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. 2024 Oct 15;5(12):100735.
doi: 10.1016/j.jtocrr.2024.100735. eCollection 2024 Dec.

Real-World Outcomes of Patients With Malignant Pleural Mesothelioma Receiving a Combination of Ipilimumab and Nivolumab as First- or Later-Line Treatment

Sabine Schmid  1 , Lisa Holer  2 , Katrin Gysel  2 , Kira-Lee Koster  3 , Sacha I Rothschild  4   5 , Laura A Boos  6 , Lorenz Frehner  1 , Sabine Cardoso Almeida  7 , Christian Britschgi  6   7 , Yannis Metaxas  8 , Michael Mark  9   10 , Patrizia Froesch  11 , Wolf-Dieter Janthur  12 , Anna Allemann  13 , Christine Waibel  5 , Catherine Von der Mühll-Schill  14 , Martin Früh  1   3 , Laetitia A Mauti  7
Affiliations

Real-World Outcomes of Patients With Malignant Pleural Mesothelioma Receiving a Combination of Ipilimumab and Nivolumab as First- or Later-Line Treatment

Sabine Schmid et al. JTO Clin Res Rep. .

Abstract

Objectives: On the basis of the positive results of CheckMate-743, first-line (1L) treatment of malignant pleural mesothelioma (MPM) with the combination of ipilimumab and nivolumab (ipi-nivo) has become a standard-of-care. Furthermore, patients who received 1L platinum/pemetrexed chemotherapy are often considered for second or further-line (2L+) ipi-nivo on the basis of MAPS2 results. Here we report on real-world survival and safety outcomes of ipi-nivo for patients with MPM in Switzerland.

Methods: Twelve cancer centers contributed data to this retrospective cohort. Baseline characteristics including age, sex, histology, programmed death-ligand 1 expression, Eastern Cooperative Oncology Group performance status (ECOG PS), and previous/subsequent therapies were collected. The efficacy and safety outcomes were assessed by local investigators.

Results: Of the 109 patients with MPM treated with ipi-nivo between November 2017 and March 2023 (median follow-up of 16.6 months) 75% had epithelioid, 9% biphasic, and 16% sarcomatoid histology. The median age was 72 years; 91% were males, and 83% had an ECOG PS of 0 to 1. Ipilimumab in combination with nivolumab was given as 1L in 43% and as 2L+ treatment in 57% of patients. The objective response rate was 21% in 1L and 15% in 2L+. Median progression-free survival was 6.5 and 2.8 months, respectively. Median overall survival (OS) from the start of ipi-nivo was 12.6 months for 1L and 6.9 months for 2L+. No differences in OS were observed depending on age and programmed death-ligand 1 expression. Nevertheless, the median OS was significantly worse in patients with an ECOG PS of 2 or higher than those with an ECOG PS of 0 to 1 (2.4 versus 11.9 months, p < 0.001). Treatment-related adverse events (TRAEs) of any grade related to ipi-nivo treatment occurred in 65 patients (62%). The highest-grade TRAE was 1 to 2 in 58% of these patients and 3 or higher in 42% Treatment discontinuation due to a TRAE occurred in 22% of patients.

Conclusion: In this real-world cohort of patients with MPM treated with ipi-nivo survival outcomes were inferior to those reported in the CheckMate-743 and MAPS2 trials, whereas safety outcomes were similar.

Keywords: Ipilimumab; Malignant pleural mesothelioma; Nivolumab; Outcome; Real-world.

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Conflict of interest statement

Dr. Schmid received institutional grants from Janssen, BMS, MSD, Marlies-Schwegler Stiftung, von Tobel Stiftung, and Swiss Life and holds positions on advisory boards and institutional speaker invitations from BMS, MSD, Roche, Merck, Sanofi, Janssen, AstraZeneca, Takeda; Travel support: Roche, Takeda, Amgen. Dr. Koster received institutional travel support from Takeda, Janssen. Dr. Rothschild received institutional honoraria from Roche, Astra Zeneca, BMS, Boehringer Ingelheim, MSD, Novartis, Amgen, Lilly, Eisai, Merck, Pfizer, Takeda, Bayer, Janssen, Otsuka, Pharmamar, and Sanofi, holds institutional advisory roles in Astra Zeneca, Boehringer Ingelheim, BMS, Pfizer, Eisai, Lilly, Merck, MSD, Novartis, Roche, Takeda, Amgen, Otsuka, Pharmamar, holds positions on institutional speaker bureaus of Roche, Sanofi, Amgen, Astra Zeneca, Takeda, received institutional research funding from Abbvie, BMS, Astra Zeneca, Boehringer Ingelheim, Merck, Roche; Travel support: Sanofi, Roche, BMS, MSD, Astra Zeneca, Takeda, Boehringer Ingelheim, Amgen, and has other relationships with Federal Drug Commission of the Federal Office of Public Health, SAKK. Dr. Brithschgi holds advisory roles in Astra Zeneca, Pfizer, Roche, Takeda, Janssen, Boehringer Ingelheim, Merck, and Sanofi, and received research funding from Bayer and travel support from Astra Zeneca, Takeda, and Amgen. Dr. Mark received consulting fees from Amgen, Astra Zeneca, BMS, MSD, Pfizer, Takeda, and Roche and travel support from Astra Zeneca, Roche, and Takeda. Dr. Froesch holds personal advisory roles in BMS, Roche, Sanofi, and Takeda, and an institutional advisory role in MSD and is an invited speaker (personal) of Janssen. Dr. Janthur received travel support from 10.13039/100004337Roche and holds advisory roles in Pharmamar and MSD. Dr. Allemann received institutional honoraria from Janssen and Astra Zeneca, and travel support from Janssen and holds institutional advisory roles in Janssen and Merck. Dr. Früh holds positions on institutional advisory boards of BMS, MSD, Astra Zeneca, Boehringer Ingelheim, Roche, Takeda, Pfizer, Janssen, Daiichi-Sankyo, and Pharmamar and received unrestricted institutional grants from BMS and Astra Zeneca. Dr. Mauti holds advisory roles in Takeda, BMS, MSD, Merck, Sanofi, Novartis, AstraZeneca, Pfizer, Regeneron, Daiichi, and Sanofi, has participated in invited talks of Amgen, and received travel support from AstraZeneca, Roche, and Sanofi and research funding from Gilead and AstraZeneca. The remaining authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Progression-free survival by treatment line.
Figure 2
Figure 2
Overall survival by treatment line.
Figure 3
Figure 3
Overall survival by key subgroups of interest: (A) age (elderly ≥ 75 and <75 years); (B) histology (epithelioid versus non-epithelioid); (C) PD-L1 expression (< versus ≥ 1%); (D) ECOG performance status (≥2 versus 0–1).
See this image and copyright information in PMC

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