My Path to Opdualag
Discover why Dr. Eric Whitman, a surgical oncologist specializing in melanoma treatment, chooses Opdualag for his patients.
Optimize 1L Dual I-O: Opdualag for Durable and Superior Efficacy1,2*
*Based on the 13.2-month median final analysis, the primary endpoint of PFS was statistically significant; mPFS† was 10.1 months (95% CI: 6.4–15.7) with Opdualag vs 4.6 months (95% CI: 3.4–5.6) with nivolumab‡ (HR=0.75§; 95% CI: 0.62–0.92; P=0.0055). At the median follow-up of 19.3 months, the final analysis for the secondary endpoint of OS was not statistically significant (HR=0.80; 95% CI: 0.64–1.01; P=0.0593); threshold for significance was P<0.04302. ORR could not be formally tested based on testing hierarchy and was descriptively analyzed for Opdualag (43%; 95% CI: 38–48) vs nivolumab (33%; 95% CI: 28–38).1,3,4 †Assessed by BICR.1 ‡Kaplan-Meier estimate.1,2 §Based on stratified Cox proportional hazards model.1
All data shown below is 5-year data based on minimum potential follow-up of 57.3 months.2
Opdualag was shown to reduce the risk of death by 22% vs nivolumab2*
Overall survival at 5 years (secondary endpoint)
Symbols represent censored observations.
5-year data2:
- Median OS‡ (95% CI):
- Opdualag: 54.8 months (33.6–81.1)
- Nivolumab: 33.2 months (25.2–44.7)
- HR (95% CI): 0.78† (0.64–0.95)
Primary analysis (19.3-month median follow-up)1,3:
- The secondary endpoint of OS was not statistically significant. HR vs nivolumab: 0.80† (95% CI: 0.64–1.01; P=0.0593); threshold for significance was P<0.04302
Endpoints were tested in hierarchical order: PFS, OS, ORR.1
*Descriptive Analyses. †Based on stratified Cox proportional hazards model.1 ‡Kaplan-Meier estimate.
1L=first-line; BICR=blinded independent central review; CI=confidence interval; HR=hazard ratio; I-O=immuno-oncology; mMel=metastatic melanoma; mPFS=median progression-free survival; NR=not reached; ORR=overall response rate; OS=overall survival; PFS=progression-free survival.
Opdualag was observed to have an 18% risk reduction of death in BRAF WT patients vs nivolumab at 5 years5*†
5-year data update for BRAF WT OS
5-year data based on minimum potential follow-up of 57.3 months.2
5-year data5:
- Median OS (95% CI):
- Opdualag: 38.6 mos (23.1-64.5)
- Nivolumab: 28.5 mos (22.0-42.3)
- HR=0.82 (95% CI: 0.64-1.04)
*Exploratory/descriptive analyses. †In RELATIVITY-047, at the median follow-up of 19.3 months, the final analysis for the secondary endpoint of OS in the ITT population was not statistically significant (HR=0.80†; 95% CI: 0.64–1.01; P=0.0593); threshold for significance was P<0.04302.1,3 ‡Based on stratified Cox proportional hazard model.
Progression-free survival per BICR at 5 years (primary endpoint)
Opdualag showed a durable and superior* progression-free survival benefit vs nivolumab1,2†
Symbols represent censored observations.
Separation of PFS curve was early—at the time of first scan (3 months)—and sustained over time1,4
5-year data2:
- Median PFS§ (95% CI):
- Opdualag: 10.2 months (6.5–15.7)
- Nivolumab: 4.6 months (3.5–6.5)
- HR (95% CI): 0.77‡ (0.65–0.92)
*Primary analysis (13.2-month median follow-up)4:
- Median PFS§ (95% CI):
- Opdualag: 10.1 months (6.4–15.7)
- Nivolumab: 4.6 months (3.4–5.6)
- HR (95% CI): 0.75‡ (0.62–0.92); P=0.006‖
†Descriptive analyses. ‡Based on stratified Cox proportional hazards model. §Kaplan-Meier Estimate. ‖Based on stratified-log rank test.
Hi, I'm Eric Whitman.
I'm a surgical oncologist specializing in melanoma and the System Medical Director of Atlantic Health System Oncology Program.
I've been practicing medicine for about 30 years.
I choose Opdualag for my melanoma patients with stage III unresectable disease or metastatic stage IV disease based on the data from the Relativity-047 study where there was a statistical improvement in median progression-free survival.
The patients I choose to treat with Opdualag have unresectable stage III melanoma or stage IV melanoma, and they fit the general criteria laid out in the Relativity-047 study.
In our practice, we use generally accepted clinical guidelines to help guide our treatment decision making for metastatic or unresectable melanoma patients.
I think that healthcare providers considering treating their patients with Opdualag should review the data from the Relativity-047 study.
Indication
Opdualag® (nivolumab and relatlimab-rmbw) is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
Opdualag is associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions (IMARs), infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation (HSCT), and embryo-fetal toxicity.
Immune-Mediated Adverse Reactions (IMARs):
IMARs which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis with renal dysfunction, and immune-mediated myocarditis.
Monitor for early identification and management.
Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
Withhold or permanently discontinue Opdualag based on severity and type of reaction.
Infusion-Related Reactions:
Interrupt, slow the rate of infusion, or permanently discontinue Opdualag based on severity of reaction.
Complications of Allogeneic HSCT:
Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.
Embryo-Fetal Toxicity:
Opdualag can cause fetal harm.
Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.
Continue watching for additional Important Safety Information.
Relativity-047 is a phase 3, randomized, double-blind, multicenter study of Opdualag.
480 mg nivolumab and 160 mg relatlimab is a fixed-dose combination every four weeks (n=355) vs nivolumab 480 mg every four weeks (n=359) by IV infusion and treatment-naïve patients with metastatic or unresectable melanoma.
Patients were allowed to have received prior adjuvant and neoadjuvant melanoma therapy. Anti–PD-1, anti–CTLA-4, or BRAF-MEK therapy was allowed as long as there was at least 6 months between the last dose of therapy and date of recurrence.
Interferon therapy was allowed as long as the last dose was at least 6 weeks prior to randomization.
Patients were stratified by PD-L1, LAG-3, BRAF mutation status, and AJCC v8 metastatic stage.
The primary endpoint of the study is progression-free survival as determined by BICR using RECIST v1.1.
Key secondary endpoints include overall survival and overall response rate as determined by BICR using RECIST v1.1.
At the primary analysis, median follow-up of 13.2 months, median PFS based on Kaplan-Meier estimate was 10.1 months with a 95% confidence interval of 6.4 to15.7 for Opdualag vs 4.6 months with a 95% confidence interval of 3.4 to 5.6 for nivolumab.
The hazard ratio based on stratified Cox proportional hazards model was 0.75 with a 95% confidence interval of 0.62 to 0.92 and a P value of 0.006 based on stratified log-rank test.
5-year data update of PFS based on minimum potential follow-up of 57.3 months.
Opdualag had a median PFS of 10.2 months with a 95% confidence interval of 6.5 to 15.7 vs 4.6 months for nivolumab with a 95% confidence interval of 3.5 to 6.5.
The hazard ratio based on stratified Cox proportional hazards model was 0.77 with a 95% confidence interval of 0.65 to 0.92.
At the primary OS analysis, median follow-up of 19.3 months, the secondary endpoint of OS was not statistically significant.
The hazard ratio based on stratified Cox proportional hazards model was 0.80 with a 95% confidence interval of 0.64 to 1.01 and a P value of 0.0593 based on stratified log-rank test.
Threshold for significance was a P value less than 0.04302.
5-year data update of OS based on minimum potential follow-up of 57.3 months.
Median OS for Opdualag was 54.8 months with a 95% confidence interval of 33.6 months to 81.1 months, whereas the median OS for nivolumab monotherapy was 33.2 months with a 95% confidence interval of 25.2 months to 44.7 months.
The hazard ratio was 0.78 with a 95% confidence interval of 0.64 to 0.95.
At the median follow-up of 19.3 months, the ORR for Opdualag was 43% with a 95% confidence interval of 38 to 48 (n=155 out of 355) vs 33% for nivolumab with a 95% confidence interval of 28 to 38 (n=117 out of 359), at the time of the final OS analysis, which was event-driven and occurred after the final PFS analysis.
ORR was not formally tested based on the testing hierarchy.
The complete response rate was 16% for Opdualag vs 14% for nivolumab and the partial response rate was 27% for Opdualag vs 18% for nivolumab.
5-year ORR for Opdualag was 44% with a 95% confidence interval of 38.7 to 49.3 (n=153 out of 355) vs 34% for nivolumab with a confidence interval of 28.8 to 38.9 (n=121 out of 359).
The complete response rate was 23% for Opdualag vs 19% for nivolumab and the partial response rate was 21% for Opdualag vs 15% for nivolumab.
Median duration of response for Opdualag was not reached with a 95% confidence interval of 47.7 to not reached, whereas the median duration of response for nivolumab monotherapy was 56 months with a 95% confidence interval of 44.6 to not reached.
In Relativity-047, the most common adverse events occurring in greater than or equal to 15%, the Grade 3 or 4 incidents for Opdualag vs nivolumab were respectively: musculoskeletal pain 4.2% vs 1.7%, fatigue 2% vs 0.6%, rash 1.4% vs 1.9%, pruritis 0% vs 0.6%, diarrhea 2% vs 1.4%, nausea 0.6% vs 0, headache 0.3% vs 0.3%, decreased appetite 0.6% vs 0.3%, and cough 0.3% vs 0%.
Indication
Opdualag® (nivolumab and relatlimab-rmbw) is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
Important Safety Information
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions (IMARs) listed herein may not include all possible severe and fatal immune-mediated adverse reactions.
IMARs, which may be severe or fatal, can occur in any organ system or tissue.
IMARs can occur at any time after starting treatment with a LAG-3 and PD-1/PD-L1 blocking antibodies.
While IMARs usually manifest during treatment, they can also occur after discontinuation of Opdualag.
Early identification and management of IMARs are essential to ensure safe use.
Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying IMARs.
Evaluate clinical chemistries including liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
In cases of suspected IMARs, initiate appropriate workup to exclude alternative etiologies, including infection.
Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
In general, if Opdualag requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less.
Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month.
Consider administration of other systemic immunosuppressants in patients whose IMARs are not controlled with corticosteroid therapy.
Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (for example, endocrinopathies and dermatologic reactions) are discussed below.
Immune-Mediated Pneumonitis
Opdualag can cause immune-mediated pneumonitis, which may be fatal. In patients treated with other PD-1/PD-L1 blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation.
Immune-mediated pneumonitis occurred in 3.7% (13 out of 355) patients receiving Opdualag, including Grade 3 (0.6%) and Grade 2 (2.3%) adverse reactions.
Pneumonitis led to permanent discontinuation of Opdualag in 0.8% and withholding of Opdualag in 1.4% of patients.
Immune-Mediated Colitis
Opdualag can cause immune-mediated colitis, defined as requiring use of corticosteroids and no clear alternate etiology.
A common symptom included in the definition of colitis was diarrhea.
Cytomegalovirus infection or reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis.
In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
Immune-mediated diarrhea or colitis occurred in 7% (24 out of 355) patients receiving Opdualag, including Grade 3 (1.1%) and Grade 2 (4.5%) adverse reactions.
Colitis led to permanent discontinuation of Opdualag in 2% and withholding of Opdualag in 2.8% of patients.
Immune-Mediated Hepatitis
Opdualag can cause immune-mediated hepatitis, defined as requiring the use of corticosteroids and no clear alternate etiology.
Immune-mediated hepatitis occurred in 6% (20 out of 355) patients receiving Opdualag, including Grade 4 (0.6%), Grade 3 (3.4%), and Grade 2 (1.4%) adverse reactions.
Hepatitis led to permanent discontinuation of Opdualag in 1.7% and withholding of Opdualag in 2.3% of patients.
Immune-Mediated Endocrinopathies
Opdualag can cause primary or secondary adrenal insufficiency, hypophysitis, thyroid disorders, and Type 1 diabetes mellitus, which can be present with diabetic ketoacidosis.
Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.
In patients receiving Opdualag, adrenal insufficiency occurred in 4.2% (15 out of 355) patients receiving Opdualag, including Grade 3 (1.4%) and Grade 2 (2.5%) adverse reactions.
Adrenal insufficiency led to permanent discontinuation of Opdualag in 1.1% and withholding of Opdualag in 0.8% of patients.
Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects.
Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated.
Hypophysitis occurred in 2.5% (9 out of 355) patients receiving Opdualag, including Grade 3 (0.3%) and Grade 2 (1.4%) adverse reactions.
Hypophysitis led to permanent discontinuation of Opdualag in 0.3% and withholding of Opdualag in 0.6% of patients.
Thyroiditis can present with or without endocrinopathy.
Hypothyroidism can follow hyperthyroidism; initiate hormone replacement, or medical management as clinically indicated.
Thyroiditis occurred in 2.8% (10 out of 355) patients receiving Opdualag, including Grade 2 (1.1%) adverse reactions.
Thyroiditis did not lead to permanent discontinuation of Opdualag.
Thyroiditis led to withholding of Opdualag in 0.3% of patients.
Hyperthyroidism occurred in 6% (22 out of 355) patients receiving Opdualag, including Grade 2 (1.4%) adverse reactions.
Hyperthyroidism did not lead to permanent discontinuation of Opdualag.
Hyperthyroidism led to withholding of Opdualag in 0.3% of patients.
Hypothyroidism occurred in 17% (59 out of 355) of patients receiving Opdualag, including Grade 2 (11%) adverse reactions.
Hypothyroidism led to the permanent discontinuation of Opdualag in 0.3% and withholding of Opdualag in 2.5% of patients.
Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.
Diabetes occurred in 0.3% (1 out of 355) patients receiving Opdualag, a Grade 3 (0.3%) adverse reaction, and no cases of diabetic ketoacidosis.
Diabetes did not lead to the permanent discontinuation or withholding of Opdualag in any patient.
Immune-Mediated Nephritis with Renal Dysfunction
Opdualag can cause immune-mediated nephritis, which is defined as requiring use of steroids and no clear etiology.
In patients receiving Opdualag, immune-mediated nephritis and renal dysfunction occurred in 2% (7 out of 355) patients, including Grade 3 (1.1%) and Grade 2 (0.8%) adverse reactions.
Immune-mediated nephritis and renal dysfunction led to permanent discontinuation of Opdualag in 0.8% and withholding of Opdualag in 0.6% of patients.
Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
Immune-Mediated Dermatologic Adverse Reactions
Opdualag can cause immune-mediated rash or dermatitis, defined as requiring use of steroids and no clear alternate etiology.
Exfoliative dermatitis, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and Drug Rash with eosinophilia and systemic symptoms has occurred with PD-1/PD-L1 blocking antibodies.
Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
Immune-mediated rash occurred in 9% (33 out of 355) patients, including Grade 3 (0.6%) and Grade 2 (3.4%) adverse reactions.
Immune-mediated rash did not lead to permanent discontinuation of Opdualag.
Immune-mediated rash led to withholding of Opdualag in 1.4% of patients.
Opdualag can cause immune-mediated myocarditis, which is defined as requiring use of steroids and no clear alternate etiology.
The diagnosis of immune-mediated myocarditis requires a high index of suspicion.
Patients with cardiac or cardio-pulmonary symptoms should be assessed for potential myocarditis.
If myocarditis is suspected, withhold dose, promptly initiate high dose steroids (prednisone or methylprednisolone 1 to 2 mg/kg/day) and promptly arrange cardiology consultation with diagnostic workup.
If clinically confirmed, permanently discontinue Opdualag for Grade 2 to 4 myocarditis.
Myocarditis occurred in 1.7% (6 out of 355) patients receiving Opdualag, including Grade 3 (0.6%) and Grade 2 (1.1%) adverse reactions.
Myocarditis led to permanent discontinuation of Opdualag in 1.7% of patients.
Other Immune-Mediated Adverse Reactions
The following clinically significant IMARs occurred at an incidence of less than 1% (unless otherwise noted) in patients who received Opdualag or were reported with the use of other PD-1/PD-L1 blocking antibodies.
Severe or fatal cases have been reported for some of these adverse reactions:
Cardiac/Vascular: pericarditis, vasculitis;
Nervous System: meningitis, encephalitis, myelitis, and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy;
Ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur..
Some cases can be associated with retinal detachment.
Various grades of visual impairment, including blindness, can occur.
If uveitis occurs in combination with other IMARs, consider a Vogt-Kayanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss;
Gastrointestinal: pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis;
Musculoskeletal and Connective Tissue: myositis/polymyositis, rhabdomyolysis (and associated sequelae including renal failure), arthritis, polymyalgia rheumatica;
Endocrine: hypoparathyroidism;
Hematologic/Immune: hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphedonitis (Kikuchi lymphedonitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection;
Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reported as the co-occurrence of either two or all three adverse reactions.
Infusion-Related Reactions
Opdualag can cause severe infusion-related reactions.
ODiscontinue Opdualag in patients with severe or life-threatening infusion-related reactions.
Interrupt or slow the rate of infusion in patients with mild to moderate infusion-related reactions.
In patients who received Opdualag as a 60-minute intravenous infusion, infusion-related reactions occurred in 7% (23 out of 355) patients.
Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 receptor blocking antibody.
Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause).
These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT.
Follow patients closely for evidence of transplant-related complications and intervene promptly.
Consider the benefit vs risks of treatment with a PD-1/PD-L1 receptor blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on its mechanism of action and data from animal studies, Opdualag can cause fetal harm when administered to a pregnant woman.
Advise pregnant women of the potential risk to a fetus.
Advise females of reproductive potential to use effective contraception during treatment with Opdualag and for at least 5 months after the last dose of Opdualag.
Lactation
There are no data on the presence of Opdualag in human milk, the effects on the breastfed child, or the effect on milk production.
Because nivolumab and relatlimab may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with Opdualag and for at least 5 months after the last dose.
Serious Adverse Reactions
In RELATIVITY-047, fatal adverse reactions occurred in 3 (0.8%) of patients who were treated with Opdualag;
these included hemophagocytic lymphohistiocytosis, acute edema of the lung, and pneumonitis.
Serious adverse reactions occurred in 36% of patients treated with Opdualag.
The most frequent serious adverse reactions reported in greater than or equal to 1% of patients treated with Opdualag were adrenal insufficiency (1.4%), anemia (1.4%), colitis (1.4%), pneumonia (1.4%), acute myocardial infarction (1.1%), back pain (1.1%), diarrhea (1.1%), myocarditis (1.1%), and pneumonitis (1.1%).
Common Adverse Reactions
The most common adverse reactions reported in greater than or equal to 20% of the patients treated with Opdualag were musculoskeletal pain (45%), fatigue (39%), rash (28%), pruritus (25%), and diarrhea (24%).
Please see U.S. Full Prescribing Information for Opdualag.
1425-US-2600151 10/26
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for metastatic or unresectable cutaneous melanoma6
First-line, National Comprehensive Cancer Network® (NCCN®) Category 1, Preferred6
- Among preferred regimens, combination checkpoint blockade is preferred over anti–PD-1 monotherapy, and may be preferred for patients with good performance status (ECOG status 0 or 1)6*
- BRAF/MEK combination therapy was moved from Category 1 “preferred regimens” to Category 1 “other recommended regimens”6†
OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
*Considerations for using combination therapy versus monotherapy include: patient’s desire for potentially improved efficacy and willingness to take on a higher risk of toxicity; absence of comorbidities or autoimmune processes that would elevate the risk of irAEs; tumor burden, patient social support, and preparedness to work with a medical team to handle toxicities.6 †High-volume symptomatic disease BRAF+ patients may benefit from BRAF/MEK inhibition, as opposed to combination immunotherapy. Otherwise, nivolumab + ipilimumab is preferred first-line over BRAF/MEK therapy.6 Category 1: Based upon high-level evidence (≥1 randomized phase 3 trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.6 Preferred intervention: Interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability.6 Other recommended intervention: Other interventions that may be somewhat less efficacious, more toxic, or based on less mature data; or significantly less affordable for similar outcomes.6
ECOG=Eastern Cooperative Oncology Group; irAE=immune-related adverse event; NCCN=National Comprehensive Cancer Network; PD-1=programmed death receptor-1.
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
OS across patient subgroups with Opdualag5
5-year data based on minimum potential follow-up of 57.3 months.2 OS at the 19.3–month median primary analysis did not meet statistical significance. Exploratory/descriptive analyses.2
ECOG PS=Eastern Cooperative Oncology Group Performance Status; LAG-3=lymphocyte-activation gene-3; LDH=lactate dehydrogenase; PD-L1=programmed death-ligand 1; ULN=upper limit of normal.
~1 in 4 patients treated with Opdualag had complete response at 5-year follow-up2*
5-year data update of ORR per BICR
Primary analysis (19.3-month median follow-up)1‡§:
- ORR† for Opdualag was 43% (95% CI: 38–48) vs 33% (95% CI: 28–38) for nivolumab
- CR was 16% for Opdualag vs 14% for nivolumab
- PR was 27% for Opdualag vs 18% for nivolumab
CR=complete response; mDOR=median duration of response; PR=partial response.
*Descriptive analyses. †Assessed by BICR. ‡At the time of the final OS analysis, which was event-driven and occurred after the final PFS analysis. §Not formally tested based on the testing hierarchy.
Safety Data
Find information about adverse reactions seen in the clinical trial.
Dosing Schedule
Learn more about the dosing schedule for this fixed-dose combination therapy.
References:
- Opdualag [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
- Tawbi HA, Hodi FS, Lipson EJ, et al. Nivolumab plus relatlimab in advanced melanoma: 5-year update of RELATIVITY-047. Poster presentation at Annual Meeting of the American Society of Clinical Oncology 2026. Poster 9532.
- Long GV, Hodi FS, Lipson EF, et al. Relatlimab and nivolumab vs nivolumab in previously untreated metastatic or unresectable melanoma: overall survival and response rates from RELATIVITY-047 (CA224-047). Oral background as ASCO Plenary Series 2022.
- Tawbi HA, Schadendorf D, Lipson EJ, et al. Relatlimab and nivolumab versus nivolumab in untreated advanced melanoma. N Engl J Med. 2022;386(1):24-34.
- Data on file. DOF-BMS-ONCO-0035. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Melanoma: Cutaneous V.2.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed June 13, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.