Search Results
Your search for ,Inc matches 1227 pages
Showing 151 - 200Elacestrant for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer
On January 27, 2023, elacestrant was approved by the U.S. Food and Drug Administration (FDA) for postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine ...
Addition of Pembrolizumab to Pemetrexed/Platinum in the First-Line Treatment of Metastatic Nonsquamous NSCLC: 5-Year Outcomes in the KEYNOTE-189 Study
As reported in the Journal of Clinical Oncology by Marina C. Garassino, MD, and colleagues, 5-year follow-up in the phase III KEYNOTE-189 trial has shown maintained progression-free and overall survival benefits with the addition of pembrolizumab to pemetrexed and platinum chemotherapy in the...
Expert Point of View: Amir T. Fathi, MD
Amir T. Fathi, MD, Associate Professor of Medicine at Harvard Medical School and Director of the Leukemia Program at Massachusetts General Cancer Center, said the approach of intensifying chemotherapy with the addition of venetoclax is one of several being studied in the upfront setting....
Darolutamide Maintenance in Patients With Metastatic Castration-Resistant Prostate Cancer Without Disease Progression on Taxane Treatment
In a European phase II trial (Swiss Group for Clinical Cancer Research [SAKK] 08/16) reported in the Journal of Clinical Oncology, Silke Gillessen, MD, and colleagues found that darolutamide maintenance improved progression-free survival vs placebo in patients with metastatic castration-resistant...
Addition of Pembrolizumab to Chemotherapy in First-Line Treatment of Metastatic Squamous NSCLC: 5-Year Update of KEYNOTE-407
As reported in the Journal of Clinical Oncology by Silvia Novello, MD, PhD, and colleagues, the 5-year update of the phase III KEYNOTE-407 trial showed continued overall survival and progression-free survival benefit with the addition of pembrolizumab to chemotherapy in the first-line treatment of...
Mosunetuzumab-axgb for Relapsed or Refractory Follicular Lymphoma
On December 22, 2022, mosunetuzumab-axgb, a bispecific CD20-directed CD3 T-cell engager, was granted accelerated approval for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.1 Supporting Efficacy Data Approval was based on findings in the...
Axatilimab for Refractory Chronic Graft-vs-Host Disease
In a phase I/II study reported in the Journal of Clinical Oncology, Carrie L. Kitko, MD, and colleagues found that axatilimab, an anti–colony-stimulating factor 1 receptor (CSF-1R) antibody, produced high response rates in patients who had undergone allogeneic hematopoietic cell transplantation and ...
Mirvetuximab Soravtansine in Patients With Platinum-Resistant Ovarian Cancer and High FRα Expression
As reported in the Journal of Clinical Oncology by Ursula A. Matulonis, MD, and colleagues, results from the phase II SORAYA study showed activity of mirvetuximab soravtansine-gynx, an antibody-drug conjugate targeting folate receptor alpha (FRα), in patients with platinum-resistant ovarian cancer...
FDA Approves Sacituzumab Govitecan-hziy for Pretreated Patients With HR-Positive, HER2-Negative Breast Cancer
On February 3, the U.S. Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy) for patients with unresectable, locally advanced or metastatic, hormone receptor (HR)-positive, HER2-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+ with a negative in situ...
MDM2 Inhibitor Milademetan in Advanced Liposarcoma, Solid Tumors, or Lymphomas
In a first-in-human, phase I, dose-escalation and dose-expansion study reported in the Journal of Clinical Oncology, Mrinal M. Gounder, MD, and colleagues identified the dose and schedule for further evaluation of the oral MDM2 inhibitor milademetan in a population of patients with advanced...
Momelotinib May Effectively Reduce Anemia and Other Symptoms for Patients With Myelofibrosis
The targeted therapy momelotinib may offer clinically significant improvement in disease-related symptoms, including anemia and spleen enlargement, for patients with myelofibrosis, according to a novel study published by Srdan Verstovsek, MD, PhD, and colleagues in The Lancet. The findings support...
Remembering Breast Cancer Pioneer Isaac Craig Henderson, MD
Isaac Craig Henderson, MD, passed away at the age of 81 at his home in San Francisco on December 26, 2022, after a brief illness. Dr. Henderson was an internationally known medical oncologist who specialized in breast cancer, beginning his career at Harvard’s then-designated Sidney Farber Cancer...
Lenvatinib and Pembrolizumab in Previously Treated Patients With Advanced Endometrial Carcinoma: Update of Study 111/KEYNOTE-146
In an analysis reported in the Journal of Clinical Oncology, Vicky Makker, MD, and colleagues provided updated findings from the phase Ib/II Study 111/KEYNOTE-146 trial of lenvatinib and pembrolizumab in previously treated patients with advanced endometrial carcinoma. The study supported the...
Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia With a Susceptible IDH1 Mutation
On December 1, 2022, the IDH1 inhibitor olutasidenib was approved for the treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1 The FDA simultaneously approved the Abbott...
KEYNOTE-394: Pembrolizumab as Second-Line Therapy in Asian Patients With Advanced HCC
As reported in the Journal of Clinical Oncology by Qin et al, the phase III KEYNOTE-394 trial showed overall and progression-free survival benefits with pembrolizumab vs placebo in previously treated Asian patients with advanced hepatocellular carcinoma (HCC). Study Details The double-blind trial...
Mirvetuximab Soravtansine for FRɑ-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
On November 14, 2022, the U.S. Food and Drug Administration (FDA) granted mirvetuximab soravtansine-gynx accelerated approval for patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three...
Study Finds Lifileucel Active in Advanced Melanoma After Disease Progression on Immune Checkpoint Inhibitors
Cell therapy with tumor-infiltrating lymphocytes (TIL) may address an important unmet need for patients with difficult-to-treat melanoma after disease progression on immune checkpoint inhibitors, according to data presented during the 2022 Society for Immunotherapy of Cancer (SITC) Annual ...
Nivolumab Plus Cabozantinib With or Without Ipilimumab in Advanced Hepatocellular Carcinoma
As reported in the Journal of Clinical Oncology by Thomas Yau, MD, and colleagues, findings in a cohort of the phase I/II CheckMate 040 trial indicated the activity of nivolumab/cabozantinib with or without ipilimumab in patients with advanced hepatocellular carcinoma. Study Details In the...
FDA Approves FoundationOne Liquid CDx as a Companion Diagnostic for a Certain Group of Tyrosine Kinase Inhibitors
On December 21, Foundation Medicine, Inc, announced that the U.S. Food and Drug Administration (FDA) approved its FoundationOne Liquid CDx as a companion diagnostic to identify patients with non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R substitutions...
Sodium Thiosulfate to Reduce the Risk of Cisplatin-Related Ototoxicity in Pediatric Patients With Localized Solid Tumors
On September 20, 2022, sodium thiosulfate was approved to reduce the risk of ototoxicity associated with cisplatin in pediatric patients (aged ≥ 1 month) with localized, nonmetastatic solid tumors.1 Supporting Efficacy Data Approval was based on findings in the multicenter open-label SIOPEL 6...
Brentuximab Vedotin Combined With Chemotherapy in Pediatric Classical Hodgkin Lymphoma
On November 10, 2022, brentuximab vedotin was approved for use in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients aged ≥ 2 years with previously untreated high-risk classical Hodgkin lymphoma.1 Supporting Efficacy Data Approval was...
Updated Subgroup Analyses From the HER2CLIMB Trial in Previously Treated Patients With HER2-Positive Breast Cancer
In updated analyses from the phase III HER2CLIMB trial reported in JAMA Oncology, Nancy U. Lin, MD, and colleagues found that the addition of tucatinib to trastuzumab and capecitabine showed improved outcomes among previously treated patients with HER2-positive breast cancer and baseline brain...
Bipartisan Comprehensive Cancer Survivorship Act Introduced
On December 14, U.S. Representative Mark DeSaulnier (D-CA), Representative Debbie Wasserman Schultz (D-FL), Senator Amy Klobuchar (D-MN), Senator Ben Cardin (D-MD), and Representative Brian Fitzpatrick (R-PA) introduced the Comprehensive Cancer Survivorship Act (CCSA)—legislation that will address...
Futibatinib for Cholangiocarcinoma With FGFR2 Gene Fusion or Other Rearrangements
On September 30, 2022, futibatinib was granted accelerated approval for adults with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.1 Supporting Efficacy ...
Adjuvant Pembrolizumab May Improve Quality of Life in Patients With High-Risk Resected Melanoma
Taken together with the primary clinical results, a secondary analysis of the phase III SWOG S1404 randomized clinical trial demonstrated that pembrolizumab provides superior clinical and patient-reported quality-of-life outcomes compared to standard of care with adjuvant ipilimumab or high-dose...
Autologous Tumor Lysate–Loaded Dendritic Cell Vaccine for Glioblastoma
In an externally controlled phase III trial reported in JAMA Oncology, Liau et al found that the addition of an autologous tumor lysate–loaded dendritic cell vaccine (DCVax-L) to standard of care improved survival in patients with newly diagnosed glioblastoma and recurrent glioblastoma compared...
PALLAS Trial: No Benefit Reported for Adjuvant Palbociclib in Stage IIA Hormone Receptor–Positive, HER2-Negative Breast Cancer
In a preplanned analysis of the stage IIA cohort of the PALLAS trial, the addition of adjuvant palbociclib to standard endocrine therapy did not improve outcomes over endocrine therapy alone. This finding suggests this agent provides no benefit in reducing the risk of early relapse in patients with ...
Addition of Enzalutamide to Salvage Radiotherapy in Patients With Biochemically Recurrent Prostate Cancer After Radical Prostatectomy
In a phase II trial (SALV-ENZA) reported in the Journal of Clinical Oncology, Phuoc T. Tran, MD, PhD, and colleagues found that the addition of enzalutamide to salvage radiotherapy improved freedom from prostate-specific antigen (PSA) progression in patients with biochemically recurrent prostate...
Margetuximab-cmkb vs Trastuzumab With Chemotherapy in Previously Treated Advanced HER2-Positive Breast Cancer: Final Overall Survival Analysis of the SOPHIA Trial
As reported in the Journal of Clinical Oncology by Hope S. Rugo, MD, FASCO, and colleagues, the final overall survival results of the pivotal phase III SOPHIA trial have shown no significant difference between margetuximab-cmkb plus chemotherapy vs trastuzumab plus chemotherapy in previously...
Cemiplimab-rwlc in Combination With Platinum-Based Chemotherapy in Advanced NSCLC With No EGFR, ALK, or ROS1 Aberrations
On November 8, 2022, cemiplimab-rwlc was approved for use in combination with platinum-based chemotherapy for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1aberrations.1 Supporting Efficacy Data Approval was supported by findings in the...
Futibatinib for Cholangiocarcinoma With FGFR2 Gene Fusion or Other Rearrangements
On September 30, 2022, futibatinib was granted accelerated approval for adults with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.1 Supporting Efficacy ...
Sodium Thiosulfate to Reduce the Risk of Cisplatin-Related Ototoxicity in Pediatric Patients With Localized Solid Tumors
On September 20, 2022, sodium thiosulfate was approved to reduce the risk of ototoxicity associated with cisplatin in pediatric patients (aged ≥ 1 month) with localized, nonmetastatic solid tumors.1 Supporting Efficacy Data Approval was based on findings in the multicenter open-label SIOPEL 6...
First-Line Pembrolizumab vs Chemotherapy in Advanced PD-L1–Positive NSCLC Without EGFR/ALK Alterations
As reported in the Journal of Clinical Oncology by Gilberto de Castro, Jr, MD, PhD, and colleagues, 5-year follow-up of the KEYNOTE-042 trial showed a maintained overall survival benefit with first-line pembrolizumab vs chemotherapy in patients with non–small cell lung cancer (NSCLC) with a PD-L1...
Lutetium Lu-177 Vipivotide Tetraxetan for PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
On March 23, 2022, the radioligand therapeutic agent lutetium Lu-177 vipivotide tetraxetan was approved for treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with an androgen receptor pathway inhibitor ...
Integrative Approaches to Managing Pain in Patients With Cancer: SIO-ASCO Guideline
Pain is highly prevalent in people with cancer throughout the disease trajectory. Often persisting for years after initial diagnosis and undertreated, it is associated with poor functional, mental, and cancer-related outcomes.1 Consequently, the need for effective pain management strategies has...
Ciltacabtagene Autoleucel in Relapsed or Refractory Multiple Myeloma
In a Chinese phase II trial (CARTIFAN-1) reported in the Journal of Clinical Oncology, Mi et al found that the anti–B-cell maturation antigen chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel was active in patients with relapsed or refractory multiple myeloma. Study Details...
Telisotuzumab Vedotin Plus Erlotinib in c-Met Protein–Expressing NSCLC
In a phase Ib trial reported in the Journal of Clinical Oncology, D. Ross Camidge, MD, PhD, and colleagues found that the combination of telisotuzumab vedotin and erlotinib showed activity in c-Met protein–expressing advanced non–small cell lung cancer (NSCLC), including those with an EGFR mutation ...
Researchers Discover Differences in Response to Pembrolizumab Among Patients With Endometrial Cancer
Researchers discovered a differential clinical response to pembrolizumab in patients with Lynch-like (mutated) vs methylated microsatellite instability–high endometrial cancer, outlining characteristics of patients who may derive benefit from immune checkpoint blockade antibodies, according to new...
Elacestrant Improves Progression-Free Survival vs Standard Endocrine Therapy in Previously Treated Estrogen Receptor–Positive, HER2-Negative Advanced Breast Cancer
As reported in the Journal of Clinical Oncology by François-Clément Bidard, MD, PhD, of the Institut Curie, Paris and Saint Cloud, and colleagues, the phase III EMERALD trial has shown prolonged progression-free survival with the oral selective estrogen receptor degrader elacestrant vs standard...
Pembrolizumab With or Without Chemotherapy vs Cetuximab/Chemotherapy in Recurrent or Metastatic Head and Neck Cancer
As reported in the Journal of Clinical Oncology by Kevin Harrington, MD, PhD, and colleagues, updated results of the phase III KEYNOTE-048 trial showed enduring survival benefits with first-line pembrolizumab alone and pembrolizumab/chemotherapy vs cetuximab/chemotherapy in patients with recurrent...
DESTINY-Breast04 Trial: T-DXd Significantly Improves Survival in Patients With HER2-Low Metastatic Breast Cancer
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) doubled progression-free survival compared with chemotherapy alone in patients with “HER2-low” metastatic breast cancer—ie, patients with low levels of HER2 expression. The agent also extended overall survival for patients with low ...
Enfortumab Vedotin-ejfv Plus Pembrolizumab in Cisplatin-Ineligible Patients With Advanced Urothelial Cancer
In a phase Ib/II study reported in the Journal of Clinical Oncology, Christopher J. Hoimes, MD, and colleagues found that first-line enfortumab vedotin-ejfv plus pembrolizumab produced a high response rate and prolonged response durations in cisplatin-ineligible, previously untreated patients with...
Ibrutinib for Pediatric Patients With Chronic Graft-vs-Host Disease
On August 24, 2022, ibrutinib was approved for pediatric patients 1 year of age or older with chronic graft-vs-host disease after failure of one or more lines of systemic therapy.1 A new oral suspension formulation is available. Supporting Efficacy Data Approval was based on findings from the...
Darolutamide Combined With Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
On August 5, 2022, darolutamide was approved for use in combination with docetaxel for patients with metastatic hormone-sensitive prostate cancer.1 Approval was based on the double-blind ARASENS trial (ClinicalTrials.gov identifier NCT02799602), in which 1,305 patients were randomly assigned to...
Addition of PD-1 Inhibitor Serplulimab to Chemotherapy in the First-Line Treatment of Extensive-Stage SCLC
As reported in JAMA by Cheng et al, an interim analysis of the phase III ASTRUM-005 trial has shown that the addition of the PD-1 inhibitor serplulimab to chemotherapy improved overall survival in the first-line treatment of patients with extensive-stage small cell lung cancer (SCLC). Study ...
Minimally Invasive vs Open Nephrectomy for Kidney Cancer: 1-Year Health-Care Expenditure and Utilization
In a retrospective cohort study reported in JAMA Network Open, Okhawere et al found that minimally invasive surgery was associated with similar or reduced total expenditures vs open surgery during the first year after partial or radical nephrectomy for kidney cancer. Study Details The study...
Overall Survival With Maintenance Olaparib in Newly Diagnosed Patients With Advanced BRCA-Mutated Ovarian Cancer: 7-Year Follow-up
As reported in the Journal of Clinical Oncology by DiSilvestro et al, the 7-year follow-up of the phase III SOLO1/GOG 3004 trial showed a reduction in risk of death by almost half with maintenance olaparib vs placebo in newly diagnosed patients with advanced ovarian cancer and a BRCA1/2 mutation,...
Pafolacianine for Intraoperative Imaging of Folate Receptor–Positive Ovarian Cancer
In a phase III trial reported in the Journal of Clinical Oncology, Janos L. Tanyi, MD, PhD, and colleagues found that use of pafolacianine infusion for intraoperative imaging improved the detection of lesions in patients with folate receptor–positive ovarian cancer, compared with using white light...
Preclinical Study Finds New Synthetic Lethal Agent Could Be Potential Treatment for Pancreatic Cancer
Researchers at The Marvin and Concetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center have found that a new synthetic lethal agent could be an effective treatment for pancreatic cancers with DNA damage repair (DDR) defects. Igor Astsaturov, MD, PhD, a co-director of the Institute...
Sequencing of Ipilimumab/Nivolumab With Encorafenib/Binimetinib in BRAF-Mutant Metastatic Melanoma
In a phase II trial (SECOMBIT) reported in the Journal of Clinical Oncology, Paolo A. Ascierto, MD, and colleagues found that sequential immunotherapy and targeted therapy with ipilimumab/nivolumab followed at disease progression by encorafenib/binimetinib was associated with good survival...
