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David S. Ettinger, MD, FACP, FCCP


Mobocertinib for EGFR Exon 20 Insertion–Positive Metastatic NSCLC

By: Cordi Craig, MS
Posted: Friday, February 25, 2022

Patients with metastatic non–small cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations tend to have a poor prognosis. However, according to a phase I/II clinical trial, mobocertinib, an oral tyrosine kinase inhibitor designed to specifically target EGFR exon 20 insertion mutations, appears to be safe and effective among this patient population. The report was published in JAMA Oncology.

“Mobocertinib appears to have a favorable risk-benefit profile in patients with previously treated EGFR exon 20–positive metastatic NSCLC,” Pasi A. Jänne, MD, PhD, of the Dana-Farber Cancer Institute, Boston, and colleagues concluded. “[It] may serve as a potential treatment option in this patient population, which has a high unmet medical need.”

The research team evaluated response, survival, and safety profiles among patients from two primary cohorts: the platinum-pretreated patient (PPP; n = 114) and the EXCLAIM (n = 96) cohorts. The median durations of follow-up were 14.2 months and 13 months, respectively. The objective response rate, median duration of response, and median progression-free survival were assessed by an independent review committee.

Antitumor activity and safety profiles seemed to be similar for both cohorts. The confirmed objective response rates for the PPP and EXCLAIM cohorts were 28% and 25%, respectively. For patients in the PPP cohort, the median duration of response was 17.5 months; the median progression-free survival and overall survival were 7.3 months and 24 months, respectively. In the EXCLAIM cohort, the median progression-free survival was 7.3 months, and the median overall survival was not reached.

Diarrhea and rash were the most common treatment-related adverse events. Gastrointestinal and skin adverse events were generally mild, and all adverse events were managed with supportive care, dose modification, or treatment discontinuation.

Disclosure: For full disclosures of the study authors, visit

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