Bristol-Myers Squibb Company (NYSE:BMY) today announced that new data from studies investigating its immunotherapies in adjuvant and advanced melanoma, non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma (mRCC) will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 30-June 3. Bristol-Myers Squibb has been at the forefront of research and discovery in the field of immuno-oncology and these data add to the growing body of research from its leading immuno-oncology pipeline, further supporting the scientific rationale for the potential of these checkpoint inhibitors as single agents or as part of a combination regimen.
"We believe that immuno-oncology has the potential to be transformational in the treatment of cancer and to have broad applicability across multiple tumor types and lines of therapy," said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb. "The studies that are yielding the data to be presented from our immuno-oncology pipeline—including longer-term follow up results, combination data in multiple tumor types, biomarker analyses, and findings in earlier lines of treatment—continue to demonstrate our commitment to leading scientific advances in this area. We are focused on the goal of changing survival expectations and the way that patients live with cancer."
Melanoma
Melanoma data across lines of therapy and stages of the disease will be featured in oral presentations on June 2 at 3 p.m. CDT. Long-term data from the advanced melanoma arm of an expanded Phase 1b trial of nivolumab as a single agent in previously-treated patients will be presented (Study -003; Abstract #9002). Long-term follow up results from a Phase 1 trial studying nivolumab and Yervoy® (ipilimumab) as a concurrent combination regimen in both previously-treated and treatment-naïve patients with advanced melanoma will also be presented and featured during an ASCO press briefing at 8 a.m. CDT (Study -004; Abstract #LBA9003). This will include data from the trial on PD-L1 status.
In addition, a Phase 3 trial evaluating the investigational use of Bristol-Myers Squibb's first approved immunotherapy, Yervoy, as an adjuvant treatment for patients with Stage 3 melanoma who are at high-risk of recurrence, will be presented for the first time and featured during the ASCO press briefing (Study -029; Abstract #LBA9008).
Lung Cancer
Bristol-Myers Squibb has a broad development program in lung cancer investigating its immunotherapies as potential treatments across histologies and lines of therapy, including evaluating the role of biomarkers.
Long-term follow up results from the NSCLC arm of Study -003 in pre-treated patients will be presented on May 31 at 1:15 p.m. CDT (Abstract #8112). Additionally, data will be featured from four arms of a Phase 1b trial evaluating nivolumab as a single agent or as part of a combination regimen, including in combination with Yervoy, in chemotherapy-naïve patients with NSCLC on June 3 at 11:30 a.m. CDT (CheckMate -012; Abstract #8024, #8023, #8022) and May 31 at 1:15 p.m. CDT (Abstract #8113). Data on PD-L1 status will also be presented.
Metastatic Renal Cell Carcinoma
Results from studies evaluating nivolumab as a single agent and as part of a regimen with other agents in mRCC will be featured in four oral presentations, including a Phase 2 dose-ranging trial in previously-treated patients (CheckMate -010; Abstract #5009) and correlative biomarker data from a Phase 1 trial in previously-treated and treatment-naïve patients (CheckMate -009; Abstract #5012) that will be presented on May 31 at 3 p.m. CDT. Additionally, results from a Phase 1 trial investigating nivolumab in a combination regimen with Yervoy, as well as in combination with sunitinib or pazopanib in previously-treated and treatment-naïve patients, will be presented on June 2 at 9:45 a.m. CDT and May 31 at 3 p.m. CDT, respectively (CheckMate -016; Abstract #4504, #5010).
Additional Data
Data from studies of other approved treatments from Bristol-Myers Squibb will also be presented at the meeting. Full session details of the 2014 Annual Meeting can be found through the ASCO iPlanner: https://iplanner.asco.org/am2014/AM2014.aspx
Immuno-oncology at Bristol-Myers Squibb
Surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment over the last several decades, but long-term survival and a positive quality of life have remained elusive for many patients with advanced disease.
To address this unmet medical need, Bristol-Myers Squibb is leading advances in a rapidly evolving field of cancer research and treatment known as immuno-oncology, which involves agents whose primary mechanism is to work directly with the body's immune system to fight cancer. The company is exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including researching the potential of combining immuno-oncology agents that target different and complementary pathways in the treatment of cancer.
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