Bayer announced that the latest research across its growing oncology portfolio will be presented at the European Society of Medical Oncology (ESMO) 2016 Congress taking place on October 7-11 in Copenhagen, Denmark. The data span a variety of difficult-to-treat cancers and include two presentations and 12 posters.
Findings from the Phase III RESORCE clinical trial evaluating Stivarga® (regorafenib) in patients with unresectable hepatocellular carcinoma (HCC) who progressed after treatment with Nexavar® (sorafenib) tablets will be presented as an oral late-breaking abstract. Another oral presentation will reveal the first-in-human dose-escalation results of the company’s investigational compound BAY 1163877, a pan-fibroblast growth factor receptor (FGFR) inhibitor, in advanced solid tumors.
Other Bayer data presentations include further results for Xofigo® (radium Ra 223 dichloride) including a prospective retreatment study in men with metastatic castration-resistant prostate cancer (mCRPC).
“Our data at ESMO reflect Bayer’s diverse approach to research and development, which prioritizes investigational compounds while continuing to explore the full potential of existing treatments in areas with high unmet medical need – such as prostate and liver cancer,” said Dario Mirski, M.D., Bayer's senior vice president and head of medical affairs for the Americas. “We welcome every opportunity to contribute to the growing body of evidence helping to drive forward therapeutic advances in oncology.”
Bayer studies at the ESMO 2016 Congress include:
Radium-223 Dichloride (radium-223)
- Radium-223 Re-Treatment From an International, Prospective, Open-Label Study in Patients With Castration-Resistant Prostate Cancer and Bone Metastases
- Poster 752P, Session: Poster Display (Hall E)
- Sunday, October 9, 2016, 1:00 pm – 2:00 pm (CEST)
- Radium-223 with concomitant bone-targeting agents in mCRPC patients treated in an international early access program (iEAP)
- Poster 750P, Session: Poster Display (Hall E)
- Sunday, October 9, 2016, 1:00 pm – 2:00 pm (CEST)
- Changes in alkaline phosphatase (ALP) dynamics and overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC) patients treated with radium-223 in an international early access program (iEAP)
- Poster 751P, Session: Poster Display (Hall E)
- Sunday, October 9, 2016, 1:00 pm – 2:00 pm (CEST)
- A phase 2 randomized, double-blind, placebo-controlled trial of radium-223 dichloride with exemestane and everolimus in patients with HER2–negative hormone receptor–positive breast cancer and bone metastases
- Trial in Progress 310TiP, Session: Poster Display (Hall E)
- Monday, October 10, 2016, 1:00 pm – 2:00 pm (CEST)
Regorafenib
- Efficacy and safety of regorafenib (REG) versus placebo (PBO) in patients (pts) with hepatocellular carcinoma (HCC) progressing on sorafenib: Results of the international, randomized phase 3 RESORCE trial
- Late-breaking Oral LBA28, Session: Gastrointestinal tumours, non-colorectal (Copenhagen)
- Saturday, October 8, 2016, 8:20 am (CEST)
- Subgroup analysis of patients with metastatic colorectal cancer (mCRC) treated with regorafenib (REG) in the phase IIIb CONSIGN trial who had progression-free survival (PFS) >4 months (m)
- Poster 506P, Session: Poster Display (Hall E)
- Saturday, October 8, 2016, 1:00 pm – 2:00 pm (CEST)
- Characteristics of patients with metastatic colorectal cancer (mCRC) treated with regorafenib (REG) who had progression-free survival (PFS) >4 months (m): Subgroup analysis of the phase III CORRECT trial
- Poster 516P, Session: Poster Display (Hall E)
- Saturday, October 8, 2016, 1:00 pm – 2:00 pm (CEST)
- A phase I study to determine the effect of regorafenib on the pharmacokinetics (PK) of substrates of P-glycoprotein (P-gp; digoxin) and breast cancer resistant protein (BCRP; rosuvastatin) in patients with advanced solid tumors
- Poster 474P, Session: Poster Display (Hall E)
- Saturday, October 8, 2016, 1:00 pm – 2:00 pm (CEST)
- A phase 1 study evaluating the pharmacokinetics (PK) and safety of regorafenib (REG) in patients with advanced solid tumors with severe renal impairment (SRI)
- Poster 507P, Session: Poster Display (Hall E)
- Saturday, October 8, 2016, 1:00 pm – 2:00 pm (CEST)
- Long-term safety of regorafenib (REG) in advanced gastrointestinal stromal tumors (GIST): Updated safety data of the phase 3 GRID trial
- Poster 1415P, Session: Poster Display (Hall E)
- Monday, October 10, 2016, 1:00 pm – 2:00 pm (CEST)
- Evaluation of exposure of regorafenib and its metabolites in cancer patients with renal impairment by modeling, simulation, and clinical study
- Poster 1556P, Session: Poster Display (Hall E)
- Monday, October 10, 2016, 1:00 pm – 2:00 pm (CEST)
- Evaluation of exposure of regorafenib and its metabolites in pediatric patients by modeling, simulation, and clinical study
- Poster 1559P, Session: Poster Display (Hall E)
- Monday, October 10, 2016, 1:00 pm – 2:00 pm (CEST)
- Phase I study of the pan-fibroblast growth factor receptor (FGFR) inhibitor BAY 1163877 with expansion cohorts for subjects based on tumor FGFR mRNA expression levels
- Oral 360O, Proffered Paper session: Developmental therapeutics (Rome)
- Saturday, October 8, 2016, 12:00 pm – 12:15 pm (CEST)
- Phase II study of roniciclib in combination with cisplatin/etoposide or carboplatin/etoposide as first-line therapy in subjects with extensive-stage disease small cell lung cancer (ED-SCLC)
- Poster 1426PD, Poster Discussion Session: Non-metastatic NSCLC and other thoracic malignancies (Berlin)
- Monday, October 10, 2016, 3:20 pm (CEST)