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Complete remissions following immunotherapy or immuno-oncology combinations in cancer patients: the MOUSEION-03 meta-analysis

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Abstract

Background

Immunotherapy has determined unprecedented long-term responses in several hematological and solid tumors. In the MOUSEION-03 study, we conducted a meta-analysis to determine the possibility of achieving complete remissions (CR) with immunotherapy or immuno-oncology combinations in cancer patients.

Methods

The primary endpoint was to assess the incidence of CR in cancer patients receiving immune checkpoint inhibitors (ICIs) alone or in combination with other agents versus control treatments. The pooled odds ratio (OR) and 95% confidence interval (CI) for CR rate were extracted.

Results

A total of 12,130 potentially relevant trials were identified; 5 phase II and 80 phase III randomized studies (37 monotherapies and 48 combinations) and 49,425 cancer patients were included. The most frequent types of malignancies were non-small cell lung cancer (n = 14,249; 29%), urothelial cancer (n = 6536; 13%), renal cell carcinoma (n = 5743; 12%), and melanoma (n = 2904; 6%). In patients treated with immunotherapy (as monotherapy or in combination with other anticancer agents), the pooled OR was 1.67 (1.52–1.84). The highest OR was registered by immune-based combinations with two ICIs (3.56, 95% CI 1.28–9.90).

Conclusions

To the best of the authors’ knowledge, no comprehensive meta-analysis on the use of ICIs and ICI-based combinations in solid tumors to systematically investigate the probability to achieve CR has been published so far. Although CR is not a common event in several cancer patients receiving immunotherapy, the MOUSEION-03 suggests that the use of ICIs may significantly increase the chance of achieving CR in comparison with control treatments.

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Acknowledgements

Fernando Sabino Marques Monteiro has received research support from Janssen, Merck Sharp and Dhome and honoraria from Janssen, Ipsen, Bristol Myers Squibb and Merck Sharp and Dhome. All unrelated to the present paper. Andrey Soares has received honoraria: Janssen, Pfizer, Bayer, Novartis, AstraZeneca, Astellas Pharma, Pierre Fabre, Merck Serono, Sanofi,Roche, Ipsen, Zodiac. Consulting or Advisory Role: Astellas Pharma, Janssen, Roche, Bayer, Lilly, AstraZeneca, Novartis, MSD, Bristol Myers Squibb, Zodiac, Amgem, Ipsen, United, Zodiac. Research Funding: Bristol Myers Squibb (Inst), Astellas (Inst), AstraZeneca (Inst). Travel, Accommodations, Expenses: AstraZeneca,Pfizer, AstellasPharma, Bristol Myers Squibb, Bayer, Roche, Janssen, Merck Serono, Sanofi, Ipsen, Zodiac. Enrique Grande has received honoraria for speaker engagements, advisory roles or funding of continuous medical education from Adacap, AMGEN, Angelini, Astellas, Astra Zeneca, Bayer, Blueprint, Bristol Myers Squibb, Caris Life Sciences, Celgene, Clovis-Oncology, Eisai, Eusa Pharma, Genetracer, Guardant Health, HRA-Pharma, IPSEN, ITM-Radiopharma, Janssen, Lexicon, Lilly, Merck KGaA, MSD, Nanostring Technologies, Natera, Novartis, ONCODNA (Biosequence), Palex, Pharmamar, Pierre Fabre, Pfizer, Roche, Sanofi-Genzyme, Servier, Taiho, and Thermo Fisher Scientific. EG has received research grants from Pfizer, Astra Zeneca, Astellas, and Lexicon Pharmaceuticals. Francesco Massari reports personal fees from Astellas, BMS, Janssen, Ipsen, MSD, and Pfizer outside the submitted work.

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Author notes

  1. Matteo Santoni and Alessandro Rizzo have equally contributed to this work.

Authors and Affiliations

  1. Oncology Unit, Macerata Hospital, Macerata, Italy

    Matteo Santoni

  2. Struttura Semplice Dipartimentale Di Oncologia Medica Per La Presa in Carico Globale del Paziente Oncologico ″Don Tonino Bello″, Istituto Di Ricerca E Cura a Carattere Scientifico (IRCCS), Istituto Tumori Giovanni Paolo II-Bari, Viale Orazio Flacco 65, 70124, Bari, Italy

    Alessandro Rizzo

  3. Department of Uro-Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland

    Jakub Kucharz

  4. Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Via Albertoni–15, 40138, Bologna, Italy

    Veronica Mollica, Matteo Rosellini, Andrea Marchetti, Elisa Tassinari & Francesco Massari

  5. Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138, Bologna, Italy

    Veronica Mollica, Matteo Rosellini, Andrea Marchetti, Elisa Tassinari & Francesco Massari

  6. Latin American Cooperative Oncology Group - LACOG, Porto Alegre, Brazil

    Fernando Sabino Marques Monteiro

  7. Oncology and Hematology Department, Hospital Santa Lucia, SHLS 716 Cj. C, Brasília, DF, 70390-700, Brazil

    Fernando Sabino Marques Monteiro

  8. Latin American Cooperative Oncology Group - LACOG, Porto Alegre, RS, Brazil

    Andrey Soares

  9. Hospital Israelita Albert Einstein, São Paulo, SP, Brazil

    Andrey Soares

  10. Centro Paulista de Oncologia/Oncoclínicas, São Paulo, SP, Brazil

    Andrey Soares & Javier Molina-Cerrillo

  11. Department of Medical Oncology, Hospital Ramón Y Cajal, 28034, Madrid, Spain

    Enrique Grande

  12. Department of Medical Oncology, MD Anderson Cancer Center Madrid, 28033, Madrid, Spain

    Nicola Battelli

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  1. Matteo Santoni
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Contributions

M.S, A.R. and F.M. wrote the main manuscript text. All authors reviewed the manuscript

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Correspondence to Francesco Massari.

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Santoni, M., Rizzo, A., Kucharz, J. et al. Complete remissions following immunotherapy or immuno-oncology combinations in cancer patients: the MOUSEION-03 meta-analysis. Cancer Immunol Immunother 72, 1365–1379 (2023). https://doi.org/10.1007/s00262-022-03349-4

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