On May 6, 2020 Incyte (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has approved TabrectaTM (capmatinib) for treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test (Press release, Incyte, MAY 6, 2020, View Source [SID1234557123]). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Tabrecta, the first and only treatment approved to specifically target NSCLC with this driver mutation, is approved for first-line and previously treated patients regardless of prior treatment type.

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Novartis has exclusive worldwide development and commercialization rights to Tabrecta, and the FDA approval of Tabrecta triggers $70 million in milestone payments from Novartis to Incyte. Incyte is also eligible to receive 12-14 % royalties on net sales of Tabrecta by Novartis.

NSCLC accounts for approximately 85% of lung cancer diagnoses1. METex14 occurs in 3-4% of newly-diagnosed metastatic NSCLC cases2 and is a recognized oncogenic driver3,4.

"We are pleased that the FDA has approved Tabrecta for patients with METex14 NSCLC," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Having a therapy that targets the recognized oncogenic driver will provide a much needed treatment option for patients with METex14 NSCLC who currently have limited treatment options. Tabrecta is the fourth Incyte molecule to be approved by the FDA, highlighting our world-class discovery program and commitment to bringing innovative medicines to patients in need."

The approval of Tabrecta is based on results5 from the pivotal GEOMETRY mono-1 Study. In the METex14 population (n=97), the confirmed overall response rate was 68% (95% CI, 48-84) and 41% (95% CI, 29-53) among treatment-naive (n=28) and previously treated patients (n=69), respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. In patients taking Tabrecta, the study also demonstrated a median duration of response of 12.6 months (95% CI, 5.5–25.3) in treatment-naive patients (19 responders) and 9.7 months (95% CI, 5.5-13.0) in previously treated patients (28 responders). The most common treatment-related adverse events (AEs) (incidence ≥20%) are peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

Capmatinib was previously granted Breakthrough Therapy designation by the FDA, which is designed to expedite the development and review of drugs for serious conditions that have shown encouraging early clinical results and may demonstrate substantial improvements over available medicines.

Full prescribing information for Tabrecta can be found at: View Source

About GEOMETRY mono-1

The Novartis-sponsored GEOMETRY mono-1 trial is a multi-center, non-randomized, open-label, multi-cohort Phase 2 study to evaluate the efficacy and safety of single-agent capmatinib in adult patients with EGFR wild-type, metastatic NSCLC as measured by ORR.

Patients (n=97) with metastatic NSCLC harboring mutations that lead to METex14 (centrally confirmed) were assigned to Cohorts 4 (n=69, previously treated patients) or 5B (n=28, treatment-naïve), and received 400 mg capmatinib tablets orally twice daily. The major efficacy outcome was ORR based on BIRC assessment per RECIST v1.1. An additional efficacy outcome was DOR by BIRC.

About Tabrecta

Tabrecta (capmatinib; formerly INC280) is a kinase inhibitor that targets MET discovered by Incyte and licensed to Novartis in 2009. Under the terms of the Agreement, Incyte granted Novartis exclusive worldwide development and commercialization rights to capmatinib and certain back-up compounds in all indications. Incyte is eligible for over $500 million in future milestones as well as royalties of between 12 and 14 percent on global sales by Novartis.