The clinical trial for Capmatinib Hydrochloride took center stage at the 2023 ESMO Congress, demonstrating its potential to treat aNSCLC.
Capmatinib Hydrochloride's R&D ProgressCapmatinib Hydrochloride is a small molecule drug that targets c-Met, a protein involved in cell growth and survival. It has shown potential therapeutic benefits in various therapeutic areas including neoplasms, skin and musculoskeletal diseases, digestive system disorders, nervous system diseases, urogenital diseases, and respiratory diseases.
According to the Patsnap Synapse, Capmatinib Hydrochloride has reached the highest phase of development, which is approved globally. And the clinical trial areas for Capmatinib Hydrochloride are primarily in the United States, China, and United Kingdom. The key indication is Non-Small Cell Lung Cancer.
Detailed Clinical Result of Capmatinib HydrochlorideThe randomized, parallel assignment, open-label, randomized, phase 3 trial (NCT04427072) was aimed to evacuate the available efficacy and safety of cap vs docetaxel (doc) from GeoMETry-III trial.
In this study, Eligible pts included EGFR wild type, ALK rearrangement−negative, stage IIIB/IIIC or IV METex14–mutated NSCLC who have progressed on 1/2L of systemic therapy. Primary and key secondary endpoints were progression-free survival (PFS) and overall response rate (ORR) by blinded independent review committee (BIRC) assessment per RECIST v1.1, respectively. Although 90 pts were planned to be included in this study, due to slow enrollment, the study was terminated early with 22 patients enrolled.
The result showed that as of Feb 15, 2023, data cutoff, 22 pts were randomized 2:1 to cap (n = 15) or doc (n = 7) arms. Baseline characteristics were generally comparable between arms. The observed benefit with cap vs doc in median PFS was not statistically significant: 6.1 months vs 4.1 months; HR, 0.46; 95% CI 0.16-1.3; P = 0.066. Of 15 pts in cap arm, 8 had partial response (53.3%, 95% CI 26.6-78.7) vs none in doc arm (95% CI 0-41.0). Disease control rate was 73.3%; 95% CI 44.9-92.2 vs 57.1%; 95% CI 18.4-90.1, respectively. Median duration of response in cap was 9.9 months; 95% CI 2.9-NE. Five of 6 doc-treated pts crossed over to cap (at 1.4, 1.9, 6.0, 6.3, and 13.7 months from doc start due to progression), which confounded the overall survival results. No new safety signals were observed for cap. Most frequent treatment-related AEs (≥25%, any grade) in cap were peripheral edema (46.7%) and nausea (33.3%); and in doc were, alopecia (66.7%), anemia (50.0%), asthenia, conjunctivitis, lacrimation increased, onycholysis (33.3% each).
It can be concluded that the numerical differences in PFS and ORR showed trends favoring cap, and together with safety, are consistent with previous results of the pivotal GeoMETry mono-1 study. The GeoMETry-III trial was terminated early due to enrollment constraints.
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