Novartis announces FDA approval of MET inhibitor Tabrecta for metastatic non-small cell lung cancer with METex14 - Seite 2

Novartis was previously granted Breakthrough Therapy Designation for capmatinib. According to FDA guidelines, treatments that receive Breakthrough Therapy Designation must target a serious or life-threatening disease and demonstrate a substantial improvement over existing therapies on one or more significant preliminary research endpoints.

The approval of Tabrecta is based on results from the pivotal GEOMETRY mono-1 Phase II multi-center, non-randomized, open-label, multi-cohort 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 v1.1¹. 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)¹. The most common treatment-related adverse events (AEs) (incidence ≥20%) are peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite¹.

“Today, and especially during these difficult times, we are incredibly proud that Tabrecta is the first treatment approved by the FDA specifically to treat patients diagnosed with this aggressive NSCLC associated with METex14,” said Susanne Schaffert, PhD, President, Novartis Oncology. “In our quest to reimagine medicine, we have worked tirelessly over the past decades to advance the understanding and treatment of NSCLC, striving to make a difference in patients’ lives, one mutation at a time. We thank all the physicians, patients and families involved in the Tabrecta clinical trials, and we remain committed to advancing innovative solutions for the patients we work to serve.”

NSCLC accounts for approximately 85% of the 2 million new lung cancer diagnoses each year worldwide, including about 228,000 in the United States^4-5. Nearly 70% of NSCLC patients have a genomic mutation⁶. METex14, a recognized oncogenic driver, occurs in approximately 3%-4% of newly diagnosed metastatic NSCLC cases (about 4,000 – 5,000 patients in the US annually)^{7-9, 2}.

“With NSCLC, understanding whether a mutation is driving the cancer is critical, and it’s important for doctors and patients to use comprehensive biomarker testing at the time of diagnosis or progression to check for mutations like those that cause METex14,” said Andrea Ferris, President and CEO of LUNGevity. “Knowing more about the molecular makeup of their tumor will help patients and their healthcare teams make informed treatment-related decisions from the start.”