Opdivo is the first anti-PD-1 agent to show a three-year survival benefit in advanced RCC, reducing the risk of death by 26% versus everolimus in the phase 3 CheckMate -025 study

PRINCETON, NJ, USA I November 6, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) announced today a three-year overall survival (OS) update from its phase 3 CheckMate -025 study, evaluating patients treated with Opdivo (nivolumab) versus everolimus in previously treated advanced renal cell carcinoma (RCC). These data are the first of any anti-PD-1 agent to demonstrate durable survival at three years in previously treated RCC. No new safety signals were identified and the data showed a safety profile consistent with two-year results. Findings from CheckMate -025 were presented on November 4 during the 16th International Kidney Cancer Symposium (KCS) in Miami, Florida.

The median OS, the primary endpoint in this study, for Opdivo was 25.8 months compared to 19.7 months with everolimus (HR 0.74; 95.45% CI: 0.63 to 0.88; p: 0.0005). The three-year OS rate was 39% for Opdivo and 30% for everolimus. The safety profile of Opdivo was consistent with that of previous reports.

“The updated results of CheckMate -025 reinforce the overall survival benefit and safety profile of Opdivo and provide further support for this therapeutic option as a standard of care for patients with previously treated advanced renal cell carcinoma,” said Padmanee Sharma, M.D., PhD., scientific director, Immunotherapy Platform, MD Anderson Cancer Center.

At 36 months, Opdivo demonstrated an objective response rate (ORR), a secondary endpoint, of 26% compared to 5% with everolimus (95% CI: 3.82 to 10.06), and the median durations of response for Opdivo and everolimus were 12.3 (95% CI: 9.1 to 18.2) and 12 months (95% CI: 6.4 to 21.7), respectively. Median progression-free survival (PFS), another secondary endpoint, was 4.2 months for Opdivo and 4.5 months for everolimus (HR 0.85; 95% CI: 0.73 to 0.99; p: 0.0371).

“The CheckMate -025 data reinforce Opdivo as the standard of care in previously treated renal cell carcinoma, with the three-year data demonstrating a continued survival benefit with a greater than six-month improvement over everolimus,” said Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “Building on the unprecedented two-year overall survival data from this trial, these are the first three-year overall survival for an anti-PD-1 agent in advanced RCC, showcasing our ongoing commitment to improving survival rates for people living with the most common type of kidney cancer in adults worldwide.”

About CheckMate -025

CheckMate -025 is an open-label, randomized phase 3 study of Opdivo versus everolimus in patients with previously treated advanced renal cell carcinoma (RCC) after prior anti-angiogenic therapy. Patients (N=803) received either Opdivo (N=406) 3 mg/kg intravenously (IV) every two weeks or everolimus (N=397) 10 mg orally once daily until disease progression or unacceptable toxicity. The primary endpoint of the study was overall survival (OS). Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), quality of life (QoL) and safety. Patient-reported QoL was measured using the kidney-specific, Functional Assessment of Cancer Therapy–Kidney Symptom Index–Disease Related Symptoms (FKSI-DRS) scale, and European Quality of Life (EuroQol)-5 Dimensions (EQ-5D) questionnaire.

With a minimum of three years of follow-up, the incidence and type of treatment-related adverse events (AEs) were consistent with the primary analysis. Treatment-related grade 3/4 AEs were experienced by 21% of patients in the Opdivo group and 37% in the everolimus group. Treatment-related grade AEs leading to discontinuation were experienced by 8% of patients in the Opdivo group and 13% in the everolimus group. The most common grade 3/4 AEs in the Opdivo arm were hepatic (3%) and GI (2%). In the everolimus arm, the most common grade 3/4 AEs were pulmonary (3%), GI (2%), and skin (1%). There were no treatment-related deaths reported in the Opdivo group and two treatment-related deaths reported in the everolimus arm at three years.

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 100,000 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 & 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 leading 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 14 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. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how patients’ tumor biology can be used as a guide for treatment decisions throughout their journey.

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 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 60 countries, including the United States, the European Union and Japan. 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 advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

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) 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) 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.

Checkmate Trials and Patient Populations

Checkmate 067 – advanced melanoma alone or in combination with YERVOY; Checkmate 037 and 066 – advanced melanoma; Checkmate 017 – squamous non-small cell lung cancer (NSCLC); Checkmate 057 – non-squamous NSCLC; Checkmate 025 – renal cell carcinoma; Checkmate 205/039 – classical Hodgkin lymphoma; Checkmate 141 – squamous cell carcinoma of the head and neck; Checkmate 275 – urothelial carcinoma; Checkmate 040 – hepatocellular carcinoma.

About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), 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, Bristol-Myers Squibb and Ono 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