PRINCETON, NJ, USA I November 12, 2016 I Bristol-Myers Squibb Company (NYSE:BMY) announced today additional results from the Phase 1/2 open-label CheckMate-032 trial investigating two combination schedules of Opdivo (nivolumab) plus Yervoy (ipilimumab) in patients with locally advanced or metastatic urothelial carcinoma (mUC) previously treated with platinum-based therapy. In these preliminary data, the primary endpoint of investigator-assessed confirmed objective response rate (ORR) was 38.5% (95% CI: 20.2 – 59.4) in patients who received Opdivo 1 mg/kg plus Yervoy 3 mg/kg (n=26) compared to 26.0% (95% CI: 17.9 – 35.5) in patients treated with Opdivo 3 mg/kg plus Yervoy 1 mg/kg (n=104). No new safety signals have been identified. The incidence of Grade 3-4 treatment-related adverse events (AEs) was 30.8% in the Opdivo 1 mg/kg plus Yervoy 3 mg/kg group and 31.7% in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg group. Treatment-related AEs led to discontinuation of therapy in 7.7% of patients in the Opdivo 1 mg/kg plus Yervoy 3 mg/kg group and 13.5% in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg group.
These data were presented at the 31st Annual Meeting and Associated Programs of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Md., during the Oral Late-breaking Abstract Session II today from 11:30 – 11:45 a.m. EST.
“Metastatic urothelial carcinoma is an area of significant unmet medical need, especially for patients in the advanced stages of the disease who have progressed on standard chemotherapy,” said Padmanee Sharma, M.D., Ph.D., study investigator and professor at The University of Texas MD Anderson Cancer Center. “Earlier this year, we presented encouraging results from this trial for Opdivo monotherapy, and now we are seeing the promise of a combination regimen with Opdivo and Yervoy for previously treated patients with this common type of advanced bladder cancer. These findings support the need for further study of combination therapy to assess outcomes and potential survival in patients with metastatic urothelial carcinoma.”
Urothelial carcinoma is the most common type of bladder cancer, accounting for approximately 90% of bladder cancer cases. Bladder cancer is the ninth most commonly diagnosed cancer in the world, with an estimated 430,000 new cases diagnosed per year and more than 165,000 deaths annually. The majority of bladder cancers are diagnosed at an early stage, but rates of recurrence and disease progression are high, and approximately 78% of patients will experience a recurrence within five years. Survival rates vary depending on the stage and type of the cancer and when it is diagnosed. For Stage IV bladder cancer, the five-year survival rate is 15%.
“These results from the CheckMate -032 study support further development of the Opdivo plus Yervoy regimen for treatment of metastatic urothelial carcinoma in platinum refractory patients,” commented Vicki Goodman, M.D., development lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb. “The findings also bolster our belief that combining our Immuno-Oncology agents, Opdivo and Yervoy, can potentially advance cancer care.”
About CheckMate -032
CheckMate -032 is an ongoing Phase 1/2 open-label trial evaluating the safety and efficacy of Opdivo monotherapy, or Opdivo combined with Yervoy, in advanced or metastatic solid tumors. The trial enrolled patients regardless of PD-L1 expression. The primary endpoint is investigator-assessed confirmed objective response rate (ORR), confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary endpoints include safety, duration of response (DOR), overall survival (OS) and progression-free survival (PFS).
Data presented at SITC is specific to a cohort of 208 patients with metastatic or locally advanced urothelial cancer (mUC) who have received one or more prior lines of platinum-based therapy. In the arms evaluating combination therapy, patients were treated with either one of two combination schedules – Opdivo 1 mg/kg plus Yervoy 3 mg/kg (n=26) or Opdivo 3 mg/kg plus Yervoy 1 mg/kg (n=104) every three weeks for four cycles, followed by Opdivo 3 mg/kg every two weeks. All patients were treated until disease progression or unacceptable toxicity. Patients were followed for a median of 7.8 months in the Opdivo 1 mg/kg plus Yervoy 3 mg/kg group (n = 26) and 16.7 months in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg group (n = 104).
For the primary endpoint, the highest ORR was observed in the Opdivo 1 mg/kg plus Yervoy 3 mg/kg group: 38.5% (95% CI: 20.2 – 59.4). The ORR was 26.0% (95% CI: 17.9 – 35.5) in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg group.
The incidence of Grade 3-4 treatment-related adverse events (AEs) was 30.8% in the Opdivo 1 mg/kg plus Yervoy 3 mg/kg group and 31.7% in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg group. Treatment-related AEs led to discontinuation of therapy in 7.7% of patients in the Opdivo 1 mg/kg plus Yervoy 3 mg/kg group and 13.5% in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg group. One death was reported in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg group due to pneumonitis.
Bristol-Myers Squibb: At the Forefront of Immuno-Oncology Science & Innovation
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 that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer.
We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents, including the first combination of two I-O agents in metastatic melanoma, and our differentiated clinical development program, which is studying broad patient populations across more than 20 types of cancers with 11 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens 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 inform which patients will benefit most from I-O therapies.
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 57 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 47 countries, including the United States and the European Union.
INDICATIONS
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 patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. 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.
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
