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immunotherapy

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...

health-care policy
immunotherapy

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...

solid tumors
immunotherapy

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...

lung cancer
immunotherapy

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...

symptom management
immunotherapy

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...

solid tumors
immunotherapy

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....

leukemia
immunotherapy

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...

solid tumors
immunotherapy

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...

solid tumors
skin cancer
immunotherapy

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...

skin cancer
immunotherapy

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...

pancreatic cancer
immunotherapy

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 ...

head and neck cancer
immunotherapy

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...

gastroesophageal cancer
immunotherapy

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 ...

lymphoma
immunotherapy

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 ...

kidney cancer
lung cancer
skin cancer
immunotherapy

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...

leukemia
lung cancer
sarcoma
immunotherapy

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...

lung cancer
immunotherapy

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...

hepatobiliary cancer
immunotherapy

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...

lung cancer
immunotherapy

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...

colorectal cancer
immunotherapy

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 ...

lung cancer
gastroesophageal cancer
bladder cancer
gastrointestinal cancer
immunotherapy

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 ...

issues in oncology
immunotherapy

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...

issues in oncology
symptom management
immunotherapy

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....

kidney cancer
issues in oncology
immunotherapy

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...

gynecologic cancers
immunotherapy

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...

gynecologic cancers
immunotherapy

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...

symptom management
immunotherapy

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...

skin cancer
immunotherapy

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...

symptom management
immunotherapy

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...

multiple myeloma
immunotherapy

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 ...

lymphoma
skin cancer
immunotherapy

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...

lung cancer
immunotherapy

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...

breast cancer
immunotherapy

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 ...

lymphoma
immunotherapy

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...

kidney cancer
immunotherapy

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 ...

skin cancer
immunotherapy

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...

lymphoma
immunotherapy

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...

leukemia
immunotherapy

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 ...

multiple myeloma
immunotherapy

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...

breast cancer
immunotherapy

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 ...

breast cancer
immunotherapy

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...

lung cancer
immunotherapy

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...

multiple myeloma
immunotherapy

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 ...

breast cancer
immunotherapy

Peter Schmid, MD, PhD, and Hope S. Rugo, MD, on Breast Cancer: Next Steps in Immunotherapy

Hope S. Rugo, MD, of the University of California, San Francisco, and Peter Schmid, MD, PhD, of Barts Cancer Institute, Queen Mary University of London, discuss ongoing trials of immunotherapy for early triple-negative breast cancer; immunotherapy in other disease subtypes such as estrogen...

colorectal cancer
hepatobiliary cancer
myelodysplastic syndromes
immunotherapy

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...

symptom management
immunotherapy

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....

skin cancer
immunotherapy

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...

breast cancer
immunotherapy

Peter Schmid, MD, PhD, and Hope S. Rugo, MD, on Metastatic Triple-Negative Breast Cancer: Atezolizumab Plus Nab-paclitaxel

Hope S. Rugo, MD, of the University of California, San Francisco, and Peter Schmid, MD, PhD, of Barts Cancer Institute, Queen Mary University of London, discuss an update of the IMpassion130 interim overall survival analysis of atezolizumab plus nab-paclitaxel in previously untreated locally...

breast cancer
immunotherapy

Hope S. Rugo, MD, and Matteo Lambertini, MD, PhD, on the SOPHIA Trial in HER2-Positive Metastatic Breast Cancer: Chemotherapy Plus Margetuximab vs Trastuzumab

Matteo Lambertini, MD, PhD, of the University of Genova and Policlinico San Martino Hospital, and Hope S. Rugo, MD, of the University of California, San Francisco, discuss findings from the SOPHIA trial on margetuximab plus chemotherapy vs trastuzumab plus chemotherapy in patients with...

gynecologic cancers
immunotherapy

Mansoor Raza Mirza, MD, and Don S. Dizon, MD, on Recurrent Platinum-Sensitive Ovarian Cancer: Niraparib Plus Bevacizumab

Don S. Dizon, MD, of the Lifespan Cancer Institute, and Mansoor Raza Mirza, MD, of Copenhagen University Hospital, discuss study findings that showed, compared with niraparib alone, niraparib plus bevacizumab improved progression-free survival in women with recurrent platinum-sensitive ovarian...

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