Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Demonstrates Continued Survival Benefit at 30-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

PRINCETON, NJ, USA I February 11, 2019 I Bristol-Myers Squibb Company (NYSE: BMY) today announced new results from the Phase 3 CheckMate -214 study, showing that therapy with Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) continued to demonstrate long-term survival benefits in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).

With a minimum follow-up of 30 months, intermediate- and poor-risk patients randomized to Opdivo plus low-dose Yervoy continued to show a significant overall survival (OS) benefit compared to those randomized to sunitinib. Additionally, at 30 months, the objective response rate (ORR) per investigator for intermediate- and poor-risk patients with Opdivo plus low-dose Yervoy improved compared to the previous analysis at a minimum of 17.5 months.

  • OS: The 30-month OS rate for the intermediate- and poor-risk population was 60% for patients treated with Opdivo plus low-dose Yervoy versus 47% for patients treated with sunitinib [Hazard Ratio (HR) 0.66 (95% Confidence Interval [CI]: 0.54, 0.80); p<0.0001].
  • ORR: Opdivo plus low-dose Yervoy was associated with a 42% ORR versus 29% with sunitinib (p=0.0001). More than half (52%) of the intermediate- and poor-risk patients who responded to Opdivo plus low-dose Yervoy had a response lasting at least 18 months versus 28% of the patients who responded to sunitinib.
  • Complete Response (CR): The CR rate was 11% with Opdivo plus low-dose Yervoy versus 1% with sunitinib.

The results were similar for the intention-to-treat (ITT, i.e., all randomized) population with Opdivo plus low-dose Yervoy, demonstrating significantly improved:

  • OS: The 30-month OS rate for the ITT population was 64% for patients treated with Opdivo plus low-dose Yervoy versus 56% for patients treated with sunitinib [HR 0.71 (95% CI: 0.59, 0.86); p=0.0003].
  • ORR: The ORR was 41% with Opdivo plus low-dose Yervoy versus 34% for sunitinib (p=0.015).
  • CR: The CR rate was 11% with Opdivo plus low-dose Yervoy versus 2% with sunitinib.

The overall safety of the combination was consistent with that observed in the 17.5-month minimum follow-up analysis and with previously reported studies of these medicines in patients with RCC. No new safety signals or drug-related deaths occurred with extended follow-up.

“The results from this 30-month follow-up from the CheckMate -214 study are meaningful as they continue to demonstrate that in patients with advanced renal cell carcinoma, a population with considerable unmet treatment needs, there is potential for long-term survival benefits with the combination of nivolumab and ipilimumab,” said CheckMate -214 investigator Nizar M. Tannir, M.D., FACP, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.

The data will be featured in a rapid oral presentation (Abstract #547) on Saturday, February 16, 2019 at the American Society of Clinical Oncology 2019 Genitourinary Cancers Symposium in San Francisco.

“We are pleased that the results from CheckMate -214 continue to provide clinical evidence that combining Opdivo and Yervoy can extend survival for certain patients with advanced renal cell carcinoma,” said Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “These follow-up data reinforce our scientific approach and ongoing commitment to delivering treatment options that help patients living with this relentless disease live longer.”

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 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 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. 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).

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 140,000 deaths worldwide each year. Clear-cell RCC is the most prevalent type of RCC and constitutes 80% to 90% of all patients. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. Globally, the five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 12.1%.

Bristol-Myers Squibb: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. The focus of our research is to increase quality, long-term survival for patients and make cure a possibility. Through a unique multidisciplinary approach powered by translational science, we harness our deep scientific experience in oncology and Immuno-Oncology (I-O) research to identify novel treatments tailored to individual patient needs. Our researchers are developing a diverse, purposefully built pipeline designed to target different immune system pathways and address the complex and specific interactions between the tumor, its microenvironment and the immune system. We source innovation internally and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines, like I-O, a reality for patients.

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 enrolled more than 25,000 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.

U.S. FDA-APPROVED INDICATIONS FOR OPDIVO ®

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

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® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Checkmate Trials and Patient Populations

Checkmate 067–advanced melanoma alone or in combination with YERVOY® (ipilimumab); Checkmate 214–intermediate or poor risk advanced renal cell carcinoma in combination with YERVOY; Checkmate 142–MSI-H/dMMR metastatic colorectal cancer; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 040–hepatocellular carcinoma; Checkmate 037/066–advanced melanoma; Checkmate 017–squamous non-small cell lung cancer (NSCLC); Checkmate 057–non-squamous NSCLC; Checkmate 025–previously treated renal cell carcinoma; Checkmate 141–squamous cell carcinoma of the head and neck; Checkmate 275–urothelial carcinoma; Checkmate 238–adjuvant treatment of melanoma.

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.

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.

SOURCE: Bristol-Myers Squibb

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