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Comparative Study
. 2019 Sep;145(9):2303-2311.
doi: 10.1007/s00432-019-02984-2. Epub 2019 Aug 8.

A systematic review of head-to-head trials of approved monoclonal antibodies used in cancer: an overview of the clinical trials agenda

Jia Luo #  1 , Go Nishikawa #  1 , Vinay Prasad  2   3   4
Affiliations
Comparative Study

A systematic review of head-to-head trials of approved monoclonal antibodies used in cancer: an overview of the clinical trials agenda

Jia Luo et al. J Cancer Res Clin Oncol. 2019 Sep.

Abstract

Background: Since 1997, several monoclonal antibodies (mAbs) targeting the same receptor or its ligand have been approved for use in oncology. However, no studies have summarized head-to-head trials of these mAbs.

Methods: Systematic search of the biomedical literature and ClinicalTrials.gov for randomized studies comparing mAbs targeting the same receptor or its ligand that have been completed and published, completed and unpublished, or ongoing. We extracted trial characteristics including phase, indication, enrollment or target enrollment, randomization, primary endpoint and sponsor.

Results: Twenty-two approved cancer mAbs had at least one other approved mAb targeting the same receptor or its ligand, totaling 41 different oncology indications. These include 5 anti-CD20 mAbs, 5 anti-PD1/PDL1 mAbs, 4 anti-HER2 mAbs, 3 anti-EGFR mAbs, 3 anti-VEGF mAbs and 2 anti-IL6/IL6R mAbs. Seventeen were completed and published and 14 were unpublished or ongoing trials. The completed and published trials enrolled 11,373 patients and tested 13 mAbs (13/22, 59%). Additionally, 13 (76%) contained drugs manufactured by the same company and 13 (76%) reached conclusions felt to be favorable to the sponsor. Of the 14 ongoing/completed unpublished trials, there is a total target enrollment of 3404 patients with 9 mAbs tested. Of these, 86% (12/14) are testing mAbs manufactured by the same company and 71% (10/14) are sponsored by the company that made the drug being tested.

Conclusions: Most trials test drugs manufactured or sponsored by the same company. An overview of clinical trials agenda may lead to more uniform testing, helping clinicians make better evidence-informed prescribing decisions.

Keywords: Head-to-head trial; Immunotherapy; Monoclonal antibodies.

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Conflict of interest statement

Dr Prasad reports receiving royalties from his book Ending Medical Reversal; that his work is funded by the Laura and John Arnold Foundation; that he has received honoraria for Grand Rounds/lectures from several universities, medical centers, and professional societies and payments for contributions to Medscape. Drs. Luo and Nishikawa have no conflict of interest.

Figures

Fig. 1
Fig. 1
Network diagram of completed and published head to head trials of mAbs of the same target or its ligand. We identified 17 of these trials. The area of each node represents the approximate total number of patients who received the drug in these studies. Nodes are color coded by manufacturer. Each line connecting two circles represents one head to head trial, and the color designates whether the result favors the sponsor, as defined in the methods
Fig. 2
Fig. 2
Network diagram of ongoing and completed but not published head to head trials of mAbs of the same target or its ligand. We identified 14 of these trials. The area of each node represents the approximate number of patients who received or will receive the drug in these studies (target enrollment divided by the number of arms). Nodes are color coded by manufacturer. Each line connecting two nodes represents one head to head trial
See this image and copyright information in PMC

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