Investigational Drug for Treating Aggressive Form of NSCLC Granted FDA's Breakthrough Therapy Designation

Officials with the FDA have granted Breakthrough Therapy Designation to Norvartis’ capmatinib therapy as an initial treatment for metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC), according to the company.¹

There are currently no FDA-approved targeted therapies to treat this aggressive form of NSCLC.² According to Novartis, the MET mutation is seen in an estimated 3-4% of all patients with NSCLC. These patients are typically older and many have a poor prognosis, limiting their treatment options.¹

Capmatinib is an oral, investigational therapy. According to Norvartis, Breakthrough Therapy Designation for capmatinib was granted based on positive primary results from the GEOMETRY mono-1 study.¹

"New lung cancer treatment options are critical, as this deadly disease affects more than 2 million new patients around the world each year," said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis, in a prepared statement.² "The GEOMETRY mono-1 results are encouraging."

In the study, primary efficacy results among treatment-naive patients (Cohort 5b: 28 patients) were a 68% overall response rate based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1 (95% CI: (47.6 - 84.1)). Forty-one percent of patients with previously treated NSCLC (Cohort 4: 69 patients) also responded (95% CI: (28.9 - 53.1)). Data on median duration of response (DOR), a key secondary endpoint, was 11.14 months (95% CI: (5.55 - NE)) and 9.72 months (95% CI: (5.55 - 12.98)), respectively. ²

Intracranial activity in 54% (n=7/13) of patients, including some cases of complete resolution of brain lesions, was also observed by ad hoc neuro-radiologist review in patients with brain lesions. ²

The most common treatment related adverse events (AE) (>=10% all grades) across all cohorts (n=334), were peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%).²

References

• Novartis investigational lung cancer therapy capmatinib (INC280) granted FDA Breakthrough Therapy Designation for patients with MET-mutated advanced non-small cell lung cancer [news release]. Basel, Switzerland; September 6, 2019: Novartis website. https://www.novartis.com/news/media-releases/novartis-investigational-lung-cancer-therapy-capmatinib-inc280-granted-fda-breakthrough-therapy-designation-patients-met-mutated-advanced-non-small-cell-lung. Accessed September 6, 2019.
• Novartis Shows Growing Strength in Lung Cancer Innovation with New Capmatinib Investigational Data and Novel Canakinumab Clinical Trials [news release]. Basel, Switzerland; June 3, 2019: Novartis website. https://www.novartis.com/news/media-releases/novartis-shows-growing-strength-lung-cancer-innovation-new-capmatinib-investigational-data-and-novel-canakinumab-clinical-trials. Accessed September 6, 2019.