Final results of DIADEM, a phase II study to investigate the efficacy and safety of durvalumab in advanced pretreated malignant pleural mesothelioma

Role of Durvalumab (Anti-PD-L1) in the Management of Mesothelioma: A Systematic Review of the Current Literature

“…In comparison to the non-epithelioid subtype, the epithelioid subtype had a more significant impact on PFS and overall OS. However, as seen in other clinical trials, sarcomatoid/biphasic MPMs were underrepresented [5]. According to the previous CheckMate 743 trial, which revealed a remarkable survival advantage favoring ipilimumab-nivolumab over chemotherapy for patients with non-epithelioid histology, this potential benefit from chemoimmunotherapy may apply particularly to patients with epithelioid MPM.…”

“…Four ICIs were assessed as monotherapies for relapsed mesothelioma, and nivolumab was approved as the standard treatment after a phase III trial demonstrated its efficacy. However, other ICIs did not yield promising outcomes in terms of OS and PFS [5,12,16,17]. Untreated individuals appear to exhibit a greater efficacy in response to immune checkpoint inhibitors, as the overall response rate and disease control rate are higher in untreated patients than in those who have received previous treatments.…”

“…observation aligns with evidence from other trials evaluating the efficacy of durvalumab in MPM. In the NIBIT-MESO-1 study, no correlation was found between baseline PD-L1 expression, assessed as a continuous variable, and the endpoints of immunerelated objective response, immune-related disease control, immune-related PFS, and 1-year OS [5]. Furthermore, there are currently no reliable biomarkers to predict the success of MPM treatment with dual-agent immunotherapy.…”

“…However, there is limited clinical benefit and support for the implementation of alternative chemotherapy lines. In spite of a statistically notable enhancement in median overall survival, the incorporation of bevacizumab to chemotherapy doublets, as reported in the MAPS study, has had no impact on clinical practice [5,6]. Despite these challenges, there is a pressing need for the development of an effective systemic therapy for mesothelioma [7].…”

Nivolumab in pretreated pleural mesothelioma: Results from an observational real-world study of patients treated within the AIFA 5% Fund

“…Since its introduction in the early 2010s, systemic treatment with immune checkpoint blockade has markedly changed the therapeutic landscape of several difficult to treat malignancies such as melanoma, non-small cell lung cancer and renal cell carcinoma. Several phase II and III studies demonstrated a limited but significant activity of single agent anti PD1/PDL-1 agents (nivolumab, pembrolizumab, durvalumab) [6][7][8][9][10][11] in the treatment of PM. The phase III trial CONFIRM 12 showed a significant benefit of nivolumab treatment over placebo in refractory PM patients, with an OS of 10.2 months vs 6.9 months (HR 0•69, 95% CI 0•52-0•91; p=0•009) and a PFS of 3 months vs 1.8 months (HR 0.67 95% CI 0•53-0•85; p=0.00012) and paved the way to level IA recommendation by ESMO guidelines for the use of nivolumab in the second/third line treatment of mesothelioma.…”