TY - JOUR
T1 - SC-002 in patients with relapsed or refractory small cell lung cancer and large cell neuroendocrine carcinoma
T2 - Phase 1 study
AU - Morgensztern, Daniel
AU - Johnson, Melissa
AU - Rudin, Charles M.
AU - Rossi, Michael
AU - Lazarov, Mirella
AU - Brickman, Daniel
AU - Fong, Abraham
N1 - Funding Information:
AbbVie and the authors thank the patients who participated in this clinical trial and all the study investigators, coordinators, and support staff for their contributions, including Bilal Tariq and Shekman Wong (pharmacokinetic analyses). Medical writing support was provided by Mary L. Smith, PhD, CMPP, Aptitude Health, Atlanta, GA, funded by AbbVie.
Funding Information:
Daniel Morgensztern: Consultant fees: AbbVie, Bristol-Myers Squibb, PharmaMar, Boehringer Ingelheim, Takeda, Gilead. Melissa Johnson: Research funding to institution: AbbVie, Acerta, Adaptimmune, Apexigen, Array BioPharma, AstraZeneca, Atreca, BeiGene, Birdie, Boehringer Ingelheim, Checkpoint Therapeutics, Corvus Pharmaceuticals, CytomX, Daiichi Sankyo, Dynavax, Lilly, EMD Serono, Genentech/Roche, Genmab, Genocea Biosciences, GlaxoSmithKline, Gritstone Oncology, Guardant Health, Hengrui Therapeutics, Immunocore, Incyte, Janssen, Jounce Therapeutics, Kadmon Pharmaceuticals, Loxo Oncology, Lycera, Merck, Mirati Therapeutics, Neovia Oncology, Novartis, OncoMed Pharmaceuticals, Pfizer, Regeneron Pharmaceuticals, Sanofi, Shattuck Labs, Stemcentrx, Syndax Pharmaceuticals, Takeda Pharmaceuticals, Tarveda, University of Michigan, WindMIL, TCR2 Therapeutics, Arcus Biosciences, Ribon Therapeutics, Amgen; consulting/advisory role (spouse): contract lobbyist for Astellas, contract lobbyist for Otsuka Pharmaceuticals; consulting/advisory role (self) – all to institution: AbbVie, Achilles Therapeutics, AstraZeneca, Atreca, Boehringer Ingelheim, Calithera Biosciences, Genentech, GlaxoSmithKline, Gritstone Oncology, Guardant Health, Incyte, Janssen, Lilly, Loxo Oncology, Merck, Mirati Therapeutics, Novartis, Pfizer, Ribon Therapeutics, Sanofi, Association of Community Cancer Centers; food/beverage/travel expenses: AbbVie, Astellas, AstraZeneca, Boehringer Ingelheim, Clovis, Daiichi Sankyo, EMD Serono, Bristol-Myers Squibb, Exelixis, Genentech/Roche, Incyte, Merck, Pfizer, Sysmex Inostics, Vapotherm, Janssen, Lilly, Novartis, Sanofi. Charles M. Rudin: Consultant for: AbbVie, Amgen, Ascentage, AstraZeneca, Celgene, Daiichi Sankyo, Genentech/Roche, Ipsen, Loxo, PharmaMar, and Vivotek. Scientific advisory boards of Bridge Medicines and Harpoon Therapeutics. Michael Rossi, Mirella Lazarov, Daniel Brickman, Abraham Fong: AbbVie employees and may own stock.
Publisher Copyright:
© 2020 Elsevier B.V.
PY - 2020/7
Y1 - 2020/7
N2 - Objectives: This phase 1 study investigated safety/tolerability, pharmacokinetics, and preliminary efficacy of SC-002, a delta-like ligand 3-directed antibody-drug conjugate, in advanced small cell lung cancer and large cell neuroendocrine carcinoma. Materials and methods: Eligible patients received SC-002 at 1 of 7 dose levels during the dose-escalation portion of the study. Results: Thirty-five enrolled patients received ≥1 dose of SC-002. Twenty-three (66%) patients experienced serious adverse events (AEs), 37% considered related to SC-002. Grade 3/4 AEs occurred in 21 (60%) and 2 (6%) patients; the most common were effusion and hypoalbuminemia. One grade 5 AE occurred in 1 patient. Five (14%) patients achieved a partial response and no patients achieved a complete response. Conclusion: SC-002 treatment was associated with systemic toxicity and limited efficacy.
AB - Objectives: This phase 1 study investigated safety/tolerability, pharmacokinetics, and preliminary efficacy of SC-002, a delta-like ligand 3-directed antibody-drug conjugate, in advanced small cell lung cancer and large cell neuroendocrine carcinoma. Materials and methods: Eligible patients received SC-002 at 1 of 7 dose levels during the dose-escalation portion of the study. Results: Thirty-five enrolled patients received ≥1 dose of SC-002. Twenty-three (66%) patients experienced serious adverse events (AEs), 37% considered related to SC-002. Grade 3/4 AEs occurred in 21 (60%) and 2 (6%) patients; the most common were effusion and hypoalbuminemia. One grade 5 AE occurred in 1 patient. Five (14%) patients achieved a partial response and no patients achieved a complete response. Conclusion: SC-002 treatment was associated with systemic toxicity and limited efficacy.
KW - Antibody-drug conjugate
KW - Delta-like ligand 3
KW - Large cell neuroendocrine carcinoma
KW - Pyrrolobenzodiazepine
KW - SC-002
KW - Small cell lung cancer
UR - http://www.scopus.com/inward/record.url?scp=85085144622&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2020.04.017
DO - 10.1016/j.lungcan.2020.04.017
M3 - Article
C2 - 32438272
AN - SCOPUS:85085144622
VL - 145
SP - 126
EP - 131
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
ER -