Real-world occurrence of severe gastrointestinal bleeding in patients receiving amivantamab plus lazertinib for NSCLC

Amivantamab plus lazertinib is an emerging targeted therapy directed against EGFR and MET pathways for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). Clinical trial have not reported significant gastrointestinal bleeding (GIB) with this therapy. In a real-world case series of 25 consecutive patients receiving aminvantamab plus lazertinib for NSCLC at Saitama Medical University (Saitama, Japan), two patients (8%) developed life-threatening GIB. Both patients exhibited progressive hypoalbuminemia and gastrointestinal mucosal edema preceding the onset of bleeding. Contrast-enhanced computed tomography and endoscopic evaluation demonstrated diffuse bowel wall edema and multiple mucosal ulcers. Both patients received apixaban. One patient recovered with supportive management, while the other died of hemorrhagic shock. The authors conclude that real-world patients, who are often older, treated in later lines of therapy, and using concomitant anticoagulants, may be more vulnerable to severe gastointestinal complications than those enrolled in controlled clinical trials.