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FDA Approves Mobocertinib for EGFR Exon 20 Insertion–Mutated NSCLC

Non-small cell lung cancer.

The FDA has approved mobocertinib (Exkivity™, Takeda) for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

In addition, the FDA has approved the OncomineTM Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to determine eligibility for treatment with mobocertinib.

"EGFR exon 20 insertion mutations represent approximately 4% to 12% of EGFR mutations in patients with NSCLC," wrote Gregory J. Riely, MD, PhD, Vice Chair of Clinical Research in the Department of Medicine at Memorial Sloan Kettering Cancer Center, and colleagues, in their publication of results of Study 101 (NCT02716116), on which the approval was based. "The identification of active EGFR tyrosine kinase inhibitors (TKIs) and other treatment strategies for patients with these recalcitrant mutations has been an ongoing priority."

In this international, non-randomized, open-label, multicohort clinical trial, the investigators evaluated 114 patients with EGFR exon 20 insertion–mutated locally advanced or metastatic NSCLC whose disease had progressed on or after platinum-based chemotherapy. Patients received mobocertinib 160 mg orally daily until disease progression or intolerable toxicity. The primary end points were overall response rate and response duration.

Mobocertinib produced an overall response rate of 28%, with a median response duration of 17.5 months.

The most common adverse reactions, occurring in more than 20% of patients, were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. The prescribing information for mobocertinib includes a boxed warning for QTc prolongation and Torsades de Pointes; additional warnings are for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.

"Mobocertinib demonstrated antitumor activity with manageable toxicity in patients with advanced EGFR exon 20 insertion NSCLC in this study," concluded Dr. Riely and colleagues in their July 2021 publication in Cancer Discovery.

This accelerated approval is based on the overall response rate and the duration of response observed in the trial. At least one confirmatory trial will be needed for continued FDA approval.

The recommended mobocertinib dose is 160 mg orally once daily until disease progression or unacceptable toxicity.

For More Information


Riely GJ, Neal JW, Camidge DR, et al (2021). Activity and safety of mobocertinib (TAK-788) in previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations from a phase I/II trial. Cancer Discov, 11(7):1688-1699. DOI:10.1158/2159-8290.CD-20-1598

Clinicaltrials.gov (2021). A study of TAK-788 in adults with non-small cell lung cancer. NLM identifier: NCT02716116.

Exkivity™ (mobocertinib) prescribing information (2021). Takeda. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215310s000lbl.pdf

US Food & Drug Administration (2021). FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mobocertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20

Image credit: Librepath. Licensed under CC BY-SA 3.0


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