Phase 1/2a, open‐label, multicenter study of RM‐1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma

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Abstract

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.

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Most cited references 31

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Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

Ahmedin Jemal, Lindsey A Torre, Rebecca Siegel … (2018)

This article provides a status report on the global burden of cancer worldwide using the GLOBOCAN 2018 estimates of cancer incidence and mortality produced by the International Agency for Research on Cancer, with a focus on geographic variability across 20 world regions. There will be an estimated 18.1 million new cancer cases (17.0 million excluding nonmelanoma skin cancer) and 9.6 million cancer deaths (9.5 million excluding nonmelanoma skin cancer) in 2018. In both sexes combined, lung cancer is the most commonly diagnosed cancer (11.6% of the total cases) and the leading cause of cancer death (18.4% of the total cancer deaths), closely followed by female breast cancer (11.6%), prostate cancer (7.1%), and colorectal cancer (6.1%) for incidence and colorectal cancer (9.2%), stomach cancer (8.2%), and liver cancer (8.2%) for mortality. Lung cancer is the most frequent cancer and the leading cause of cancer death among males, followed by prostate and colorectal cancer (for incidence) and liver and stomach cancer (for mortality). Among females, breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death, followed by colorectal and lung cancer (for incidence), and vice versa (for mortality); cervical cancer ranks fourth for both incidence and mortality. The most frequently diagnosed cancer and the leading cause of cancer death, however, substantially vary across countries and within each country depending on the degree of economic development and associated social and life style factors. It is noteworthy that high-quality cancer registry data, the basis for planning and implementing evidence-based cancer control programs, are not available in most low- and middle-income countries. The Global Initiative for Cancer Registry Development is an international partnership that supports better estimation, as well as the collection and use of local data, to prioritize and evaluate national cancer control efforts. CA: A Cancer Journal for Clinicians 2018;0:1-31. © 2018 American Cancer Society.

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Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck

Robert Ferris, George Blumenschein, Jérôme Fayette … (2016)

Background Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum chemotherapy have a very poor prognosis and limited therapeutic options. Nivolumab, an anti-programmed death 1 (PD-1) monoclonal antibody, was assessed as treatment for this condition. Methods In this randomized, open-label, phase 3 trial, we assigned, in a 2:1 ratio, 361 patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy to receive nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks or standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab). The primary end point was overall survival. Additional end points included progression-free survival, rate of objective response, safety, and patient-reported quality of life. Results The median overall survival was 7.5 months (95% confidence interval [CI], 5.5 to 9.1) in the nivolumab group versus 5.1 months (95% CI, 4.0 to 6.0) in the group that received standard therapy. Overall survival was significantly longer with nivolumab than with standard therapy (hazard ratio for death, 0.70; 97.73% CI, 0.51 to 0.96; P=0.01), and the estimates of the 1-year survival rate were approximately 19 percentage points higher with nivolumab than with standard therapy (36.0% vs. 16.6%). The median progression-free survival was 2.0 months (95% CI, 1.9 to 2.1) with nivolumab versus 2.3 months (95% CI, 1.9 to 3.1) with standard therapy (hazard ratio for disease progression or death, 0.89; 95% CI, 0.70 to 1.13; P=0.32). The rate of progression-free survival at 6 months was 19.7% with nivolumab versus 9.9% with standard therapy. The response rate was 13.3% in the nivolumab group versus 5.8% in the standard-therapy group. Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of the patients in the nivolumab group versus 35.1% of those in the standard-therapy group. Physical, role, and social functioning was stable in the nivolumab group, whereas it was meaningfully worse in the standard-therapy group. Conclusions Among patients with platinum-refractory, recurrent squamous-cell carcinoma of the head and neck, treatment with nivolumab resulted in longer overall survival than treatment with standard, single-agent therapy. (Funded by Bristol-Myers Squibb; CheckMate 141 ClinicalTrials.gov number, NCT02105636 .).

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Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study

Barbara Burtness, Kevin Harrington, Richard Greil … (2019)

Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response.

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Author and article information

Contributors

David M. Cognetti:

ORCID: https://orcid.org/0000-0001-7039-3055

david.cognetti@jefferson.edu

Journal

Journal ID (nlm-ta): Head Neck

Journal ID (iso-abbrev): Head Neck

Journal ID (doi): 10.1002/(ISSN)1097-0347

Journal ID (publisher-id): HED

Title: Head & Neck

Publisher: John Wiley & Sons, Inc. (Hoboken, USA )

ISSN (Print): 1043-3074

ISSN (Electronic): 1097-0347

Publication date (Electronic): 09 October 2021

Publication date (Print): December 2021

Volume: 43

Issue: 12 ( doiID: 10.1002/hed.v43.12 )

Pages: 3875-3887

Affiliations

[ ¹ ] Department of Otolaryngology—Head and Neck Surgery Thomas Jefferson University Philadelphia Pennsylvania USA

[ ² ] Sidney Kimmel Cancer Center Thomas Jefferson University Philadelphia Pennsylvania USA

[ ³ ] Department of Medical Oncology Thomas Jefferson University Philadelphia Pennsylvania USA

[ ⁴ ] Department of Medical Oncology Virginia Piper Cancer Institute Minneapolis Minnesota USA

[ ⁵ ] Department of Otolaryngology—Head and Neck Surgery Virginia Piper Cancer Institute Minneapolis Minnesota USA

[ ⁶ ] Department of Thoracic/Head and Neck Medical Oncology University of Texas MD Anderson Cancer Center Houston Texas USA

[ ⁷ ] Department of Hematology, Oncology, and Cell Therapy Rush University Medical Center Chicago Illinois USA

[ ⁸ ] Department of Otorhinolaryngology Rush University Medical Center Chicago Illinois USA

[ ⁹ ] Department of Otolaryngology—Head and Neck Surgery University of Oklahoma Health Sciences Center Oklahoma City Oklahoma USA

[ ¹⁰ ] Division of Hematology and Oncology University of Oklahoma Health Sciences Center Oklahoma City Oklahoma USA

[ ¹¹ ] Department of Otolaryngology University of Colorado Head and Neck Specialists Denver Colorado USA

[ ¹² ] Division of Head and Neck Surgical Oncology University of California San Francisco San Francisco California USA

[ ¹³ ] Department of Clinical Development Rakuten Medical, Inc San Mateo California USA

[ ¹⁴ ] Department of Biostatistics Rakuten Medical Japan Tokyo Japan

[ ¹⁵ ] Department of Translational Sciences Rakuten Medical, Inc San Diego California USA

[ ¹⁶ ] Department of Head and Neck Surgery University of Texas MD Anderson Cancer Center Houston Texas USA

Author notes

[*] [* ] Correspondence

David M. Cognetti, Department of Otolaryngology—Head and Neck Surgery, Thomas Jefferson University, 925 Chestnut Street, 6th Floor, Philadelphia, 19107, PA, USA.

Email: david.cognetti@ 123456jefferson.edu

Author information

David M. Cognetti https://orcid.org/0000-0001-7039-3055

Article

Publisher ID: HED26885

DOI: 10.1002/hed.26885

PMC ID: 9293150

PubMed ID: 34626024

SO-VID: 3bda1ac6-5d5b-4164-a281-2b599f5e18b3

License:

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

History

Date revision received : 24 August 2021

Date received : 03 March 2021

Date accepted : 16 September 2021

Page count

Figures: 3, Tables: 3, Pages: 13, Words: 7805

Funding

Funded by: Rakuten Medical

Custom metadata

source-schema-version-number 2.0

cover-date December 2021

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.7 mode:remove_FC converted:18.07.2022

ScienceOpen disciplines: Otolaryngology

Keywords: cetuximab–ir700 conjugate,light‐activatable dye (irdye 700dx),recurrent head and neck squamous cell carcinoma (rhnscc),rm‐1929 photoimmunotherapy,tumor‐targeted monoclonal antibody

Data availability:

ScienceOpen disciplines: Otolaryngology

Keywords: cetuximab–ir700 conjugate, light‐activatable dye (irdye 700dx), recurrent head and neck squamous cell carcinoma (rhnscc), rm‐1929 photoimmunotherapy, tumor‐targeted monoclonal antibody

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Phase 1/2a, open‐label, multicenter study of RM‐1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma

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Abstract

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Conclusions

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NTT Journal for Theology and the Study of Religion

Most cited references 31

Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck

Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study

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