PMID- 34626024
OWN - NLM
STAT- MEDLINE
DCOM- 20211122
LR  - 20220721
IS  - 1097-0347 (Electronic)
IS  - 1043-3074 (Print)
IS  - 1043-3074 (Linking)
VI  - 43
IP  - 12
DP  - 2021 Dec
TI  - Phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in 
      patients with locoregional, recurrent head and neck squamous cell carcinoma.
PG  - 3875-3887
LID - 10.1002/hed.26885 [doi]
AB  - BACKGROUND: Recurrent head and neck squamous cell carcinoma (rHNSCC) represents a 
      significant global health burden with an unmet medical need. In this study we 
      determined the safety and efficacy of RM-1929 photoimmunotherapy in patients with 
      heavily pretreated rHNSCC. METHODS: RM-1929 (anti-EGFR-IR700 dye conjugate) was 
      infused, followed by tumor illumination. We evaluated safety, tumor response, and 
      pharmacokinetics. RESULTS: Nine patients were enrolled in Part 1 (dose-finding) 
      and 30 patients in Part 2 (safety and efficacy). No dose-limiting toxicities were 
      experienced in Part 1; 640 mg/m(2) with fixed light dose (50 J/cm(2) or 100 J/cm) 
      was recommended for Part 2. Adverse events (AEs) in Part 2 were mostly mild to 
      moderate but 19 (63.3%) patients had AE >/=Grade 3, including 3 (10.0%) with 
      serious AEs leading to death (not treatment related). Efficacy in Part 2: 
      unconfirmed objective response rate (ORR) 43.3% (95% CI 25.46%-62.57%); confirmed 
      ORR 26.7% (95% CI 12.28%-45.89%); median overall survival 9.30 months (95% CI 
      5.16-16.92 months). CONCLUSIONS: Treatment was well tolerated. Responses and 
      survival following RM-1929 photoimmunotherapy in heavily pretreated patients with 
      rHNSCC were clinically meaningful and warrant further investigation. CLINICAL 
      TRIAL INFORMATION: NCT02422979.
CI  - (c) 2021 The Authors. Head & Neck published by Wiley Periodicals LLC.
FAU - Cognetti, David M
AU  - Cognetti DM
AUID- ORCID: 0000-0001-7039-3055
AD  - Department of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University, 
      Philadelphia, Pennsylvania, USA.
AD  - Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, 
      Pennsylvania, USA.
FAU - Johnson, Jennifer M
AU  - Johnson JM
AD  - Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, 
      Pennsylvania, USA.
AD  - Department of Medical Oncology, Thomas Jefferson University, Philadelphia, 
      Pennsylvania, USA.
FAU - Curry, Joseph M
AU  - Curry JM
AD  - Department of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University, 
      Philadelphia, Pennsylvania, USA.
AD  - Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, 
      Pennsylvania, USA.
FAU - Kochuparambil, Samith T
AU  - Kochuparambil ST
AD  - Department of Medical Oncology, Virginia Piper Cancer Institute, Minneapolis, 
      Minnesota, USA.
FAU - McDonald, Darren
AU  - McDonald D
AD  - Department of Otolaryngology-Head and Neck Surgery, Virginia Piper Cancer 
      Institute, Minneapolis, Minnesota, USA.
FAU - Mott, Frank
AU  - Mott F
AD  - Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD 
      Anderson Cancer Center, Houston, Texas, USA.
FAU - Fidler, Mary J
AU  - Fidler MJ
AD  - Department of Hematology, Oncology, and Cell Therapy, Rush University Medical 
      Center, Chicago, Illinois, USA.
FAU - Stenson, Kerstin
AU  - Stenson K
AD  - Department of Otorhinolaryngology, Rush University Medical Center, Chicago, 
      Illinois, USA.
FAU - Vasan, Nilesh R
AU  - Vasan NR
AD  - Department of Otolaryngology-Head and Neck Surgery, University of Oklahoma Health 
      Sciences Center, Oklahoma City, Oklahoma, USA.
FAU - Razaq, Mohammad A
AU  - Razaq MA
AD  - Division of Hematology and Oncology, University of Oklahoma Health Sciences 
      Center, Oklahoma City, Oklahoma, USA.
FAU - Campana, John
AU  - Campana J
AD  - Department of Otolaryngology, University of Colorado Head and Neck Specialists, 
      Denver, Colorado, USA.
FAU - Ha, Patrick
AU  - Ha P
AD  - Division of Head and Neck Surgical Oncology, University of California San 
      Francisco, San Francisco, California, USA.
FAU - Mann, Grace
AU  - Mann G
AD  - Department of Clinical Development, Rakuten Medical, Inc, San Mateo, California, 
      USA.
FAU - Ishida, Kosuke
AU  - Ishida K
AD  - Department of Biostatistics, Rakuten Medical Japan, Tokyo, Japan.
FAU - Garcia-Guzman, Miguel
AU  - Garcia-Guzman M
AD  - Department of Translational Sciences, Rakuten Medical, Inc, San Diego, 
      California, USA.
FAU - Biel, Merrill
AU  - Biel M
AD  - Department of Clinical Development, Rakuten Medical, Inc, San Mateo, California, 
      USA.
FAU - Gillenwater, Ann M
AU  - Gillenwater AM
AD  - Department of Head and Neck Surgery, University of Texas MD Anderson Cancer 
      Center, Houston, Texas, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02422979
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20211009
PL  - United States
TA  - Head Neck
JT  - Head & neck
JID - 8902541
RN  - PQX0D8J21J (Cetuximab)
SB  - IM
MH  - Antineoplastic Combined Chemotherapy Protocols
MH  - Cetuximab/therapeutic use
MH  - *Head and Neck Neoplasms/therapy
MH  - Humans
MH  - *Immunotherapy
MH  - *Neoplasm Recurrence, Local/drug therapy
MH  - Phototherapy
MH  - *Squamous Cell Carcinoma of Head and Neck/therapy
PMC - PMC9293150
OTO - NOTNLM
OT  - RM-1929 photoimmunotherapy
OT  - cetuximab-IR700 conjugate
OT  - light-activatable dye (IRDye 700DX)
OT  - recurrent head and neck squamous cell carcinoma (rHNSCC)
OT  - tumor-targeted monoclonal antibody
COIS- David M. Cognetti: Honoraria (Intuitive Surgical); Consulting or Advisory Role 
      (Rakuten Medical). Jennifer M. Johnson: Consulting or Advisory Role 
      (Bristol-Myers Squibb; Foundation Medicine; Rakuten Medical); Research Funding 
      (AstraZeneca; Bristol-Myers Squibb; Merck). Joseph M. Curry: Consulting or 
      Advisory Role (Rakuten Medical); Research Funding (AstraZeneca; Castle 
      Biosciences). Samith T. Kochuparambil: none. Darren McDonald: Consulting or 
      Advisory Role (Rakuten Medical). Frank Mott: none. Mary J. Fidler: Honoraria 
      (AstraZeneca); Consulting or Advisory Role (AstraZeneca; Genentech; G1 
      Therapeutics, Rakuten Medical); Speakers' Bureau (Merck; Genentech); Research 
      Funding (Biodesix; Pfizer). Kerstin Stenson: Stock or Other Ownership (Abbott; 
      Abbvie; Biogen; Bristol-Myers Squibb; Celgene); Honoraria (UpToDate); Travel, 
      Accommodations, Expenses (Rakuten Medical). Nilesh R. Vasan: Employment (Adroit 
      Surgical LLC); Leadership (Adroit Surgical LLC); Stock or Other Ownership (Adroit 
      Surgical LLC); Patents, Royalties, Other Intellectual Property (Adroit Surgical 
      LLC; University of Oklahoma Board of Regents). Mohammad A. Razaq: Honoraria 
      (AstraZeneca); Speakers' Bureau (Merck & Co); Stock or Other Ownership (Amgen); 
      Travel, Accommodation, Expenses (Merck). John Campana: Travel, Accommodations, 
      Expenses (Axogen). Patrick Ha: Consulting or Advisory Role (Bayer/LOXO Oncology, 
      Rakuten Medical); Travel, Accommodations, Expenses (Genentech). Educational 
      funding (Stryker, Johnson & Johnson, Medtronic, Axogen). Grace Mann: Employment 
      (Rakuten Medical); Stock or Other Ownership (Rakuten Medical). Kosuke Ishida: 
      Employment (Rakuten Medical; Boehringer Ingelheim). Miguel Garcia-Guzman: 
      Employment (Rakuten Medical); Leadership (Rakuten Medical); Stock or Other 
      Ownership (Vertex Pharma; Gilead); Patents, Royalties, Other Intellectual 
      Property (UC Irvine; Rakuten Medical). Merrill Biel: Employment (Rakuten 
      Medical); Leadership (Rakuten Medical); Stock and Other Ownership Interests 
      (Rakuten Medical); Travel, Accommodation, Expenses (Rakuten Medical). Ann M. 
      Gillenwater: Consulting or Advisory Role (Rakuten Medical Inc., Masimo 
      Corporation).
EDAT- 2021/10/10 06:00
MHDA- 2021/11/23 06:00
PMCR- 2022/07/18
CRDT- 2021/10/09 06:34
PHST- 2021/08/24 00:00 [revised]
PHST- 2021/03/03 00:00 [received]
PHST- 2021/09/16 00:00 [accepted]
PHST- 2021/10/10 06:00 [pubmed]
PHST- 2021/11/23 06:00 [medline]
PHST- 2021/10/09 06:34 [entrez]
PHST- 2022/07/18 00:00 [pmc-release]
AID - HED26885 [pii]
AID - 10.1002/hed.26885 [doi]
PST - ppublish
SO  - Head Neck. 2021 Dec;43(12):3875-3887. doi: 10.1002/hed.26885. Epub 2021 Oct 9.