New long-term data on Opdivo and the Opdivo + Yervoy regimen shows survival benefit across lines of therapy in advanced melanoma
Longest follow-up for the Opdivo + Yervoy regimen from study 004 shows 3-year overall survival rate of 68% across Phase I dosing cohorts.
Bristol-Myers Squibb (BMS) has announced new long-term data of Opdivo in treatment-naïve BRAF wild-type advanced melanoma from CheckMate -066. In the trial, Opdivo continued to demonstrate superior overall survival versus dacarbazine with 57.7% of patients alive at 2 years compared to 26.7% of patients treated with dacarbazine. The safety profile of Opdivo was consistent with prior studies. The 2-year survival and safety data from CheckMate -066 represent the longest follow-up from a randomized study of any PD-1 immune checkpoint inhibitor in the first-line setting of advanced melanoma. These data will be presented as a late-breaking presentation at the Society for Melanoma Research (SMR) 2015 International Congress in San Francisco, CA, 18–21 from November.
BMS is also presenting updated data from various Phase I cohorts of Study 004 evaluating the Opdivo + Yervoy Regimen in patients with unresectable or metastatic melanoma, including up to 3-year overall survival. The Phase Ib Study 004 is a dose-finding study on which the proof of concept for Opdivo + Yervoy Regimen approval was based.
“The long-term survival data for our Immuno-Oncology agent,Opdivo, as a single agent and in combination with Yervoy presented at SMR shows our continued commitment to improve outcomes for patients with advanced melanoma,” said Michael Giordano, M.D., senior vice president, head of Oncology Development, BMS. “The Opdivo + Yervoy Regimen has shown compelling potential for providing improved duration of response and long-term survival for some patients, and, as single agents, Opdivo and Yervoy continue to play a critical role as core components of the treatment continuum for advanced melanoma in appropriate patients.”
The global incidence of melanoma has been increasing over the past three decades, and despite recent advances in treatment, patients with advanced or metastatic disease often have a poor prognosis. Currently, 5-year survival rates for advanced melanoma are between 5% and 19%
.Related News
-
News Understanding the Benefits and Advances of Cleanroom Technology
In an industry where precision and sterility are crucial concerns, cleanrooms play a vital role in maintaining the integrity of pharmaceutical products like drugs, vaccines, and other medical products. So, what is a cleanroom?
-
News AbbVie secures GBP£1.2 billion deal for Gilgamesh’s psychedelic programme
AbbVie has penned a significant agreement to acquire the bretisilocin programme from Gilgamesh Pharmaceuticals for up to £1.2 billion, marking a bold step in the pharmaceutical giant's quest to develop treatments for psychiatric disorders. -
News Gates Foundation commits US$2.5 billion to women’s health research
The Bill & Melinda Gates Foundation has announced a substantial US$2.5 billion commitment to accelerate research and development focused exclusively on women's health through 2030.
-
News Mid-year review: notable FDA drug approvals of 2025
As we fly past the halfway point of 2025, the pharmaceutical landscape reliably continues to evolve with innovative therapies addressing critical medical needs. The FDA has already approved 17 groundbreaking medications this year, each representin... -
News US FDA announces new priority vouchers for accelerated review times
The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening th... -
News Google-backed start-up raises US$600 million to support AI drug discovery and design
London-based Isomorphic Labs, an AI-driven drug design and development start-up backed by Google’s AI research lab DeepMind, has raised US$600 million in its first external funding round by Thrive Capital. The funding will provide further power t... -
News AstraZeneca to invest US$2.5 billion in Beijing R&D centre
Amid investigations of former AstraZeneca China head Leon Wang in 2024, AstraZeneca have outlined plans to establish its sixth global strategic R&D centre in China. Their aim is to further advance life sciences in China with major research and manufact... -
News Experimental drug for managing aortic valve stenosis shows promise
The new small molecule drug ataciguat is garnering attention for its potential to manage aortic valve stenosis, which may prevent the need for surgery and significantly improve patient experience.