Real-World Data for Nivolumab in Patients with Malignant Mesothelioma
Historically, standard treatment for advanced malignant pleural mesothelioma (MPM) included cisplatin plus pemetrexed. Nivolumab, an anti–PD-1 monoclonal antibody, shows efficacy against pretreated MPM and has been authorized for use in Japan. However, data supporting the efficacy and safety of nivolumab in MPM are limited; only a small number of patients were studied in the MERIT trial. To supplement these data, researchers accumulated real-world efficacy and safety data for nivolumab in patients with advanced MPM.
A total of 79 patients with MPM treated between August and December 2018, including 63 males and 16 females, were included in this retrospective analysis. Most of these patients (62 of 79) had an ECOG performance status (PS) of 0-1; 5 were ECOG 3. Nivolumab was administered as second-, third-, and fourth-line or later treatment for 50, 15, and 14 of these 79 patients, respectively.
Among 71 patients who were examined for efficacy, the response rate associated with nivolumab was 27%, and the disease control rate was 66%. By the histology type, response rates and disease control rates were 23% and 65% for the epithelioid type, 56% and 89% for the sarcomatoid type, and 20% and 40% for the biphasic type, respectively. Median progression-free survival (PFS) was 4.1 months, and median overall survival (OS) was 14.3 months.
The efficacy of nivolumab was analyzed based on the neutrophil-to-lymphocyte ratio (NLR) in the peripheral blood. Median PFS and median OS in the NLR ≥3.0 group were 3.7 months and 15.5 months, respectively. For patients in the NLR <3.0 group, median PFS and median OS were 5.0 months and 14.3 months, respectively. There were no significant differences in response rate, PFS, and OS between the NLR <3.0 group and the NLR ≥3.0 group.
Hypothyroidism (grade 1/2) was observed in 11 of 79 patients, fatigue (grade 1/2) in 11 of 79 patients, renal dysfunction (grade 1 to 3) in 6 of 79 patients, loss of appetite (grade 1/2) in 3 of 79 patients, rash (grade 1) in 3 of 79 patients, pneumonia (grade 2 or 3) in 2 of 79 patients, and hypopituitarism (grade 2 or 3) in 2 patients.
Researchers concluded that this retrospective study of real-world patients demonstrates the effectiveness and safety of nivolumab for pretreated MPM were similar to the findings from the MERIT study. NLR is not effective as a predictive marker of the effect of nivolumab for MPM. PS is an independent factor contributing to PFS and OS in patients with MPM; nivolumab should be administered when PS is favorable.
Mikami K, Yokoi T, Takahashi R, et al. Efficacy and safety of nivolumab for malignant mesothelioma in the real world. J Clin Oncol. 2020;38:suppl (abstract 9052).