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.

Citation:

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