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Table of Contents
Year : 2021  |  Volume : 4  |  Issue : 4  |  Page : 809-810

Nivolumab in relapsed malignant mesothelioma: Is it ‘CONFIRM’ed?

Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India

Date of Submission12-Dec-2021
Date of Decision13-Dec-2021
Date of Acceptance13-Dec-2021
Date of Web Publication29-Dec-2021

Correspondence Address:
Ajay Gogia
Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi - 110 029
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/crst.crst_317_21

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How to cite this article:
Sasi A, Gogia A. Nivolumab in relapsed malignant mesothelioma: Is it ‘CONFIRM’ed?. Cancer Res Stat Treat 2021;4:809-10

How to cite this URL:
Sasi A, Gogia A. Nivolumab in relapsed malignant mesothelioma: Is it ‘CONFIRM’ed?. Cancer Res Stat Treat [serial online] 2021 [cited 2022 Aug 20];4:809-10. Available from: https://www.crstonline.com/text.asp?2021/4/4/809/334237

The phase III placebo-controlled randomized trial by Fennell et al. studied single agent nivolumab in the salvage setting in mesothelioma and observed a significant progression free survival (PFS) (3.2 vs. 1.8 months) and overall survival (OS) (10.2 vs. 6.9 months) benefit with nivolumab compared to placebo.[1] We laud the authors for their efforts for improving the therapeutic armamentarium of a disease with dismal outcomes and a pressing need for change in the treatment landscape. However, we would like to express our concerns pertaining to the translation of the demonstrated survival benefits of nivolumab into clinical practice.

It has been seen previously that >40% of patients presenting with relapsed mesothelioma are considered ineligible for recruitment in randomized controlled trials of immunotherapy (as was the case with Fennell et al.'s study) on account of strict eligibility criteria.[2] This could significantly dilute the small statistically significant benefit that immunotherapy seemingly confers. In a real-world analysis of Dutch patients with relapsed mesothelioma, the median PFS and OS in patients treated with nivolumab were 2.3 months and 6.7 months, respectively.[3] The median OS was not reached in the subset of patients who achieved partial response with immunotherapy, which was about 10% of the entire cohort.[3] It would be interesting to analyze the OS in the sub-group of patients achieving partial response in the CONFIRM[1] trial as well.

In addition, we believe that placebo was not an appropriate choice as a comparator in this trial. Second-line chemotherapy may be an option in the salvage setting as recommended by international guidelines.[4] Even the recent PROMISE-meso trial did not show evidence of a survival benefit with pembrolizumab over gemcitabine-based chemotherapy in relapsed mesothelioma.[5] We believe that to establish a more expensive treatment modality as the standard of care, we must have strong evidence of an advantage over current treatment practices.

A better characterization of this cohort by molecular profiling of the tumor and its microenvironment is therefore imperative to understand which patients truly stand to benefit from immunotherapy.

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Conflicts of interest

There are no conflicts of interest.

  References Top

Fennell DA, Ewings S, Ottensmeier C, Califano R, Hanna GG, Hill K, et al. Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): A multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol 2021;22:1530-40.  Back to cited text no. 1
Lau B, Boyer M, Lee JH, Kao S. Clinical trials eligibility of patients with malignant pleural mesothelioma: Use of novel therapies and outcomes. Clin Lung Cancer 2020;21:378-83.e1.  Back to cited text no. 2
Cantini L, Belderbos RA, Gooijer CJ, Dumoulin DW, Cornelissen R, Baart S, et al. Nivolumab in pre-treated malignant pleural mesothelioma: Real-world data from the Dutch expanded access program. Transl Lung Cancer Res 2020;9:1169-79.  Back to cited text no. 3
National Comprehensive Cancer Network. Malignant Pleural Mesothelioma. Version 2; 2021. Available from: https://www.nccn.org/professionals/physician_gls/pdf/mpm.pdf. [Last accessed on 2021 Nov 26].  Back to cited text no. 4
Popat S, Curioni-Fontecedro A, Dafni U, Shah R, O'Brien M, Pope A, et al. A multicentre randomised phase III trial comparing pembrolizumab versus single-agent chemotherapy for advanced pre-treated malignant pleural mesothelioma: The European Thoracic Oncology Platform (ETOP 9-15) PROMISE-meso trial. Ann Oncol 2020;31:1734-45.  Back to cited text no. 5


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