Durvalumab with platinum plus pemetrexed

A phase II, single-arm, multicenter trial (PrE0505 [NCT02899195]) included 55 patients with unresectable, treatment-naive, pleural mesothelioma. Patients received up to six cycles of durvalumab (an anti–programmed death-ligand 1 [PD-L1] antibody) with a platinum plus pemetrexed. The primary end point was OS compared with historical controls (cisplatin and pemetrexed).[5]

A phase II, single-arm, multicenter trial (PrE0505 [NCT02899195]) included 55 patients with unresectable, treatment-naive, pleural mesothelioma. Patients received up to six cycles of durvalumab (an anti–programmed death-ligand 1 [PD-L1] antibody) with a platinum plus pemetrexed. The primary end point was OS compared with historical controls (cisplatin and pemetrexed).[5]

After a median follow-up of 24.2 months, the median OS was 20.4 months (95% CI, 13.0–28.5) for patients in the durvalumab arm compared with the historical control of 12.1 months (HR, 0.034; one-sided P = .0014).[5][Level of evidence C1]

A phase II, single-arm, multicenter trial (PrE0505 [NCT02899195]) included 55 patients with unresectable, treatment-naive, pleural mesothelioma. Patients received up to six cycles of durvalumab (an anti–programmed death-ligand 1 [PD-L1] antibody) with a platinum plus pemetrexed. The primary end point was OS compared with historical controls (cisplatin and pemetrexed).[5]

The median PFS was 6.7 months (95% CI, 6.1–8.4), and the objective response rate was 56.4% (95% CI, 42.3%–69.7%).

A phase II, single-arm, multicenter trial (PrE0505 [NCT02899195]) included 55 patients with unresectable, treatment-naive, pleural mesothelioma. Patients received up to six cycles of durvalumab (an anti–programmed death-ligand 1 [PD-L1] antibody) with a platinum plus pemetrexed. The primary end point was OS compared with historical controls (cisplatin and pemetrexed).[5]

In a non-predefined subgroup analysis, patients with epithelioid malignant pleural mesothelioma had a higher objective response rate (65.9% vs. 28.6%; P = .03), and longer median OS (24.3 months vs. 9.2 months; HR, 0.27; 95% CI, 0.13–0.57; P < .001) than patients with nonepithelioid malignant pleural mesothelioma.

A phase II, single-arm, multicenter trial (PrE0505 [NCT02899195]) included 55 patients with unresectable, treatment-naive, pleural mesothelioma. Patients received up to six cycles of durvalumab (an anti–programmed death-ligand 1 [PD-L1] antibody) with a platinum plus pemetrexed. The primary end point was OS compared with historical controls (cisplatin and pemetrexed).[5]

Responding tumors with epithelioid histology were characterized by a higher degree of genomic instability. Favorable clinical outcomes were also observed in patients with a higher immunogenic mutational burden and a more diverse T-cell repertoire, and in individuals with germline alterations in cancer-predisposing genes.

A phase II, single-arm, multicenter trial (PrE0505 [NCT02899195]) included 55 patients with unresectable, treatment-naive, pleural mesothelioma. Patients received up to six cycles of durvalumab (an anti–programmed death-ligand 1 [PD-L1] antibody) with a platinum plus pemetrexed. The primary end point was OS compared with historical controls (cisplatin and pemetrexed).[5]

Grade 3 or higher treatment-related adverse events occurred in 65.5% of patients and included anemia (20%), hyponatremia (9%), fatigue (7%), leukopenia (5%), thrombocytopenia (5%), and hypertension (5%). There were no treatment-related deaths.