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Pembrolizumab plus platinum-pemetrexed chemotherapy may be a new treatment option for patients with advanced pleural mesothelioma, according to research published in The Lancet.
Results from a phase 3 study showed that adding pembrolizumab to platinum-pemetrexed chemotherapy can improve response rates, progression-free survival (PFS), and overall survival (OS) in these patients.
This multicenter, open-label study (ClinicalTrials.gov Identifier: NCT02784171) enrolled 440 patients with previously untreated, advanced pleural mesothelioma who were ineligible for surgery. Patients had a median age of 71 years, 76% were men, 79% were White, and 60% had a PD-L1 combined positive score of 1 or higher.
The patients were randomly assigned to receive chemotherapy alone (n=218) or with pembrolizumab (n=222). All patients received cisplatin (75 mg/m²) or carboplatin (AUC, 5-6 mg/mL per min) plus pemetrexed (500 mg/m²) every 3 weeks for up to 6 cycles. Patients in the pembrolizumab arm also received pembrolizumab (200 mg) every 3 weeks for up to 2 years.
At a median follow-up of 16.16 months, the median OS was 17.3 months with pembrolizumab plus chemotherapy and 16.1 months with chemotherapy alone (hazard ratio [HR], 0.79; 95% CI, 0.64-0.98; P =.0324). The 2-year OS rate was 39% with pembrolizumab and 33% without it. The 3-year OS rate was 25% and 17%, respectively.
The median PFS was 7.13 months in the pembrolizumab arm and 7.16 months in the chemotherapy-alone arm (HR, 0.80; 95% CI 0.65-0.99; P =.0372). The 1-year PFS rate was 26% with pembrolizumab arm and 17% without it. The 2-year PFS rate was 9% and 4%, respectively.
The objective response rate was 62% in the pembrolizumab arm and 38% in the chemotherapy-alone arm (odds ratio, 2.70; 95% CI, 1.8-4.0; P <.0001). The median duration of response was 5.8 months and 5.5 months, respectively.
Adverse events (AEs) occurred in 98% of patients in the pembrolizumab arm and 95% of those in the chemotherapy-alone arm. The most common AEs in both arms were fatigue and nausea. Diarrhea, skin effects, and myelosuppression were more common in the pembrolizumab arm than in the chemotherapy arm.
Grade 3-4 AEs occurred in 27% of patients who received pembrolizumab and 15% of patients who received chemotherapy alone. Treatment-related hospital admissions occurred in 18% and 6% of patients, respectively.
There were 9 deaths considered related or possibly related to study treatment. Seven of these deaths occurred in patients receiving pembrolizumab, and the causes were sepsis (n=3), cardiac arrest (n=1), febrile neutropenia (n=1), dyspnea (n=1), and pneumonitis (n=1). The 2 potentially treatment-related deaths in the chemotherapy arm were due to myocardial infarction and sepsis.
“The addition of pembrolizumab to platinum-pemetrexed was a tolerable regimen that resulted in improved overall survival, progression-free survival, and objective response rates compared with platinum-pemetrexed alone, regardless of PD-L1 expression,” the researchers wrote. “This regimen, already familiar to thoracic medical oncologists for the treatment of non-small cell lung cancer, represents a new treatment option for patients with advanced pleural mesothelioma, especially for patients at risk of adverse outcomes due to early or rapid progression.”
Disclosures: This research was partly supported by Merck & Co. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Chu Q, Perrone F, Greillier L, et al. Pembrolizumab plus chemotherapy versus chemotherapy in untreated advanced pleural mesothelioma in Canada, Italy, and France: A phase 3, open-label, randomised controlled trial. Lancet. Published online November 3, 2023. doi:10.1016/S0140-6736(23)01613-6
This article originally appeared on Cancer Therapy Advisor
