Bristol Myers Squibb (BMS ) has reported positive three-year data from the CheckMate -743 clinical trial where first-line therapy with Opdivo (nivolumab) plus Yervoy (ipilimumab) offered a lasting survival benefit in unresectable malignant pleural mesothelioma (MPM) patients, irrespective of histology.
The open-label, multicentre, randomised Phase III trial assessed Opdivo plus Yervoy versus platinum-based standard-of-care chemotherapy with pemetrexed and cisplatin or carboplatin in already untreated unresectable MPM patients.
Overall survival (OS) in all randomised subjects was the trial’s primary goal.
Progression-free survival (PFS), objective response rate (ORR) and duration of response (DOR) were assessed as additional efficacy outcome measures.
Exploratory goals comprised safety, pharmacokinetics, immunogenicity and subject reported outcomes.
According to the trial data, 23% of the subjects receiving Opdivo plus Yervoy were alive at three years as against 15% on chemotherapy.
Treatment with combination therapy continued to demonstrate a decline in mortality risk.
Furthermore, median OS in subjects on Opdivo plus Yervoy was 18.1 months compared to 14.1 months in the chemotherapy arm.
The safety profile of the dual immunotherapy combination was in line with already reported results in first-line MPM, without any new safety signals detected.
Several subjects who responded to the dual immunotherapy combination continued to respond compared to those receiving chemotherapy after a follow-up of three years and nearly one year without treatment.
In addition, Opdivo plus Yervoy offered a longer DOR after three years.
Bristol Myers Squibb thoracic cancers development lead and vice-president Abderrahim Oukessou said: “The results from the CheckMate -743 trial have changed the way physicians treat malignant pleural mesothelioma, a disease that had no new systemic treatment options for nearly 15 years before the approval of Opdivo plus Yervoy.
“We continue to see more evidence for the sustained survival benefits of dual immunotherapy across several tumours, including durable overall survival at four years in non-small cell lung cancer.”
In July, BMS reported that Opdivo plus Yervoy failed to meet the primary goals of Phase III CheckMate -651 trial in platinum-eligible recurrent or metastatic squamous cell carcinoma of the head and neck patients.