Bristol-Myers Squibb Opdivo+Yervoy combination approved by the European Union

Compilenewborn

On June 2, Bristol-Myers Squibb announced that the European Commission had approved the Opdivo+Yervoy combination as the first-line treatment for adult patients with unresectable malignant pleural mesothelioma (MPM)

The approval is based on the results of the CheckMate-743 study, which is the first and only positive Phase 3 study for the first-line immunotherapy treatment of MPM

The decision of the European Commission allows the use of the Opdivo+Yervoy combination in the first-line treatment of unresectable MPM in the 27 EU member states as well as Iceland, Liechtenstein and Norway

Mesothelioma is a devastating disease, usually only discovered decades after exposure to asbestos

The Opdivo+Yervoy combination is the first new regimen for the treatment of MPM in the past 15 years and has been proven to significantly prolong patient survival

Up to now, the Opdivo+Yervoy combination has been approved in the European Union to treat 4 different advanced cancers: mesothelioma, non-small cell lung cancer, melanoma, and renal cell carcinoma

CheckMate-743 is an open-label, multi-center, randomized phase 3 clinical trial that compares the Opdivo+Yervoy combination with platinum-containing standard-of-care chemotherapy (pemetrexed+cisplatin or carboplatin) against previously untreated malignant Efficacy of patients with pleural mesothelioma (n=605)

——OS (primary endpoint): The median OS of the Opdivo+Yervoy group was 18.

——Overall Response Rate (ORR): The Opdivo+Yervoy group is similar to the chemotherapy group, being 40% and 43%, respectively

——Duration of Response (DoR): Compared with the chemotherapy group, the DoR of the Opdivo+Yervoy group was significantly improved (median: 11.

-Progression-free survival (PFS): The median PFS of the Opdivo+Yervoy group was 6.

——Safety: The most common adverse reactions (incidence ≥10%) in the Opdivo+Yervoy group include fatigue (43%), diarrhea (31%), skin rash (30%), musculoskeletal pain (27 %), nausea (24%), loss of appetite (24%), itching (21%), constipation (19%) and hypothyroidism (13%)

Reference source: Bristol Myers Squibb Receives European Commission Approval for Opdivo