Capmatinib Tablets lucicapma

[Product Name] Capmatinib Tablets

[English Name] Capmatinib Tablets

[Other Names] Capmatinib

[Specification] 200 mg/tablet; 60 tablets/box.

[Manufacturer] Lucius Pharmaceutical (Laos) Co., Ltd.

[Summary]

Capmatinib is a kinase inhibitor targeting MET, including mutants resulting from exon 14 skipping. MET exon 14 skipping leads to the deletion of a regulatory domain within the protein, thereby reducing its negative regulation and resulting in increased downstream MET signaling. Capmatinib inhibits the growth of cancer cells driven by mutant MET variants lacking the clinically targetable exon 14 region, and demonstrates anti-tumor activity in murine tumor xenograft models derived from human lung tumors harboring mutations that result in MET exon 14 skipping or MET amplification. Capmatinib inhibits MET phosphorylation triggered by hepatocyte growth factor binding or by MET amplification, as well as the phosphorylation of downstream signaling proteins mediated by MET, and the proliferation and survival of MET-dependent cancer cells.

[Indications]

Indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor mutations leading to mesenchymal-epithelial transition (MET) exon 14 skipping.

[Specification]

200 mg/tablet; 60 tablets/box.

[Dosage and Administration]

Two tablets (400 mg) orally twice daily, with or without food; swallow tablets whole; do not crush or chew the tablets.

[Adverse Reactions]

The most common adverse reactions (≥20%) are peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

[Warnings and Precautions]

Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Permanently discontinue LuciCapma in patients with ILD/pneumonitis.

Hepatotoxicity: Monitor liver function tests. Based on severity, withhold, reduce the dose, or permanently discontinue LuciCapma.

Risk of Photosensitivity: May cause photosensitivity reactions. Advise patients to limit direct exposure to ultraviolet (UV) light. Embryo-Fetal Toxicity: May cause fetal harm. Patients should be advised of the potential risk to the fetus and to use effective methods of contraception.

[Safety and Efficacy]

Based on the positive results from the pivotal Phase II clinical study, GEOMETRY mono-1. This was an international, prospective, multi-cohort, non-randomized, open-label study conducted in 97 adult patients with locally advanced or metastatic NSCLC whose tumors harbored *MET* exon 14 skipping (*MET*ex14) mutations. In the study, patients received LuciCapma 400 mg tablets orally twice daily.

The results showed that, as assessed by a Blinded Independent Review Committee (BIRC) according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1): (1) In treatment-naïve patients (Cohort 5b: 28 patients who had not received prior treatment), the Overall Response Rate (ORR) was 68% (95% CI: 48–84), and the median Duration of Response (DOR) was 12.6 months (95% CI: 5.5–25.3). (2) In previously treated patients (Cohort 4: 69 patients who had received prior treatment), the ORR was 41% (95% CI: 29–53), and the DOR was 9.7 months (95% CI: 5.5–13.0). (3) The most common treatment-related adverse events included peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

These results demonstrate the therapeutic potential of LuciCapma in patients with NSCLC harboring *MET* exon 14 skipping mutations. The superior ORR data observed in the treatment-naïve patient group, compared to the previously treated group, highlights the clinical relevance of early diagnostic testing and prompt treatment in this highly challenging patient population.

[Contraindications]

None.

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Discard any remaining, unused LuciCapma six weeks after first opening the bottle.