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Showing 1 - 50Nivolumab/Brentuximab Vedotin in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma
As reported in the Journal of Clinical Oncology by Zinzani et al, findings in a phase II expansion cohort of the CheckMate 436 study indicated high levels of activity with the combination of nivolumab and brentuximab vedotin in relapsed or refractory primary mediastinal large B-cell lymphoma. As...
T-Cell Receptor Gene Therapy in HPV-Associated Epithelial Cancers
In a first-in-human phase I/II study reported in the Journal of Clinical Oncology, Doran et al found that autologous genetically engineered T cells expressing a T-cell receptor directed against the human papillomavirus (HPV)16 E6 oncoprotein were capable of inducing tumor regression in metastatic,...
Pooled Analysis of 4-Year Survival With Nivolumab Therapy in Patients With Previously Treated Advanced NSCLC
In an analysis reported in The Lancet Oncology, Antonia et al identified long-term survival rates with nivolumab therapy in patients with previously treated advanced non–small cell lung cancer (NSCLC). The pooled analysis included data from the CheckMate 017, 057, 063, and 003 trials, each...
Immune-Related Adverse Events Requiring Hospitalization in Patients Receiving Immune Checkpoint Inhibitors
In a single-center analysis reported in the Journal of Oncology Practice, Balaji et al found that immune-related adverse events associated with immune checkpoint inhibitor treatment often require hospitalization and multidisciplinary management. The study involved data from patients who had...
CMS Finalizes Decision to Cover CAR T-Cell Therapy for Medicare Beneficiaries
On August 7, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy among recipients of Medicare benefits. FDA-approved CAR T-cell therapies are approved to...
Comparison of Biomarker Assay Types in Predicting Response to Anti–PD-1/PD-L1 Treatment
In a systematic review and meta-analysis reported in JAMA Oncology, Lu et al found that multiplex immunohistochemistry/immunofluorescence (mIHC/IF) assays appeared to have greater accuracy vs other types of assays in predicting response to anti–programmed cell death protein 1/programmed cell...
Maintenance Bevacizumab, Pemetrexed, or Both in Advanced Nonsquamous NSCLC
In the phase III ECOG-ACRIN 5508 trial, reported in the Journal of Clinical Oncology by Ramalingam et al, maintenance pemetrexed or bevacizumab was associated with no significant improvement in overall survival vs the bevacizumab control group alone, and was associated with greater toxicity in...
What Causes Liver Injury During Treatment With Pembrolizumab?
Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a...
Cell-Free DNA Sequencing Highly Concordant With Tissue-Based Testing in the Detection of Microsatellite Instability Status
Microsatellite instability (MSI) is an important predictive biomarker of response to immune checkpoint blockade in solid cancers. However, despite recommendations by clinical practice guidelines, MSI is often not assessed, usually due to tissue insufficiency, unavailability, or infeasibility....
Ibrutinib/Rituximab vs Standard Chemoimmunotherapy in Previously Untreated CLL
In an interim analysis of the phase III E1912 trial reported in The New England Journal of Medicine, Shanafelt et al found that ibrutinib/rituximab improved progression-free and overall survival vs standard chemoimmunotherapy in patients 70 years old or younger with previously untreated chronic...
Tumor-Associated Antigen Cytotoxic T Cells in Relapsed or Refractory Solid Tumors
In a phase I trial reported in the Journal of Clinical Oncology, Hont et al found that treatment of relapsed or refractory solid tumors with ex vivo expanded autologous multiantigen-associated specific cytotoxic T cells—or, tumor-associated antigen cytotoxic T cells—was safe and showed...
FDA Pipeline: Breakthrough Therapy for Melanoma, Investigational New Drug for Advanced Solid Tumors
This week, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to bempegaldesleukin in combination with nivolumab for advanced melanoma and cleared an investigational new drug application for a phase I trial of SB 11285 in advanced solid tumors. Breakthrough...
Post Hoc 5-Year Follow-up of Pembrolizumab vs Ipilimumab in Advanced Melanoma
In a post hoc 5-year follow-up of the KEYNOTE-006 trial reported in The Lancet Oncology, Robert et al found that pembrolizumab maintained overall and progression-free survival benefits over ipilimumab in patients with advanced melanoma. In the primary analysis from the trial, both pembrolizumab...
Durvalumab With or Without Tremelimumab in Metastatic Pancreatic Cancer
In the first stage of a phase II trial reported in JAMA Oncology, O’Reilly et al found poor activity of durvalumab with or without tremelimumab in metastatic pancreatic ductal adenocarcinoma. Owing to the lack of efficacy, study expansion was not pursued. The lead-in open-label safety ...
Palbociclib Plus Cetuximab in Platinum- and Cetuximab-Resistant HPV-Unrelated Head and Neck Cancer
In a phase II study reported in The Lancet Oncology, Adkins et al found that the combination of the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib and the EGFR inhibitor cetuximab showed activity in patients with either platinum- or cetuximab-resistant human papillomavirus...
FDA Approves Pembrolizumab for Some Patients With PD-L1–Positive Esophageal Cancer
On July 30, the U.S. Food and Drug Administration (FDA) approved the programmed cell death protein 1 inhibitor pembrolizumab (Keytruda) as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed ...
Rituximab Maintenance in Previously Untreated Follicular Lymphoma: 9-Year Follow-up
As reported in the Journal of Clinical Oncology by Bachy et al, 9-year follow-up of the phase III PRIMA trial indicated a maintained progression-free survival benefit of maintenance rituximab vs observation following first-line induction therapy for follicular lymphoma. As in the prior reports from ...
Five-Year Survival in Heavily Pretreated Patients Receiving Nivolumab Monotherapy
As reported by Topalian et al in JAMA Oncology, long-term follow up of patients from a phase I expansion cohort study indicated 5-year overall survival rates of 34.2%, 27.7%, and 15.6% among patients who received nivolumab monotherapy for advanced melanoma, renal cell carcinoma (RCC), and...
FDA Pipeline: Label Update for Durvalumab in NSCLC; Applications Accepted in Epithelioid Sarcoma, AML
Recently, the U.S. Food and Drug Administration (FDA) approved the inclusion of overall survival from the PACIFIC trial in the U.S. prescribing information for durvalumab and accepted applications for a new drug in the treatment of epithelioid sarcoma and two orphan drugs in the treatment of acute...
Pembrolizumab After Stereotactic Body Radiotherapy in Advanced NSCLC
In a Dutch phase II study reported in JAMA Oncology, Theelen et al found that although use of stereotactic body radiotherapy prior to pembrolizumab increased the objective response rate vs pembrolizumab alone in metastatic non–small cell lung cancer (NSCLC), the difference did not meet study...
FDA Grants Breakthrough Therapy Designation to Pembrolizumab Plus Lenvatinib in Advanced HCC
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the programmed cell death protein 1 inhibitor pembrolizumab in combination with the multiple kinase inhibitor lenvatinib for the potential first-line treatment of patients with advanced unresectable...
Immunotherapy After Locally Ablative Therapy for Oligometastatic NSCLC
In a single-center phase II trial reported in JAMA Oncology, Bauml et al found that pembrolizumab given after locally ablative therapy appeared to be associated with improved outcomes in patients with oligometastatic non–small cell lung cancer (NSCLC). In the study, 45 evaluable...
Maintenance Panitumumab vs Panitumumab/Fluorouracil/Leucovorin in RAS Wild-Type Metastatic Colorectal Cancer
In an Italian phase II trial reported in JAMA Oncology, Pietrantonio et al found that maintenance panitumumab alone was inferior in terms of progression-free survival (PFS) compared to maintenance panitumumab plus fluorouracil/leucovorin in RAS wild-type metastatic colorectal cancer. Study Details ...
Ramucirumab Plus Pembrolizumab in Previously Treated Advanced Gastroesophageal Cancer, NSCLC, and Urothelial Carcinoma
Results from a phase IB trial expansion stage reported in The Lancet Oncology by Herbst et al showed the combination of ramucirumab plus pembrolizumab had manageable toxicity and antitumor activity in previously treated advanced gastroesophageal cancer, non–small cell lung cancer (NSCLC), and ...
Incidence of Olaratumab Infusion-Related Reactions
In a study reported in the Journal of Oncology Practice, Van Tine et al found that infusion-related reactions occurred in 14.4% of patients receiving olaratumab in clinical trials, with grade ≥ 3 events occurring in 2.3%. (Olaratumab was withdrawn from the global market on April 25, 2019, based...
Immune Checkpoint Inhibitor Rechallenge After Immune-Related Adverse Events
In a study reported in JAMA Oncology, Simonaggio et al found that rechallenge with an immune checkpoint inhibitor after occurrence of immune-related adverse events was associated with occurrence of an immune-related adverse event in approximately half of patients, with no increase in severity....
Benefit Seen With Targeted Therapies in Elderly and Medically Complex Patients With Metastatic RCC
Many elderly and medically complex patients with metastatic renal cell carcinoma (RCC)—who are often underrepresented in clinical trials—saw overall survival benefits from treatment with targeted therapies, according to a study that analyzed 13 years of data on Medicare patients...
GOG-0218: Final Overall Survival Results for Addition of Bevacizumab to Chemotherapy in Ovarian Cancer
The final overall survival analysis of the phase III GOG-0218 trial, reported in the Journal of Clinical Oncology by Tewari et al, showed no benefit of adding bevacizumab to chemotherapy in women with newly diagnosed, incompletely resected, advanced ovarian cancer. The trial included 1,873 women...
Activity of Niraparib Plus Pembrolizumab in Recurrent Ovarian Carcinoma
In a pooled analysis of the phase I/II TOPACIO/KEYNOTE-162 study reported in JAMA Oncology, Konstantinopoulos et al found evidence of activity of combined niraparib and pembrolizumab in a cohort of patients with recurrent ovarian carcinoma. Study Details The analysis included 60 evaluable women...
Treatment of Immune Checkpoint Inhibitor Immune-Related Cutaneous Adverse Events
In a study reported in the Journal of Clinical Oncology, Phillips et al found that immune-related cutaneous adverse events in patients receiving immune checkpoint inhibitors generally responded to symptom- and phenotype-directed dermatologic therapies, and that biologic therapies were effective in...
ECHO-301/KEYNOTE-252: Addition of Epacadostat to Pembrolizumab in Unresectable or Metastatic Melanoma
As reported in The Lancet Oncology by Long et al, the phase III ECHO-301/KEYNOTE-252 trial showed no improvement in progression-free or overall survival with the addition of the IDO1 inhibitor epacadostat to pembrolizumab in unresectable stage III or stage IV melanoma. Study Details In the...
Multidisciplinary Approach for Addressing Immunotherapy-Related Toxicities
New research published in JNCCN—Journal of the National Comprehensive Cancer Network and presented by Jarushka Naidoo, MBBCh, at the NCCN 2019 Annual Conference suggests that institutions and networks that utilize immunotherapy should consider establishing multidisciplinary teams for...
FDA Approves Daratumumab in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed, Transplant-Ineligible Patients With Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received approval ...
15-ICML: Final Data From ALCANZA: Brentuximab Vedotin for CD30-Positive CTCL
Final analyses from the ALCANZA study, a phase III trial investigating brentuximab vedotin vs physician’s choice for the treatment of CD30-positive cutaneous T-cell lymphoma (CTCL), were presented by Horwitz et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract...
Outcomes of Immune Checkpoint Inhibitor Treatment in Patients With Advanced NSCLC Receiving Baseline Corticosteroids
In a single-center study reported in the Journal of Clinical Oncology, Ricciuti et al found better outcomes with immune checkpoint inhibitor treatment among patients with advanced non–small cell lung cancer (NSCLC) receiving baseline prednisone equivalent of ≥ 10 mg daily for...
Niraparib Plus Pembrolizumab in Advanced Triple-Negative Breast Cancer
In the phase II TOPACIO/KEYNOTE-162 trial reported in JAMA Oncology, Vinayak et al found evidence of activity of combined niraparib and pembrolizumab in a cohort of patients with advanced or metastatic triple-negative breast cancer, with higher response rates seen in patients with BRCA mutations or ...
15-ICML: Post Hoc Analysis of MAVORIC Study: Mogamulizumab in Patients With Previously Treated Cutaneous T-Cell Lymphoma
The MAVORIC study—presented by Scarisbrick et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 034)—examined the efficacy of mogamulizumab, a monoclonal antibody that targets the CC chemokine receptor 4 (CCR4), in patients with previously treated mycosis...
Activity 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...
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...
