ONO PHARMACEUTICAL CO., LTD. (PRINCETON, NJ, October 28, 2015) - Bristol-Myers Squibb Company (NYSE:BMY) announced that it received the Prix Galien USA 2015 Award for Best Biotechnology Product for Opdivo (nivolumab), the Company's PD-1 immune checkpoint inhibitor.
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. Also, 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. Opdivo received expanded FDA approval in previously-treated metastatic non-small cell lung cancer in the same month. 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: Renal Cell Carcinoma (RCC), 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. In Japan, ONO launched it for the treatment of unresectable melanoma in September 2014. Also, ONO is conducting clinical development programs including RCC, NSCLC, Head and Neck Cancer, Gastric Cancer, Esophageal Cancer, Hepatocellular Carcinoma, Hodgkin Lymphoma, Urothelial Cancer and Glioblastoma.
Attached from the following page is the press release made by BMS for your information.
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ONO PHARMACEUTICAL CO., LTD.
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Bristol-Myers Squibb team honored for its innovative approach to the scientific discovery and development of its PD-1 immune checkpoint inhibitor, Opdivo, in the treatment of advanced melanoma and squamous non-small cell lung cancer
Represents the second award from Prix Galien USA given to Bristol-Myers Squibb's Immuno-
Oncology portfolio; Yervoy (ipilimumab) received Best Biotechnology Product in 2012
(PRINCETON, NJ, October 28, 2015) - Bristol-Myers Squibb Company (NYSE:BMY) today announced that it received the Prix Galien USA 2015 Award for Best Biotechnology Product for Opdivo (nivolumab), the Company's PD-1 immune checkpoint inhibitor. Bristol-Myers Squibb was recognized for its innovative discovery and development of Opdivo in approved indications for previously treated metastatic squamous non-small cell lung cancer (NSCLC), and in unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor, for which it received accelerated approval based on tumor response rate and durability of response. Since the submission for the Best Biotechnology Award, Opdivo has also been approved by the U.S. Food and Drug Administration (FDA) in the combination of Opdivo + Yervoy, the first FDA- approved regimen of two Immuno-Oncology agents, in BRAF V600 wild-type unresectable or metastatic melanoma, as well as for the treatment of patients with metastatic non-squamous NSCLC with progression on or after platinum-based chemotherapy.
The announcement was made during the ninth annual Prix Galien USA Awards Ceremony held on October 27, 2015 in New York City. The Prix Galien USA Award, which is selected by a preeminent scientific committee that includes several Nobel Laureates, honors outstanding achievements in improving the human condition through the development of innovative therapies. This is the second honor received by Bristol-Myers Squibb in the Best Biotechnology Product category, making it the only company to receive this award for two Immuno-Oncology agents. In 2012, Yervoy received the award, following its initial approval for unresectable or metastatic melanoma. Building on this pioneering science, the Company continues to research the potential of Immuno-Oncology to extend survival in some of the hardest-to-treat cancers.
'We are pleased to be acknowledged for our Company's scientific contributions to this historic time in cancer research, when the science of Immuno-Oncology is helping to change expectations in cancer care,' said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer,
Bristol-Myers Squibb. 'Receiving the Prix Galien USA 2015 Award for Best Biotechnology Product underscores our efforts with the Opdivo early- and late-stage clinical program in patients with some of the hardest-to-treat cancers, like advanced melanoma and squamous non-small cell lung cancer.'
About Opdivo
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials - as monotherapy or in combination with other therapies - in which more than 8,000 patients have been enrolled worldwide.
Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in more than 37 countries including the United States, Japan, and in the European Union.
In the U.S., Opdivo is indicated for patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. Opdivo is also approved for use in combination with Yervoy, for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. These indications are approved under accelerated approval based on tumor response rate and durability of response. Continued approval for
these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. Opdivo is also indicated in the U.S. 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.
IMPORTANT SAFETY INFORMATION
Immune-mediated pneumonitis or interstitial lung disease, including fatal cases, occurred with OPDIVO treatment. Across the clinical trial experience with solid tumors, fatal immune-mediated pneumonitis occurred in 0.5% (5/978) of patients receiving OPDIVO as a single agent. In Checkmate 037, pneumonitis, including interstitial lung disease, occurred in 3.4% (9/268) of patients receiving OPDIVO and none of the 102 patients receiving chemotherapy. Immune-mediated pneumonitis occurred in 2.2% (6/268) of patients receiving OPDIVO; Grade 3 (n=1) and Grade 2 (n=5). In Checkmate 057, immune- mediated pneumonitis, including interstitial lung disease, occurred in 3.4% (10/287) of patients receiving OPDIVO as a single agent: Grade 3 (n=5), Grade 2 (n=2), and Grade 1 (n=3). Across the clinical trial experience in 188 patients with melanoma who received OPDIVO in combination with YERVOY, in Checkmate 069 (n=94) and an additional dose-finding study (n=94), fatal immune- mediated pneumonitis occurred in 0.5% (1/188) of patients. In Checkmate 069, there were six additional patients who died without resolution of abnormal respiratory findings. Monitor patients for signs with radiographic imaging and symptoms of pneumonitis. Administer corticosteroids for Grade 2 or greater pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In Checkmate 069, pneumonitis, including interstitial lung disease, occurred in 10% (9/94) of patients receiving OPDIVO in combination with YERVOY and 2.2% (1/46) of patients receiving YERVOY. Immune-mediated pneumonitis occurred in 6% (6/94) of patients receiving OPDIVO in combination with YERVOY: Grade 5 (n=1), Grade 3 (n=2) and Grade 2 (n=3).
Immune-Mediated ColitisImmune-mediated colitis can occur with OPDIVO treatment. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. As a single agent, withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon restarting OPDIVO. In combination with YERVOY, withhold OPDIVO for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis upon restarting OPDIVO. In Checkmate 037, diarrhea or colitis occurred in 21% (57/268) of patients receiving OPDIVO and 18% (18/102) of patients receiving chemotherapy. Immune-mediated colitis occurred in 2.2% (6/268) of patients receiving OPDIVO; Grade 3 (n=5) and Grade 2 (n=1). In Checkmate 057, diarrhea or colitis occurred in 17% (50/287) of patients receiving OPDIVO as a single agent. Immune-mediated colitis occurred in 2.4% (7/287) of patients: Grade 3 (n=3), Grade 2 (n=2), and Grade 1 (n=2). In Checkmate 069, diarrhea or colitis occurred in 57% (54/94) of patients receiving OPDIVO in combination with YERVOY and 46% (21/46) of patients receiving YERVOY. Immune-mediated colitis occurred in 33% (31/94) of patients receiving OPDIVO in combination with YERVOY: Grade 4 (n=1), Grade 3 (n=16), Grade 2 (n=9), and Grade 1 (n=5).
In a separate YERVOY Phase 3 study, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal
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