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Showing 201 - 250Activity of Nivolumab for Renal Cell Carcinoma Brain Metastases
In an analysis of the phase II GETUG-AFU 26 NIVOREN study reported in the Journal of Clinical Oncology, Flippot et al found that nivolumab had limited activity in patients with previously untreated brain metastases from clear cell renal cell carcinoma. The study assessed nivolumab in patients with ...
Comparison of Combination Dosing Schedules of Neoadjuvant Ipilimumab/Nivolumab in Macroscopic Stage III Melanoma
In the phase II OpACIN-neo study reported in The Lancet Oncology, Rozeman et al identified a promising dosing schedule for neoadjuvant ipilimumab/nivolumab in macroscopic stage III melanoma. Study Design The trial included 86 evaluable patients with resectable stage III melanoma involving the...
Rate and Outcome of Late Relapses in Patients With DLBCL Treated With Immunochemotherapy
In a study reported in the Journal of Clinical Oncology, Wang et al identified the rates and outcomes of relapses of diffuse large B-cell lymphoma (DLBCL) in patients who had achieved 24-month event-free survival (EFS) after immunochemotherapy. Study Details The study involved 1,324...
EHA 2019: ASCEND Trial Compares Acalabrutinib vs Investigator’s Choice in Relapsed or Refractory CLL
The randomized, global, multicenter, open-label phase III ASCEND trial evaluated the efficacy and safety of acalabrutinib vs investigator’s choice of rituximab/idelalisib or rituximab/bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Ghia et al presented ...
EHA 2019: CASSIOPEIA Trial Examines Addition of Daratumumab to Standard Treatment Before and After ASCT in Multiple Myeloma
In the phase III CASSIOPEIA trial, reported in The Lancet and presented at the 24th Annual Congress of the European Hematology Association (EHA; Abstract S145) by Moreau et al, daratumumab plus bortezomib/thalidomide/dexamethasone (D-VTd) given before and after autologous stem cell transplantation...
2019 ASCO: 3-Year Outcomes in the KRISTINE Trial on Neoadjuvant Trastuzumab Emtansine Plus Pertuzumab in HER2-Positive Breast Cancer
As reported at the 2019 ASCO Annual Meeting (Abstract 500) and in the Journal of Clinical Oncology by Hurvitz et al, 3-year outcomes in the phase III KRISTINE trial showed that neoadjuvant trastuzumab emtansine (T-DM1) plus pertuzumab was associated with increased risk of event-free survival events ...
TONIC: PD-1 Blockade in Metastatic Triple-Negative Breast Cancer
Clinical and translational data from the TONIC trial, published in a research letter by Voorwerk et al in Nature Medicine, indicated that short-term doxorubicin and cisplatin may induce a more favorable tumor microenvironment and increase the likelihood of response to programmed cell death protein...
KEYNOTE-001: 5-Year Overall Survival With Pembrolizumab in Advanced NSCLC
Long-term follow-up of the phase I KEYNOTE-001 study reported in the Journal of Clinical Oncology by Garon et al showed that pembrolizumab monotherapy was associated with an estimated 5-year overall survival of 23.2% for treatment-naive patients and 15.5% for previously treated patients with...
MAIA Trial: Addition of Daratumumab to Lenalidomide/Dexamethasone in Untreated Myeloma Ineligible for ASCT
In the phase III MAIA trial reported in The New England Journal of Medicine, Facon et al found that the addition of daratumumab to lenalidomide/dexamethasone significantly improved progression-free survival in previously untreated multiple myeloma ineligible for autologous stem cell transplantation ...
FDA Pipeline: Designations and Reviews in Myelofibrosis, Myelodysplastic Syndromes, Biliary Tract Cancer, and T-Cell Receptor Therapy
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for momelotinib in myelofibrosis, granted Priority Review to a biologics license application for luspatercept in myelodyslastic syndromes and beta-thalassemia, granted Orphan Drug designation for a new chemical...
Resuming Immune Checkpoint Inhibitor Therapy After Immune-Mediated Diarrhea and Colitis
In a retrospective multicenter study reported in the Journal of Clinical Oncology, Abu-Sbeih et al found that approximately one-third of patients resuming immune checkpoint inhibitor therapy after improvement in immune-mediated diarrhea and colitis experienced a recurrence of the adverse effect....
2019 ASCO: OPTiM Study on T-VEC for Unresectable Melanoma
New research on the immunotherapy talimogene laherparepvec (T-VEC)—an injectable oncolytic virus—for patients with unresectable melanoma was presented by Milhem et al at the 2019 ASCO Annual Meeting (Abstract 9524). Researchers reported the ad hoc analysis of progression-free survival...
Sara A. Hurvitz, MD, on HER2-Positive Breast Cancer: KRISTINE Trial on Neoadjuvant Trastuzumab, Pertuzumab, and Chemotherapy
Sara A. Hurvitz, MD, of the David Geffen School of Medicine, University of California Los Angeles, discusses 3-year outcomes from the first phase III study to test a non-conventional regimen for the neoadjuvant and adjuvant treatment of HER2-positive breast cancer (Abstract 500).
2019 ASCO: Combination Therapy With SurVaxM in Newly Diagnosed Glioblastoma
Ahluwalia et al shared research results on SurVaxM at the 2019 ASCO Annual Meeting, reporting that combination therapy with the immunotherapy vaccine was more effective than standard therapy for nearly all patients with newly diagnosed glioblastoma in a phase II trial (Abstract 2016). SurVaxM...
2019 ASCO: CLL14 Trial Evaluates First-Line Venetoclax/Obinutuzumab in Previously Untreated CLL
The phase III CLL14 trial—reported by Fischer et al at the 2019 ASCO Annual Meeting (Abstract 7502) and in The New England Journal of Medicine—found that the BCL2 inhibitor venetoclax plus the monoclonal antibody obinutuzumab prolonged progression-free survival vs obinutuzumab and...
CheckMate 205: Nivolumab in Newly Diagnosed, Advanced Classical Hodgkin Lymphoma
Findings in a cohort of the phase II CheckMate 205 study, reported in the Journal of Clinical Oncology by Ramchandren et al, indicate that nivolumab monotherapy followed by nivolumab plus doxorubicin, vinblastine, and dacarbazine (N-AVD) is highly active in newly diagnosed, advanced-stage classical ...
FDA Approves Pembrolizumab for the First-Line Treatment of Head and Neck Squamous Cell Carcinoma
On June 10, the U.S. Food and Drug Administration (FDA) approved the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was...
FDA Approves Polatuzumab Vedotin-piiq in Combination With Bendamustine and a Rituximab Product for DLBCL
On June 10, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin-piiq (Polivy), a CD79b-directed antibody-drug conjugate, in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma...
Adverse Events and Outcomes in Patients Receiving Anti–PD-1/PD-L1 Antibody Treatment for Advanced Urothelial Cancer
In an analysis reported in the Journal of Clinical Oncology, Maher et al found that treatment-related adverse events of special interest and immune-mediated adverse events were more common among patients with advanced urothelial cancer with vs without response to anti–programmed cell death...
FDA Pipeline: Reviews and Designations in Multiple Myeloma, Lymphoma, Prostate Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review for daratumumab in combination with a triplet therapy in multiple myeloma, Breakthrough Therapy designation to copanlisib for marginal zone lymphoma, and Fast Track designation for ARV-110 in metastatic...
2019 ASCO: NEOSTAR: Neoadjuvant Nivolumab Plus Ipilimumab in Early-Stage, Resectable NSCLC
Neoadjuvant treatment with nivolumab plus ipilimumab resulted in an overall major pathologic response rate of 33% of treated patients with early-stage, resectable non–small cell lung cancer (NSCLC). With these results, the combination immunotherapy met the prespecified trial...
2019 ASCO: Rituximab, Lenalidomide, and Ibrutinib Prior to Chemotherapy in DLBCL
Results of the phase II Smart Start trial revealed that combination targeted therapy consisting of rituximab, lenalidomide, and ibrutinib had an 84.6% overall response rate (ORR) and 38.5% complete response rate (CRR) when given prior to any chemotherapy for newly diagnosed patients with a...
Ahmad A. Tarhini, MD, PhD, on High-Risk Melanoma: Adjuvant Ipilimumab vs High-Dose Interferon-α2b
Ahmad A. Tarhini, MD, PhD, of Emory University and Winship Cancer Institute, discusses phase III findings from the U.S. Intergroup E1609 trial, which showed survival benefits for patients with resected high-risk melanoma—for the first time in the history of melanoma adjuvant therapy (Abstract...
IMpower130: Addition of First-Line Atezolizumab to Chemotherapy in Metastatic Nonsquamous NSCLC
As reported in The Lancet Oncology by West et al, the phase III IMpower130 trial found that the addition of atezolizumab to carboplatin plus nab-paclitaxel significantly improved overall and progression-free survival in first-line treatment of stage IV nonsquamous non–small cell lung cancer...
Javier Sastre, MD, PhD, on Colorectal Cancer: Bevacizumab and FOLFOXIRI in Metastatic Disease
Javier Sastre, MD, PhD, of Hospital Clinico San Carlos, discusses phase III findings on the assessment of circulating tumor cells as a prognostic factor and FOLFOXIRI plus bevacizumab combination outcomes for patients with poor-prognosis colorectal cancer (Abstract 3507).
Ziad Bakouny, MD, and Toni K. Choueiri, MD, on Renal Cell Carcinoma: Checkpoint Inhibitors and Genomic Characterization of Sarcomatoid/Rhabdoid Disease
Toni K. Choueiri, MD, and Ziad Bakouny, MD, both of Dana-Farber Cancer Institute, discuss a retrospective review of genomically profiled patients with sarcomatoid/rhabdoid renal cell cancer who were found to have better outcomes with immune checkpoint inhibitors and to harbor mutations associated...
Miriam Knoll, MD, and Richard J. White, DO, on Non–Small Cell Lung Cancer: Predicting Radiotherapy/Immunotherapy Treatment Outcomes
Miriam Knoll, MD, of Hackensack University Medical Center, and Richard J. White, DO, of Allegheny Health Network, discuss improved overall survival among younger female patients with non–small cell lung cancer who have a lower comorbidity score, lower grade, private insurance, and treatment with...
Yoland C. Antill, MD, on Endometrial Cancer: PHAEDRA Trial on Durvalumab and Mismatch Repair Status
Yoland C. Antill, MD, of Cabrini Health, discusses phase II data on the effect of durvalumab, a PD-L1 inhibitor, as a single agent in the setting of recurrent or advanced endometrial cancer. Her research compares the response in mismatch repair–deficient and –proficient tumors (Abstract 5501).
2019 ASCO: Enfortumab Vedotin Shows Activity in Previously Treated, Locally Advanced or Metastatic Urothelial Cancer
The single-arm, phase II EV-201 trial showed treatment with enfortumab vedotin—an agent targeting Nectin-4, a protein found in 97% of urothelial cancers—produced responses in 44% of patients with locally advanced or metastatic forms of urothelial cancer. Patients had previously been...
David J. Kwiatkowski, MD, PhD, on Non–Small Cell Lung Cancer: Neoadjuvant Immunotherapy for Resectable Disease
David J. Kwiatkowski, MD, PhD, of Brigham and Women’s Hospital and Dana-Farber Cancer Institute, discusses an interim analysis and biomarker data from a multicenter study showing that 19% of patients with NSCLC had a major pathologic response to preoperative treatment with atezolizumab (Abstract...
Kamran A. Ahmed, MD, on Cervical Cancer: Stereotactic Body Radiation Therapy Plus Atezolizumab
Kamran A. Ahmed, MD, of the H. Lee Moffitt Cancer Center and Research Institute, reports on a trial in progress that is investigating whether treatment with atezolizumab plus hypofractionated radiation therapy will improve the objective response rate compared with atezolizumab alone in patients...
2019 ASCO: Novel Immunotherapy for Recurrent, Metastatic, or Persistent Cervical Cancer
There is a high, unmet need for effective treatments for patients with recurrent, metastatic, or persistent cervical cancer—most patients are young, and survival rates are poor. Adoptive cell transfer using tumor-infiltrating lymphocytes (TILs) has demonstrated durable responses in some...
2019 ASCO: KEYNOTE-062: Pembrolizumab With or Without Chemotherapy vs Chemotherapy in Advanced Gastric or GEJ Adenocarcinoma
The randomized, phase III KEYNOTE-062 trial achieved its primary endpoint, showing that for patients with programmed cell death ligand 1 (PD-L1)-positive, HER2-negative, advanced gastric or gastroesophageal junction (GEJ) cancer, initial therapy with pembrolizumab resulted in noninferior overall...
2019 ASCO: KEYNOTE-001: 5-Year Survival Data for Patients With Advanced NSCLC Treated With Pembrolizumab
Five-year data from the phase Ib KEYNOTE-001 trial showed that treatment with pembrolizumab was safe and effective and substantially increased overall survival in patients with advanced non–small cell lung cancer (NSCLC). Specifically, 23.2% of people who had not previously been treated with...
2019 ASCO: Final Analysis of KEYNOTE-048: First-Line Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
The phase III KEYNOTE-048 trial is examining the efficacy of pembrolizumab alone, pembrolizumab/cisplatin or carboplatin/fluorouracil (5-FU), or cetuximab/cisplatin or carboplatin/5-FU as first-line therapy for recurrent or metastatic head and neck squamous cell carcinoma. At the second interim...
Addition of Bevacizumab to Carboplatin/Pemetrexed in Nonsquamous NSCLC
New research published by Bagley et al in JNCCN—Journal of the National Comprehensive Cancer Network used a large real-world data set to demonstrate a modest but consistent survival benefit associated with adding bevacizumab to carboplatin/pemetrexed in advanced nonsquamous non–small...
Polatuzumab Vedotin and Immunochemotherapy in Previously Untreated Diffuse Large B-Cell Lymphoma
As reported in The Lancet Oncology, Tilly et al found that the combination of polatuzumab vedotin, an antibody-drug conjugate targeting the CD79b component of the B-cell receptor, with immunochemotherapy showed high response rates in the phase II portion of a phase I/II study in previously...
CheckMate 032: Extended Follow-up of Nivolumab and Nivolumab/Ipilimumab Cohorts in Previously Treated Metastatic Urothelial Carcinoma
As reported in the Journal of Clinical Oncology by Sharma et al, follow-up of the cohort receiving nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg the phase I/II CheckMate 032 trial showed the regimen produced high levels of activity in platinum-treated, unresectable, locally advanced or metastatic ...
IMmotion151: First-Line Atezolizumab/Bevacizumab vs Sunitinib in Metastatic Renal Cell Carcinoma
In the phase III IMmotion151 trial reported in The Lancet, Rini et al found that atezolizumab plus bevacizumab prolonged progression-free survival vs sunitinib in patients with previously untreated, programmed cell death ligand 1 (PD-L1)-positive, metastatic renal cell carcinoma. Study Details...
Early-Stage Study of Nivolumab Alone or in Combination With Cisplatin/Gemcitabine in Biliary Tract Cancer
In a Japanese phase I trial reported by Ueno et al in The Lancet Gastroenterology & Hepatology, researchers found nivolumab showed activity and had a manageable safety profile in patients with unresectable or recurrent biliary tract cancer. Methods The open-label phase I trial was conducted...
Predicting Response to Immunotherapy in Squamous Cell Carcinoma
According to a study published by Kacew et al in the European Journal of Cancer, copy number alterations in the chromosome 3q arm may be linked to immunotherapy response in patients with cutaneous squamous cell carcinoma. In fact, this and other genetic markers may prove to be useful...
Tumor Mutational Burden as a Marker of Response to Immunotherapy in MSI-High Metastatic Colorectal Cancer
Foundational research recently published by Schrock et al in Annals of Oncology may help patients with microsatellite instability (MSI)-high metastatic colorectal cancer decide whether to choose immunotherapy or chemotherapy as their first treatment option. “Immunotherapy is the new,...
Axitinib Plus Pembrolizumab in Advanced Sarcomas
In a phase II trial reported in The Lancet Oncology, Wilky et al found evidence of activity of axitinib plus pembrolizumab in advanced sarcomas, including alveolar soft-part sarcoma. Study Details The study involved 33 patients with advanced or metastatic sarcomas, including alveolar soft-part...
Addition of Decitabine to Camrelizumab in Relapsed or Refractory Classical Hodgkin Lymphoma
In a single-center phase II trial reported in the Journal of Clinical Oncology, Nie et al found a higher complete response rate with the addition of low-dose decitabine to the programmed cell death protein 1 (PD-1) inhibitor camrelizumab in anti–PD-1 treatment–naive patients with...
Anti-BCMA CAR T-Cell Therapy in Relapsed or Refractory Multiple Myeloma
In a phase I trial reported in The New England Journal of Medicine, Raje et al found that bb2121, a chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen (BCMA), was safe in heavily pretreated patients with relapsed or refractory multiple myeloma. Investigators reported ...
PD-1 Inhibitor–Associated Cutaneous Toxicity and Clinical Outcomes in Advanced Melanoma
In a research letter published in JAMA Oncology, Quach et al found that cutaneous toxicities related to anti–programmed cell death protein 1 (PD-1) treatment—specifically, vitiligo and rash—were associated with improved clinical outcomes in advanced melanoma. Study Details The...
Treatment-Related Adverse Events With PD-1/PD-L1 Inhibitors in Clinical Trials
In a systematic review and meta-analysis reported in JAMA Oncology, Wang et al characterized treatment-related adverse event profiles associated with monotherapy use of programmed cell death protein 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors in clinical trials. Study Details...
Association Between Clinical Outcomes and Patient Characteristics/Genomic Profiles in Lung Cancer
As reported in JAMA, Singal et al used a clinicogenomic database in routine clinical practice to identify associations between treatment outcomes and patient characteristics or tumor genomic profiles in the setting of non–small cell lung cancer (NSCLC). The study cohort of 4,064 patients...
IMblaze370: Atezolizumab With or Without Cobimetinib vs Regorafenib in Previously Treated Advanced Colorectal Cancer
In the phase III IMblaze370 trial reported in The Lancet Oncology, Eng et al found no survival benefit with third-line atezolizumab with or without cobimetinib vs regorafenib in patients with locally advanced or metastatic colorectal cancer. Study Details The open-label trial included 363...
ASH President Comments on Medicare Proposal for CAR T-Cell Therapy
Earlier this week, the Centers for Medicare & Medicaid Services (CMS) proposed to improve the reimbursement currently given to hospitals that provide chimeric antigen receptor T-cell (CAR-T) therapy to patients with blood cancer as part of the Fiscal Year 2020 Inpatient Prospective Payment...
