Only* OPDIVO® (nivolumab)
+ YERVOY® (ipilimumab)
offers dual I-O durability
Delivering a chance for long-term
survival1
mMelanoma, 1L intermediate/poor-risk aRCC, and 1L mNSCLC
in patients who express PD-L1 (≥1%).1
I-O=immuno-oncology; mMelanoma=unresectable or metastatic melanoma; mNSCLC=metastatic non-small cell lung cancer; PD-L1=programmed death ligand 1.
Please select a tab and scroll down to explore efficacy and relevant data below.
1L Metastatic Non-Small Cell Lung Cancer
in Checkmate 2271
For previously untreated patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations1
In the Checkmate 227 (mNSCLC), in patients with PD-L1 expression ≥1% with a median follow-up of 54.8 months, the 4-year OS rate for OPDIVO + YERVOY was 29% vs 18% for chemotherapy.† Primary analysis at 29.3 months minimum follow up: mOS was 17.1 months with OPDIVO + YERVOY vs 14.9 months with chemotherapy. HR=0.79 (95% CI: 0.67–0.94); P=0.0066.1-3
Checkmate 227 Study Information1,3
Checkmate 227 was a randomized, open-label phase 3 trial in patients with metastatic or recurrent NSCLC. Part 1a of the study included patients (18 years of age or older) with histologically confirmed Stage IV or recurrent NSCLC, ECOG performance status 0 or 1, no prior anticancer therapy, and had PD-L1 expression ≥1%. Patients with known EGFR mutations or ALK translocations sensitive to available targeted inhibitor therapy, untreated brain metastases, carcinomatous meningitis, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded. Patients with PD-L1 tumor expression ≥1% were randomized to OPDIVO 3 mg/kg q2w + YERVOY 1 mg/kg q6w (n=396) or platinum-doublet chemotherapy‡ (n=397). Tumor specimens were evaluated prospectively using the PD-L1 IHC 28-8 pharmDx assay at a central laboratory. The primary endpoint in Part 1a was OS in patients with PD-L1 ≥1%. The pre-specified descriptive efficacy outcome measures included PFS. Treatment continued until disease progression, unacceptable toxicity, or for up to 2 years.1,3
Select Important Safety Information
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 additional Important Safety Information below.
Overall survival for PD-L1 ≥1% (extended follow-up analysis)1-3
Median follow-up of 54.8 months2
- Median OS at primary analysis (minimum follow-up of 29.3 months) in patients with tumor PD-L1 expression ≥1%1,3
- OPDIVO + YERVOY: 17.1 months (n=396 [95% Cl: 15.0–20.1])
- Chemotherapy: 14.9 months (n=397 [95% Cl: 12.7–16.7])
- HR=0.79 (95% CI: 0.67–0.94; P=0.0066)
- Median PFS with a median follow-up of 54.8 months: 5.1 months (95% CI: 4.1–6.3) with OPDIVO + YERVOY and 5.6 months (95% CI: 4.6–5.8) with chemo alone; HR=0.81; 95% CI: 0.68–0.961,2
- In Checkmate 227 Part 1a, PFS, ORR, and DOR were pre-specified descriptive analyses. The primary efficacy outcome measure was OS1
- 29% of patients enrolled had SQ disease; 71% had NSQ disease1
Learn more about OPDIVO + YERVOY for 1L mNSCLC
Select Important Safety Information
In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure.
In Checkmate 227, the most common (≥20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%).
Please see additional Important Safety Information below.
Metastatic Melanoma in Checkmate 067
For patients with unresectable or metastatic melanoma1
In the Checkmate 067 (mMelanoma) follow-up analysis at ~6.5 years, OS for OPDIVO + YERVOY was 49% vs 23% for YERVOY. mOS was reached at 72.1 months for OPDIVO + YERVOY vs 19.9 months with YERVOY. Primary analysis at 28 months: HR+ 0.55 (95% CI: 0.44–0.69); P<0.0001.1,4
Checkmate 067 Study Information1
OPDIVO + YERVOY was evaluated in a double-blind, randomized study of previously untreated, unresectable, or metastatic melanoma. Patients were randomized (1:1:1) to receive OPDIVO + YERVOY (OPDIVO 1 mg/kg and YERVOY 3 mg/kg q3w for 4 doses, followed by OPDIVO monotherapy 3 mg/kg q2w§), or OPDIVO 3 mg/kg q2w, or YERVOY 3 mg/kg q3w for 4 doses plus placebo. Major efficacy outcome measures were investigator-assessed PFS and OS. Additional efficacy outcome measures were confirmed ORR and DOR.1
§The recommended dose of OPDIVO is 1 mg/kg administered as an IV infusion over 30 minutes, followed by YERVOY 3 mg/kg administered as an IV infusion over 90 minutes on the same day, q3w for a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier. After completing 4 doses of the combination, administer OPDIVO as a single agent, either 240 mg q2w or 480 mg q4w, as an IV infusion over 30 minutes until disease progression or unacceptable toxicity.1Select Important Safety Information
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 additional Important Safety Information below.
A chance for durable survival with 49% of ITT patients alive at ~6.5 years4,5
OPDIVO + YERVOY median overall survival (mOS) was reached after 6 years of follow-up4
mOS at ~6.5 years (95% CI, months):
- OPDIVO + YERVOY: 72.1 (38.2–NR)
- OPDIVO: 36.9 (28.2–58.7)
- YERVOY: 19.9 (16.8–24.6)
This study was not designed to compare OPDVIO + YERVOY with OPDIVO.
CI=confidence interval; DOR=duration of response; HR=hazard ratio; ITT=intention to treat; mOS=median overall survival; NR=not reached; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; q2w=every 2 weeks; q3w=every 3 weeks; q4w=every 4 weeks.Select Important Safety Information
In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%) and pyrexia (10% and 1.0%).
In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%).
Please see additional Important Safety Information below.
1L Advanced Renal Cell Carcinoma
in Checkmate 214
For previously untreated patients with intermediate or poor-risk advanced renal cell carcinoma1
Overall survival data in Checkmate 214
- In the Checkmate 214 (aRCC) extended follow-up analysis at 48 months, the mOS was 48.1 months for OPDIVO + YERVOY (95% CI: 35.6–NE) vs 26.6 months for sunitinib (95% CI: 22.1–33.5), HR=0.65 (95% CI: 0.54-0.78). The 48-month OS rate for OPDIVO + YERVOY was 50% vs 35.8% for sunitinib. The mOS at primary analysis (median follow-up time of 25.2 months) for OPDIVO + YERVOY was not yet reached (95% CI: 28.2–NE) vs 25.9 months for sunitinib (95% CI: 22.1–NE), HR=0.63 (99.8% CI: 0.44–0.89); P<0.0001.1,6,7
Overall response rate|| in Checkmate 214
- Overall response rate at primary analysis (median follow-up of 25.2 months) was 41.6% (n=177/425 [95% CI: 36.9–46.5]); CR: 9.4% [n=40]; PR: 32.2% [n=137] for OPDIVO + YERVOY vs 26.5% (n=112/422 [95% CI: 22.4–31.0]); CR: 1.2% [n=5]; PR: 25.4% [n=107] for sunitinib (P<0.0001)1,7
Progression-free survival|| in Checkmate 214
- Progression-free survival at primary analysis (median follow-up of 25.2 months) for OPDIVO + YERVOY and sunitinib was 11.6 months (95% CI: 8.7–15.5) vs 8.4 months (95% CI: 7.0–10.8), respectively, HR=0.82 (99.1% CI: 0.64–1.05). Per a pre-specified analysis, PFS did not meet statistical significance1,7
Checkmate 214 Study Information1,7
Checkmate 214 was a phase 3, randomized (1:1), open-label study of OPDIVO 3 mg/kg IV and YERVOY 1 mg/kg IV (n=425) every 3 weeks for 4 doses, followed by OPDIVO 3 mg/kg IV every 2 weeks¶ vs sunitinib (n=422) 50 mg administered orally once daily for 4 weeks, followed by 2 weeks off every cycle, in patients with previously untreated intermediate-/poor-risk aRCC. Patients were stratified by IMDC prognostic score and region, and treatment was continued until disease progression or unacceptable toxicity. The co-primary endpoints in IMDC intermediate-/poor-risk patients were OS, ORR,|| and PFS.1,7||
Select Important Safety Information
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 additional Important Safety Information below.
Overall survival in intermediate or poor-risk patients1,6,7
- mOS at primary analysis (median follow-up time of 25.2 months): Median OS was not yet reached for OPDIVO + YERVOY (95% CI: 28.2–NE) vs 25.9 months for sunitinib: (95% CI: 22.1–NE); HR=0.63 (99.8% CI: 0.44–0.89); P<0.00011,7
- In the primary analysis (median follow-up time of 25.2 months), the pre-specified 12-month overall survival rate was 80% (95% CI: 76–84) with OPDIVO + YERVOY vs 72% (95% CI: 67–76) with sunitinib7
- The 48-month overall survival rate analysis was not pre-specified within the study protocol7
- mOS at extended follow-up (minimum follow-up time of 48 months) was 48.1 months (95% CI: 35.6–NE) for OPDIVO + YERVOY vs 26.6 months for sunitinib (95% CI: 22.1–33.5), HR=0.65 (95% CI: 0.54–0.78)6
- The 48-month OS rate for OPDIVO + YERVOY was 50% vs 35.8% for sunitinib
Learn more about OPDIVO + YERVOY for 1L intermediate or poor-risk aRCC
Select Important Safety Information
Serious adverse reactions occurred in 59% of patients receiving OPDIVO + YERVOY. The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDVIO + YERVOY were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis; for sunitinib they were pneumonia, pleural effusion, and dyspnea.
In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) were fatigue (58%), rash (39%), diarrhea (38%), musculoskeletal pain (37%), pruritus (33%), nausea (30%), cough (28%), pyrexia (25%), arthralgia (23%), decreased appetite (21%), dyspnea (20%), and vomiting (20%).
Please see additional Important Safety Information below.
1L Metastatic
Non-Small Cell Lung Cancer in Checkmate 2271
For previously untreated patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations1
In the Checkmate 227 (mNSCLC), in patients with PD-L1 expression ≥1% with a median follow-up of 54.8 months, the 4-year OS rate for OPDIVO + YERVOY was 29% vs 18% for chemotherapy.† Primary analysis at 29.3 months minimum follow up: mOS was 17.1 months with OPDIVO + YERVOY vs 14.9 months with chemotherapy. HR=0.79 (95% CI: 0.67–0.94); P=0.0066.1-3
Select Important Safety Information
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 additional Important Safety Information below.
Checkmate 227 Study Information1,3
Checkmate 227 was a randomized, open-label phase 3 trial in patients with metastatic or recurrent NSCLC. Part 1a of the study included patients (18 years of age or older) with histologically confirmed Stage IV or recurrent NSCLC, ECOG performance status 0 or 1, no prior anticancer therapy, and had PD-L1 expression ≥1%. Patients with known EGFR mutations or ALK translocations sensitive to available targeted inhibitor therapy, untreated brain metastases, carcinomatous meningitis, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded. Patients with PD-L1 tumor expression ≥1% were randomized to OPDIVO 3 mg/kg q2w + YERVOY 1 mg/kg q6w (n=396) or platinum-doublet chemotherapy‡ (n=397). Tumor specimens were evaluated prospectively using the PD-L1 IHC 28-8 pharmDx assay at a central laboratory. The primary endpoint in Part 1a was OS in patients with PD-L1 ≥1%. The pre-specified descriptive efficacy outcome measures included PFS. Treatment continued until disease progression, unacceptable toxicity, or for up to 2 years.1,3
Overall survival for PD-L1 ≥1% (extended follow-up analysis)1-3
Median follow-up of 54.8 months2
- Median OS at primary analysis (minimum follow-up of 29.3 months) in patients with tumor PD-L1 expression ≥1%1,3
- OPDIVO + YERVOY: 17.1 months (n=396 [95% Cl: 15.0–20.1])
- Chemotherapy: 14.9 months (n=397 [95% Cl: 12.7–16.7])
- HR=0.79 (95% CI: 0.67–0.94; P=0.0066)
- Median PFS with a median follow-up of 54.8 months: 5.1 months (95% CI: 4.1–6.3) with OPDIVO + YERVOY and 5.6 months (95% CI: 4.6–5.8) with chemo alone; HR=0.81; 95% CI: 0.68–0.961,2
- In Checkmate 227 Part 1a, PFS, ORR, and DOR were pre-specified descriptive analyses. The primary efficacy outcome measure was OS1
- 29% of patients enrolled had SQ disease; 71% had NSQ disease1
Select Important Safety Information
In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure.
In Checkmate 227, the most common (≥20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%).
Please see additional Important Safety Information below.
Learn more about OPDIVO + YERVOY for 1L mNSCLC
Metastatic Melanoma in Checkmate 067
For patients with unresectable or metastatic melanoma1
In the Checkmate 067 (mMelanoma) follow-up analysis at ~6.5 years, OS for OPDIVO + YERVOY was 49% vs 23% for YERVOY. mOS was reached at 72.1 months for OPDIVO + YERVOY vs 19.9 months with YERVOY. Primary analysis at 28 months: HR+ 0.55 (95% CI: 0.44–0.69); P<0.0001.1,4
Select Important Safety Information
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 additional Important Safety Information below.
Checkmate 067 Study Information1
OPDIVO + YERVOY was evaluated in a double-blind, randomized study of previously untreated, unresectable, or metastatic melanoma. Patients were randomized (1:1:1) to receive OPDIVO + YERVOY (OPDIVO 1 mg/kg and YERVOY 3 mg/kg q3w for 4 doses, followed by OPDIVO monotherapy 3 mg/kg q2w§), or OPDIVO 3 mg/kg q2w, or YERVOY 3 mg/kg q3w for 4 doses plus placebo. Major efficacy outcome measures were investigator-assessed PFS and OS. Additional efficacy outcome measures were confirmed ORR and DOR.1
§The recommended dose of OPDIVO is 1 mg/kg administered as an IV infusion over 30 minutes, followed by YERVOY 3 mg/kg administered as an IV infusion over 90 minutes on the same day, q3w for a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier. After completing 4 doses of the combination, administer OPDIVO as a single agent, either 240 mg q2w or 480 mg q4w, as an IV infusion over 30 minutes until disease progression or unacceptable toxicity.1A chance for durable survival with 49% of ITT patients alive at ~6.5 years4,5
OPDIVO + YERVOY median overall survival (mOS) was reached after 6 years of follow-up4
mOS at ~6.5 years (95% CI, months):
- OPDIVO + YERVOY: 72.1 (38.2–NR)
- OPDIVO: 36.9 (28.2–58.7)
- YERVOY: 19.9 (16.8–24.6)
This study was not designed to compare OPDIVO + YERVOY with OPDIVO.
CI=confidence interval; DOR=duration of response; HR=hazard ratio; ITT=intention to treat; mOS=median overall survival; NR=not reached; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; q2w=every 2 weeks; q3w=every 3 weeks; q4w=every 4 weeks.Select Important Safety Information
In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%) and pyrexia (10% and 1.0%).
In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%).
Please see additional Important Safety Information below.
1L Advanced Renal Cell Carcinoma in Checkmate 214
For previously untreated patients with intermediate or poor-risk advanced renal cell carcinoma1
Overall survival data in Checkmate 214
- In the Checkmate 214 (aRCC) extended follow-up analysis at 48 months, the mOS was 48.1 months for OPDIVO + YERVOY (95% CI: 35.6–NE) vs 26.6 months for sunitinib (95% CI: 22.1–33.5), HR=0.65 (95% CI: 0.54-0.78). The 48-month OS rate for OPDIVO + YERVOY was 50% vs 35.8% for sunitinib. The mOS at primary analysis (median follow-up time of 25.2 months) for OPDIVO + YERVOY was not yet reached (95% CI: 28.2–NE) vs 25.9 months for sunitinib (95% CI: 22.1–NE), HR=0.63 (99.8% CI: 0.44–0.89); P<0.0001.1,6,7
Overall response rate|| in Checkmate 214
- Overall response rate at primary analysis (median follow-up of 25.2 months) was 41.6% (n=177/425 [95% CI: 36.9–46.5]); CR: 9.4% [n=40]; PR: 32.2% [n=137] for OPDIVO + YERVOY vs 26.5% (n=112/422 [95% CI: 22.4–31.0]); CR: 1.2% [n=5]; PR: 25.4% [n=107] for sunitinib (P<0.0001)1,7
Progression-free survival|| in Checkmate 214
- Progression-free survival at primary analysis (median follow-up of 25.2 months) for OPDIVO + YERVOY and sunitinib was 11.6 months (95% CI: 8.7–15.5) vs 8.4 months (95% CI: 7.0–10.8), respectively, HR=0.82 (99.1% CI: 0.64–1.05). Per a pre-specified analysis, PFS did not meet statistical significance1,7
Select Important Safety Information
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 additional Important Safety Information below.
Checkmate 214 Study Information1,7
Checkmate 214 was a phase 3, randomized (1:1), open-label study of OPDIVO 3 mg/kg IV and YERVOY 1 mg/kg IV (n=425) every 3 weeks for 4 doses, followed by OPDIVO 3 mg/kg IV every 2 weeks¶; vs sunitinib (n=422) 50 mg administered orally once daily for 4 weeks, followed by 2 weeks off every cycle, in patients with previously untreated intermediate-/poor-risk aRCC. Patients were stratified by IMDC prognostic score and region, and treatment was continued until disease progression or unacceptable toxicity. The co-primary endpoints in IMDC intermediate-/poor-risk patients were OS, ORR,|| and PFS.1,7||
Overall survival in intermediate or poor-risk patients1,6,7
- mOS at primary analysis (median follow-up time of 25.2 months): Median OS was not yet reached for OPDIVO + YERVOY (95% CI: 28.2–NE) vs 25.9 months for sunitinib: (95% CI: 22.1–NE); HR=0.63 (99.8% CI: 0.44–0.89); P<0.00011,7
- In the primary analysis (median follow-up time of 25.2 months), the pre-specified 12-month overall survival rate was 80% (95% CI: 76–84) with OPDIVO + YERVOY vs 72% (95% CI: 67–76) with sunitinib7
- The 48-month overall survival rate analysis was not pre-specified within the study protocol7
- mOS at extended follow-up (minimum follow-up time of 48 months) was 48.1 months (95% CI: 35.6–NE) for OPDIVO + YERVOY vs 26.6 months for sunitinib (95% CI: 22.1–33.5), HR=0.65 (95% CI: 0.54–0.78)6
- The 48-month OS rate for OPDIVO + YERVOY was 50% vs 35.8% for sunitinib
Select Important Safety Information
Serious adverse reactions occurred in 59% of patients receiving OPDIVO + YERVOY. The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDVIO + YERVOY were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis; for sunitinib they were pneumonia, pleural effusion, and dyspnea.
In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) were fatigue (58%), rash (39%), diarrhea (38%), musculoskeletal pain (37%), pruritus (33%), nausea (30%), cough (28%), pyrexia (25%), arthralgia (23%), decreased appetite (21%), dyspnea (20%), and vomiting (20%).
Please see additional Important Safety Information below.