353O - Efficacy and safety of ENZ-124 versus innovator cetuximab in combination with platinum-based chemotherapy in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck (SCCHN)

Background

Head and neck cancer ranks as the sixth most common cancer globally with around 650000 new squamous cell carcinoma cases diagnosed yearly. EGFR is consistently expressed in SCCHN serving as an unfavorable prognostic factor; cetuximab a chimeric monoclonal antibody effectively inhibits EGFR by blocking ligand binding and enhancing immune cell targeting This study evaluates ENZ-124 biosimilarity with cetuximab in Indian patients with recurrent locoregional or metastatic SCCHN.

Methods

This prospective multicenter randomized non-inferiority study enrolled a total of 180 patients with recurrent locoregional or metastatic SCCHN. The patients were stratified based on the type of disease and randomized in a 2:1 ratio to receive either ENZ-124 or innovator cetuximab in combination with platinum-based chemotherapy. The study was conducted at 30 centers across India and PK assessments were performed on 30 patients.

Results

The study enrolled 180 patients, randomized 2:1 for ENZ-124 or innovator cetuximab with platinum-based chemotherapy. The analysis of 141 subjects showed DCR percentages of 94.8% for ENZ-124 and 100% for IC. No significant difference was found (p=0.1773). For ORR, ENZ-124 achieved 55.2%, and IC achieved 60%. Again, no significant difference existed (p=0.5924). All secondary endpoints showed ENZ-124 non-inferior to innovator cetuximab. A total of 1279 treatment-emergent adverse events (TEAEs) were reported. No significant difference existed (p=0.8364) in patients experiencing at least one AE. Out of 1279 TEAEs, 136 events in 77 patients (42.8%) related to the investigational product. 87 AEs in 47 patients (39.2%) were attributed to ENZ-124, while 49 AEs in 30 patients (50%) were related to the reference product safety analysis, including clinical laboratory data, anti-cetuximab antibody assessments, and other parameters, demonstrated comparable safety and immunogenicity.

Conclusions

This study shows ENZ-124 as a biosimilar of innovator cetuximab, the first approved biosimilar cetuximab from India.

Clinical trial identification

CTRI/2019/09/021256 [Registered on: 16/09/2019].

Editorial acknowledgement

Legal entity responsible for the study

Alkem Lab & Enzene Biosciences.

Funding

Alkem Lab.

Disclosure

N. Dhamne: Non-Financial Interests, Personal, Principal Investigator, I must disclose that I have a conflict of interest in presenting the independent data of Alkems' biosimilar trial, as I was the principal investigator for Alkems' biosimilar trial.: Alkem. M. Jain, R. Nagarkar, S.K.K. Das Majumdar, C.D. Deshmukh, R. Dana, P. Ganesan, K. Chatterjee, S. Chatterjee, K. Prabhash, A. Sharma: Non-Financial Interests, Personal and Institutional, Principal Investigator: Alkem. V.K. Mahobia, R. Kumar, P. S.S., H. Malhotra, S.V. Aagre: Non-Financial Interests, Personal, Coordinating PI: Alkem. M. A, P.K. Chaitnya, V.G. Choudhary, V. Maniar: Financial Interests, Personal, Coordinating PI: Alkem.