Capmatinib......... 200mg.

Capmatinib instructions

Product Name: Capanib

Manufacturer: Alliance Pharmaceuticals

Chinese name: Capmatinib

English name: Capmatinib

Drug approval number: 11 L 0934/22

【Summary】

Capmatinib is a kinase inhibitor targeting MET, including mutants resulting from exon 14 skipping. MET exon 14 skipping results in a protein lacking regulatory domains that decrease its negative regulation, leading to increased downstream MET signaling. Capmatinib inhibits the growth of cancer cells driven by mutant MET variants lacking clinically achievable exon 14 concentrations and exhibits antitumor activity in murine tumor xenograft models derived from human lung tumors with mutations resulting 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 MET-mediated phosphorylation of downstream signaling proteins and the proliferation and survival of MET-dependent cancer cells.

【Indications】

For the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor mutations that result in mesenchymal-epithelial transition (MET) exon 14 skipping.

【Specification】

200 mg/tablet, 56 tablets/box.

【Storage】

Store at 20°C to 25°C (68°C to 77°F); short-distance transport is permitted at a temperature range of 15 to 30°C (59–86°F).

Throw away any remaining unused LuciCapma 6 weeks after you first open the bottle.

【Usage and Dosage】

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

【Adverse Reactions】

The most common adverse reactions (≥20%) were 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 dose, or permanently discontinue LuciCapma.

Photosensitivity Risk: May cause photosensitivity reactions. Advise patients to limit direct UV exposure.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Safety and efficacy

Based on the positive results of the pivotal Phase II clinical study GEOMETRY mono-1. This is an international, prospective, multi-cohort, non-randomized, open-label study conducted in 97 adult patients with locally advanced or metastatic NSCLC whose tumors have MET exon 14 skipping (METex14) mutations. In the study, patients took LuciCapma 400mg tablets orally twice daily.

The results showed that the double-blind independent review committee (BIRC) evaluated the efficacy evaluation criteria in solid tumors version 1.1 (RECIST v1.1): (1) In the first-line treatment patients (cohort 5b: 28 patients, who had not received previous 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 the previously treated patients (cohort 4: 69 patients, who had received previous 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 reveal the therapeutic potential of LuciCapma in NSCLC patients harboring MET exon 14 skipping mutations. The superior ORR data in the treatment-naive group compared to the previously treated group highlight the clinical relevance of early diagnostic testing and early treatment in this challenging patient population.

【Taboo】

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