Press release
Incyte Announces Pivotal GEOMETRY mono-1 Study Results of Capmatinib (Tabrecta™) in Patients with METex14 Metastatic Non-Small Cell Lung Cancer Published in NEJM
— Tabrecta is the first and only therapy approved by the FDA to specifically target metastatic non-small cell lung cancer (NSCLC) with a mutation that leads
About this update from Incyte Corporation
[{"type":"text","content":"\n— Tabrecta is the first and only therapy approved by the FDA to specifically target metastatic non-small cell lung cancer (NSCLC) with a mutation that leads to MET exon 14 skipping (METex14)\n\n\n— Tabrecta is the fourth molecule discovered by Incyte scientists to be approved by the FDA\n\n\n— Novartis has exclusive worldwide development and commercialization rights to Tabrecta\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq: INCY) today announced that data from the Novartis pivotal Phase 2 GEOMETRY mono-1 study demonstrating that treatment with Tabrecta™ (capmatinib) resulted in positive overall response rates (ORR) with durable responses among adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to skipping of MET exon 14 (METex14) have been published in The New England Journal of Medicine.1\n\n\nMET, a receptor tyrosine kinase coded by the MET gene, normally plays an important role in cell signaling, proliferation and survival.2 Many cancers are associated with abnormal signaling through the MET receptor pathway, caused by multiple mechanisms including point mutations, insertions/deletions that lead to skipping of exon 14.2 Results from the GEOMETRY mono-1 study describe METex14 as an important biomarker for physicians to consider when selecting metastatic NSCLC treatment options; and emphasize the importance of broad molecular testing for NSCLC patients.\n\n\n“The GEOMETRY mono-1 study results published in The New England Journal of Medicine further highlight the clinical benefit that Tabrecta can provide to patients with metastatic METex14 NSCLC,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “Having a therapy that targets a recognized oncogenic driver offers a much-needed treatment option for patients living with this aggressive form of lung cancer and we are proud that the world-class discovery program at Incyte contributed to the fulfillment of this unmet medical need.”\n\n\nPublished data from the GEOMETRY mono-1 study demonstrate that in the METex14 population (n=97), the ORR as confirmed by the Blinded Independent Radiology Committee (BIRC) was 68% (95% CI, 48-84) among treatment-naïve patients (n=28) and 41% (95% CI, 29-53) among previously treated patients (n=69).1 In patients with METex14 who responded to treatment with Tabrecta, the study als...