FDA Grants Tepotinib Breakthrough Therapy Designation for NSCLC with Certain Alterations

By Cassie Homer
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The FDA has granted breakthrough therapy designation to the investigational therapy tepotinib for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations who progressed after platinum-based chemotherapy, according to a press release.

MET signaling pathways are found in about 3-5% of NSCLC cases and are associated with aggressive tumors and poor prognosis.


Scientist. Source: Getty

“Tepotinib was associated with robust objective responses with durability that has not previously been seen in patients with metastatic NSCLC harboring MET exon 14 skipping alterations, selected by either tissue or liquid biopsy approaches,” said Luciano Rossetti , Global Head of Research & Development for the Biopharma business of Merck KGaA, Darmstadt, Germany. “This breakthrough therapy designation further underscores the potential of tepotinib, and we aim to advance this program and deliver this medicine as quickly as possible to NSCLC patients who may benefit.”

The FDA based the designation on data from the ongoing VISION study. The study found that among 73 efficacy-evaluable patients with NSCLC with MET exon 14 skipping alterations, 50% demonstrated an overall response using LBx testing. When using TBx testing researchers reported an ORR of 45.1%. 

The overall median duration of response was 12.4 months and 17.1 months among LBx-identified patients, as assessed by IRC and investigators, respectively, while among TBx-identified patients, 15.7 and 14.3 months were observed, respectively.

Researchers did not observed any grade 4 or 5 treatment-related adverse events; most events were grade 1 or 2. Among the 87 patients evaluable for safety, the most common adverse events included peripheral edema (48.3%), nausea (23.0%) diarrhea (20.7%), increased blood creatinine (12.6%), increased lipase (4.6%), fatigue (3.4%) and vomiting (3.4%).

 

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