Opdivo Plus Yervoy Combination Delivered Overall Survival Benefit Across PD-L1 Expression Levels in Intermediate- and Poor-Risk Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Results also show that patients reported significantly better kidney cancer symptom control in the Opdivo (nivolumab) plus Yervoy (ipilimumab) arm compared to the sunitinib arm

PRINCETON, NJ, USA I November 7, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) announced today results from a new exploratory analysis of the phase 3 CheckMate -214 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus the standard of care, sunitinib, in intermediate- and poor-risk patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). In an exploratory analysis of PD-L1 expression subgroups, an overall survival (OS) advantage was seen with the Opdivo plus Yervoy combination over sunitinib in both the PD-L1 expression level <1% [HR= 0.73, (CI: 95% 0.56 to 0.96)] and ≥1% subgroups [HR= 0.45 (CI: 95% 0.29 to 0.71)]. The median overall survival (OS) was not reached for the Opdivo plus Yervoy combination or sunitinib for those with PD-L1 levels < 1%, and for patients with PD-L1 expression levels ≥1%, the median OS was not reached for the combination and was 19.6 months for sunitinib. The safety profile of Opdivo plus Yervoy was consistent with that of previous reports.

These data will be presented on November 10 at the Society for Immunotherapy of Cancer’s (SITC) 32nd Annual Meeting in National Harbor, MD, during the High Impact Clinical Trial Results Session from 3:50 to 4:05 PM EST (Abstract #O38). Previously, the Company announced the phase 3 trial stopped early, at the Data Monitoring Committee’s recommendation, for statistically significant superiority in OS with Opdivo plus Yervoy versus sunitinib. Results of CheckMate -214, including the primary endpoints of OS, objective response rate (ORR) and progression-free survival (PFS) in intermediate- and poor-risk patients, were presented earlier this year at the European Society for Medical Oncology (ESMO) 2017 Congress on September 10 in Madrid, Spain.

“After seeing overall survival data from CheckMate -214 two months ago, the scientific community has been eager to understand the role of subgroups in these results,” said Robert J. Motzer, M.D., Jack and Dorothy Byrne Chair in Clinical Oncology, Memorial Sloan Kettering Cancer Center. “We’re pleased to show that in CheckMate -214, patients with first-line advanced renal cell carcinoma saw an overall survival benefit across PD-L1 expression levels. The PD-L1 analysis results, quality of life data and safety profile advance our understanding of the combination’s potential to address a high unmet need for intermediate- and poor-risk patients with advanced disease.”

Findings from an exploratory endpoint showed patients reported statistically significantly better kidney cancer symptom control with the Opdivo plus Yervoy combination compared to sunitinib, when assessed using a valid tumor-specific patient-reported kidney cancer scale in the FKSI-19. Through the first six months of data, when completion rates exceeded 80%, a 3-6 point difference was observed, which is considered clinically meaningful.

“As a leader in Immuno-Oncology, we are committed to improving overall survival and are encouraged by these results in patients with advanced renal cell carcinoma, whose treatment options remain limited,” said Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “We continue to evaluate the potential of Opdivo plus Yervoy in this population and look forward to discussing these results with regulatory authorities.”

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. Patients in the combination group received Opdivo 3 mg/kg plus Yervoy 1 mg/kg every 3 weeks for 4 doses followed by Opdivo 3 mg/kg every 2 weeks. Patients in the comparator group received sunitinib 50 mg once daily for 4 weeks, followed by 2 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), objective response rate (ORR), and progression-free survival (PFS) in an intermediate- to poor-risk patient population (approximately 75% of patients). Safety is a secondary endpoint.

Grade 3/4 adverse events (AEs) were reported in 46% of patients (252/547) in the combination group, compared with 63% of patients (337/535) in the sunitinib group. The most common grade 3/4 AEs in the combination group were fatigue (4%), diarrhea (4%), nausea (2%), decreased appetite (1%), and, in less than 1% each, pruritus, hypothyroidism and hypertension. In the sunitinib group, the most common grade 3/4 AEs were hypertension (16%), fatigue (9%), Palmar-plantar erythrodysaesthesia syndrome (9%), diarrhea (5%), stomatitis (3%), mucosal inflammation (3%), nausea (1%), decreased appetite (1%), and in less than 1% each, hypothyroidism and dysgeusia. Adverse events (AEs) leading to discontinuation were reported in 22% of patients (120/547) in the combination group, compared with 12% of patients in the sunitinib group (64/535). Seven treatment-related deaths occurred in the combination group and four in the sunitinib group.

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 adults 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

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