- The Opdivo + low-dose Yervoy
combination is the first and only treatment to show significantly
superior overall survival versus sunitinib in intermediate- and
poor-risk advanced renal cell carcinoma, including a survival
benefit regardless of PD-L1 expression1,2
- Treatment with Opdivo + Yervoy
delivered higher objective response rates, including more complete
responses, than sunitinib1,2
- In the CheckMate -214 trial, which used
dosing optimized for advanced renal cell carcinoma, Opdivo + Yervoy
was associated with fewer overall Grade 3 or 4 adverse reactions
than sunitinib1,2
Bristol-Myers Squibb Company (NYSE: BMY) today announced that
Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg
(injections for intravenous use) was approved by the U.S. Food and
Drug Administration (FDA) as the first Immuno-Oncology combination
therapy for previously untreated patients with intermediate- and
poor-risk advanced renal cell carcinoma (RCC).1,2 In the Phase 3
CheckMate -214 clinical trial, the Opdivo + Yervoy combination
demonstrated a significant and unprecedented increase in overall
survival (OS) in this patient population compared to a current
standard of care, sunitinib. An OS benefit was observed regardless
of PD-L1 expression level.1,2,3 Opdivo + Yervoy also delivered
durable responses, with a higher objective response rate (ORR)
compared to sunitinib.1,2 Patients in the CheckMate -214 trial
received four cycles of the Opdivo + low-dose Yervoy combination,
followed by Opdivo maintenance therapy.1,2 In the combination arm
of the trial, 79% of patients received all four doses of Opdivo +
Yervoy and went on to the Opdivo monotherapy phase.4 Flexible
dosing options are available during the Opdivo maintenance phase
(480 mg infused every four weeks or 240 mg infused every two
weeks).
This press release features multimedia. View
the full release here:
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OPDIVO® (nivolumab) + YERVOY®
(ipilimumab) product photo. Please see the U.S. Full Prescribing
Information for OPDIVO and YERVOY, including Boxed WARNING for
YERVOY regarding immune-mediated adverse reactions, below.
“Our goal is to provide cancer patients with medicines that have
the potential to extend their lives. As the first treatment option
to increase overall survival for subgroups of patients with
advanced RCC compared to sunitinib, the Opdivo plus low-dose Yervoy
combination helps deliver on that promise,” said Johanna Mercier,
head, U.S. Commercial, Bristol-Myers Squibb. “This approval
demonstrates our commitment to bringing Immuno-Oncology treatments
that may improve outcomes to a broader range of RCC patients.”
Opdivo is associated with the following Warnings and
Precautions: immune-mediated pneumonitis, colitis, hepatitis,
endocrinopathies, nephritis and renal dysfunction, skin adverse
reactions, encephalitis, other adverse reactions; infusion
reactions; and embryo-fetal toxicity. Please see the Important
Safety Information section below, including Boxed WARNING for
Yervoy regarding immune-mediated adverse reactions.1,2
Results from the CheckMate -214 trial in patients with
previously untreated intermediate- and poor-risk advanced RCC
include:
- Overall Survival: Opdivo +
Yervoy reduced the risk of death by 37% versus sunitinib (hazard
ratio [HR] 0.63; 99.8% confidence interval [CI]: 0.44 to 0.89;
p<0.0001).1,2 The median OS was not yet reached for Opdivo +
Yervoy (95% CI: 28.2 to not estimable [NE]) and was 25.9 months for
sunitinib (95% CI: 22.1 to NE).1,2,3
- Objective Response Rate: Opdivo
+ Yervoy was associated with a 41.6% ORR (95% CI: 36.9 to 46.5;
p<0.0001; n=177/425) versus 26.5% for sunitinib (95% CI: 22.4 to
31.0; n=112/422).1,2
- Complete and Partial Response
Rates: The complete response (CR) rate was 9.4% for Opdivo +
Yervoy (n=40/425) and 1.2% for sunitinib (n=5/422), and the partial
response (PR) rate was 32.2% for Opdivo + Yervoy (n=137/425) and
25.4% for sunitinib (n=107/422).1,2
- Duration of Response: Among
patients who responded, median duration of response (durability)
for Opdivo + Yervoy was not yet reached (95% CI: 21.8 to NE),
compared to 18.2 months for sunitinib (95% CI: 14.8 to NE).1,2
- Progression-Free Survival:
Progression-free survival (PFS) was 11.6 months for the Opdivo +
Yervoy combination, compared to 8.4 months for sunitinib (HR 0.82;
99.1% CI: 0.64 to 1.05; p=not significant), which did not reach
statistical significance.1,2
Among those with advanced RCC, 75% to 80% have one or more risk
factors and are considered intermediate- and poor-risk patients
according to International Metastatic Renal Cell Carcinoma Database
Consortium criteria.5,6 These patients historically had a poor
prognosis, and although there have been a number of treatment
advances over the past decade, additional options to improve
overall survival are still needed.7,8 Currently, only 36% of
patients with advanced RCC survive beyond one year, and only 8%
will live past five years.7,9
“Physicians treating advanced RCC have had few options to help
achieve the goal of improved survival,” said Robert J. Motzer,
M.D., medical oncologist, Jack and Dorothy Byrne chair in clinical
oncology, Memorial Sloan Kettering Cancer Center. “Data from the
CheckMate -214 trial demonstrated superior overall survival with
Opdivo + Yervoy, showing the potential for the combination to
become a new standard of care for patients with intermediate- and
poor-risk advanced RCC. What's more, the combination resulted in
fewer overall Grade 3 and 4 adverse reactions compared to
sunitinib. Because of these encouraging results, we now have a new
treatment option for newly diagnosed advanced RCC patients across
PD-L1 expression levels.”
In CheckMate -214, the combination was associated with fewer
overall Grade 3 or 4 adverse events than sunitinib (65% versus
76%).1,2 Treatment discontinuation due to adverse events occurred
in 31% of patients in the Opdivo + Yervoy arm, compared to 21% in
the sunitinib arm. Fifty-four percent (54%) of patients receiving
Opdivo + Yervoy and 43% of patients receiving sunitinib had a dose
delay for an adverse reaction. In the sunitinib group, 53% of
patients required a dose reduction, which was not permitted for
patients treated with the Opdivo + Yervoy combination. Serious
adverse reactions occurred in 59% of patients receiving Opdivo +
Yervoy and in 43% of patients receiving sunitinib.1,2
“Kidney cancer is the deadliest of all urological cancers, and
too many patients are faced with this grim diagnosis,” said Dena
Battle, president, KCCure. “Today’s approval of Opdivo + Yervoy for
advanced RCC has the potential to transform the first-line
treatment landscape for kidney cancer. But for patients, it is more
than just a new therapy option – it represents hope for a longer
life.”
Approval Based on CheckMate -214 Trial:
Demonstrating Superior Overall Survival and Objective Response Rate
vs. Sunitinib
CheckMate -214 is a Phase 3, randomized, open-label study
evaluating the combination of Opdivo + Yervoy versus sunitinib in
patients with previously untreated advanced RCC. In the
intermediate- and poor-risk study population, 425 patients received
Opdivo 3 mg/kg plus Yervoy 1 mg/kg every three weeks for four
doses, followed by Opdivo 3 mg/kg every two weeks, and 422 patients
received sunitinib 50 mg once daily for four weeks, followed by two
weeks off every cycle.1,2 The recommended dosing for the Opdivo +
Yervoy combination is Opdivo 3 mg/kg followed by Yervoy 1 mg/kg
each infused intravenously over 30 minutes on the same day every
three weeks for four doses. After completing four doses of the
combination, Opdivo should be administered intravenously 240 mg
every two weeks or 480 mg every four weeks over 30 minutes until
disease progression or unacceptable toxicity.1,2
The primary efficacy outcome measures of the trial were OS, ORR
(CR+PR) and PFS as determined by an independent radiographic review
committee (IRRC) in intermediate- and poor-risk patients. Patients
were included regardless of their PD-L1 status.1,2 Data from
CheckMate -214 were presented at the European Society for Medical
Oncology Congress in September 2017 and the Society for
Immunotherapy of Cancer Annual Meeting in November 2017 and were
published in the New England Journal of Medicine in March
2018.3,10,11
Select Safety Profile for the CheckMate
-214 Trial
The most frequent serious adverse reactions reported in at least
2% of patients receiving Opdivo + Yervoy were diarrhea, pyrexia,
pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea,
adrenal insufficiency and colitis. The most common adverse
reactions (≥20%) reported in patients receiving Opdivo + Yervoy
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%).1,2
About Renal Cell
Carcinoma
Renal cell carcinoma is the most common type of kidney cancer in
adults, accounting for nearly 15,000 deaths in the United States
each year.12,13 Clear-cell RCC is the most prevalent type of RCC
and constitutes 70% to 80% of all patients.14 Renal cell carcinoma
is approximately twice as common in men as in women.15 In the
United States, the five-year survival rate for those diagnosed with
metastatic, or advanced, kidney cancer is 8%.7
INDICATION
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab),
is indicated for the treatment of patients with intermediate or
poor-risk, previously untreated advanced renal cell carcinoma
(RCC).
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for
intravenous use.
IMPORTANT SAFETY
INFORMATION
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY can result in severe and fatal immune-mediated adverse
reactions. These immune-mediated reactions may involve any organ
system; however, the most common severe immune-mediated adverse
reactions are enterocolitis, hepatitis, dermatitis (including toxic
epidermal necrolysis), neuropathy, and endocrinopathy. The majority
of these immune-mediated reactions initially manifested during
treatment; however, a minority occurred weeks to months after
discontinuation of YERVOY.
Assess patients for signs and symptoms of enterocolitis,
dermatitis, neuropathy, and endocrinopathy and evaluate clinical
chemistries including liver function tests (LFTs),
adrenocorticotropic hormone (ACTH) level, and thyroid function
tests at baseline and before each dose.
Permanently discontinue YERVOY and initiate systemic
high-dose corticosteroid therapy for severe immune-mediated
reactions.
Immune-Mediated Pneumonitis
OPDIVO can cause immune-mediated pneumonitis. Fatal cases have
been reported. Monitor patients for signs with radiographic imaging
and for symptoms of pneumonitis. Administer corticosteroids for
Grade 2 or more severe pneumonitis. Permanently discontinue for
Grade 3 or 4 and withhold until resolution for Grade 2. In patients
receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated
pneumonitis occurred in 4.4% (24/547) of patients.
Immune-Mediated Colitis
OPDIVO can cause immune-mediated colitis. Monitor patients for
signs and symptoms of colitis. Administer corticosteroids for Grade
2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO
monotherapy for Grade 2 or 3 and permanently discontinue for Grade
4 or recurrent colitis upon re-initiation of OPDIVO. When
administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2
and permanently discontinue for Grade 3 or 4 or recurrent colitis.
In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg,
immune-mediated colitis occurred in 10% (52/547) of patients.
Immune-Mediated Hepatitis
OPDIVO can cause immune-mediated hepatitis. Monitor patients for
abnormal liver tests prior to and periodically during treatment.
Administer corticosteroids for Grade 2 or greater transaminase
elevations. Withhold OPDIVO for Grade 2 and permanently discontinue
OPDIVO for Grade 3 or 4. In patients receiving OPDIVO 3 mg/kg with
YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547)
of patients.
Immune-Mediated Endocrinopathies
OPDIVO can cause immune-mediated hypophysitis, immune-mediated
adrenal insufficiency, autoimmune thyroid disorders, and Type 1
diabetes mellitus. Monitor patients for signs and symptoms of
hypophysitis, signs and symptoms of adrenal insufficiency, thyroid
function prior to and periodically during treatment, and
hyperglycemia. Administer hormone replacement as clinically
indicated and corticosteroids for Grade 2 or greater hypophysitis.
Withhold for Grade 2 or 3 and permanently discontinue for Grade 4
hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal
insufficiency. Withhold for Grade 2 and permanently discontinue for
Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement
therapy for hypothyroidism. Initiate medical management for control
of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently
discontinue for Grade 4 hyperglycemia.
In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg,
hypophysitis occurred in 4.6% (25/547) of patients. In patients
receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency
occurred in 7% (41/547) of patients. In patients receiving OPDIVO 3
mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting
in hypothyroidism occurred in 22% (119/547) of patients.
Hyperthyroidism occurred in 12% (66/547) of patients receiving this
dose of OPDIVO with YERVOY. In patients receiving OPDIVO 3 mg/kg
with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547) of
patients.
Immune-Mediated Nephritis and Renal Dysfunction
OPDIVO can cause immune-mediated nephritis. Monitor patients for
elevated serum creatinine prior to and periodically during
treatment. Administer corticosteroids for Grades 2-4 increased
serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently
discontinue for Grade 4 increased serum creatinine. In patients
receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated
nephritis and renal dysfunction occurred in 4.6% (25/547) of
patients.
Immune-Mediated Skin Adverse Reactions and Dermatitis
OPDIVO can cause immune-mediated rash, including Stevens-Johnson
syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases
with fatal outcome. Administer corticosteroids for Grade 3 or 4
rash. Withhold for Grade 3 and permanently discontinue for Grade 4
rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and
refer the patient for specialized care for assessment and
treatment; if confirmed, permanently discontinue. In patients
receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash
occurred in 16.6% (91/547) of patients.
Immune-Mediated Encephalitis
OPDIVO can cause immune-mediated encephalitis. Evaluation of
patients with neurologic symptoms may include, but not be limited
to, consultation with a neurologist, brain MRI, and lumbar
puncture. Withhold OPDIVO in patients with new-onset moderate to
severe neurologic signs or symptoms and evaluate to rule out other
causes. If other etiologies are ruled out, administer
corticosteroids and permanently discontinue OPDIVO for
immune-mediated encephalitis. Encephalitis occurred in one patient
receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg (0.2%) after
approximately 4 months of exposure.
Other Immune-Mediated Adverse Reactions
Based on the severity of the adverse reaction, permanently
discontinue or withhold OPDIVO, administer high-dose
corticosteroids, and, if appropriate, initiate hormone-replacement
therapy. Across clinical trials of OPDIVO monotherapy or in
combination with YERVOY, the following clinically significant
immune-mediated adverse reactions, some with fatal outcome,
occurred in <1.0% of patients receiving OPDIVO: myocarditis,
rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and
abducens nerve paresis, demyelination, polymyalgia rheumatica,
autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism,
systemic inflammatory response syndrome, gastritis, duodenitis,
sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi
lymphadenitis), motor dysfunction, vasculitis, aplastic anemia,
pericarditis, and myasthenic syndrome.
If uveitis occurs in combination with other immune-mediated
adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome,
which has been observed in patients receiving OPDIVO and may
require treatment with systemic steroids to reduce the risk of
permanent vision loss.
Infusion Reactions
OPDIVO can cause severe infusion reactions, which have been
reported in <1.0% of patients in clinical trials. Discontinue
OPDIVO in patients with Grade 3 or 4 infusion reactions.
Interrupt or slow the rate of infusion in patients with
Grade 1 or 2. In a separate study in which patients received
OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion,
infusion-related reactions occurred in 2.2% (8/368) and 2.7%
(10/369) of patients, respectively. Additionally, 0.5% (2/368) and
1.4% (5/369) of patients, respectively, experienced adverse
reactions within 48 hours of infusion that led to dose delay,
permanent discontinuation or withholding of OPDIVO. In patients
receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related
reactions occurred in 5.1% (28/547) of patients.
Embryo-Fetal Toxicity
Based on their mechanisms of action, OPDIVO and YERVOY 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 an OPDIVO- or YERVOY- containing regimen and for at
least 5 months after the last dose of OPDIVO.
Lactation
It is not known whether OPDIVO or YERVOY is present in human
milk. Because many drugs, including antibodies, are excreted in
human milk and because of the potential for serious adverse
reactions in nursing infants from an OPDIVO-containing regimen,
advise women to discontinue breastfeeding during treatment. Advise
women to discontinue breastfeeding during treatment with YERVOY and
for 3 months following the final dose.
Serious Adverse Reactions
In Checkmate 214, serious adverse reactions occurred in 59% of
patients receiving OPDIVO plus YERVOY and in 43% of patients
receiving sunitinib. The most frequent serious adverse reactions
reported in at least 2% of patients were diarrhea, pyrexia,
pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea,
adrenal insufficiency, and colitis; in patients treated with
sunitinib, they were pneumonia, pleural effusion, and dyspnea.
Common Adverse Reactions
In Checkmate 214, the most common adverse reactions reported in
at least 20% of patients treated with OPDIVO plus YERVOY (n=547) vs
sunitinib (n=535) were fatigue (58% vs 69%), rash (39% vs 25%),
diarrhea (38% vs 58%), musculoskeletal pain (37% vs 40%), pruritus
(33% vs 11%), nausea (30% vs 43%), cough (28% vs 25%), pyrexia (25%
vs 17%), arthralgia (23% vs 16%), and decreased appetite (21% vs
29%).
Please see U.S. Full Prescribing Information for OPDIVO and
YERVOY, including Boxed WARNING regarding immune-mediated
adverse reactions for YERVOY.
Bristol-Myers Squibb &
Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of
everything we do. Our vision for the future of cancer care is
focused on researching and developing transformational
Immuno-Oncology (I-O) medicines for hard-to-treat cancers that
could potentially improve outcomes for these patients.
We are advancing the scientific understanding of I-O through our
extensive portfolio of investigational compounds and approved
agents. Our differentiated clinical development program is studying
broad patient populations across more than 50 types of cancers with
24 clinical-stage molecules designed to target different immune
system pathways. Our deep expertise and innovative clinical trial
designs position us to advance I-O/I-O, I-O/chemotherapy,
I-O/targeted therapies and I-O/radiation therapies across multiple
tumors and potentially deliver the next wave of therapies with a
sense of urgency. Through our leading translational capabilities,
we are pioneering immune biology research and identifying a number
of potentially predictive biomarkers, including PD-L1, TMB,
MSI-H/dMMR and LAG-3, advancing the possibility of precision
medicine for more patients with cancer.
We understand making the promise of I-O a reality for the many
patients who may benefit from these therapies requires not only
innovation on our part but also close collaboration with leading
experts in the field. Our partnerships with academia, government,
advocacy and biotech companies support our collective goal of
providing new treatment options to advance the standards of
clinical practice.
About Bristol-Myers Squibb’s Patient
Access Support
Bristol-Myers Squibb remains committed to providing assistance
so that cancer patients who need our medicines can access them and
expedite time to therapy.
BMS Access Support®, the Bristol-Myers Squibb patient access and
reimbursement program, is designed to help appropriate patients
initiate and maintain access to BMS medicines during their
treatment journey. BMS Access Support offers benefit investigation,
prior authorization assistance and co-pay assistance for eligible,
commercially insured patients. More information about our access
and reimbursement support can be obtained by calling BMS Access
Support® at 1-800-861-0048 or by visiting
www.bmsaccesssupport.com.
About the Bristol-Myers Squibb and Ono
Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono
Pharmaceutical Co., Bristol-Myers Squibb expanded its territorial
rights to develop and commercialize Opdivo globally
except in Japan, South Korea and Taiwan, where Ono had retained all
rights to the compound at the time. On July 23, 2014, Ono and
Bristol-Myers Squibb further expanded the companies’ strategic
collaboration agreement to jointly develop and commercialize
multiple immunotherapies – as single agents and combination
regimens – for patients with cancer in Japan, South Korea and
Taiwan.
About Bristol-Myers
Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking
Statement
This press release contains “forward-looking statements” as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that
affect Bristol-Myers Squibb’s business, particularly those
identified in the cautionary factors discussion in Bristol-Myers
Squibb’s Annual Report on Form 10-K for the year ended December 31,
2017 in our Quarterly Reports on Form 10-Q and our Current Reports
on Form 8-K. Bristol-Myers Squibb undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise.
References
1. Opdivo Prescribing Information. Opdivo U.S. Product
Information. Last updated: April 2018. Princeton, NJ: Bristol-Myers
Squibb Company.2. Yervoy Prescribing Information. Yervoy U.S.
Product Information. Last updated: April 2018. Princeton, NJ:
Bristol-Myers Squibb Company.3. Motzer R, Tannir N, McDermott D, et
al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced
Renal-Cell Carcinoma. N Engl J Med. 2018;378(14):1277-1290.4. Data
on file. NIVO 136. Princeton, NJ: Bristol-Myers Squibb.5. Ko JJ,
Xie W, Kroeger N, et al. The International Metastatic Renal Cell
Carcinoma Database Consortium model as a prognostic tool in
patients with metastatic renal cell carcinoma previously treated
with first-line targeted therapy: a population-based study. Lancet
Oncol. 2015;16(3):293-300.6. Heng DYC, Xie W, Regan M, et al.
External validation and comparison with other models of the
International Metastatic Renal-Cell Carcinoma Database Consortium
prognostic model: a population-based study. Lancet Oncol.
2013;14(2):141-148.7. American Cancer Society. Survival Rates for
Kidney Cancer by Stage.
https://www.cancer.org/cancer/kidney-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed March 27, 2018.8. Sun M, Thuret R, Abdollah F, et al.
Age-adjusted incidence, mortality, and survival rates of stage
specific renal cell carcinoma in North America: a trend analysis.
Eur Urol. 2011;59(1):135-141.9. Surveillance, Epidemiology, and End
Results Program. Kidney and Renal Pelvis Cancer SEER Survival Rates
by Time Since Diagnosis, 2003-2013 By Stage at Diagnosis. National
Cancer Institute.
https://seer.cancer.gov/explorer/application.php?site=72&data_type=4&graph_type=6&compareBy=stage&chk_sex_1=1&chk_sex_3=3&chk_sex_2=2&chk_race_1=1&chk_age_range_1=1&chk_stage_101=101&chk_stage_106=106&advopt_precision=1&showDataFor=sex_1_and_race_1_and_age_range_1.
Published April 14, 2016. Updated December 1, 2018. Accessed March
27, 2018.10. Escudier B, Tannir N, McDermott D, et al. CheckMate
214: efficacy and safety of nivolumab plus ipilimumab vs sunitinib
for treatment-naïve advanced or metastatic renal cell carcinoma,
including IMDC risk and PD-L1 expression subgroups. Presentation
at: European Society of Medical Oncology Annual Meeting; September,
2017; Madrid, Spain.11. Motzer R, Tannir N, McDermott D, et al.
Nivolumab + ipilimumab (N+I) vs sunitinib (S) for treatment‐naïve
advanced or metastatic renal cell carcinoma (aRCC): results from
CheckMate 214, including overall survival by subgroups.
Presentation: Society for Immunotherapy of Cancer Annual Meeting;
November, 2017; National Harbor, Maryland.12. American Cancer
Society. Key Statistics About Kidney Cancer.
https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html.
Accessed January 12, 2018.13. Cancer.net. Kidney Cancer:
Introduction.
https://www.cancer.net/cancer-types/kidney-cancer/introduction.
Published August 2017. Accessed March 27, 2018.14. Mehdi A,
Riazalhosseini Y. Epigenome aberrations: Emerging Driving Factors
of the Clear Cell Renal Cell Carcinoma. Int J Mol Sci. 2017 Aug
16;18(8)1774.15. Terris M, Klaassen Z, Kabaria R. Renal Cell
Carcinoma: Links and Risks. Int J Nephrol Renovasc Dis. 2016
;9:45-52.
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Bristol-Myers Squibb CompanyMedia Inquiries:Laurel
Sacks, 609-302-5456laurel.sacks@bms.comorInvestors:Tim
Power, 609-252-7509timothy.power@bms.comorBill Szablewski,
609-252-5894william.szablewski@bms.com
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