ONO PHARMACEUTICAL CO., LTD. (PRINCETON, NJ, January 23, 2016) - Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival (PFS). FDA also expands use of Opdivo as single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients, based on accelerated approval
In USA, Opdivo was approved under accelerated approval for the treatment of unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor in December 2014 and approved for the treatment of metastatic squamous NSCLC with progression on or after platinum-based chemotherapy in March 2015. Opdivo in combination with Yervoy for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma received the approval in October 2015. Also, Opdivo received expanded FDA approval in previously- treated metastatic non-small cell lung cancer in the same month. Furthermore, Opdivo was approved for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy, and for the treatment of patients with BRAF V600 wild-type (WT) unresectable or metastatic melanoma as a single agent in November 2015. In EU, Opdivo was approved for the treatment of advanced (unresectable or metastatic) melanoma in adults regardless of BRAF status in June 2015.
European Commission approved Nivolumab BMS for the treatment of locally advanced or metastatic squamous NSCLC after prior chemotherapy in July 2015.
Also, BMS has a robust clinical development program in a variety of tumor types overseas, including: Head and Neck Cancer, Blood Cancer, Glioblastoma, Colorectal Cancer, Pancreatic Cancer, Gastric Cancer, Hepatocellular Carcinoma, Triple-Negative Breast Cancer, Small-Cell Lung Cancer, Urothelial Cancer, etc. In Japan, ONO launched it for the treatment of unresectable melanoma in September 2014. ONO was approved for the treatment of patients with unresectable, advanced or recurrent NSCLC in December 2015. Also, ONO is conducting clinical development programs including RCC, NSCLC, Head and Neck Cancer, Gastric Cancer, Esophageal Cancer, Hepatocellular Carcinoma, Hodgkin Lymphoma, Urothelial Cancer, Glioblastoma, Ovarian Cancer, etc.
Attached from the following page is the press release made by BMS for your information.
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Opdivo + Yervoy Regimen now indicated for unresectable or metastatic melanoma patients, regardless of BRAF mutational status, based on accelerated approval1
Demonstrated significantly superior progression-free survival vs. Yervoy alone in CheckMate -067 with the first and only FDA-approved combination of immune checkpoint inhibitors1,2
FDA also expands use of Opdivo as single-agent to include previously untreated BRAF
mutation-positive advanced melanoma patients, based on accelerated approval1
With this seventh approval for Opdivo in just over a year, and the fourth for late-stage melanoma, more patients fighting cancer now have access to Immuno-Oncology treatment options1
(PRINCETON, NJ, January 23, 2016) - Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.1 This indication is approved under accelerated approval based on progression-free survival (PFS).1
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1 This approval expands the original indication for the Opdivo + Yervoy Regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial, in which PFS and overall survival (OS) were co-primary endpoints.1,2
Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, encephalitis, other adverse reactions; infusion reactions; and embryofetal toxicity.1 Please see the Important Safety Information section below, including Boxed WARNING for Yervoy regarding immune-mediated adverse reactions.
"For nearly a decade, our researchers have worked tirelessly to find treatment options that could improve outcomes for patients with late-stage melanoma, a particularly aggressive cancer, and we are incredibly proud of today's approval to expand the use of the Opdivo + Yervoy Regimen to include patients with BRAF mutation-positive unresectable or metastatic melanoma. CheckMate -067 is the first Phase 3 study to observe the efficacy and safety of both Opdivo as a single-agent as well as in combination with Yervoy versus Yervoy alone," said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb. "To make this treatment option available to more patients is truly a milestone in the fight against this deadly disease."
The FDA also expanded the use of Opdivo as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients.1 The use of Opdivo as a single- agent in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma is approved under accelerated approval based on progression-free survival.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1 Opdivo was approved by the FDA in November 2015, for use in previously untreated patients with BRAF V600 wild-type unresectable or metastatic melanoma.1
"Patients with metastatic melanoma historically have a very challenging disease. Recent advances in our understanding of the immune response to cancer has yielded therapies which provide meaningful responses and hope. The combination of two Immuno-Oncology treatments, nivolumab and ipilimumab, has been shown to provide these patients with a much needed improvement in progression-free survival and response rates," said Jedd D. Wolchok, MD, PhD, Chief, Melanoma and Immunotherapeutics Service, Department of Medicine and Ludwig Center at Memorial Sloan Kettering Cancer Center. "This expanded approval for the nivolumab and ipilimumab regimen provides more advanced melanoma patients with an Immuno-Oncology combination treatment, and the potential for improved outcomes."
Expanded Approval Based on Efficacy Demonstrated in a Phase 3 Trial
CheckMate -067 is a Phase 3, double-blind, randomized study that evaluated the Opdivo
+ Yervoy Regimen or Opdivo monotherapy vs. Yervoy monotherapy in patients with previously untreated advanced melanoma.1, 2 The trial evaluated previously untreated patients, including both BRAF V600 mutant and wild-type advanced melanoma, and enrolled 945 patients who were randomized to receive the Opdivo + Yervoy Regimen (Opdivo 1 mg/kg plus Yervoy 3 mg/kg
every 3 weeks for 4 doses followed by Opdivo 3 mg/kg every 2 weeks thereafter; n=314), Opdivo monotherapy (Opdivo 3 mg/kg every 2 weeks; n=316) or Yervoy monotherapy (Yervoy 3 mg/kg every 3 weeks for 4 doses followed by placebo every 2 weeks; n=315).1 Patients were
treated until progression or unacceptable toxic effects.1 The median duration of exposure was 2.8
months (range: 1 day to 18.8 months) for patients in the Opdivo + Yervoy Regimen arm with a median of four doses (range: 1 to 39 for Opdivo; 1 to 4 for Yervoy), and 6.6 months (range: 1 day to 17.3 months) duration for the Opdivo monotherapy arm with a median of 15 doses (range: 1 to 38).1,2 The co-primary endpoints were PFS and OS; the study is ongoing and patients continue to
be followed for OS.2
Results from the trial demonstrated a statistically significant improvement in PFS in patients with advanced melanoma treated with the Opdivo + Yervoy Regimen (pOpdivo as a single-agent (pYervoy monotherapy.1 Median PFS was 11.5 months (95% CI: 8.9-16.7) for the Opdivo + Yervoy Regimen and 6.9 months (95% CI: 4.3-9.5) for Opdivo monotherapy, vs. 2.9 months (95% CI: 2.8-3.4) for Yervoy monotherapy.1 The Opdivo + Yervoy Regimen demonstrated a 58% reduction in the risk of disease progression
vs. Yervoy (HR: 0.42; 95% CI: 0.34-0.51; pOpdivo monotherapy demonstrated a 43% risk reduction vs. Yervoy monotherapy (HR: 0.57; 95% CI: 0.47-0.69; p1
In addition, the Opdivo + Yervoy Regimen and Opdivo monotherapy demonstrated higher confirmed objective response rates (ORR; 50% and 40%; p
vs. Yervoy monotherapy (14%).1 The percentage of patients with a complete response was 8.9%,
8.5% and 1.9%, favoring the Regimen and Opdivo monotherapy over Yervoy monotherapy.1 Partial responses were seen in 41% of patients treated with the Opdivo + Yervoy Regimen, 31% of patients treated with Opdivo monotherapy, and 12% of patients treated with Yervoy monotherapy. The Opdivo + Yervoy Regimen delivered durable responses, with three of four (76%) patients experiencing an ongoing response of at least six months (range: 1.2+ to 15.8+).1 Of patients in the Opdivo monotherapy and Yervoy monotherapy arms, 74% and 63% experienced an ongoing response of at least six months, respectively (ranges: 1.3+ to 14.6+; 1.0+ to 13.8+).1
"The melanoma community is excited to see the ongoing developments in research from the pharmaceutical industry, including Bristol-Myers Squibb, who made the first approved combination of two Immuno-Oncology treatments available to more patients fighting this
ONO Pharmaceutical Co. Ltd. issued this content on 28 January 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 28 January 2016 02:17:39 UTC
Original Document: http://www.ono.co.jp/eng/news/pdf/sm_cn160128.pdf
