Opdivo (nivolumab) Plus Yervoy (ipilimumab) Shows Response in Pre-Treated Patients with Metastatic Castration-Resistant Prostate Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Feb 14, 2019– Bristol-Myers Squibb Company (NYSE: BMY) today announced data evaluating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) in patients with metastatic castration-resistant prostate cancer (mCRPC). Results from an interim analysis of the Phase 2 CheckMate -650 trial showed that among 32 asymptomatic or minimally symptomatic patients whose disease had progressed after second-generation hormone therapy and who had not received chemotherapy (cohort 1), with a median follow-up of 11.9 months, the objective response rate (ORR) was 25%. Additionally, among 30 patients whose disease progressed after taxane-based chemotherapy (cohort 2), with a median follow-up of 13.5 months, the ORR was 10%.

Across both cohorts, higher response rates were seen in certain patient sub-groups, including patients with high (above median) tumor mutational burden and patients with homologous recombination deficiency.

The overall safety profile was consistent with prior studies of Opdivo in combination with Yervoy with this dosing schedule. Grade three to five treatment-related adverse events occurred in 42% of patients in cohort 1 and 53% of patients in cohort 2.

“The results from CheckMate -650 provide strong rationale for the development of combination immune checkpoint therapy for the treatment of prostate cancer, which is considered a cold tumor with few tumor-infiltrating lymphocytes,” said Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology at The University of Texas MD Anderson Cancer Center. “The clinical results from this study are encouraging and provide the foundation to test the combination strategy in a larger cohort of patients.”

The data were featured today in an oral session (Abstract #142) at the American Society of Clinical Oncology 2019 Genitourinary Cancers Symposium in San Francisco.

“Assessing the effect of biomarkers on treatment outcomes is an important part of our ongoing multidisciplinary approach to research in translational medicine,” said Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “These interim results are exciting and reinforce our commitment to identifying the patient populations most likely to derive benefit from Immuno-Oncology-based regimens across tumor types and in hard-to-treat patient populations.”

About CheckMate -650

CheckMate -650 is an ongoing Phase 2 open-label trial, evaluating the safety and efficacy of Opdivo in combination with Yervoy in patients with metastatic castration-resistant prostate cancer (mCRPC). The trial includes two cohorts: asymptomatic or minimally symptomatic patients who progressed after second-generation hormone therapy and have not received chemotherapy for mCRPC; and patients who progressed after taxane-based chemotherapy. Patients received Opdivo 1 mg/kg plus Yervoy 3 mg/kg for four doses, followed by Opdivo 480 mg every four weeks. Co-primary endpoints include objective response rate (ORR) and radiographic progression-free survival (rPFS). Safety is a secondary endpoint. Exploratory endpoints include correlation of biomarkers with efficacy and prostate-specific antigen (PSA) response.

About Castration-Resistant Prostate Cancer

Prostate cancer is the second most frequently diagnosed cancer in men, with almost 1.28 million new cases diagnosed worldwide in 2018. Unlike many early-stage prostate cancers that need normal levels of testosterone to grow, castration-resistant prostate cancer (CRPC) continues to grow even when the amount of testosterone in the body is reduced to castrate levels. CRPC patients have a very high likelihood of having or developing metastases, meaning the cancer has spread to other areas of the body. While the five-year survival rate for most stages of prostate cancer is almost 100%, the five-year survival rate for prostate cancer that has spread to distant lymph nodes, bones or other organs is approximately 29%.

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 […]

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