A randomized phase II study comparing the efficacy and safety of the glyco-optimized anti-EGFR antibody tomuzotuximab against cetuximab in patients with recurrent and/or metastatic squamous cell cancer of the head and neck - the RESGEX study.

BACKGROUND

The aim of the RESGEX study was to compare the efficacy and safety of the anti-epidermal growth factor receptor (anti-EGFR) antibody tomuzotuximab against cetuximab both in combination with chemotherapy in patients with recurrent and/or metastatic squamous cell cancer of the head and neck in the first-line treatment.

PATIENTS AND METHODS

In this phase II trial 240 patients were equally randomized for six cycles to receive either tomuzotuximab (initial dose 990 mg then 720 mg) weekly and cisplatin 100 mg/m

RESULTS

Median progression-free survival was 6.5 months [95% confidence interval (CI) 5.9-7.9 months] in the tomuzotuximab group and 6.2 months (95% CI 5.8-7.3 months) in the cetuximab group (P = 0.86). The median overall survival (OS) estimate was 11.6 months (95% CI 9.5-17.2 months) in the tomuzotuximab group and 13.8 months (95% CI 12.3-16.4 months) in the cetuximab group (P = 0.96). In an exploratory analysis a small subgroup of p16-positive patients had a significantly longer OS compared with p16-negative patients (hazard ratio 1.860, 95% CI 1.09-3.16, P = 0.02).

CONCLUSIONS

The glyco-engineered antibody tomuzotuximab failed to demonstrate improved efficacy with a chemotherapeutic backbone in the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma. It remains a so far unanswered question whether such antibody would partner better with different drugs such as checkpoint inhibitors.

Informations de copyright

Crown Copyright © 2021. Published by Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Disclosure KK reports advisory board participation, invited speaker or conference honoraria from Merck, Sanofi, Merck Sharp & Dohme, Glycotope, Roche, Novartis, and Bristol-Myers Squibb. JF reports personal fees from MSD, BMS, AstraZeneca, Merck, Innate, Roche, Pfizer, and Rakuten; and nonfinancial support from MSD, BMS, AstraZeneca, and Pfizer. AK reports consulting fees from MSD and BMS, and payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from AstraZeneca, BMS, MSD, and Merck; he also participates on a DSMB or Advisory Board of MSD, BMS, and Merck. AD reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events as well as participation on a DSMB or Advisory Board of MSD, Sanofi, BMS, and Nanobiotix. PS reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from MSD, Merck Serono, AstraZeneca, and BMS; and support for attending meetings and/or travel from BMS, MSD, and Merck Serono. He participates on a DSMB or Advisory Board of MSD, BMS, and Merck Serono; and reports stock or stock options from AstraZeneca and BMS. GF reports grants or contracts from Merck Serono; consulting fees from BMS, MSD, Roche, Merck, Amgen, Bayer, Sanofi-Aventis, and Servier; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from BMS, MSD, Merck, Roche, Amgen, Falk, and Servier. PD reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Pfizer, LEO Pharma, and VIFOR Pharma; and support for attending meetings and/or travel for Pfizer and LEO Pharma. AJ is employee at Premier Research, the CRO conducting the study. IA-F, BD, AZ, and HB are employees or consultants at Glycotope, the sponsor of the study. In addition, HB owns stock or stock option of Glycotope. SO reports advisory board participation, invited speaker or conference honoraria from Merck, Sanofi, Merck Sharp & Dohme, and Bristol-Myers Squibb. UK reports advisory board participation, invited speaker or conference honoraria from Amgen, Astra Zeneca, Merck, Merck Sharp & Dohme, Glycotope, Novartis, Pfizer, Roche, and Bristol-Myers Squibb; research grants from AstraZeneca, Merck, and Pfizer. All other authors have declared no conflicts of interest.