Bristol Myers Squibb Announces Phase 3 CheckMate-743 Trial of Opdivo Plus Yervoy Meets Primary Endpoint in First-Line Malignant Pleural Mesothelioma

From Jike Pharmaceutical News

On April 20, Bristol-Myers Squibb (BMS) announced that the pivotal Phase 3 CheckMate-743 trial, evaluating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for previously untreated malignant pleural mesothelioma (MPM), had met its primary endpoint of overall survival (OS). According to a pre-specified interim analysis conducted by an independent data monitoring committee, the combination of Opdivo and Yervoy demonstrated a statistically significant and clinically meaningful improvement in OS compared with chemotherapy (pemetrexed plus cisplatin or carboplatin). BMS stated that it would engage with regulatory authorities regarding the trial data and present the study results at upcoming medical conferences.

CheckMate-743 is an open-label, multicenter, randomized phase 3 trial evaluating the efficacy of Opdivo in combination with Yervoy versus chemotherapy (pemetrexed and cisplatin or carboplatin) in patients with previously untreated malignant pleural mesothelioma (MPM). Opdivo was administered at a dose of 3 mg/kg every two weeks, and Yervoy at a dose of 1 mg/kg every six weeks. The primary endpoint of the trial was overall survival (OS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and efficacy outcomes based on PD-L1 expression levels.

Malignant pleural mesothelioma is a rare and highly aggressive primary tumor of the pleura, strongly associated with asbestos exposure. The clinical presentation of MPM is atypical, and the prognosis is poor across all histological subtypes, with limited treatment options. In patients with previously untreated advanced or metastatic malignant pleural mesothelioma, the median survival is less than one year, and the five-year survival rate is approximately 10%.

Dr. Sabine Maier, Head of Thoracic Cancer Drug Development at Bristol-Myers Squibb (BMS), stated, “Malignant pleural mesothelioma is an aggressive disease with limited therapeutic advances over the past decade. These topline results from the CheckMate-743 trial demonstrate the potential of Opdivo plus Yervoy in patients with previously untreated malignant pleural mesothelioma and provide another example of the efficacy and safety of dual immunotherapy combination treatment across multiple tumor types.”

In July 2014, Opdivo became the first PD-1 immune checkpoint inhibitor to receive regulatory approval worldwide. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan, and China. In October 2015, the combination regimen of Opdivo and Yervoy became the first immuno-oncology combination therapy to receive regulatory approval for the treatment of metastatic melanoma, and it has since been approved in more than 50 countries, including the United States and the European Union. Yervoy is a monoclonal antibody that targets cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). On March 25, 2011, the U.S. FDA approved Yervoy as a monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved in more than 50 countries for the treatment of unresectable or metastatic melanoma.

References:

[1] Bristol Myers Squibb Announces Positive Topline Result from Pivotal Phase 3 Trial Evaluating Opdivo® (nivolumab) plus Yervoy® (ipilimumab) vs. Chemotherapy in Previously Untreated Malignant Pleural Mesothelioma. Retrieved 2020-04-20, from https://www.businesswire.com/news/home/20200420005225/en

Original Title: Phase 3 Trial of Opdivo Combined with Yervoy as First-Line Treatment for Malignant Pleural Mesothelioma Meets OS Endpoint

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