Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Antibodies May Have Role in ‘TKI World’ of EGFR-mutant NSCLC

Key clinical point: Both JNJ-372, an EGFR and MET bispecific antibody, and U3-1402, a HER3-directed antibody-drug conjugate (ADC), demonstrated manageable safety profiles and preliminary antitumor activity in phase 1 study results.

Major finding: In a phase 1 study of JNJ-372, 32 out of 108 patients (30%) had a partial response after treatment. In a phase 1 study of U3-1402, the response rate was about 31%, or 5 out of 16 patients, including 4 confirmed partial responses.

Study details: Two phase 1 studies, one with 108 patients and one with 16 patients.

Disclosures: Dr. Bauman reported a consulting or advisory role with Pfizer. Dr. Haura provided disclosures related to Bristol-Myers Squibb; Janssen Oncology, Boehringer Ingelheim, FORMA Therapeutics, Ignyta, Janssen, Lilly, and Ventana, plus a patent pending on technology related to kinase inhibitor sensitivity biomarkers. Dr. Jänne reported disclosures related to Gatekeeper Pharmaceuticals, Loxo, Araxes Pharma, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Lilly, and others.


Haura EB, et al. ASCO 2019. Abstract 9009, Jänne PA, et al. ASCO 2019. Abstract 9010.