U.S. Food and Drug Administration expands approval of Yervoy® (ipilimumab) to include pediatric patients 12 years and older with unresectable or metastatic melanoma

Bristol-Myers SquibbBristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy ® (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Yervoy was evaluated in two trials of pediatric patients: a dose-finding study in 33 patients aged two to 21 years with relapsed or refractory solid tumors and an open-label, single-arm trial in 12 adolescents (ages ranging from 12 to 16 years) with previously treated or untreated, unresectable Stage 3 or 4 malignant melanoma. The overall safety profile of Yervoy in children and adolescents was consistent with the safety profile in adults, and similarities in disease between adult and pediatric patients 12 years and older allow for extrapolation of data. Based on a population pharmacokinetic analysis, exposure in adolescents 12 years and older is comparable to that in adults for the approved dose of 3 mg/kg, administered intravenously over 90 minutes every three weeks for a total of four doses.(1)

Yervoy is associated with a Boxed Warning and can result in severe to fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. Please see below for additional Important Safety Information, including Boxed Warning regarding immune-mediated adverse reactions.

"When my daughter was diagnosed with melanoma, our entire family was devastated," said Brenda Busby, mother to a 12-year-old patient and pediatric program coordinator, Melanoma Research Foundation. "As someone who has lived with the many challenges of pediatric cancer, I know how important it is for patients and their families who face metastatic melanoma to have access to new therapies."

"Metastatic melanoma is extremely rare in children and adolescents, which makes it particularly difficult to investigate in clinical trials. Though designing clinical trials in small pediatric populations can be challenging, this group of investigators committed to bringing a new therapy to those in need," said Lia Gore, MD, University of Colorado School of Medicine and Children’s Hospital of Colorado. "Ipilimumab's approval represents the culmination of a long effort and gives physicians the ability to expand immuno-oncology - one of the most exciting areas of medicine(2) - for the treatment of young adults with metastatic melanoma."

The U.S. FDA approval for Yervoy in patients 12 years and older with metastatic melanoma marks Bristol-Myers Squibb’s first pediatric indication for an immuno-oncology medicine. The expanded indication builds upon six years of experience with Yervoy, which has been used to treat more than 38,000 adult patients with metastatic melanoma since its first approval.(3)

"Despite significant advancements in oncology research for adults in recent years, treatment options continue to be limited for pediatric patients with metastatic melanoma," said Chris Boerner, PhD, president and head of U.S. commercial operations, Bristol-Myers Squibb. "At Bristol-Myers Squibb, we are committed to providing meaningful support to the pediatric oncology community. This latest approval of Yervoy exemplifies our ongoing effort to expand the availability of therapies for younger cancer patients."

As part of its commitment to children and adolescents with cancer, Bristol-Myers Squibb continues to explore pediatric applications for investigational oncology agents within its broad development program. In addition, Bristol-Myers Squibb supports organizations and initiatives focused on pediatric patients and their families.

About the Yervoy Studies in Pediatric Patients
Yervoy has been evaluated in a total of 45 pediatric patients across two clinical trials. The safety and effectiveness of Yervoy have been established in pediatric patients 12 years and older. The use of Yervoy in this age group is supported by evidence from adequate and well-controlled studies of Yervoy in adults and population pharmacokinetic data demonstrating that the exposure at a dose of 3 mg/kg in the pediatric and adult populations is comparable. In addition, the tumor biology and the course of advanced melanoma is sufficiently similar in adults and pediatric patients 12 years and older to allow extrapolation of data from adults to pediatric patients.

In a dose-finding trial, Yervoy was evaluated in 33 pediatric patients with relapsed or refractory solid tumors. Patients enrolled in the study ranged from two to 21 years of age, with a median age of 13 years, and 20 of the patients were 12 years of age or older. Yervoy was administered at doses of 1, 3, 5 and 10 mg/kg intravenously over 90 minutes every three weeks for four doses and then every 12 weeks thereafter until progression or treatment discontinuation.(1)

Yervoy was also evaluated in an open-label, single-arm trial in 12 pediatric patients 12 years and older with previously treated or untreated, unresectable Stage 3 or 4 malignant melanoma. Patients received Yervoy 3 mg/kg (four patients) or 10 mg/kg (eight patients) intravenously over 90 minutes every three weeks for four doses.(1)

Of the 17 patients 12 years of age and older with melanoma treated with Yervoy across both studies, two patients experienced objective responses, including one partial response that was sustained for 16 months.(1)

The approved dose for Yervoy in pediatric patients with unresectable or metastatic melanoma is 3 mg/kg, administered intravenously over 90 minutes every three weeks for a total of four doses.

About the Population Pharmacokinetic Analysis
Based on a population pharmacokinetic analysis using available pooled data from 565 patients from four phase 2 adult studies (N=521) and two pediatric studies (N=44), body weight normalized clearance of Yervoy is comparable between adult and pediatric subjects.

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

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 the 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 a patient’s 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 Yervoy
Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

About Bristol-Myers Squibb’s Patient Access Support
Bristol-Myers Squibb remains committed to providing a comprehensive set of programs and services so that cancer patients who need our medicines can access them and expedite time to therapy.

BMS Access Support®, the Bristol-Myers Squibb Patient Access and Reimbursement Services program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance and co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support services can be obtained by calling BMS Access Support® at 1-800-861-0048 or by visiting www.bmsaccesssupport.com.

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.

1. Yervoy Prescribing Information. Yervoy U.S. Product Information. Last updated: July 2017. Princeton, NJ: Bristol-Myers Squibb Company.
2 Eggermont AM. Can immuno-oncology offer a truly pan-tumour approach to therapy? Ann Oncol. 2012 Sep; 23 Suppl 8:viii53-7.
3. IMS APLD data. April 2011-April 2017.

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