Bristol Myers Squibb Redefines First-Line Treatment Landscape in Classical Hodgkin Lymphoma with Expanded U.S. and EU Approvals for Opdivo® (nivolumab)
Bristol Myers Squibb today announced that Opdivo® (nivolumab) has received approval for two new classical Hodgkin Lymphoma (cHL) indications in the U.S. and the European Union (EU). The U.S. Food and Drug Administration (FDA) granted approval of Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV cHL.1 In the EU, the European Commission (EC) approved Opdivo in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents, and adults up to 30 years of age with relapsed or refractory cHL after one prior line of therapy.2
“These approvals represent a defining moment for people living with classical Hodgkin Lymphoma,” said Monica Shaw, MD, Senior Vice President of Oncology Commercialization. “In the U.S., we are particularly proud that Opdivo in combination with AVD now stands as an immunotherapy combination available for adults and pediatric patients, ages 12 and older, with previously untreated advanced disease.1 Concurrently, in the EU, Opdivo in combination with brentuximab vedotin has also achieved a milestone as the first immunotherapy combination for certain relapsed or refractory patients.2 These milestones reflect our continued commitment to advancing science that meaningfully improves the lives of patients and families worldwide.”
The U.S. approval is based on the Phase 3 SWOG 1826 (CA2098UT) study, evaluating Opdivo in combination with AVD for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV cHL.3 A submission based on SWOG 1826 study is also currently under evaluation by the European Medicines Agency (EMA).
Opdivo and Yervoy are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials. Please see the Important Safety Information section below.
The EU approval is based on the Phase 2 CheckMate -744 (CA209744) study, evaluating Opdivo in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory cHL after one prior line of therapy.4
“For decades, treatment approaches in classical Hodgkin Lymphoma have presented significant challenges, both for newly diagnosed patients and those facing relapse,”5,6 said Alex Herrera, M.D., Chief of Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope National Medical Center. “In the U.S., the nivolumab-based combination for patients with previously untreated Stage III or IV cHL demonstrated improved progression-free survival compared with standard of care, BV-AVD. The SWOG 1826 study provides data for frontline use of this immunotherapy-based regimen.”5
“The availability of another treatment option for people living with certain types of Hodgkin lymphoma can make a real difference,” says Gwen Nichols, M.D., Chief Medical Officer of Blood Cancer United. “Each new FDA-approved therapy brings renewed hope for patients and their families, and advances like this one signal meaningful progress in improving outcomes for people facing this disease.”5
SWOG 1826 (Study CA209-8UT) demonstrated a 58% reduction in the risk of disease progression or death as determined per investigator (Hazard Ratio [HR] 0.42; 95% Confidence Interval [CI] 0.27–0.67; P=<0.0001). The trial demonstrated a statistically significant improvement in the primary endpoint of progression-free survival (PFS) for patients who received Opdivo in combination with AVD, which reflect a median follow-up of 13.7 months in the intention to treat population. After a median follow-up of 36.7 months, the median overall survival (OS) had not been reached in either treatment arm with a total of 26 deaths: 9 (1.8%) deaths in the Opdivo in combination with AVD arm and 17 (3.4%) deaths in the BV plus AVD arm.7
Select Safety Profile from SWOG 1826 (CA2098UT)
Serious adverse reactions occurred in 39% of patients receiving Opdivo in combination with doxorubicin, vinblastine, and dacarbazine (AVD) (n=490). The most frequent serious adverse reactions reported in ≥5% patients who received Opdivo in combination with AVD were peripheral neuropathy (41%), neutropenia (7%), pyrexia (7%), febrile neutropenia (6%), and nausea (6%). Fatal adverse reactions occurred in 3 patients (0.6%), all from sepsis. The most common adverse reactions were nausea (70%), neutropenia (61%), fatigue (59%), anemia (51%), constipation (49%), leukopenia (44%), musculoskeletal pain (42%), transaminases increase (41%), vomiting (33%), and stomatitis (30%).
About SWOG 1826 (CA2098UT)
SWOG 1826, also known as CA2098UT, is a randomized, multicenter, Phase 3 study evaluating Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL).3 The study is designed to assess progression-free survival as the primary endpoint, with key secondary endpoints that include overall survival and other measures of efficacy and safety.3
The SWOG 1826 study is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) under a Cooperative Research and Development Agreement with Bristol Myers Squibb and conducted in the NCI National Clinical Trials Network (NCTN) led by the SWOG Cancer Research Network in collaboration with the Children’s Oncology Group (COG).3 It is the largest cHL study conducted in the NCTN.3 Bristol Myers Squibb co-sponsored the study and supplied Opdivo to the NCI through a Cooperative Research and Development agreement.3
About CheckMate -744 (CA209744)
CheckMate -744, also known as CA209744, is a risk-based, response-adapted, open-label, Phase 2 study investigating Opdivo® (nivolumab) in combination with brentuximab vedotin for children, adolescents, and young adults (between 5 and 30 years old) with CD30+ classical Hodgkin lymphoma (cHL) that has relapsed or is refractory after first-line treatment.4 The study aimed to determine the safety and efficacy of nivolumab plus brentuximab vedotin, with a subsequent treatment arm of brentuximab vedotin plus bendamustine for patients with a suboptimal response.4 The trial evaluated the overall effectiveness and tolerability of these regimens in this younger, relapsed/refractory patient population.4
Data from the Phase 2 CheckMate -744 study were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2023 and demonstrated that Opdivo in combination with brentuximab vedotin achieved high complete metabolic response rates in children, adolescents, and young adults with relapsed or refractory cHL after one prior line of therapy.6 The response-adapted regimen enabled the majority of patients to proceed to consolidation while maintaining a manageable safety profile.6 Responses were durable at follow-up, supporting the potential of Opdivo-based, chemotherapy-sparing approaches in this population.6
About Classical Hodgkin Lymphoma
Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.8 HL is the most common cancer diagnosed in adolescents (ages 15-19).9 It is most often diagnosed in early adulthood (ages 20-39) and late adulthood (older than 55 years of age).10 Classical Hodgkin lymphoma is the most common type of HL, accounting for 95% of cases.11 Despite progress in frontline therapy, advanced-stage HL still carries a substantial risk of relapse, highlighting the need for innovative approaches.10
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 Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.
The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
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