PRINCETON -
Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients. These data will be presented in an oral presentation (Abstract #363) during the
Among intermediate- and poor-risk patients (n=847), Opdivo plus Yervoy (n=425) maintained efficacy after eight years (99.1 months median), with improvements seen in overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and duration of response (DOR) over sunitinib: OS: Median OS was 46.7 months for intermediate- and poor-risk patients treated with Opdivo plus Yervoy vs. 26.0 months with sunitinib (Hazard Ratio [HR] 0.69; 95% Confidence Interval [CI]: 0.59 to 0.81). The 90-month landmark OS rates were 32.9% vs. 22.0%, respectively.
DOR: Median DOR was 82.8 months for patients treated with Opdivo plus Yervoy compared to 19.8 months with sunitinib.
PFS: Median PFS by independent radiology review committee (IRRC) was 12.4 months with Opdivo plus Yervoy vs. 8.5 months with sunitinib (HR 0.73; 95% CI: 0.61 to 0.87), tripling the 90-month landmark PFS rate at 25.4% vs. 8.5%, respectively.
ORR: ORR benefits were maintained with Opdivo plus Yervoy compared to sunitinib (42% vs. 27%). In addition, four times more patients treated with the combination achieved complete responses (CR) than with sunitinib (12% vs. 3%).
Additionally, in the intent-to-treat (ITT) population (n=1,096), Opdivo plus Yervoy (n=550) demonstrated long-term benefits across endpoints
OS: Among all randomized patients treated with Opdivo plus Yervoy, median OS was 52.7 months vs. 37.8 months with sunitinib (HR 0.72; 95% CI: 0.62 to 0.83).
DOR: For patients treated with Opdivo plus Yervoy, median DOR was 76.2 months compared to 25.1 months with sunitinib.
PFS: Median PFS by
ORR: ORR was better with Opdivo plus Yervoy compared to sunitinib (39% vs. 33%), and four times more patients treated with the combination achieved CR (12% vs. 3%).
'It is incredible to see that after eight years in the CheckMate -214 trial, which represents the longest reported follow up of any Phase 3 trial of a checkpoint inhibitor combination therapy in advanced renal cell carcinoma, the combination of nivolumab and ipilimumab continues to provide superior survival and durable responses for these patients,' said
The safety profile of Opdivo plus Yervoy was manageable using established treatment algorithms, and no new safety signals emerged with extended follow-up.
'The updated data from CheckMate -214 with Opdivo plus Yervoy in advanced or metastatic renal cell carcinoma to be presented at ASCO GU speak to our long-standing leadership with immunotherapy not only in genitourinary cancers, but across multiple tumor types. These extended results further exemplify to the scientific community the potential that we have long recognized for immunotherapy to transform treatment paradigms in oncology,' said
About CheckMate -214
CheckMate -214 is a Phase 3, randomized, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). Patients in the combination group (n=550) 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. Patients in the comparator group (n=546) received sunitinib 50 mg once daily for four weeks, followed by two weeks off before continuation of treatment. Patients were treated until progression or unacceptable toxic effects for up to two years. The primary endpoints of the trial are overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) in an intermediate- to poor-risk patient population (approximately 75% of patients). ORR was assessed by independent radiology review committee (IRRC).
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 431,000 new cases and 179,000 deaths worldwide each year. RCC is approximately twice as common in men as in women, with the highest rates of the disease in
Cancer can have a relentless grasp on many parts of a patient's life, and
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
About Yervoy
Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On
About the
In 2011, through a collaboration agreement with
About
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 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 future study results may not be consistent with the results to date, that Opdivo (nivolumab) plus Yervoy (ipilimumab) for the indication described in this release will be commercially successful, that any marketing approvals, if granted, may have significant limitations on their use, and, that continued approval of such combination treatment for such indication described in this release may be contingent upon verification and description of clinical benefit in additional confirmatory trials. 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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