David R. Spigel
A5018054038- Lung Cancer Treatments and Mutations
- Cancer Immunotherapy and Biomarkers
- Lung Cancer Research Studies
- Cancer Genomics and Diagnostics
- Colorectal Cancer Treatments and Studies
- Lung Cancer Diagnosis and Treatment
- Neuroendocrine Tumor Research Advances
- Cancer Treatment and Pharmacology
- Pancreatic and Hepatic Oncology Research
- Cancer therapeutics and mechanisms
- Peptidase Inhibition and Analysis
- HER2/EGFR in Cancer Research
- CAR-T cell therapy research
- Cancer Diagnosis and Treatment
- Gastric Cancer Management and Outcomes
- Advanced Breast Cancer Therapies
- Immunotherapy and Immune Responses
- Monoclonal and Polyclonal Antibodies Research
- Renal cell carcinoma treatment
- Lymphoma Diagnosis and Treatment
- Chronic Lymphocytic Leukemia Research
- Economic and Financial Impacts of Cancer
- Radiomics and Machine Learning in Medical Imaging
- Oral and Maxillofacial Pathology
- PI3K/AKT/mTOR signaling in cancer
Sarah Cannon
2016-2025
Tennessee Oncology
2016-2025
Sarah Cannon Research Institute
2010-2025
Peking University Cancer Hospital
2024
Zhengzhou University
2024
Peking University
2024
Henan Cancer Hospital
2024
University Hospitals Seidman Cancer Center
2024
Dana-Farber Cancer Institute
2007-2023
Canon (United States)
2018-2019
Blockade of programmed death 1 (PD-1), an inhibitory receptor expressed by T cells, can overcome immune resistance. We assessed the antitumor activity and safety BMS-936558, antibody that specifically blocks PD-1.
Nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, disrupts PD-1-mediated signaling and may restore antitumor immunity.
Patients with advanced squamous-cell non-small-cell lung cancer (NSCLC) who have disease progression during or after first-line chemotherapy limited treatment options. This randomized, open-label, international, phase 3 study evaluated the efficacy and safety of nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, as compared docetaxel in this patient population.We randomly assigned 272 patients to receive at dose mg per kilogram body weight every 2...
An earlier analysis in this phase 3 trial showed that durvalumab significantly prolonged progression-free survival, as compared with placebo, among patients stage III, unresectable non-small-cell lung cancer (NSCLC) who did not have disease progression after concurrent chemoradiotherapy. Here we report the results for second primary end point of overall survival.We randomly assigned patients, a 2:1 ratio, to receive intravenously, at dose 10 mg per kilogram body weight, or matching placebo...
The efficacy and safety of the anti-programmed death ligand 1 (PD-L1) monoclonal antibody atezolizumab, as compared with those platinum-based chemotherapy, first-line treatment for patients metastatic non-small-cell lung cancer (NSCLC) PD-L1 expression are not known.We conducted a randomized, open-label, phase 3 trial involving nonsquamous or squamous NSCLC who had previously received chemotherapy on at least 1% tumor cells tumor-infiltrating immune assessed by SP142 immunohistochemical...
Abstract KRAS is the most common oncogenic driver in lung adenocarcinoma (LUAC). We previously reported that STK11/LKB1 (KL) or TP53 (KP) comutations define distinct subgroups of KRAS-mutant LUAC. Here, we examine efficacy PD-1 inhibitors these subgroups. Objective response rates to blockade differed significantly among KL (7.4%), KP (35.7%), and K-only (28.6%) (P < 0.001) Stand Up To Cancer (SU2C) cohort (174 patients) with LUAC patients treated nivolumab CheckMate-057 phase III...
Purpose Programmed death 1 is an immune checkpoint that suppresses antitumor immunity. Nivolumab, a fully human immunoglobulin G4 programmed inhibitor antibody, was active and generally well tolerated in patients with advanced solid tumors treated phase I trial expansion cohorts. We report overall survival (OS), response durability, long-term safety non–small-cell lung cancer (NSCLC) receiving nivolumab this trial. Patients Methods (N = 129) heavily pretreated NSCLC received 1, 3, or 10...
Early cancer detection could identify tumors at a time when outcomes are superior and treatment is less morbid. This prospective case-control sub-study (from NCT02889978 NCT03085888) assessed the performance of targeted methylation analysis circulating cell-free DNA (cfDNA) to detect localize multiple types across all stages high specificity.
The phase III PACIFIC trial compared durvalumab with placebo in patients unresectable, stage non-small-cell lung cancer and no disease progression after concurrent chemoradiotherapy. Consolidation was associated significant improvements the primary end points of overall survival (OS; stratified hazard ratio [HR], 0.68; 95% CI, 0.53 to 0.87; P = .00251) progression-free (PFS [blinded independent central review; RECIST v1.1]; HR, 0.52; 0.42 0.65; < .0001), manageable safety. We report updated,...
Panitumumab, a fully human antibody targeting the epidermal growth factor receptor, is active in patients with metastatic colorectal cancer (mCRC). This trial evaluated panitumumab added to bevacizumab and chemotherapy (oxaliplatin- irinotecan-based) as first-line treatment for mCRC.Patients were randomly assigned within each cohort or without 6 mg/kg every 2 weeks. The primary end point was progression-free survival (PFS) oxaliplatin cohort. Tumor assessments performed 12 weeks reviewed...
Somatic mutations in the epidermal growth factor receptor (EGFR) correlate with increased response patients non-small-cell lung cancer (NSCLC) treated EGFR tyrosine kinase inhibitors (TKIs). The multicenter iTARGET trial prospectively examined first-line gefitinib advanced NSCLC harboring and explored significance of mutation subtypes TKI resistance mechanisms.Chemotherapy-naïve >or= 1 clinical characteristic associated underwent direct DNA sequencing tumor tissue exons 18 to 21. Patients...
Purpose Nivolumab, a programmed death-1 inhibitor, prolonged overall survival compared with docetaxel in two independent phase III studies previously treated patients advanced squamous (CheckMate 017; ClinicalTrials.gov identifier: NCT01642004) or nonsquamous 057; NCT01673867) non-small-cell lung cancer (NSCLC). We report updated results, including pooled analysis of the studies. Methods Patients stage IIIB/IV (N = 272) 582) NSCLC and disease progression during after prior platinum-based...
Purpose In two phase III studies, nivolumab, a programmed death-1 (PD-1) inhibitor antibody, improved overall survival (OS) versus docetaxel in pretreated advanced non–small-cell lung cancer (NSCLC). We report 5-year follow-up results from an early I study of nivolumab this patient population and describe characteristics survivors. Patients Methods with pretreated, NSCLC received 1, 3, or 10 mg/kg every 2 weeks 8-week cycles for up to 96 weeks. OS the time first dose was estimated by...
CheckMate 568 is an open-label phase II trial that evaluated the efficacy and safety of nivolumab plus low-dose ipilimumab as first-line treatment advanced/metastatic non-small-cell lung cancer (NSCLC). We assessed association with programmed death ligand 1 (PD-L1) expression tumor mutational burden (TMB).Two hundred eighty-eight patients previously untreated, recurrent stage IIIB/IV NSCLC received 3 mg/kg every 2 weeks 6 weeks. The primary end point was objective response rate (ORR) in 1%...
Nivolumab, a monoclonal antibody that inhibits programmed cell death 1, is approved by the US Food and Drug Administration for treating advanced melanoma, renal carcinoma (RCC), non-small lung cancer (NSCLC), other malignancies. Data on long-term survival among patients receiving nivolumab are limited.To analyze overall (OS) identify clinical laboratory measures associated with tumor regression OS.This was secondary analysis of phase 1 CA209-003 trial (with expansion cohorts), which...
Purpose Patients with extensive-stage disease small-cell lung cancer (SCLC) have poor survival outcomes despite first-line chemotherapy etoposide and platinum. This randomized, double-blind phase III study evaluated the efficacy safety of ipilimumab or placebo plus platinum in patients newly diagnosed SCLC. Methods were randomly assigned at a ratio one to receive (cisplatin carboplatin) 10 mg/kg every 3 weeks for total four doses each phased induction schedule (chemotherapy cycles four;...
Immunotherapy has revolutionized the treatment of advanced non-small-cell lung cancer (NSCLC). In two phase III trials (CheckMate 017 and CheckMate 057), nivolumab showed an improvement in overall survival (OS) favorable safety versus docetaxel patients with previously treated, squamous nonsquamous NSCLC, respectively. We report 5-year pooled efficacy from these trials.Patients (N = 854; 017/057 pooled) ECOG PS ≤ 1, progression during or after first-line platinum-based chemotherapy were...
Increased hepatocyte growth factor/MET signaling is associated with poor prognosis and acquired resistance to epidermal factor receptor (EGFR) -targeted drugs in patients non-small-cell lung cancer (NSCLC). We investigated whether dual inhibition of MET/EGFR results clinical benefit NSCLC.Patients recurrent NSCLC were randomly assigned at a ratio one receive onartuzumab plus erlotinib or placebo erlotinib; crossover was allowed progression. Tumor tissue required assess MET status by...
Purpose Detection of specific molecular alterations in tumors guides the selection effective targeted treatment patients with several types cancer. These may occur other tumor for which efficacy therapy remains unclear. The MyPathway study evaluates and safety selected therapies that harbor relevant genetic but are outside current labeling these treatments. Methods ( ClinicalTrials.gov identifier: NCT02091141) is a multicenter, nonrandomized, phase IIa multiple basket study. Patients...
BackgroundLong-term data with immune checkpoint inhibitors in non-small-cell lung cancer (NSCLC) are limited. Two phase III trials demonstrated improved overall survival (OS) and a favorable safety profile the anti-programmed death-1 antibody nivolumab versus docetaxel patients previously treated advanced squamous (CheckMate 017) nonsquamous 057) NSCLC. We report results from ≥3 years' follow-up, including subgroup analyses of liver metastases, who historically have poorer prognosis among...