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issues in oncology
immunotherapy

Uncommon Lethal Complications of Immune Checkpoint Inhibitors

In a systematic review and meta-analysis reported in JAMA Oncology, Wang et al identified frequency and types of fatal toxic effects in patients receiving immune checkpoint inhibitor therapy. Study Details The study involved analysis of fatal immune checkpoint inhibitor–associated toxic...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Pertuzumab and Trastuzumab Plus Chemotherapy in HER2-Positive, Metastatic Gastric or Gastroesophageal Junction Cancer

As reported in The Lancet Oncology by Tabernero et al, the phase III JACOB trial showed no significant overall survival benefit of adding pertuzumab (Perjeta) to trastuzumab (Herceptin) plus chemotherapy in first-line treatment of HER2-positive metastatic gastric or gastroesophageal junction...

prostate cancer
immunotherapy

Mismatch Repair Mutations and Immunotherapy in Prostate Cancer

A group of men with especially aggressive prostate cancer may respond unusually well to immunotherapy, according to a study published by Rodrigues et al in the Journal of Clinical Investigation. The research offers the possibility of effective treatment, with clinical trials already underway. An...

lung cancer
immunotherapy

Bevacizumab Treatment Beyond Disease Progression in Advanced NSCLC

As reported in JAMA Oncology by Gridelli et al, the phase IIIB AvaALL trial did not show improved overall survival with continued bevacizumab (Avastin) treatment beyond disease progression in patients with advanced non–small cell lung cancer (NSCLC), although some improvements in subsequent...

Issues in Oncology
Immunotherapy

Expert Point of View: Ian Olver, MD, PhD

COMMENTING ON the importance of this topic at a press conference during the 2018 Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) Annual Meeting, Ian Olver, MD, PhD, Immediate Past President of MASCC and Director of the University of...

Issues in Oncology
Immunotherapy

Cardiac Issues Related to Checkpoint Inhibitors Still Largely Understudied

IMMUNE CHECKPOINT inhibitors represent a giant step forward in the treatment of many cancers, and as these agents have “come of age” in the past few years, so has the collective understanding of their potential for causing adverse events. Although checkpoint inhibitors are known to be associated...

sarcoma
immunotherapy

Immune Checkpoint Inhibitors in Patients With HIV-Associated Kaposi Sarcoma

Widespread use of antiretroviral therapy in the treatment of patients infected with human immunodeficiency virus (HIV) has led to a decline in the incidence of HIV-related Kaposi sarcoma, an incurable malignancy associated with HIV. Nevertheless, about 15% of these patients will go on to...

breast cancer
immunotherapy

Adding First-Line Pertuzumab to Trastuzumab Plus Aromatase Inhibitor in Advanced Breast Cancer

In the phase II PERTAIN trial reported in the Journal of Clinical Oncology, Rimawi et al found that adding pertuzumab to trastuzumab plus an aromatase inhibitor improved progression-free survival in patients with advanced HER2-positive, hormone receptor–positive breast cancer. Study Details ...

cns cancers
skin cancer
immunotherapy

Immunotherapy Combination in Melanoma Brain Metastases

In the phase II CheckMate 204 study reported in The New England Journal of Medicine, Tawbi et al found that combined nivolumab (Opdivo) and ipilimumab (Yervoy) produced a high rate of intracranial clinical benefit in patients with melanoma brain metastases. Study Details The study included 94...

gastroesophageal cancer
immunotherapy

Immunotherapy in Advanced Esophagogastric Cancer

As reported in the Journal of Clinical Oncology by Janjigian et al, the phase I/II CheckMate-032 study has shown activity of nivolumab (Opdivo) and nivolumab plus ipilimumab (Yervoy) in advanced esophagogastric cancer. In the esophagogastric cohort of the multicohort study, 160 patients (who...

multiple myeloma
immunotherapy

FDA Accepts sBLA for Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for elotuzumab (Empliciti) in combination with pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who...

lung cancer
immunotherapy

Baseline Steroids and Efficacy of PD-1/PD-L1 Inhibitors in NSCLC

In a study reported in the Journal of Clinical Oncology, Arbour et al found that baseline treatment with corticosteroids was associated with poorer efficacy of programmed cell death protein 1 (PD-1) or programmed death cell ligand 1 (PD-L1) inhibitors in patients with non–small cell lung...

leukemia
lymphoma
immunotherapy

CAR T-Cell Therapy in Europe: Differing Decisions on Approval of Two Agents

The European Commission (EC) recently approved the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) in the European Union (EU) for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is...

lymphoma
immunotherapy

FDA Approves Ibrutinib Plus Rituximab for Waldenström’s Macroglobulinemia

The U.S. Food and Drug Administration (FDA) has approved ibrutinib (Imbruvica) plus rituximab (Rituxan) for the treatment of adult patients with Waldenström's macroglobulinemia (WM). With this approval, the ibrutinib prescribing information now includes combination use with rituximab,...

Leukemia
Immunotherapy

Blinatumomab in Adult and Pediatric Patients With B-Cell Precursor Acute Lymphoblastic Leukemia

EARLY IN 2018, blinatumomab (Blincyto) was granted accelerated approval for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease ≥ 0.1%.1,2 Supporting Efficacy Data APPROVAL WAS...

skin cancer
immunotherapy

Gene-Expression Predictor for Immunotherapy Response in Melanoma

In a new study, researchers developed a gene expression predictor that can indicate whether melanoma in a specific patient is likely to respond to treatment with immune checkpoint inhibitors. Their research was published by Auslander et al in Nature Medicine. “There is a critical need to be...

head and neck cancer
immunotherapy

Induction Chemotherapy Followed by Cetuximab and Radiotherapy vs Concurrent Chemoradiotherapy in Head and Neck Cancer

As reported in the Journal of Clinical Oncology by Geoffrois et al, the European phase III GORTEC (Groupe Oncologie Radiothèrapie Tête et Cou) 2007-02 trial has shown no improvement in progression-free survival with induction chemotherapy followed by cetuximab and radiotherapy (RT) vs...

lung cancer
immunotherapy

FDA Approves Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC

Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum as first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Pembrolizumab...

bladder cancer
immunotherapy

FDA Updates Prescribing Information for Pembrolizumab and Atezolizumab in Urothelial Carcinoma

On August 16, 2018, the U.S. Food and Drug Administration (FDA) updated the prescribing information for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) to require the use of an FDA-approved companion diagnostic test to determine programmed cell death ligand 1 (PD-L1) levels in tumor tissue...

head and neck cancer
immunotherapy

Cetuximab With Radiotherapy Found to Be Inferior to Standard Treatment in HPV-Positive Oropharyngeal Cancer

An interim analysis of data from a randomized clinical trial of patients with human papillomavirus (HPV)-positive oropharyngeal cancer found that treatment with radiation therapy and cetuximab (Erbitux) is associated with worse overall and progression-free survival compared to the current standard...

cns cancers
immunotherapy

Bevacizumab and Temozolomide in First Recurrence of Glioma Without 1p/19q Codeletion

In a phase II trial funded by the European Organisation for Research and Treatment of Cancer and reported in The Lancet Oncology, van den Bent et al found no evidence of a survival benefit with the addition of bevacizumab (Avastin) to temozolomide in patients with a first recurrence of World Health ...

lung cancer
immunotherapy

FDA Approves Nivolumab for Certain Patients With Previously Treated Small Cell Lung Cancer

Today, nivolumab (Opdivo) received approval from the U.S. Food and Drug Administration (FDA) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been...

leukemia
immunotherapy

Bendamustine Followed by Obinutuzumab Plus Venetoclax in Treatment-Naive and Relapsed/Refractory CLL

In a German phase II trial reported in The Lancet Oncology, Cramer et al found promising response rates with bendamustine followed by obinutuzumab (Gazyva) plus venetoclax (Venclexta) in both treatment-naive and relapsed/refractory chronic lymphocytic leukemia (CLL). In the trial, patients with an ...

Hematologic Malignancies
Multiple Myeloma
Immunotherapy

Daratumumab in Newly Diagnosed Transplant-Ineligible Multiple Myeloma

In May 2018, daratumumab (Darzalex) was approved for use in combination with VMP (bortezomib, melphalan, and prednisone) in the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1 Supporting Efficacy Data Approval was based on...

Lymphoma
Immunotherapy

For Hodgkin Lymphoma, PD-1 Blockade Is Not the Final Answer

Although programmed cell death protein 1 (PD-1) blockade is highly effective in Hodgkin lymphoma, not all patients respond, and not all responses are durable. Stephen M. Ansell, MD, PhD, Chair of the Mayo Clinic Lymphoma Group and Professor of Medicine at the Mayo Clinic, Rochester, described...

colorectal cancer
immunotherapy

FDA Grants Breakthrough Therapy Designation for Encorafenib Plus Binimetinib and Cetuximab in BRAF V600E–Mutant Metastatic Colorectal Cancer

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for encorafenib (Braftovi) in combination with binimetinib (Mektovi) and cetuximab (Erbitux) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC), as detected by...

Palliative Care
Immunotherapy

Meeting the Challenges of Immunotherapy-Related Toxicities

In 2011, the U.S. Food and Drug Administration (FDA) approved ipilimumab (Yervoy), an anticytotoxic T-lymphocyte– associated antigen 4 (CTLA-4), the first checkpoint inhibitor for the treatment of advanced melanoma.1 Since then, several more checkpoint inhibitors directed at both the programmed...

leukemia
issues in oncology
immunotherapy

Guidelines for Pediatric CAR T-Cell Therapy Developed

Almost 1 year after the U.S. Food and Drug Administration (FDA) approval of chimeric antigen receptor (CAR) T-cell therapy for children with acute lymphoblastic leukemia (ALL), researchers at The University of Texas MD Anderson Cancer Center and the Pediatric Acute Lung Injury and...

lung cancer
immunotherapy

Osimertinib Resistance Mechanisms in EGFR T790M–Positive NSCLC

In a study reported in JAMA Oncology, Oxnard et al found early resistance and a number of competing resistance mechanisms in acquired osimertinib (Tagrisso) resistance associated with loss of the T790M mutation conferring resistance to prior EGFR tyrosine kinase inhibitor (TKI) treatment in...

Lung Cancer
Immunotherapy

Durvalumab After Chemoradiation in Unresectable Stage III NSCLC

Early in 2018, durvalumab (Imfinzi) was approved for the treatment of unresectable stage III non–small cell lung cancer (NSCLC) that has not progressed following concurrent platinum-based chemotherapy and radiation therapy.1,2 Supporting Efficacy Data Approval was based on a planned interim...

Lymphoma
Immunotherapy

More Antibody-Drug Conjugates Expected to Impact Treatment of Lymphoma

FOR THE TREATMENT of lymphoma, antibody-drug conjugates (ADCs) are becoming an important class of drugs, as described at the 2018 Pan Pacific Lymphoma Conference by Brad Kahl, MD, Professor of Medicine at Washington University School of Medicine, St. Louis.1  “We have one ADC—brentuximab vedotin...

Lymphoma
Immunotherapy

CAR T-Cell Therapy in Lymphoma: Challenges Come With Success

THE EMERGENCE of chimeric antigen receptor (CAR) T-cell therapy has sparked a wave of optimism in hematologic malignancies, but as experience in using CAR T-cell therapy has grown, new challenges have surfaced. A pioneer in the field, David G. Maloney, MD, PhD, enlightened attendees on these issues ...

gynecologic cancer
immunotherapy

FDA Grants Breakthrough Therapy Designation to Lenvatinib Plus Pembrolizumab in Endometrial Carcinoma

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lenvatinib (Lenvima) in combination with pembrolizumab (Keytruda) for the potential treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient...

breast cancer
immunotherapy

Adjuvant Bevacizumab in High-Risk HER2-Negative Breast Cancer

In an article in the Journal of Clinical Oncology, Miller et al reported final results of the Eastern Cooperative Oncology Group phase III E5103 trial, initiated in 2007, which showed no benefit of adding bevacizumab (Avastin) to adjuvant therapy in patients with HER2-negative, node-positive or...

Hematologic Malignancies
Leukemia
Immunotherapy

FDA Approves Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia

On July 20, 2018, the U.S. Food and Drug Administration approved ivosidenib (Tibsovo) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Approval was based on an open-label, single-arm, multicenter...

head and neck cancer
immunotherapy

KEYNOTE-048: Pembrolizumab Monotherapy in Head and Neck Squamous Cell Carcinoma

The phase III KEYNOTE-048 trial, which is investigating pembrolizumab (Keytruda) for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), met a primary endpoint of overall survival (OS) as monotherapy in patients whose tumors expressed programmed cell death ...

breast cancer
gastroesophageal cancer
gastrointestinal cancer
immunotherapy

European Commission Approves Trastuzumab Biosimilar

The European Commission (EC) has approved Trazimera, a biosimilar to trastuzumab (Herceptin), for the treatment of human epidermal growth factor (HER2)–overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. This approval...

lung cancer
immunotherapy

Ado-Trastuzumab Emtansine in HER2-Mutant Lung Cancer

As reported by Li and colleagues in the Journal of Clinical Oncology, the HER2-targeted antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla) showed activity in advanced HER2-mutant lung adenocarcinoma. Study Details The current report involves a cohort of patients with HER2-mutant lung...

gastrointestinal cancer
immunotherapy

Ability of Assay to Predict Response to Immunotherapy in Patients With Advanced Gastric Cancer

Researchers from Samsung Medical Center and Guardant Health, Inc have demonstrated the feasibility of determining a measure analogous to tumor mutation burden, a promising biomarker that may predict patient response to certain immunotherapies, utilizing the Guardant360 assay, a...

lung cancer
immunotherapy

IMpower 132: Atezolizumab in Combination With Pemetrexed and Platinum-Based Chemotherapy in Advanced Nonsquamous NSCLC

The phase III IMpower132 study met its co-primary endpoint of progression-free survival and demonstrated that the combination of atezolizumab (Tecentriq) plus chemotherapy (cisplatin or carboplatin plus pemetrexed [Alimta]) reduced the risk of disease worsening or death compared to chemotherapy...

lymphoma
immunotherapy

Julie M. Vose, MD, MBA, and David G. Maloney, MD, PhD, on NHL: Update on CAR T-Cell Therapies

Julie M. Vose, MD, MBA, of the University of Nebraska Medical Center, and David G. Maloney, MD, PhD, of Fred Hutchinson Cancer Research Center and winner of this year’s Oliver Press Memorial Award, discuss three CAR T-cell products for lymphoma treatment, comparing their efficacy, toxicity, ease of use, and the clinical resources needed.

symptom management
immunotherapy

Susan Blumel, RN, BSN, and Laura J. Zitella, MS, RN, ACNP-BC, AOCN, on Managing Toxicities of Immunotherapy

Susan Blumel, RN, BSN, of the University of Nebraska Medical Center, and Laura J. Zitella, MS, RN, ACNP-BC, AOCN, of Stanford Health Center, discuss immunotherapy, CAR T-cell toxicities, and the principles of team management.

lymphoma
immunotherapy

Stephen M. Ansell, MD, PhD, on Hodgkin Lymphoma: Beyond Checkpoint Inhibitors

Stephen M. Ansell, MD, PhD, of the Mayo Clinic, discusses the efficacy of PD-1 blockade in Hodgkin lymphoma, new findings related to PD-1 therapy, current combination approaches, and future treatments.

Lung Cancer
Immunotherapy

Immunotherapy Gave Me Back My Life

Despite the fact that my father was a smoker and I watched him die a horrible death from lung cancer in the 1970s, until 4 years before my own lung cancer diagnosis in 2012, I, too, was a heavy smoker for most of my adult life. Still, cancer was the farthest thing from my mind when I made an...

Gynecologic Cancers
Immunotherapy

Bevacizumab Plus Chemotherapy in Advanced Ovarian Cancer

ON JUNE 13, 2018, bevacizumab (Avastin) was granted approval for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection1,2. The...

Bladder Cancer
Immunotherapy

No Survival Benefit for Atezolizumab inPD-L1–Positive Urothelial Cancer

As reported in The Lancet by Thomas Powles, MD, of Barts Cancer Institute, Queen Mary University of London, and colleagues, the phase III IMvigor211 trial showed no survival benefit for atezolizumab vs physician’s choice of chemotherapy in platinum-treated locally advanced or metastatic urothelial...

hepatobiliary cancer
immunotherapy

FDA Grants Breakthrough Therapy Designation for Atezolizumab/Bevacizumab Combination as First-Line Treatment for Advanced or Metastatic HCC

The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) as a first-line treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver...

symptom management
immunotherapy

Delayed Skin Effects of Anti–PD-1 Therapy

Patients with cancer receiving anti–programmed cell death protein 1 (anti–PD-1) therapies who develop lesions, eczema, psoriasis, or other forms of autoimmune diseases affecting the skin may experience those adverse reactions on a delay—sometimes even after treatment has...

Colorectal Cancer
Immunotherapy

Nivolumab Plus Low-Dose Ipilimumab Approved for Second-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer

On July 11, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the treatment of adult and pediatric patients aged 12 years and older with microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) metastatic colorectal...

Lung Cancer
Immunotherapy

Atezolizumab Plus Chemotherapy Extends Survival in Squamous NSCLC Regardless of PD-L1 Level

Patients with advanced squamous non–small cell lung cancer (NSCLC) had a greater benefit from first-line treatment with the combination of atezolizumab (Tecentriq) plus chemotherapy vs chemotherapy alone in the randomized, phase III, IMpower131 clinical trial.1 At the landmark of 12-month...

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