TY - JOUR
T1 - Phase i trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas
AU - Wermke, Martin
AU - Felip, Enriqueta
AU - Gambardella, Valentina
AU - Kuboki, Yasutoshi
AU - Morgensztern, Daniel
AU - Hamed, Zohra Oum
AU - Liu, Meiruo
AU - Studeny, Matus
AU - Owonikoko, Taofeek K.
N1 - Funding Information:
This study was funded by Boehringer Ingelheim. M Wermke received honoraria from Novartis, Pfizer, Roche, Lilly; reports consulting or advisory role for Bristol-Myers Squibb, Novartis, Pfizer, Cellex GmbH, Lilly, Boehringer Ingelheim, ISA Pharmaceuticals, GEMoaB, Roche, MSD, AstraZeneca, Amgen, Immatics; received research funding from Roche; travel, accommodations, expenses from Pfizer, Bristol-Myers Squibb, AstraZeneca, Roche Amgen, GEMoaB. E Felip received personal fees for advisory boards from AbbVie, Guardant Health, Janssen, Medscape, Merck KGaA, GlaxoSmithKline, Bayer; advisory board and speakers’ bureau fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda; speakers’ bureau fees from Prime Oncology, Touchime; research funding from Grant for Oncology Innovation (GOI), Fundacion Merck Salud; Grífols: independent member of the board. Y Kuboki received honoraria from Taiho, ONO, Bayer, Sanofi; consulting fees from Takeda, Boehringer Ingelheim, Taiho; grants or funds from Taiho, Takeda, ONO, AbbVie, AstraZeneca, Boehringer In-gelheim, Incyte, Amgen, Chugai, GSK, Genmab, Astellas, Daiichi-Sankyo. D Morgensztern received consulting fees from AbbVie, Gilead, PharmaMar, Lilly, Bristol-Myers Squibb, G1 Therapeutics, Mirati, Boehringer Ingelheim. ZO’ Hamed, M Liu and M Studeny report employment with Boehringer Ingelheim. TK Owonikoko received consulting fees from Novartis, Celgene, Lilly, Sandoz, Ab-bVie, Eisai, G1 Therapeutics, Takeda, Seattle Genetics, Bristol-Myers Squibb, MedImmune, BerGenBio, Lilly, Amgen, AstraZeneca, PharmaMar, Boehringer Ingelheim, EMD Serono, XCovery, Bayer, Heron Pharmaceutical, ARMO BioSciences, Merck, Bayer, Jazz Pharmaceuticals; and research funding from Novartis, Astellas Pharma, Bayer, StemCentRx, Regeneron, AstraZeneca/MedImmune, AbbVie, G1 Therapeutics, Bristol-Myers, Corvus Pharmaceuticals, United Therapeutics, Amgen, Loxo/Lilly, Fujifilm, Pfizer, Aeglea Biotherapeutics, Incyte, Merck, Mersana, Turning Point, and Oncorus. V Gambardella reports no conflicts of interest. All authors met criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE) and did not receive payment related to the development of the manuscript. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Funding Information:
Medical writing support for the development of this manuscript, under the direction of the authors, was provided by L Pritchard, of Ashfield MedComms, an Inizio company, and funded by Boehringer Ingelheim.
Publisher Copyright:
© 2022 The Authors.
PY - 2022/8
Y1 - 2022/8
N2 - Poorly differentiated neuroendocrine carcinomas such as small-cell lung cancer (SCLC) have poor survival and high relapse rates. DLL3 is found on these carcinomas and has become a target of increasing interest in recent years. The bispecific DLL3/CD3 T-cell engager BI 764532 has been shown to induce complete tumor regression in a human T cell-engrafted mouse model. Here, we describe the study design of a first-in-human, phase I, multicenter, open-label, non-randomized, dose-escalation study in patients with SCLC or other DLL3-positive neuroendocrine carcinomas. The study will determine the maximum tolerated dose and evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of BI 764532 monotherapy.
AB - Poorly differentiated neuroendocrine carcinomas such as small-cell lung cancer (SCLC) have poor survival and high relapse rates. DLL3 is found on these carcinomas and has become a target of increasing interest in recent years. The bispecific DLL3/CD3 T-cell engager BI 764532 has been shown to induce complete tumor regression in a human T cell-engrafted mouse model. Here, we describe the study design of a first-in-human, phase I, multicenter, open-label, non-randomized, dose-escalation study in patients with SCLC or other DLL3-positive neuroendocrine carcinomas. The study will determine the maximum tolerated dose and evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of BI 764532 monotherapy.
KW - BI 764532
KW - DLL3
KW - T-cell engager
KW - neuroendocrine carcinoma
KW - small-cell lung cancer
UR - http://www.scopus.com/inward/record.url?scp=85134213452&partnerID=8YFLogxK
U2 - 10.2217/fon-2022-0196
DO - 10.2217/fon-2022-0196
M3 - Article
C2 - 35815644
AN - SCOPUS:85134213452
SN - 1479-6694
VL - 18
SP - 2639
EP - 2649
JO - Future Oncology
JF - Future Oncology
IS - 24
ER -