patients. at the data cutoff date on October 28, 2023, the ORR assessed by BIRC was 65.8% [95% confidence interval (CI): 54.3% to 76.1%], with 70.5% (95% CI: 54.8% to 83.2%) in treatment-naïve and 60.0% (95% CI: 42.1% to 76.1%) in pre-treated populations. The median duration of response (DOR) assessed by BIRC was 8.3 (95% CI: 6.2 to 18.3) months, the median progression-free survival (PFS) was 7.7 (95% CI: 7.6 to 9.7) months, and the median overall survival (OS) was 19.4 (95% CI: 12.1 to 30.1) months, with a median OS of 25.4 [95% CI: 11.7 to not evaluable (NE)] months in treatment-naïve population and 16.3 (95% CI: 8.7 to NE) months in the pre-treated population. The most common treatment-related adverse events (any grade) were oedema (67/84, 79.8%) and hypoalbuminemia (32/84, 38.1%). Grade ≥3 treatment-related adverse events occurred in 53.6% (45/84) patients. Treatment-related adverse events leading to permanent discontinuation occurred in 8.3% (7/84) of patients.
Conclusions: Gumarontinib showed promising efficacy and acceptable toxicities in East Asian population, with a rapid onset of action, substantial and durable response, which can be converted into a long-term survival benefit.
Indexed on Europe PMC as PubMed record 41132955 (DOI 10.21037/tlcr-2025-638). Its abstract cites the registry id NCT04270591, which is how it was matched to this trial; no figure has been checked by an editor.
A second publication from the trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
- Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.
- Chosen as a later report by words in its title (updated, long-term, final, overall survival or a year count), not by reading the paper.