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Capmatinib Granted Regular Approval for Metastatic Non–Small Cell Lung Cancer

Non–small cell lung cancer micrograph.

The FDA has granted regular approval to capmatinib (Tabrecta®, Novartis Pharmaceuticals Corp.) for treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) who have tumors evolving into the mesenchymal-epithelial transition exon 14 skipping (METex14) mutation. Capmatinib was previously granted accelerated approval in May 2020 based on initial data from the GEOMETRY mono-1 trial (NCT02414139); due to updated results, the FDA is now converting it to regular approval.

"Activation of the MET pathway is associated with many cancers and can be caused by overexpression, gene amplification, and MET exon 14 skipping mutations, which can result from point mutations or from insertions or deletions," wrote Juergen Wolf, MD, Medical Director of the Center for Integrated Oncology at the University Hospital of Cologne, Germany, and colleagues in their report of the GEOMETRY mono-1 trial, on which approval was based. "Preliminary clinical data showed low-grade toxic effects and a promising efficacy of capmatinib monotherapy in patients with MET-dysregulated NSCLC."

The safety and efficacy were measured in the updated results of the phase 2, multicenter, open-label, multi-cohort, non-randomized trial, which saw 160 patients, including 60 treatment-naive and 100 previously treated, receive 400 mg of capmatinib orally twice daily until disease progression or unacceptable toxicity. The primary end point was overall response rate, and the key secondary end point was duration of response, assessed by a blinded independent review committee.

With an updated follow-up of 22 months, to determine durability of response and to verify clinical benefit, the 60 treatment-naive patients had an overall response rate of 68% with a median duration of response of 16.6 months. For the 100 patients who had previously undergone treatment, the overall response rate was 44% with a median duration of response of 9.7 months.

The most common adverse events in ≥20% of patients receiving capmatinib were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.

"Together with the continued manageable toxicity profile, the data support capmatinib as a valuable targeted treatment option for METex14 NSCLC patients," concluded Dr. Wolf and colleagues in their updated results of the GEOMETRY mono-1 trial.

The recommended dose for adult patients being treated for metastatic NSCLC with tumors leading to a METex14 mutation is 400 mg of capmatinib orally twice daily with or without food.

For More Information

Wolf J, Seto T, Han JY, et al (2020). Capmatinib in MET exon 14-mutated or MET-amplified non–small-cell lung cancer. N Engl J Med; 383(10):944-957. DOI:10.1056/NEJMoa2002787

Wolf J, Garon EB, Groen HJM, et al (2021). Capmatinib in MET exon 14-mutated, advanced NSCLC: Updated results from the GEOMETRY mono-1 study. J Clin Oncol; 39(15_suppl):9020-9020. DOI: 10.1200/JCO.2021.39.15_suppl.9020

Clinicaltrials.gov (2022). Clinical study of oral cMET inhibitor INC280 in adult patients with EGFR wild-type advanced non–small cell lung cancer (Geometry Mono-1). NLM identifier: NCT02414139

Tabrecta® (capmatinib) prescribing information (2022). Novartis Pharmaceutical Corp. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213591s004lbl.pdf

US Food and Drug Administration (2022). FDA approves capmatinib for metastatic non–small cell lung cancer. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capmatinib-metastatic-non-small-cell-lung-cancer/

Image credit: Librepath. Licensed under CC BY-SA 3.0


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