125P - Final results of APOLLON-11 and SOYUZ-APOLLON study: Multicentre prospective observational post-authorization study of bevacizumab biosimilar in patients with metastatic colorectal cancer in real-world practice

Background

Bevacizumab biosimilar (Avegra®) became available for patients in Russia since 2015. Since introduction, no real-world data except clinical cases was available. We decided to assess the safety and effectiveness of Avegra® in patients treated in daily practice according to national treatment protocols. Depending on the geography the study was divided into Apollon-11, conducted in Moscow, and Soyuz-Apollon, conducted in 18 regions of Russia. The final analysis summarizes pooled results of all regions.

Methods

This multicentre prospective observational post-authorization study of bevacizumab biosimilar combined with chemotherapy in patients with metastatic colorectal cancer was conducted in 28 centres in Russia from December 2019 to January 2023. Patients with metastatic colorectal cancer (mCRC), treated with bevacizumab at a dose of 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with standard chemotherapy regimens as a first line of therapy were included. Primary safety endpoints were the incidence of adverse reactions (ARs) related to bevacizumab and the rate of treatment discontinuation due to ARs.

Results

438 patients with mCRC in 28 research centres of the Russian Federation were included in the study. Median age of patients was 62 (28–87) years, ECOG performance status of £1. Most of the tumors were left-sided (67.8%) and had at least one RAS/BRAF mutation (55.9%). After median follow-up of 7.3 months, adverse reactions occurred in 11%, of which 2.7% were grade ³3. Treatment was discontinued in 2.8% of patients due to adverse reactions. Objective response was achieved in 37.9% of patients (95% CI 31.4 - 41.6) with 2.8% of complete responses. Median progression-free survival was 9.4 months (95% CI 8.1 - 10.7). Median overall survival was not reached.

Conclusions

Our findings are consistent with previously known bevacizumab safety and efficacy profile. Numerically low incidence of ARs is most likely due to reduced reporting of adverse events in real-world clinical practice settings.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

BIOCAD.

Funding

BIOCAD.

Disclosure

A. Tryakin, M. Fedyanin, F.V. Moiseenko: Financial Interests, Personal, Coordinating PI: BIOCAD. M. Mariam, O. Mironov, D. Stroyakovskiy, N. Sokolov, S. Orlova, E. Mantsyrev, A.V. Sultanbaev, A. Teterich, K. Babina, D. Yukalchuk, S. Borzyanitsa, A. Isyangulova, A. Saidullaeva, I. Chernova, E. Bobrova, N. Fadeeva: Financial Interests, Personal, Local PI: BIOCAD.