Pharmaceutical Business review

Phase II trial of capmatinib demonstrates positive results in NSCLC

Image: Novartis headquarters in Basel, Switzerland. Photo: courtesy of Novartis AG.

The GEOMETRY mono-1 study showed an overall response rate (ORR) of 72.0% (95% CI: 50.6-87.9) in treatment-naive patients and 39.1% (95% CI: 27.6-51.6) in previously treated patients.

ORR was assessed by blinded independent review committee (BIRC). Adverse events (AEs) were consistent with previously reported data and no new safety signals were observed. Results of the Phase II study were presented today at the European Society for Medical Oncology (ESMO) 2018 Congress.

University Hospital Cologne’s Juergen Wolf said: “These preliminary findings reveal the potential of capmatinib in MET exon-14 skipping mutated NSCLC patients.

“Compared to the previously treated patient groups, the primary advantage in terms of overall response rate reported in treatment-naive patients highlights the clinical relevance for an earlier diagnostic testing and prompt treatment of this challenging patient population.”

NSCLC is the most common type of lung cancer, impacting more than 2 million people per year. Approximately 3-4% of all patients with NSCLC have an identified MET mutation.

Though rare, this mutation is an indicator of especially poor prognosis and there is currently no approved therapy designed to target this mutation.

Novartis oncology global drug development head Samit Hirawat said: “Patients diagnosed with advanced MET mutated NSCLC represent an unmet medical need and often face a poor prognosis.

“We are encouraged by the GEOMETRY mono-1 results and the potential for capmatinib to help patients with this disease.”

Source: Company Press Release