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FDF

Date: 04-May-2021

US FDA Accepts For Priority Review Bristol Myers SBLA For Opdivo As Adjuvant Treatment For Patients With Muscle-invasive Urothelial Carcinoma

Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma, based on results from the CheckMate -274 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 3, 2021.

“After patients undergo surgery for muscle-invasive urothelial carcinoma, they continue to face uncertainties given the high rate of disease recurrence and the lack of safe and effective treatment options,” said Dana Walker, M.D., M.S.C.E., vice president, development programme lead, genitourinary cancers, Bristol Myers Squibb. “Based on the ground-breaking disease-free survival results from CheckMate -274, we believe Opdivo has the potential to change the future of treatment for muscle-invasive urothelial carcinoma. We look forward to working with the FDA towards the goal of bringing the first adjuvant immunotherapy option to these patients in the US.”

The filing was based on results from the pivotal CheckMate -274 trial, the first positive phase 3 trial of an immunotherapy in this setting. In the trial, Opdivo demonstrated a statistically significant and clinically meaningful increase in disease-free survival (DFS) vs. placebo, regardless of patients’ PD-L1 expression levels. Opdivo was generally well tolerated, with a safety profile that was consistent with previously reported Opdivo studies in patients with solid tumors. Results from the primary analysis of CheckMate -274 were presented in an oral presentation during the American Society of Clinical Oncology Genitourinary Cancers Symposium in February 2021. CheckMate -274 is one of four positive phase 3 trials for Opdivo-based treatments in earlier stages of cancers, including muscle-invasive urothelial carcinoma (CheckMate -274), melanoma (CheckMate -238), esophageal/gastroesophageal junction cancer (CheckMate -577) and non-small cell lung cancer (CheckMate -816).

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -274 clinical trial.

CheckMate -274 is a phase 3 randomized, double-blind, multi-center study evaluating Opdivo compared to placebo in patients with muscle-invasive urothelial cancer at a high risk of recurrence after radical surgery. A total of 709 patients were randomized 1:1 to receive Opdivo 240 mg or placebo every two weeks for up to one year. The primary endpoints of the trial are DFS in all randomized patients (i.e., the intention-to-treat population) and in the subset of patients whose tumors express PD-L1 =1%. Key secondary endpoints include overall survival, non-urothelial tract recurrence free survival and disease-specific survival.

Urothelial carcinoma, which most frequently begins in the cells that line the inside of the bladder, is the 10th most common cancer in the world, with approximately 550,000 new cases diagnosed annually. In addition to the bladder, urothelial carcinoma can occur in other parts of the urinary tract, including the ureters and renal pelvis. The majority of urothelial carcinomas are diagnosed at an early stage, but rates of recurrence and disease progression are high. More than 50% of patients who undergo radical resection for muscle-invasive urothelial carcinoma will experience disease recurrence. For patients whose disease recurs as metastatic cancer, the prognosis is poor, even with systemic treatment.

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 programme 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 treated more than 35,000 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