PRINCETON -
'This positive CHMP opinion underscores the potential of Opdivo in the EU treatment landscape for esophageal squamous cell carcinoma, with the ATTRACTION-3 trial showing clinically meaningful survival coupled with a favorable safety profile,' said
The CHMP positive opinion was based on results from the Phase 3 ATTRACTION-3 trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) in patients who received Opdivo versus chemotherapy, as well as a favorable safety profile. The study enrolled adults who were refractory or intolerant to at least one fluoropyrimidine- and platinum-based combination regimen, regardless of PD-L1 expression level.
To date, Opdivo has been approved in five countries, including
About ATTRACTION-3
ATTRACTION-3 (ONO-4538-24/CA209-473; NCT02569242) is a Phase 3, multi-center, randomized, open-label global study, evaluating Opdivo versus chemotherapy (docetaxel or paclitaxel) for patients with esophageal cancer refractory or intolerant to first-line combination therapy with fluoropyrimidine- and platinum-based drugs. Patient enrollment occurred predominantly in
Patients treated in the Opdivo arm showed 12- and 18-month OS rates of 47% (95% CI: 40 to 54) and 31% (95% CI: 24 to 37), respectively, versus 34% (95% CI: 28 to 41) and 21% (95% CI: 15 to 27) among patients in the chemotherapy arm. Survival benefit with Opdivo was observed regardless of tumor PD-L1 expression levels. An exploratory analysis of patient-reported outcomes showed significant overall improvement in quality of life with Opdivo versus chemotherapy.
Fewer treatment-related adverse events (TRAEs) were reported with Opdivo versus chemotherapy, with a rate of 66% for any grade TRAEs for patients receiving Opdivo compared to 95% for patients receiving chemotherapy. Patients in the Opdivo arm also experienced a lower incidence of Grade 3 or 4 TRAEs compared to those in the chemotherapy arm (18% versus 63%), and the percentage of patients experiencing TRAEs leading to discontinuation was the same in both arms (9%).
About Esophageal Cancer
Esophageal cancer is the seventh most common cancer and the sixth most common cause of death from cancer worldwide. The five-year relative survival rate is 8% or less for patients diagnosed with metastatic disease. Each year, 53,000 new cases of esophageal cancer are diagnosed in
At
Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo's leading global development program is based on
In
CheckMate Trials and Patient Populations
CheckMate 037-previously treated metastatic melanoma; CheckMate 066-previously untreated metastatic melanoma; CheckMate 067-previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; CheckMate 227-previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; CheckMate 9LA-previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; CheckMate 017-second-line treatment of metastatic squamous non-small cell lung cancer; CheckMate 057-second-line treatment of metastatic non-squamous non-small cell lung cancer; CheckMate 032-small cell lung cancer; CheckMate 743-previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; CheckMate 025-previously treated renal cell carcinoma; CheckMate 214-previously untreated renal cell carcinoma, in combination with YERVOY; CheckMate 205/039-classical Hodgkin lymphoma; CheckMate 141-recurrent or metastatic squamous cell carcinoma of the head and neck; CheckMate 275-urothelial carcinoma; CheckMate 142-MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040-hepatocellular carcinoma, as a single agent or in combination with YERVOY; CheckMate 238-adjuvant treatment of melanoma; ATTRACTION-3-esophageal squamous cell carcinoma
About the
In 2011, through a collaboration agreement with
About
Celgene and
Cautionary Statement Regarding Forward-Looking Statements
This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the CHMP opinion is not binding on the EC, that Opdivo plus Yervoy may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all and, if approved, whether such combination treatment for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect
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