Bristol-Myers Squibb show breadth of oncology development program and focus on improving overall survival across multiple cancers

Overall survival data from CheckMate -227 Part 1 evaluating Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in advanced non-small cell lung cancer featured in ESMO Presidential Symposium

Five-year survival data on Opdivo plus Yervoy in advanced melanoma from CheckMate -067, the longest follow-up from a dual Immuno-Oncology Phase 3 trial

New data exploring potential of Opdivo and Opdivo plus Yervoy in esophageal, cervical and prostate cancers

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol-Myers Squibb Company (NYSE: BMY) today announced the presentation of clinical, translational and health outcomes research across 18 tumor types, highlighting the breadth of the company’s innovative oncology development program at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, September 27 to October 1. Research will be presented from over 66 Bristol-Myers Squibb-sponsored studies, investigator-sponsored studies and collaborations, and includes new data on Opdivo and the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination that adds to the existing body of clinical evidence for these regimens to improve survival outcomes and quality of life for patients with cancer.

• Final analysis of CheckMate -227 Part 1, which met its co-primary endpoint of overall survival, demonstrating a superior benefit for Opdivo plus low-dose Yervoy versus chemotherapy in first-line non-small cell lung cancer (NSCLC) patients whose tumors express PD-L1 ≥1%.
• Five-year survival outcomes data from CheckMate -067 evaluating Opdivo plus Yervoy in advanced melanoma.
• Three-year results on recurrence-free survival and distant metastasis-free survival from the Phase 3 CheckMate -238 trial investigating adjuvant Opdivo versus Yervoy in resected stage III/IV melanoma.
• First presentation of Phase 3 data evaluating Opdivo versus chemotherapy in advanced esophageal cancer, which will be featured in an ESMO Presidential Symposium.
• Interim results for Opdivo plus Yervoy in cervical cancer from the combination cohort of CheckMate -358.
• Innovative translational research examining novel biomarkers and diagnostic pathways geared towards enabling a more precise and customized approach to care based on each patient’s unique disease biology.
• Health economic outcomes research encompassing real-world evidence in second-line lung cancer, head and neck cancer, and melanoma, as well as other novel types of evidence demonstrating the clinical value of Opdivo plus Yervoy versus targeted therapies in advanced melanoma and renal cell carcinoma.

“The breadth of data we are presenting at ESMO demonstrates our focus on research that delivers transformative therapies, explores new approaches in difficult-to-treat tumors and highlights the commitment we have to patients with cancer,” said Fouad Namouni, head, Oncology Development, Bristol-Myers Squibb. “We look forward to sharing five-year overall survival data in advanced melanoma and final results from CheckMate -227 Part 1 in the first-line treatment of patients with non-small cell lung cancer, data from two of the three types of cancer where the Opdivo plus Yervoy regimen has shown an overall survival benefit in randomized Phase 3 trials.”

Key Bristol-Myers Squibb data being presented at the ESMO 2019 Congress include:

Non-Small Cell Lung Cancer

• Final efficacy and safety results from Part 1 of the Phase 3 CheckMate -227 study evaluating Opdivo plus low-dose Yervoy in patients with first-line NSCLC. These data (Presentation #LBA4_PR) will be featured in the official Press Programme and in a Presidential Symposium on Saturday, September 28 from 4:30-6:20 PM CEST.

Melanoma

• Five-year survival outcomes from the Phase 3 CheckMate -067 trial evaluating the durability and sustained clinical benefit of Opdivo plus Yervoy in advanced melanoma. These data (Presentation #LBA68_PR) will be featured in the official Press Programme and in a Proffered Paper session on Saturday, September 28 from 8:30-10:15 AM CEST.
• Three-year efficacy and biomarker results from the Phase 3 CheckMate -238 trial investigating adjuvant Opdivo versus Yervoy in resected stage III/IV melanoma. These data (Presentation #1310O) will be featured in a Proffered Paper session on Saturday, September 28 from 8:30-10:15 AM CEST.

Prostate Cancer

• Phase 2 results from the CheckMate -9KD study assessing the clinical activity seen with Opdivo in combination with docetaxel in male patients with metastatic castration-resistant prostate cancer. These data (Presentation #LBA52) will be featured in a Poster Discussion on Sunday, September 29 from 8:30-9:45 AM CEST.

Gastrointestinal Cancer

• First presentation of the final analysis from the randomized Phase 3 ATTRACTION-3 study evaluating Opdivo versus chemotherapy in patients with unresectable advanced or recurrent esophageal squamous cell carcinoma that is refractory to or intolerant of one prior fluoropyrimidine/platinum-based therapy. These data (Presentation #LBA11) will be featured in a Presidential Symposium on Monday, September 30 from 4:30-6:15 PM CEST.
• Phase 3 results from the CheckMate -459 study of Opdivo compared to standard of care sorafenib as a first-line treatment in patients with advanced hepatocellular carcinoma. These data (Presentation #LBA38_PR) will be featured on Friday, September 27 in a Proffered Paper Session from 2-3:30 PM CEST.

Cervical Cancer

• Interim analysis from the Opdivo plus Yervoy cohort of the Phase 1/2 CheckMate -358 study in patients with recurrent or metastatic cervical cancer. These data (Presentation #LBA62) will be featured in a Proffered Paper Session on Sunday, September 29 from 8:30-10 AM CEST.

Translational Medicine and Early Assets

• Translational data from a clinical study will highlight a potential predictive composite biomarker approach to aid in the biology-driven selection of patients for Immuno-Oncology (I-O) therapy. These data (Presentation #1874O) will be featured in a Proffered Paper session on Saturday, September 28 from 8:30-10 AM CEST.
• New findings featuring emerging technologies that enable deeper exploration of tumor biology and the tumor microenvironment, and may ultimately inform our approach to I-O resistance, will also be presented. Research on how spatial analysis of immune and tumor cells in gastric and urothelial tumors may impact use of predictive biomarkers for I-O therapy (Presentation #2021P) will be showcased in a Poster Display session on Saturday, September 28 from 12-1 PM CEST. Data highlighting the application of an artificial intelligence-based computed tomography imaging platform to detect early radiomic changes associated with sensitivity to treatment in patients with squamous NSCLC (Presentation #1910P) and the development of a multiplex chromogenic immunohistochemistry approach for simultaneous quantitation, spatial analysis and checkpoint expression of tumor infiltrating lymphocytes (Presentation #128P) will be presented in a Poster Display session on Monday, September 30 from 12-1 PM CEST.