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lymphoma
immunotherapy

Reem Karmali, MD, on Lymphomas and CAR T-Cell Therapy

Reem Karmali, MD, of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, discusses CAR T-cell therapy for relapsed/refractory DLBCL and other subtypes of lymphomas, ways to manage toxicities, and how to integrate this treatment into care plans.

lung cancer
immunotherapy

WCLC 2018: PACIFIC Trial: Overall Survival With Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC

As reported at the current International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer (Abstract PL02.01) and in The New England Journal of Medicine by Antonia et al, the phase III PACIFIC trial has shown significantly improved overall survival—a...

Immunotherapy

A Journey Through the Immune System

Although the basic concept of using the body’s immune defense mechanisms to fight cancer has been around for centuries, the idea of using immunotherapy in cancer, in general, returned to prominence when Dr. Thomas Burnet first proposed the theory of cancer immunosurveillance in 1957. Despite...

lung cancer
immunotherapy

FDA Accepts sBLA for Pembrolizumab Monotherapy in First-Line Treatment of Locally Advanced or Metastatic PD-L1–Expressing NSCLC

The U.S. Food and Drug Administration (FDA) granted Priority Review to a new supplemental biologics license application (sBLA) seeking approval for pembrolizumab (Keytruda) as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non–small cell lung...

lung cancer
immunotherapy

Hyperprogressive Disease in Advanced NSCLC Treated With PD-1/PD-L1 Inhibitors

In a French study reported in JAMA Oncology, Ferrara et al found that hyperprogressive disease appeared to be more common with programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitor treatment than single-agent chemotherapy among previously treated patients with...

breast cancer
immunotherapy

Sequential vs Concurrent Neoadjuvant Therapy in HER2-Positive Breast Cancer

As reported in JAMA Oncology by Buzdar et al, the phase III ACOSOG Z1041 (Alliance) trial showed no difference in disease-free or overall survival with sequential vs concurrent neoadjuvant anthracycline and trastuzumab in patients with operable HER2-positive breast cancer. An earlier report from...

kidney cancer
immunotherapy

Avelumab Plus Axitinib in Previously Untreated Patients With Advanced Kidney Cancer

The results of the pivotal phase III JAVELIN Renal 101 study—which evaluated avelumab (Bavencio) in combination with axitinib (Inlyta) compared with sunitinib (Sutent) as initial therapy for patients with advanced renal cell carcinoma—were recently announced. As part of a planned...

Issues in Oncology
Immunotherapy
Hematologic Malignancies
Leukemia

CAR T-Cell Therapy for CLL

A pair of new studies from researchers at the Abramson Cancer Center of the University of Pennsylvania are shedding light on why patients with advanced chronic lymphocytic leukemia (CLL) respond or do not respond to chimeric antigen receptor (CAR) T-cell therapy. Although CAR T-cell therapy is...

Gynecologic Cancers
Immunotherapy

Pembrolizumab for Advanced Cervical Cancer Progressing During or After Chemotherapy

In June 2018, pembrolizumab (Keytruda) was approved for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed cell death ligand 1 (PD-L1; combined positive score [CPS] ≥ 1), as determined by a U.S....

Solid Tumors
Breast Cancer
Immunotherapy

Addition of Bevacizumab to Neoadjuvant Therapy in BRCA1/2-Mutant Triple-Negative Breast Cancer

In an analysis from the GeparQuinto trial reported in the Journal of Clinical Oncology, Peter A. Fasching, MD, of Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, and colleagues found that the addition of bevacizumab (Avastin) to neoadjuvant chemotherapy increased the...

Hematologic Malignancies
Lymphoma
Immunotherapy

Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On June 13, 2018, pembrolizumab (Keytruda) was granted...

Immunotherapy

Update on Clinical Trials of Novel Therapies

Long-term follow-up data on axicabtagene ciloleucel (Yescarta) in lymphoma, potential partners for nivolumab (Opdivo) in solid tumors, and a targeted agent for RET-altered cancers were featured during the developmental therapeutics program at the 2018 ASCO Annual Meeting. At the Best of ASCO...

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...

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