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kidney cancer
immunotherapy

Neeraj Agarwal, MD, and Thomas Powles, MD, PhD, on Renal Cell Carcinoma: KEYNOTE-426 on First-Line Pembrolizumab Plus Axitinib vs Sunitinib

Neeraj Agarwal, MD, of Huntsman Cancer Institute, University of Utah Health Care, and Thomas Powles, MD, PhD, of Queen Mary University of London, discuss phase III study findings on outcomes with combination therapy for intermediate/poor-risk and sarcomatoid subgroups of renal cell carcinoma (Abstract 4500).  

bladder cancer
immunotherapy

Daniel P. Petrylak, MD, on Urothelial Cancer: Enfortumab Vedotin Monotherapy for Locally Advanced or Metastatic Disease

Daniel P. Petrylak, MD, of Yale School of Medicine, discusses study results on enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors (Abstract LBA4505).

bladder cancer
immunotherapy

2019 ASCO: Enfortumab Vedotin Shows Activity in Previously Treated, Locally Advanced or Metastatic Urothelial Cancer

The single-arm, phase II EV-201 trial showed treatment with enfortumab vedotin—an agent targeting Nectin-4, a protein found in 97% of urothelial cancers—produced responses in 44% of patients with locally advanced or metastatic forms of urothelial cancer. Patients had previously been...

lung cancer
immunotherapy

David J. Kwiatkowski, MD, PhD, on Non–Small Cell Lung Cancer: Neoadjuvant Immunotherapy for Resectable Disease

David J. Kwiatkowski, MD, PhD, of Brigham and Women’s Hospital and Dana-Farber Cancer Institute, discusses an interim analysis and biomarker data from a multicenter study showing that 19% of patients with NSCLC had a major pathologic response to preoperative treatment with atezolizumab (Abstract 8503).

head and neck cancer
immunotherapy

Danny Rischin, MD, on Head and Neck Squamous Cell Carcinoma: KEYNOTE-048 Trial on Pembrolizumab

Danny Rischin, MD, of Peter MacCallum Cancer Centre, discusses phase III results that support pembrolizumab with and without platinum-based chemotherapy plus fluorouracil as new first-line standards of care for recurrent or metastatic head and neck squamous cell carcinoma (Abstract 6000).

gynecologic cancers
immunotherapy

Kamran A. Ahmed, MD, on Cervical Cancer: Stereotactic Body Radiation Therapy Plus Atezolizumab

Kamran A. Ahmed, MD, of the H. Lee Moffitt Cancer Center and Research Institute, reports on a trial in progress that is investigating whether treatment with atezolizumab plus hypofractionated radiation therapy will improve the objective response rate compared with atezolizumab alone in patients with recurrent, persistent, or metastatic cervical cancer (Abstract TPS5596).

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Josep Tabernero, MD, PhD, on Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: Pembrolizumab With or Without Chemotherapy vs Chemotherapy

Josep Tabernero, MD, PhD, of the Vall d’Hebron Institute of Oncology, discusses phase III findings of the KEYNOTE-062 study showing that, for some patients with advanced gastric or gastroesophageal junction cancer, pembrolizumab may improve survival and may be an effective alternative to chemotherapy, with fewer side effects (Abstract LBA4007).

lung cancer
immunotherapy

Edward B. Garon, MD, on Advanced Non–Small Cell Lung Cancer: KEYNOTE-001 Trial on Pembrolizumab

Edward B. Garon, MD, of the David Geffen School of Medicine at the University of California, Los Angeles, discusses long-term survival data on patients with advanced non–small cell lung cancer treated with pembrolizumab and those with PD-L1 expressed in at least half of their tumor cells (Abstract LBA9015).

gynecologic cancer
immunotherapy

2019 ASCO: Novel Immunotherapy for Recurrent, Metastatic, or Persistent Cervical Cancer

There is a high, unmet need for effective treatments for patients with recurrent, metastatic, or persistent cervical cancer—most patients are young, and survival rates are poor. Adoptive cell transfer using tumor-infiltrating lymphocytes (TILs) has demonstrated durable responses in some...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

2019 ASCO: KEYNOTE-062: Pembrolizumab With or Without Chemotherapy vs Chemotherapy in Advanced Gastric or GEJ Adenocarcinoma

The randomized, phase III KEYNOTE-062 trial achieved its primary endpoint, showing that for patients with programmed cell death ligand 1 (PD-L1)-positive, HER2-negative, advanced gastric or gastroesophageal junction (GEJ) cancer, initial therapy with pembrolizumab resulted in noninferior overall...

lung cancer
immunotherapy

2019 ASCO: KEYNOTE-001: 5-Year Survival Data for Patients With Advanced NSCLC Treated With Pembrolizumab

Five-year data from the phase Ib KEYNOTE-001 trial showed that treatment with pembrolizumab was safe and effective and substantially increased overall survival in patients with advanced non–small cell lung cancer (NSCLC). Specifically, 23.2% of people who had not previously been treated with...

issues in oncology
immunotherapy

Lee S. Schwartzberg, MD, FACP: 2019 Update on the ACCC Immuno-Oncology Institute: Using Immunotherapy in the Community Setting

Lee S. Schwartzberg, MD, of the West Cancer Center, reports on this past year’s progress of the ACCC initiative to speed adoption of immunotherapeutics in community practices.

head and neck cancer
immunotherapy

2019 ASCO: Final Analysis of KEYNOTE-048: First-Line Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The phase III KEYNOTE-048 trial is examining the efficacy of pembrolizumab alone, pembrolizumab/cisplatin or carboplatin/fluorouracil (5-FU), or cetuximab/cisplatin or carboplatin/5-FU as first-line therapy for recurrent or metastatic head and neck squamous cell carcinoma. At the second interim...

lung cancer
immunotherapy

Addition of Bevacizumab to Carboplatin/Pemetrexed in Nonsquamous NSCLC

New research published by Bagley et al in JNCCN—Journal of the National Comprehensive Cancer Network used a large real-world data set to demonstrate a modest but consistent survival benefit associated with adding bevacizumab to carboplatin/pemetrexed in advanced nonsquamous non–small...

lymphoma
immunotherapy

Polatuzumab Vedotin and Immunochemotherapy in Previously Untreated Diffuse Large B-Cell Lymphoma

As reported in The Lancet Oncology, Tilly et al found that the combination of polatuzumab vedotin, an antibody-drug conjugate targeting the CD79b component of the B-cell receptor, with immunochemotherapy showed high response rates in the phase II portion of a phase I/II study in previously...

bladder cancer
immunotherapy

CheckMate 032: Extended Follow-up of Nivolumab and Nivolumab/Ipilimumab Cohorts in Previously Treated Metastatic Urothelial Carcinoma

As reported in the Journal of Clinical Oncology by Sharma et al, follow-up of the cohort receiving nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg the phase I/II CheckMate 032 trial showed the regimen produced high levels of activity in platinum-treated, unresectable, locally advanced or metastatic ...

Issues in Oncology
Immunotherapy

NCCN Roundtable Tackles Issues With Innovative Immunotherapies

Immunotherapies are radically changing outcomes, but while helping patients, they are creating complexities surrounding their cost. At the 2019 Annual Conference of the National Comprehensive Cancer Network® (NCCN®), a roundtable of experts, including clinicians and payers, discussed how chimeric...

kidney cancer
immunotherapy

IMmotion151: First-Line Atezolizumab/Bevacizumab vs Sunitinib in Metastatic Renal Cell Carcinoma

In the phase III IMmotion151 trial reported in The Lancet, Rini et al found that atezolizumab plus bevacizumab prolonged progression-free survival vs sunitinib in patients with previously untreated, programmed cell death ligand 1 (PD-L1)-positive, metastatic renal cell carcinoma. Study Details...

hepatobiliary cancer
immunotherapy

Early-Stage Study of Nivolumab Alone or in Combination With Cisplatin/Gemcitabine in Biliary Tract Cancer

In a Japanese phase I trial reported by Ueno et al in The Lancet Gastroenterology & Hepatology, researchers found nivolumab showed activity and had a manageable safety profile in patients with unresectable or recurrent biliary tract cancer. Methods The open-label phase I trial was conducted...

Bladder Cancer
Immunotherapy

Lenvatinib Plus Pembrolizumab Shows Activity in Advanced Urothelial Cancer

THE COMBINATION of lenvatinib plus pembrolizumab has demonstrated antitumor activity in patients with advanced urothelial cancer, including patients receiving later-line treatment. Results of a phase Ib/II trial showed an objective response rate of 25% and a median progression-free survival of 5.4...

Kidney Cancer
Immunotherapy

Front-Line Therapy in Advanced Renal Cell Carcinoma: Developing a New Standard

THE FRONT-LINE systemic treatment landscape for metastatic renal cell carcinoma has undergone tremendous movement over the past several years. A better understanding of the current management paradigm for therapy-naive patients warrants a reflection of historic landmark clinical trials that have...

Kidney Cancer
Immunotherapy

First-Line Therapy for Advanced Kidney Cancer: Combination Treatment vs Sunitinib

  TWO RECENTLY reported phase III trials have shown the benefits of combination therapy vs sunitinib in the first-line treatment of advanced renal cell carcinoma. As reported in The New England Journal of Medicine by Brian I. Rini, MD, of Cleveland Clinic Taussig Cancer Institute, and colleagues,...

Immunotherapy
Breast Cancer
Lung Cancer
Prostate Cancer
Kidney Cancer
Bladder Cancer
Colorectal Cancer
Pancreatic Cancer
Sarcoma
Leukemia
Skin Cancer
Head and Neck Cancer

NCCN Clinical Practice Guidelines in Oncology: 2019 Updates

In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®), covering eight tumor types. NCCN Guidelines are now published for more than 70 tumor types and topics. Some of the key updates for 2019 were presented...

Kidney Cancer
Immunotherapy

Expert Point of View: Tracy Rose, MD, MPH

THE FORMAL DISCUSSANT of the KEYNOTE-427 trial, Tracy Rose, MD, MPH, of the University of North Carolina, Chapel Hill, told listeners: “I think pembrolizumab should now be considered an option for non–clear cell kidney cancer. Response rates, however, remain inferior to those seen in clear cell...

Kidney Cancer
Immunotherapy

KEYNOTE-427: Pembrolizumab Shows Activity in Advanced Non–Clear Cell Kidney Cancer

IMMUNOTHERAPY WITH the checkpoint inhibitor pembrolizumab may prove to be an effective option for patients with advanced non–clear cell renal cell carcinoma, according to results in cohort B of the KEYNOTE-427 trial, presented at the 2019 Genitourinary Cancers Symposium.1 Kidney cancers with a...

skin cancer
immunotherapy

Predicting Response to Immunotherapy in Squamous Cell Carcinoma

According to a study published by Kacew et al in the European Journal of Cancer, copy number alterations in the chromosome 3q arm may be linked to immunotherapy response in patients with cutaneous squamous cell carcinoma. In fact, this and other genetic markers may prove to be useful...

colorectal cancer
immunotherapy

Tumor Mutational Burden as a Marker of Response to Immunotherapy in MSI-High Metastatic Colorectal Cancer

Foundational research recently published by Schrock et al in Annals of Oncology may help patients with microsatellite instability (MSI)-high metastatic colorectal cancer decide whether to choose immunotherapy or chemotherapy as their first treatment option. “Immunotherapy is the new,...

sarcoma
immunotherapy

Axitinib Plus Pembrolizumab in Advanced Sarcomas

In a phase II trial reported in The Lancet Oncology, Wilky et al found evidence of activity of axitinib plus pembrolizumab in advanced sarcomas, including alveolar soft-part sarcoma. Study Details The study involved 33 patients with advanced or metastatic sarcomas, including alveolar soft-part...

lymphoma
immunotherapy

Addition of Decitabine to Camrelizumab in Relapsed or Refractory Classical Hodgkin Lymphoma

In a single-center phase II trial reported in the Journal of Clinical Oncology, Nie et al found a higher complete response rate with the addition of low-dose decitabine to the programmed cell death protein 1 (PD-1) inhibitor camrelizumab in anti–PD-1 treatment–naive patients with...

Pancreatic Cancer
Immunotherapy

Study Finds Immune Enrichment Improves Outcomes in Pancreatic Cancer With Activated but Not Normal Stroma

ALTHOUGH IMMUNOTHERAPIES have had limited success in pancreatic cancer to date, findings from a molecular analysis of the tumor microenvironment suggest that certain subtypes may be more responsive to treatment. According to data presented at the 2019 Society of Surgical Oncology Annual Cancer...

Immunotherapy
Lung Cancer

Pembrolizumab as Third-Line Option for Extensive-Stage Small Cell Lung Cancer

USE OF the anti–programmed cell death protein 1 (anti–PD-1) checkpoint inhibitor pembrolizumab after two or more prior lines of therapy led to responses in patients with advanced small cell lung cancer (SCLC) in a pooled analysis of two clinical trials: phase Ib KEYNOTE-028 and phase II...

Breast Cancer
Pancreatic Cancer
Sarcoma
Immunotherapy
Issues in Oncology

AACR Study Presentations Include New Data in Breast and Prostate Cancers, Sarcoma, and High-Risk Individuals

THE 2019 American Association for Cancer Research (AACR) Annual Meeting was held March 29 to April 3 in Atlanta. In addition to our regular coverage of news stories from the meeting, here are some brief highlights of additional noteworthy studies. Stage IV HER2-Positive Breast Cancer: Surgery or No ...

Neuroendocrine Tumors
Immunotherapy

Expert Point of View: Namrata Vijayvergia, MD

NAMRATA VIJAYVERGIA, MD, of Fox Chase Cancer Center, Philadelphia, commented on this study. “This is an important study because it is done in a rare tumor type; not a lot of clinical trials are conducted in this disease. Recently, three other studies of single-agent therapy with checkpoint...

Neuroendocrine Tumors
Immunotherapy

Dual-Immunotherapy Approach Shows Efficacy in High-Grade Neuroendocrine Tumors

COMBINING TWO established immunotherapy agents achieved tumor shrinkage in rare, aggressive, extrapancreatic high-grade neuroendocrine tumors, according to the results of SWOG S1609, a phase II clinical basket trial also known as DART (Dual Anti– CLTA-4 and Anti–PD-1 Blockade in Rare Tumors). The...

Kidney Cancer
Immunotherapy

Front-Line Therapy in Advanced Renal Cell Carcinoma: Developing a New Standard

THE FRONT-LINE systemic treatment landscape for metastatic renal cell carcinoma has undergone tremendous movement over the past several years. A better understanding of the current management paradigm for therapy-naive patients warrants a reflection of historic landmark clinical trials that have...

Immunotherapy
Skin Cancer

Neoadjuvant Immunotherapy Associated With Improved Outcomes in Patients With Locally Advanced Melanoma

ACCORDING TO DATA from a small prospective study presented at the 2019 Society of Surgical Oncology Annual Cancer Symposium,1 neoadjuvant immunotherapy significantly prolonged relapse-free survival vs adjuvant immunotherapy in patients with stage III or oligometastatic stage IV melanoma intended...

multiple myeloma
immunotherapy

Anti-BCMA CAR T-Cell Therapy in Relapsed or Refractory Multiple Myeloma

In a phase I trial reported in The New England Journal of Medicine, Raje et al found that bb2121, a chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen (BCMA), was safe in heavily pretreated patients with relapsed or refractory multiple myeloma. Investigators reported ...

skin cancer
immunotherapy

PD-1 Inhibitor–Associated Cutaneous Toxicity and Clinical Outcomes in Advanced Melanoma

In a research letter published in JAMA Oncology, Quach et al found that cutaneous toxicities related to anti–programmed cell death protein 1 (PD-1) treatment—specifically, vitiligo and rash—were associated with improved clinical outcomes in advanced melanoma. Study Details The...

symptom management
immunotherapy

Treatment-Related Adverse Events With PD-1/PD-L1 Inhibitors in Clinical Trials

In a systematic review and meta-analysis reported in JAMA Oncology, Wang et al characterized treatment-related adverse event profiles associated with monotherapy use of programmed cell death protein 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors in clinical trials. Study Details...

gynecologic cancer
immunotherapy

GOG-252: Intravenous vs Intraperitoneal Chemotherapy in Advanced Ovarian Carcinoma

In the phase III NRG Oncology/Gynecologic Oncology Group (GOG)-252 study reported in the Journal of Clinical Oncology, Walker et al found no progression-free survival benefit of postsurgical intraperitoneal (IP) chemotherapy vs intravenous (IV) chemotherapy, each combined with bevacizumab, in...

lung cancer
immunotherapy

Association Between Clinical Outcomes and Patient Characteristics/Genomic Profiles in Lung Cancer

As reported in JAMA, Singal et al used a clinicogenomic database in routine clinical practice to identify associations between treatment outcomes and patient characteristics or tumor genomic profiles in the setting of non–small cell lung cancer (NSCLC). The study cohort of 4,064 patients...

colorectal cancer
immunotherapy

IMblaze370: Atezolizumab With or Without Cobimetinib vs Regorafenib in Previously Treated Advanced Colorectal Cancer

In the phase III IMblaze370 trial reported in The Lancet Oncology, Eng et al found no survival benefit with third-line atezolizumab with or without cobimetinib vs regorafenib in patients with locally advanced or metastatic colorectal cancer. Study Details The open-label trial included 363...

health-care policy
hematologic malignancies
immunotherapy

ASH President Comments on Medicare Proposal for CAR T-Cell Therapy

Earlier this week, the Centers for Medicare & Medicaid Services (CMS) proposed to improve the reimbursement currently given to hospitals that provide chimeric antigen receptor T-cell (CAR-T) therapy to patients with blood cancer as part of the Fiscal Year 2020 Inpatient Prospective Payment...

Immunotherapy
Skin Cancer

Molecular Profiles and Immunotherapy Outcomes in BRAF V600E– and V600K–Mutant Melanoma

In a study reported in Clinical Cancer Research, Alexander M. Menzies, MD, of Melanoma Institute Australia, The University of Sydney, and Royal North Shore and Mater Hospitals, and colleagues found that BRAF V600K melanomas are less responsive to BRAF inhibitor with or without MEK inhibitor...

Solid Tumors
Immunotherapy

Preliminary Results Show Activity for Mesothelin‑Directed CAR T-Cell Therapy in Malignant Mesothelioma

A phase I clinical trial showed encouraging results with chimeric antigen receptor (CAR) T-cell therapy targeted to the mesothelin protein in patients with mesothelin-associated malignant pleural solid tumors—primarily, malignant mesothelioma—that had progressed following standard platinum-based...

Immunotherapy

The Microbiome: The Next Target in Cancer Therapy

With the recent breakthroughs in immunotherapy, treatments that modulate the immune system are now being used across numerous cancer types and across the spectrum of disease with significant success, but not all patients achieve objective responses. There is still a critical need to better...

kidney cancer
immunotherapy

FDA Approves Pembrolizumab Plus Axitinib for First-Line Treatment of Advanced Renal Cell Carcinoma

On April 19, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYNOTE-426 Approval was based on KEYNOTE-426, a randomized, multicenter, open-label trial conducted in ...

lung cancer
immunotherapy

KEYNOTE-042: Pembrolizumab vs Chemotherapy in Previously Untreated Locally Advanced or Metastatic NSCLC With PD-L1 Expression ≥ 1%

As reported in The Lancet by Mok et al, the KEYNOTE-042 trial has shown an improvement in overall survival with pembrolizumab vs standard chemotherapy in previously untreated patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) without a sensitizing EGFR mutation or ...

gynecologic cancer
immunotherapy

KEYNOTE-158: Pembrolizumab in Previously Treated Advanced Cervical Cancer

As reported in the Journal of Clinical Oncology by Chung et al, the phase II KEYNOTE-158 trial showed activity of pembrolizumab in previously treated programmed cell death ligand 1 (PD-L1)-positive advanced cervical cancer. The study supported the 2018 accelerated approval of pembrolizumab in this...

lung cancer
immunotherapy

FDA Expands Pembrolizumab Indication for NSCLC in First-Line Setting

Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or those with metastatic NSCLC....

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