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Found 2 Presentations For Request "Abs: 776P"
776P - Phase II trial of concurrent nivolumab in urothelial bladder cancer with radiation therapy in localized/locally advanced disease for chemotherapy ineligible patients [NUTRA trial]
- Ulka N. Vaishampayan (Ann Arbor, United States of America)
Abstract
Background
Bladder cancer is a disease of the elderly and this frail patient population, or patients with significant comorbidities, are ineligible for cystectomy or standard radiation and chemotherapy. We are conducting a study in a chemotherapy and cystectomy ineligible patient population with the combination of a programmed death (PD-1) inhibitor, nivolumab, and radiation therapy in localized/locally advanced urothelial cancer patients.
Methods
Eligible patients have muscle invasive bladder cancer (MIBC) and are not candidates for standard chemoradiation strategy due to at least one of the following criteria: performance status of 2, creatinine clearance < 60ml/min or cardiac disease, neuropathy, or intolerance to previous treatment that would render the patient ineligible for chemotherapy. The primary endpoint is progression free survival (PFS) rate at 12 months. Nivolumab is started within 3 days of radiation therapy and is administered at the dose of 240 mg intravenously every 2 weeks for a maximum of 6 months. Total radiation dose of 64 gray in 32 fractions was administered per standard of care for bladder cancer. If local lymph nodes were clinically involved, they had to be radiated.
Results
To date, 17 patients have been enrolled; median age is 78 years (range 54 to 95 years) 13 males and 4 females, Median creatinine clearance was 51ml/min (range 26-123ml/min). Four patients were clinical stage T3 /T4 and one patient had N1 disease. Nivolumab and radiation therapy toxicities were as expected: 5 patients needed steroids due to immune-mediated adverse events; diarrhoea in 2, thyroid dysfunction in 2 and immune cystitis in 1 patient. No treatment related deaths were noted. 6 of 14 patients demonstrated complete response, 4 had residual T1 disease or carcinoma in situ and 4 had disease progression. PDL-1 combined positive score (CPS) was <1% in all non responders except one patient with CPS of 5%. PFS and overall survival outcome data will be presented.
Conclusions
Concurrent nivolumab and radiation therapy is tolerable and showed promising early efficacy in an elderly population with multiple comorbidities. PDL-1 expression is a potential biomarker to guide patient selection.
Clinical trial identification
NCT03421652.
Legal entity responsible for the study
Karmanos Cancer Center.
Funding
Bristol Myers Squibb Inc.
Disclosure
U.N. Vaishampayan: Honoraria (self), Research grant/Funding (institution): Bristol Myers Squibb; Honoraria (self): Bayer; Honoraria (self), Research grant/Funding (self): Exelixis; Honoraria (self): Pfizer; Honoraria (self), Research grant/Funding (institution): Astellas; Advisory/Consultancy, Research grant/Funding (institution): Alkermes; Advisory/Consultancy, Research grant/Funding (institution): Merck. S. George: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): BMS; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Research grant/Funding (institution): Merck; Research grant/Funding (institution): Agensys; Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Research grant/Funding (institution): Eisai; Advisory/Consultancy, Research grant/Funding (institution): Astellas; Research grant/Funding (institution): Calithera; Research grant/Funding (institution): Immunomedics; Advisory/Consultancy: EMD Serono; Advisory/Consultancy: Genentech; Advisory/Consultancy, Research grant/Funding (institution): Corvus; Advisory/Consultancy: Exelixis. All other authors have declared no conflicts of interest.
1165P - Subgroup analysis by Ki-67 and primary tumour origins of the randomized, placebo-controlled phase III study of surufatinib in advanced well-differentiated extrapancreatic neuroendocrine tumours (SANET-ep)
- Zhiwei Zhou (Guangzhou, China)
Abstract
Background
Surufatinib, a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptors (1,2,3), fibroblast growth factor receptor 1 and colony stimulating factor 1 receptor, has demonstrated superior efficacy in extrapancreatic neuroendocrine tumors (NETs) in a phase III study (SANET-ep, ESMO 2019 Abs. LBA76). The proliferation marker Ki-67 and primary tumor origins are the major prognostic factors in NETs.
Methods
The post-hoc efficacy analysis of surufatinib versus placebo was conducted by Ki-67 subcategory (<3%, 3-10%, >10%) and primary tumor origins (foregut, midgut, hindgut, others or unknown) in patients (pts) with advanced well-differentiated (grade 1 or 2) extrapancreatic NETs. The primary endpoint (progression-free survival [PFS]) and secondary endpoint (objective response rate [ORR]) both by investigator assessment (RECIST1.1) were analyzed.
Results
Median PFS was significantly prolonged with surufatinib compared to placebo in subgroups of Ki-67 3-10% (7.6 vs 4.6 months [mo], hazard ratio [HR] 0.47,
Conclusions
Surufatinib demonstrated clinically significant benefits for pts with advanced well-differentiated extrapancreatic NETs compared to placebo. Results of this exploratory analysis were consistent with those reported for the SANET-ep primary analysis, and improved outcomes were observed across major subgroups.
Clinical trial identification
NCT02588170.
Legal entity responsible for the study
Hutchison MediPharma Limited.
Funding
Hutchison MediPharma Limited.
Disclosure
J. Li, J. He: Full/Part-time employment: Hutchison MediPharma Limited. W. Su: Shareholder/Stockholder/Stock options, Full/Part-time employment: Hutchison MediPharma Limited. All other authors have declared no conflicts of interest.