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

Popat, Sanjay; Curioni-Fontecedro, Alessandra; Dafni, Urania; Shah, R.; O’Brien, Mary; Pope, Anthony; Fisher, P.M.; Spicer, James; Roy, Amy; Gilligan, David; Gautschi, Oliver; Nadal, Ernest; Janthur, Wolf-Dieter; Castro, R. López; Campelo, Rosario García; Rusakiewicz, Sylvie; Letovanec, Igor; Polydoropoulou, Varvara; Roschitzki-Voser, Heidi; Ruepp, Barbara; Gasca-Ruchti, A.; Peters, Solange; Stahel, Rolf A.

doi:10.1016/j.annonc.2020.09.009

Cited by 173 publications

(161 citation statements)

References 25 publications

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“…In the malignant mesothelioma cohort of KEYNOTE-028, an objective response rate (ORR) of 20% and median response duration of 12 months were observed, similar to the ORR of 22% and median overall survival of 11.5 months in NCT02399371. However, the results of a randomized phase III trial (NCT02991482, PROMISE-meso) (11) found no difference in median PFS or OS (median OS of 10.7 months for pembrolizumab versus 11.7 months for gemcitabine or vinorelbine).…”

Section: Discussionmentioning

confidence: 99%

Pembrolizumab-induced myocarditis in a patient with malignant mesothelioma: plasma exchange as a successful emerging therapy—case report

Schiopu¹,

Käsmann²,

Schönermarck³

et al. 2021

Transl Lung Cancer Res

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Malignant mesothelioma is an aggressive cancer associated with prior exposure to asbestos and dismal prognosis. Immune checkpoint inhibitor therapy is currently approved by the Food and Drug Administration for pre-treated malignant pleural mesothelioma. We describe a 75-year-old patient with disseminated, progressive malignant mesothelioma receiving 2 cycles of pembrolizumab who presented with generalized muscle weakness, shortness of breath, double vision and ptosis. There was no previous history of cardiovascular disease. The clinical picture, supported by the detection of anti-titin autoantibodies suggested myasthenia gravis (MG). Also, cardiac biomarkers were elevated. Echocardiography showed new severely reduced ejection fraction. A 12-lead resting electrocardiogram (ECG) revealed ST segment elevation in the posterior leads with polymorphic ventricular extrasystoles. Because cardiac catheterization revealed no relevant coronary lesions, immune checkpoint inhibitor-associated myocarditis and MG were suspected.Management and Outcome: The patient was started on steroids. Within a few days of presentation respiratory failure set in and the patient was intubated. Recurrent arrhythmias followed, which were treated by repeated emergency electrical cardioversion. In order to relieve myasthenic symptoms, plasma exchange was initiated and 10 cycles were carried out. This consequently also led to an improvement of myocarditis.Upon discharge, the ejection fraction recovered. The patient recovered and was alive at 1-year follow-up, without relevant limitations to his quality of life. Discussion and Conclusion: The article further discusses the use of plasma exchange for immune checkpoint inhibitor-associated myocarditis based on a review of literature. We conclude that patients showing no improvement after steroid therapy for immune checkpoint inhibitor-related myocarditis should be evaluated for plasma exchange, which appears to be an effective treatment option.

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Section: Discussionmentioning

confidence: 99%

Pembrolizumab-induced myocarditis in a patient with malignant mesothelioma: plasma exchange as a successful emerging therapy—case report

Schiopu¹,

Käsmann²,

Schönermarck³

et al. 2021

Transl Lung Cancer Res

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“…Immunotherapy data from randomized clinical trials are emerging. In the randomized Phase III PROMISE-meso trial in patients with MPM that progressed on or after platinum-based chemotherapy, pembrolizumab monotherapy significantly improved objective response rate but did not improve progression-free survival or OS compared with single agent chemotherapy [32]. However, CheckMate 743 (ClinicalTrials.gov: NCT02899299), a Phase III clinical trial investigating nivolumab + ipilimumab versus pemetrexed + platinum as first-line SACT in patients with unresectable MPM, was recently reported to have met its primary end point of OS (median, 18.1 vs 14.1 months; hazard ratio, 0.74; 95% CI: 0.61-0.89; p = 0.002) [19].…”

Section: Discussionmentioning

confidence: 98%

Treatment Patterns and Outcomes of Patients with Advanced Malignant Pleural Mesothelioma in a Community Practice Setting

et al. 2021

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Aim: To assess real-world treatment patterns and outcomes among patients with advanced malignant pleural mesothelioma. Patients & methods: Retrospective database analysis. Results: In all, 469 patients received first-line systemic anticancer therapy (SACT) at community centers. Median follow-up from diagnosis was 11.6 months. Pemetrexed + platinum was the most common first-line SACT; similar proportions of patients received cisplatin or carboplatin with pemetrexed. Only a small proportion of patients received second- and third-line therapies. Median overall survival for first-line SACT was 12.0 months (95% CI: 10.7–14.2). Results were similar with pemetrexed + cisplatin and pemetrexed + carboplatin. Median overall survival with second-line SACT was 6.4 months (95% CI: 5.1–7.6). Conclusion: There is a need for more effective SACTs for advanced malignant pleural mesothelioma.

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“…Examples of ICIs used in the clinic include the CTLA‐4 inhibitors ipilimumab and tremelimumab, the PD‐1 inhibitors nivolumab and pembrolizumab, and the PD‐L1 inhibitors durvalumab, avelumab, and atezolizumab. These ICIs have been investigated in several clinical trials for advanced mesothelioma as monotherapy (Table 1) 32‐39 and in combination therapies (see Table 2 40‐47 Table 3 48 ). On October 2, 2020, the FDA approved the combination of nivolumab plus ipilimumab as first‐line treatment for patients with unresectable malignant pleural mesothelioma 44…”

Section: Immunotherapy With Immune Checkpoint Inhibitors As New Frontmentioning

confidence: 99%

“…The phase 3 PROMISE‐meso trial (ClinicalTrials.gov identifier NCT02991482) randomized 144 patients with advanced, pretreated mesothelioma to receive either pembrolizumab 200 mg every 3 weeks or physician's choice of salvage chemotherapy 47 . The ORR was 22% for the pembrolizumab group compared with 6% for the chemotherapy group.…”

Section: Immunotherapy With Immune Checkpoint Inhibitors As New Frontmentioning

confidence: 99%

Malignant mesothelioma: Advances in immune checkpoint inhibitor and mesothelin‐targeted therapies

Ghafoor

Sengupta

et al. 2021

Cancer

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Malignant mesothelioma is an aggressive cancer with a poor prognosis and limited treatment options. For many years, the only US Food and Drug Administration‐approved first‐line treatment for unresectable mesothelioma was pemetrexed plus cisplatin. However, the recent approval of nivolumab plus ipilimumab as frontline treatment for patients with pleural mesothelioma marks a significant milestone for the treatment of this disease. In this review, the authors describe recent advances in therapeutic strategies for the treatment of patients with advanced, unresectable mesothelioma, highlighting the emerging use of immunotherapy and mesothelin‐targeted therapies for the management of malignant mesothelioma.

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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

Cited by 173 publications

References 25 publications

Pembrolizumab-induced myocarditis in a patient with malignant mesothelioma: plasma exchange as a successful emerging therapy—case report

Pembrolizumab-induced myocarditis in a patient with malignant mesothelioma: plasma exchange as a successful emerging therapy—case report

Treatment Patterns and Outcomes of Patients with Advanced Malignant Pleural Mesothelioma in a Community Practice Setting

Malignant mesothelioma: Advances in immune checkpoint inhibitor and mesothelin‐targeted therapies

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