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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...

Skin Cancer
Immunotherapy

Immunotherapy in Merkel Cell Carcinoma: ‘Field Has Been Thrown on Its Head’

At the 2018 ASCO Annual Meeting, investigators presented long-term follow-up data for immunotherapy in patients with Merkel cell carcinoma and new data for its use in the neoadjuvant setting. The results drew high interest from attendees and a number of questions were raised following the...

hepatobiliary cancer
immunotherapy

FDA Grants Priority Review to sBLA for Pembrolizumab in Advanced Hepatocellular Carcinoma

The U.S. Food and Drug Administration (FDA) recently accepted and granted priority review for a new supplemental biologics license application (sBLA) seeking approval for pembrolizumab (Keytruda) as a second-line treatment for patients with advanced hepatocellular carcinoma. This sBLA, which is...

head and neck cancer
immunotherapy

Pazopanib Plus Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

As reported in The Lancet Oncology by Adkins et al, the addition of the angiogenesis inhibitor pazopanib (Votrient) to cetuximab (Erbitux) in a phase Ib and expansion cohort study showed activity in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). In the...

cns cancers
skin cancer
immunotherapy

First-Line Treatment With Checkpoint Inhibitors in Patients With Melanoma Brain Metastases

An analysis of newly diagnosed patients with cutaneous melanoma brain metastases treated with checkpoint blockade immunotherapy has found the treatment was associated with an increase in median overall survival of 12.4 months compared with 5.2 months—a 1.4-fold improvement. The benefit was...

colorectal cancer
immunotherapy

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

Today, 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)...

issues in oncology
palliative care
immunotherapy

A. Oliver Sartor, MD, on Issues in Immunotherapy

A. Oliver Sartor, MD, of Tulane University, speaks anecdotally about immunotherapy for prostate cancer and shares his experiences in speaking to patients with late-stage disease about the knowns, unknowns, risks, and toxicities of using a therapy outside the context of a clinical trial setting. The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.

issues in oncology
palliative care
immunotherapy

Owen A. O’Connor, MD, PhD, on Issues in Immunotherapy

Owen A. O'Connor, MD, PhD, of Columbia University Medical Center, shares his perspective on immunotherapy for patients with late-stage cancer in the context of a clinical trial setting and recent Right-to-Try legislation. The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.

lung cancer
immunotherapy

FDA Accepts sBLA for Pembrolizumab in Combination With Chemotherapy as First-Line Treatment for Metastatic Squamous NSCLC

The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) in combination with carboplatin/paclitaxel or nab-paclitaxel (Abraxane) as a first-line treatment for metastatic squamous non–small cell lung...

solid tumors
immunotherapy

Pembrolizumab in Platinum-Refractory or Relapsed Thymic Epithelial Tumors

In a Korean single-center phase II study reported in the Journal of Clinical Oncology, Cho et al found that pembrolizumab (Keytruda) was active in advanced thymic epithelial tumors progressing after platinum-based chemotherapy. Study Details The study included 26 patients with thymic carcinoma...

Skin Cancer
Immunotherapy

Treatment Beyond Disease Progression in Melanoma: Challenge Centers on Knowing Who May Benefit

Dr. Weiss is Assistant Professor (Medical Oncology), Developmental Therapeutics, Melanoma Program, Yale Cancer Center. Dr. Sznol is Professor of Medicine (Medical Oncology); Co-Director, Cancer Immunology Program, Yale Cancer Center Co-Director, Yale SPORE in Skin Cancer, New Haven, Connecticut.  ...

Skin Cancer
Immunotherapy

Outcomes in Patients With Melanoma Treated With Anti–PD-1 Antibody Beyond Disease Progression

A POOLED analysis by the U.S. Food and Drug Administration (FDA) has shown a benefit of treatment beyond disease progression on Response Evaluation Criteria in Solid Tumors (RECIST) in some patients receiving anti–programmed cell death protein 1 (anti–PD-1) antibodies for unresectable or...

Skin Cancer
Immunotherapy

Early Data Suggest TLR9 Agonist May Combat PD-1 Resistance in Advanced Melanoma

COMBINING CMP-001, a Toll-like receptor 9 (TLR9) agonist, plus pembrolizumab (Keytruda) appears to overcome resistance to anti–programmed cell death protein 1 (anti–PD-1) therapy, according to a preliminary phase Ib study.1 Adding CMP-001 to pembrolizumab was well tolerated, with antitumor efficacy ...

Multiple Myeloma
Immunotherapy

CAR T-Cell Therapy: Updated Data Remain Favorable in Heavily Pretreated Patients With Myeloma

IN AN UPDATE of a phase I trial, a heavily pretreated population of patients with multiple myeloma continued to respond to the chimeric antigen receptor (CAR) T-cell therapy bb2121.1 The results presented at the 2018 ASCO Annual Meeting confirmed previous findings for bb2121 in the dose-escalation...

Lung Cancer
Immunotherapy

More Evidence of Benefit With Immunotherapy and Chemotherapy in Nonsquamous Non–Small Cell Lung Cancer

ATEZOLIZUMAB (TECENTRIQ) plus bevacizumab (Avastin) plus a platinum doublet (ABCP) improved overall survival by 22% compared with bevacizumab plus a platinum doublet (BCP) in patients with advanced wild-type (without an identified mutation) nonsquamous non–small cell lung cancer (NSCLC), according...

Lung Cancer
Immunotherapy

KEYNOTE-407: Pembrolizumab Plus Chemotherapy Benefits Response, Survival in Squamous NSCLC

THE COMBINATION of pembrolizumab (Keytruda) plus platinum-based chemotherapy improved overall survival, response rates, and duration of response in patients with advanced squamous cell non–small cell lung cancer (NSCLC) compared with chemotherapy alone irrespective of programmed cell death ligand 1 ...

Prostate Cancer
Immunotherapy

Apalutamide in Nonmetastatic Castration-Resistant Prostate Cancer

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. Earlier this year, apalutamide (Erleada) was approved for ...

skin cancer
immunotherapy

New Guide Helps Clinicians Navigate Immunotherapy in Merkel Cell Carcinoma

Fred Hutchinson Cancer Research Center researchers have published a new guide to help clinicians navigate a recent revolution in care for advanced Merkel cell carcinoma. The guide was published in JNCCN–Journal of the National Comprehensive Cancer Network, and it accompanies NCCN’s new...

breast cancer
immunotherapy

IMpassion130: Atezolizumab Plus Nab-Paclitaxel in Metastatic or Locally Advanced Triple-Negative Breast Cancer

The phase III IMpassion130 study has met its co-primary endpoint of progression-free survival (PFS). Results demonstrated that the combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) as first-line treatment significantly reduced the risk of disease worsening or death in patients...

Leukemia
Immunotherapy

Outcomes of Tisagenlecleucel Therapy in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia

As reported in The New England Journal of Medicine by Shannon L. Maude, MD, PhD, of Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, the phase II ELIANA trial has shown that the anti-CD19 chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) ...

skin cancer
immunotherapy

FDA Accepts sBLA for Pembrolizumab as Adjuvant Therapy in Advanced Melanoma

The U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. The Prescription Drug User Fee Act, or...

lung cancer
immunotherapy

IMpower133: Atezolizumab in Combination With Chemotherapy in Previously Untreated, Extensive-Stage Small Cell Lung Cancer

The phase III IMpower133 study recently met its coprimary endpoints of overall survival (OS) and progression-free survival (PFS) at its first interim analysis. The study demonstrated that first-line treatment with the combination of atezolizumab (Tecentriq) plus chemotherapy (carboplatin and...

lung cancer
immunotherapy

FDA Accepts sBLA for First-Line Nivolumab Plus Low-Dose Ipilimumab in NSCLC With Tumor Mutational Burden ≥ 10 mut/mb

The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) for the first-line treatment of advanced non–small cell lung cancer (NSCLC) in patients with a tumor mutational burden...

skin cancer
immunotherapy

MAGE-A3 Immunotherapeutic as Adjuvant Therapy for MAGE-A3–Positive Stage III Melanoma

In the phase III DERMA trial reported in The Lancet Oncology, Dreno et al found that an adjuvant MAGE-A3 immunotherapeutic provided no benefit vs placebo in patients with resected MAGE-A3–positive stage IIIB or IIIC melanoma. Development of the agent for use in melanoma has been stopped. The ...

breast cancer
immunotherapy

Trastuzumab Biosimilar vs Reference Trastuzumab in HER2-Positive Early Breast Cancer

In the phase III LILAC equivalence trial reported in The Lancet Oncology, von Minckwitz et al found similar efficacy and safety with the trastuzumab biosimilar ABP 980 vs reference trastuzumab (Herceptin) in HER2-positive early breast cancer. On local review, the risk difference and risk ratio (RR) ...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Second-Line Pembrolizumab vs Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer

As reported in The Lancet by Shitara et al, the phase III KEYNOTE-061 trial showed no significant overall survival benefit with pembrolizumab vs paclitaxel in patients with advanced gastric or gastroesophageal junction cancer progressing on platinum-fluoropyrimidine treatment with programmed cell...

bladder cancer
immunotherapy

FDA Restricts Use of Pembrolizumab or Atezolizumab to Treat Urothelial Cancer Due to Efficacy Concerns in Some Patients

As of June 20, the U.S. Food and Drug Administration (FDA) has restricted the use of pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The restriction results from a...

lymphoma
immunotherapy

Outcomes by Chemotherapy Backbone for Obinutuzumab vs Rituximab in Previously Untreated Follicular Lymphoma

In an analysis of the GALLIUM trial reported in the Journal of Clinical Oncology, Hiddemann and colleagues found that obinutuzumab (Gazyva) appeared to provide consistent progression-free survival benefit vs rituximab (Rituxan) in previously untreated follicular lymphoma, irrespective of which...

lung cancer
immunotherapy

Addition of Atezolizumab to Bevacizumab and Chemotherapy in First-Line Treatment of Metastatic Nonsquamous NSCLC

As reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine by Socinski et al, the phase III IMpower150 trial has shown that the addition of atezolizumab (Tecentriq) to bevacizumab (Avastin) plus chemotherapy significantly improved progression-free and overall survival in ...

lung cancer
immunotherapy

FDA Expands Approval of Pembrolizumab for First-Line Treatment of NSCLC

The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) for use in combination with chemotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC). KEYNOTE-021 This...

Breast Cancer
Immunotherapy

Priming the Immune System: Neoadjuvant Durvalumab Plus Chemotherapy May Be Beneficial in Triple-Negative Breast Cancer

The addition of durvalumab -(Imfinzi) to anthracycline/taxane-based chemotherapy had encouraging results as neoadjuvant therapy for early triple-negative breast cancer in the randomized phase II GeparNuevo study presented at the 2018 ASCO Annual Meeting.1 The results were positive in a subgroup of...

skin cancer
immunotherapy

Activity of the PD-1 Inhibitor Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma

As reported at the 2018 ASCO Annual Meeting (Abstract 9519) and in The New England Journal of Medicine by Migden et al, results of early-phase testing show activity of the programmed cell death protein 1 (PD-1) inhibitor cemiplimab in advanced cutaneous squamous cell carcinoma. Currently, no...

lymphoma
immunotherapy

EHA 2018: Tisagenlecleucel Demonstrates More Than 1-Year Durability of Response in Adults With Relapsed or Refractory DLBCL

Fourteen-month results from the JULIET clinical trial showed ongoing durable responses are achievable with tisagenlecleucel (Kymriah) when administered to adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This updated analysis was presented by Borchmann et al at ...

leukemia
immunotherapy

EHA 2018: Obinutuzumab or Rituximab Plus Chlorambucil in CLL

Data from the final analysis of the CLL11 study evaluating obinutuzumab (Gazyva)-based treatment in previously untreated chronic lymphocytic leukemia (CLL) was presented by Goede et al during the Presidential Symposium at the 23rd Annual Congress of the European Hematology Association (EHA)...

hepatobiliary cancer
immunotherapy

KEYNOTE-224: Pembrolizumab in Advanced Hepatocellular Carcinoma Pretreated With Sorafenib

As reported in The Lancet Oncology by Zhu et al, the phase II KEYNOTE-224 study has shown activity of pembrolizumab in advanced hepatocellular carcinoma (HCC) pretreated with sorafenib. Study Details In the study, 104 eligible patients who were intolerant of or progressed on sorafenib were...

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