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Key Studies in Lung Cancer: Independent Conference Coverage of the World Conference on Lung Cancer 2020

Shirish M. Gadgeel, MD
Nicolas Girard, MD, PhD
Released: March 31, 2021

Mesothelioma

Phase III CONFIRM Study of Nivolumab vs Placebo in Relapsed Mesothelioma: Study Design

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Nicolas Girard, MD, PhD:
Immune checkpoint inhibitors have previously shown some efficacy in single‑arm phase II studies.34,35 At the Presidential Symposium, Fennel and colleagues36 presented data from the randomized, double-blind phase III CONFIRM trial study evaluating nivolumab vs placebo in patients with relapsed malignant mesothelioma. Patients received either nivolumab 240 mg or placebo on Day 1 every 2 weeks. Treatment was continued until disease progression, unacceptable toxicity, withdrawal, or up to 1 year. The coprimary endpoints were investigator-reported OS and PFS, and key secondary endpoints included PFS (per RECIST), ORR, HRQoL, and safety.

Phase III CONFIRM Study of Nivolumab vs Placebo in Relapsed Mesothelioma: Baseline Characteristics

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Nicolas Girard, MD, PhD:
In CONFIRM, treatment arms were mostly well balanced at baseline except perhaps regarding PD-L1 tumor proportion score allocation where the percentage in the nivolumab arm was slightly higher compared with the placebo arm (37% vs 29%). Most patients in both treatment arms had mesothelioma with epithelioid histology (88%) and pleural involvement (95%), and they had received at least 1 previous line of treatment.

Phase III CONFIRM Study of Nivolumab vs Placebo in Relapsed Mesothelioma: OS and PFS by Investigator

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Nicolas Girard, MD, PhD:
In this study, we saw a significant benefit in median OS for nivolumab compared with placebo, which was reported at 9.2 months vs 6.6 months (P = .018), respectively. The median PFS was also improved with nivolumab at 3.0 months vs 1.8 months (P = .001) with placebo, which indicates to me a positive study. However, we have to put the results of the CONFIRM trial, of nivolumab vs placebo, into context with those of the negative PROMISE‑meso study evaluating pembrolizumab vs standard chemotherapy of gemcitabine/vinorelbine in malignant pleural mesothelioma, which was presented at the 2019 ESMO meeting.37

Phase III CONFIRM Study of Nivolumab vs Placebo in Relapsed Mesothelioma: OS by PD-L1 and Histology

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Nicolas Girard, MD, PhD:
Looking at OS outcomes by PD-L1 status and tumor histology, survival benefit did not appear to correlate with PD-L1–positive status (P = .864), PD-L1–negative status (P = .115), or nonepithelioid histology (P = .572). However, compared with placebo, patients with epithelioid histology treated with nivolumab experienced a significant benefit with a median OS of 9.4 vs 6.6 months (P = .021) and a 12-month OS rate of 40.0% vs 26.7%.

Phase III CONFIRM Study of Nivolumab vs Placebo in Relapsed Mesothelioma: Safety Summary

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Nicolas Girard, MD, PhD:
Regarding safety, the proportion of patients with any-grade AEs (94% vs 94%), any grade ≥3 AEs (45% vs 42%), serious AEs (41% vs 44%), and serious grade ≥3 AEs (36% vs 39%) was comparable between nivolumab and placebo treatment arms. As expected, more patients in the placebo arm went on to receive further immunotherapy than those in the nivolumab arm (12.6% vs 1.4%). Median duration of treatment with nivolumab was 84 days vs 43 days with placebo. There were 9 deaths on this study, 5 in the nivolumab arm and 4 with placebo.

Phase III CONFIRM Study of Nivolumab vs Placebo in Relapsed Mesothelioma: Conclusions

Nicolas Girard, MD, PhD:
My takeaway from the CONFIRM trial of nivolumab monotherapy in malignant mesothelioma is that this is a positive study, and particularly so for patients with epithelioid histology. The main drawback from the study is that nivolumab was compared with placebo. Thus, I don’t know how to integrate these results from the CONFIRM trial into the current treatment strategy for patients with mesothelioma. The other point that I would like to make is that we now have data in the first‑line setting with nivolumab plus ipilimumab from the CheckMate 743 trial (NCT02899299), which showed a clinical benefit for dual ICI vs chemotherapy in patients with malignant pleural mesothelioma (median OS: 18.1 vs 14.1 months; HR: 0.74; P = .0020).38 Therefore, to me, most patients will be treated with immunotherapy in the first‑line setting.

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