Zhou C, Ramalingam SS, Kim TM, et al. - A clinically meaningful benefit as well as a manageable safety were conferred by mobocertinib (an oral tyrosine kinase inhibitor) in patients with previously treated EGFR exon 20 insertion (EGFRex20ins)-positive metastatic non–small cell lung cancer (mNSCLC).

• This is a 3-part, open-label, phase 1/2 nonrandomized clinical trial of mobocertinib in patients with previously treated EGFRex20ins-positive mNSCLC.

• Antitumor activity of mobocertinib was evident in platinum-pretreated EGFRex20ins-positive mNSCLC, with a confirmed objective response rate (ORR) of 28%, median duration of response of 17.5 months, and median progression-free survival of 7.3 months by independent review committee (IRC) assessments.

• In the EXCLAIM cohort (a single-arm extension cohort of patients with previously treated EGFRex20ins-positive mNSCLC), confirmed ORR by IRC assessment was 25% and by investigator assessment was 32%.

• Gastrointestinal and cutaneous adverse events occurred but were largely manageable.