The Lynx Group

Exkivity Receives Accelerated Approval for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

October 2021, Vol 12, No 5

On September 15, 2021, the FDA accelerated the approval of mobocertinib (Exkivity; Takeda Pharmaceuticals), a tyrosine kinase inhibitor, for the treatment of adults with locally advanced or metastatic non−small-cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by the FDA-approved Oncomine Dx Target Test (Life Technologies Corporation), which was approved on the same day as a companion diagnostic for mobocertinib. The FDA granted mobocertinib priority review, breakthrough therapy designation, and orphan drug designation.

NSCLC accounts for approximately 85% of lung cancer cases worldwide; however, only 1% to 2% of patients have EGFR exon 20 insertion mutations, according to the World Health Organization.

The FDA approved mobocertinib based on the results of an international, open-label, multicohort clinical trial of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. Patients received mobocertinib 160 mg orally daily until disease progression or intolerable toxicity. Efficacy was evaluated in 114 patients whose disease had progressed on or after platinum-based chemotherapy. The overall response rate (ORR) was 28% (95% confidence interval [CI], 20%-37%) with a median duration of response (DOR) of 17.5 months (95% CI, 7.4-20.3).

The most common (>20%) adverse reactions were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain.

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