Novartis Announces First Overall Survival Data for MET Inhibitor Tabrecta in First-Line Treatment of METex14-Mutated Metastatic NSCLC

Recently, at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, Novartis announced updated Phase 2 clinical trial data for the oral, highly selective small-molecule MET inhibitor Tabrecta (capmatinib) in the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). These patients harbored genetic mutations causing MET exon 14 skipping (METex14). The press release noted that this is the first time Novartis has disclosed overall survival data for Tabrecta. Tabrecta is the first targeted therapy approved by the FDA for this patient population.

The trial results showed that the median overall survival (OS) for treatment-naïve and previously treated patients was 20.8 months and 13.6 months, respectively. Additionally, the overall response rates for treatment-naïve and previously treated patients were 67.9% (95% CI: 47.6, 84.1) and 40.6% (95% CI: 28.9, 53.1), respectively.

No new safety signals or unexpected safety findings were observed. 98% of subjects experienced at least one adverse event (AE) of any grade, with the majority being Grade 3 or 4; 50.9% of subjects experienced at least one serious adverse event (SAE). 13% of AEs were suspected to be treatment-related. The most common adverse events (>20%) were peripheral edema, nausea, vomiting, increased blood creatinine, dyspnea, fatigue, and decreased appetite.

Lung cancer is the most common cancer worldwide, with over 2 million newly diagnosed cases annually. Currently, the 5-year survival rate for lung cancer is below 20%. Lung cancer is primarily classified into two main types: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC accounting for approximately 80% to 85% of all cases. Nearly one-third of patients with metastatic NSCLC may harbor mutations, while the frequency of MET exon 14 skipping (METex14) mutations in metastatic NSCLC cases ranges from 3% to 4%. Currently, clinical treatment options for NSCLC patients are limited, often resulting in a poor prognosis.

Note: The original text has been abridged.

References:

[1] First Published Overall Survival and Updated Overall Response Data in Patients with METex14 metastatic NSCLC. Retrieved June 4, 2021, from https://www.novartis.com/news/media-releases/novartis-announces-tabrecta-first-published-overall-survival-and-updated-overall-response-data-patients-metex14-metastatic-nsclc

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