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gynecologic cancers
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....

lung cancer
immunotherapy

ELCC 2019: Does Maintenance Immunotherapy Improve Survival in Patients With Advanced SCLC?

Maintenance immunotherapy did not improve survival in patients with extensive-stage small cell lung cancer (SCLC), according to late-breaking results from the CheckMate 451 study presented today by Owonikoko et al at the European Lung Cancer Congress 2019 (Abstract LBA1_PR). Around 60% to 70% of...

lung cancer
issues in oncology
immunotherapy

ELCC 2019: Immunotherapy in Elderly Patients With Advanced NSCLC

Two studies reported at the European Lung Cancer Congress (ELCC) 2019 provided new insights on the efficacy and safety of immunotherapy in elderly patients with advanced non–­small cell lung cancer (NSCLC). Although around half of all people newly diagnosed with NSCLC are elderly (Pallis ...

gynecologic cancers
immunotherapy

Lenvatinib Plus Pembrolizumab in Advanced Endometrial Cancer

In an interim analysis of a phase II study reported in The Lancet Oncology, Makker et al found that lenvatinib plus pembrolizumab was active in advanced endometrial cancer. Study Details In the study, 54 patients from 11 sites with metastatic endometrial cancer unselected for microsatellite...

lymphoma
immunotherapy

AUGMENT: Addition of Lenalidomide to Rituximab in Relapsed or Refractory Indolent Lymphoma

In the phase III AUGMENT trial reported in the Journal of Clinical Oncology, Leonard et al found that the addition of lenalidomide to rituximab significantly prolonged progression-free survival in patients with relapsed or refractory indolent lymphoma. Study Details The double-blind trial...

colorectal cancer
immunotherapy

BEACON Colorectal Cancer Trial: Safety Lead-in With Triplet Therapy for BRAF V600E–Mutant Metastatic Disease

As reported in the Journal of Clinical Oncology by Van Cutsem et al, treatment with encorafenib, binimetinib, and cetuximab for BRAF V600E–mutant metastatic colorectal cancer was associated with a manageable safety profile and evidence of activity in the safety lead-in to the phase III BEACON ...

skin cancer
immunotherapy

AACR 2019: Entinostat Plus Pembrolizumab in Patients With Melanoma Previously Treated With Anti–PD-1 Therapy

A combination of the experimental histone deacetylase (HDAC) inhibitor entinostat with the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab showed clinical responses in patients with melanoma that had progressed on prior anti–PD-1 treatment, according to results from the phase...

pancreatic cancer
immunotherapy

AACR 2019: CD40 Antibody Combined With Chemotherapy in Advanced Pancreatic Cancer

An interim analysis of a small phase Ib study by O’Hara et al evaluating the CD40 agonistic monoclonal antibody APX005M in combination with gemcitabine and nab-paclitaxel with or without the programmed cell death protein 1 (PD-1) inhibitor nivolumab in untreated patients with metastatic...

lung cancer
immunotherapy

AACR 2019: Data Analysis Shows Activity of Pembrolizumab in Pretreated Patients With Advanced Small Cell Lung Cancer

The results of an analysis of pooled data from the phase Ib KEYNOTE-028 trial and the phase II KEYNOTE-158 study of the anti–programmed cell death protein 1 monoclonal antibody pembrolizumab in the treatment of advanced small cell lung cancer has found that the therapy provided antitumor...

sarcoma
immunotherapy

AACR 2019: HER2-Targeted CAR T-Cell Therapy Plus Chemotherapy in Advanced Sarcoma

A small phase I study by Navai et al investigated a combination of lymphodepletion chemotherapy and HER2-specific chimeric antigen receptor (CAR) T-cell therapy for pediatric and adult patients with advanced HER2-positive sarcoma. The combination showed promising antitumor activity and was found to ...

colorectal cancer
immunotherapy

Pertuzumab Plus Trastuzumab in HER2-Amplified Metastatic Colorectal Cancer

As reported in The Lancet Oncology by Meric-Bernstam et al, the combination of pertuzumab and trastuzumab showed activity in HER2-amplified metastatic colorectal cancer in the phase IIa multiple basket study MyPathway. The study is evaluating activity of targeted therapies in nonindicated tumor...

skin cancer
immunotherapy

Immunotherapy Directed Against Precancerous Skin Lesions May Prevent Squamous Cell Carcinoma

A treatment previously shown to treat the precancerous skin lesions called actinic keratosis now appears to also reduce the chance that these pretreated lesions will develop into squamous cell carcinoma. In a report published by Rosenberg et al in JCI Insight, researchers found that treatment with...

gynecologic cancers
immunotherapy

SGO 2019: Dendritic Cell–Based Immunotherapy in Combination With Chemotherapy in Recurrent Ovarian Cancer

Results from a clinical trial presented by Cibula et al at the Society of Gynecologic Oncology’s (SGO) 50th Annual Meeting on Women’s Cancer showed that a new immunotherapy treatment significantly prolongs survival in women with recurrent ovarian cancer when added to standard...

prostate cancer
immunotherapy

Viral Vector–Based Immunotherapy in Metastatic Castration-Resistant Prostate Cancer

In a phase III trial reported in the Journal of Clinical Oncology, Gulley et al found that PROSTVAC, a viral vector-based immunotherapy, did not improve overall survival or 6-month event-free survival vs placebo in patients with asymptomatic or minimally symptomatic metastatic castration-resistant...

lung cancer
immunotherapy

Nivolumab Plus Ipilimumab in Advanced NSCLC: Outcomes by PD-L1 and Tumor Mutational Burden Status

As reported in the Journal of Clinical Oncology by Ready et al, the phase II CheckMate 568 trial has shown that higher tumor mutational burden is associated with response, irrespective of programmed cell death ligand 1 (PD-L1) expression in first-line nivolumab plus low-dose ipilimumab treatment of ...

skin cancer
immunotherapy

Safety Comparison of Two Dosing Regimens for Nivolumab Plus Ipilimumab in Advanced Melanoma

In the phase IIIb/IV CheckMate 511 study reported by Lebbé et al in the Journal of Clinical Oncology, a regimen of nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg (NIVO3+IPI1) was found to significantly reduce the incidence of treatment-related grade 3 to 5 adverse events compared with...

breast cancer
immunotherapy

FDA Grants Accelerated Approval to Atezolizumab/Nab-Paclitaxel; Regular Approval Contingent on Confirmatory Trials

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) plus nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) for the treatment of adults with unresectable, locally advanced or metastatic, programmed cell death ligand 1 (PD-L1)-positive ...

skin cancer
immunotherapy

A Single Dose of a PD-1 Inhibitor Before Surgery May Predict Outcomes in Patients With Melanoma

A single dose of a programmed cell death protein 1 (PD-1) inhibitor before resection for melanoma may predict clinical outcomes for patients. Researchers from the Abramson Cancer Center at the University of Pennsylvania—who documented this finding in the largest cohort of patients to be...

lung cancer
immunotherapy

2019 ASCO-SITC: Can Plasma Cell–Free DNA Aid in Predicting Response to Checkpoint Inhibitors in NSCLC?

Researchers hypothesized that targeting some genetic alterations in plasma cell–free DNA—along with early monitoring—could be an effective, noninvasive method for predicting response to immune checkpoint inhibitors in advanced non–small cell lung cancer (NSCLC). Findings...

lung cancer
immunotherapy

2019 ASCO-SITC: Efficacy and Safety of Less Frequent Dosing of Second-Line Nivolumab for Non–Small Cell Lung Cancer

Researchers reported similar efficacy and safety with an every-4-week regimen of nivolumab in the second-line setting compared to an every-2-week schedule in patients with non–small cell lung cancer (NSCLC). Edward B. Garon, MD, and colleagues presented the results of an interim analysis of...

solid tumors
immunotherapy

2019 ASCO-SITC: Combined Targeting of TIM-3 and PD-L1 Immune Checkpoint Pathways in Advanced Relapsed or Refractory Solid Tumors

A phase Ia/Ib trial was launched in order to evaluate the safety of LY3321367, an anti–T-cell immunoglobulin domain and mucin domain–containing molecule-3 (TIM-3) antibody, administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in...

breast cancer
immunotherapy

2019 ASCO-SITC: Combination Immunotherapy for Breast Cancer With Trastuzumab and a HER2-Targeted Vaccine

After preclinical findings showed shared activity between trastuzumab and HER2-targeted vaccines, researchers evaluated adjvuant nelipepimut-S plus granulocyte-macrophage colony-stimulating factor (GM-CSF) with trastuzumab compared to trastuzumab with GM-CSF alone in patients with HER2...

colorectal cancer
lung cancer
immunotherapy

TAT 2019: Trends in Distribution of Cancer Type in Phase I Trials

The proportion of early-stage drug trials tackling the most common tumor types has declined sharply since the early 1990s, as less common cancers receive increasing attention in trials, according to new research presented by Sato et al at the TAT 2019–International Congress on Targeted...

solid tumors
immunotherapy

TAT 2019: Use of the Lung Immune Prognostic Index in Stratifying Outcomes in Patients Treated With Immune Checkpoint Inhibitors

The Lung Immune Prognostic Index (LIPI) calculated prior to the initiation of treatment may be used to stratify patients with diverse tumor types into groups that significantly associate with outcome following immune checkpoint inhibitor therapy, according to a retrospective study presented at the...

issues in oncology
immunotherapy

TAT 2019: Barriers to Clinical Trial Access for Adolescents vs Young Adults With Cancer

Compared to young adults, adolescents with the same types of cancer have far less access to immunotherapy and/or targeted therapies, according to findings presented at the TAT 2019–International Congress on Targeted Anticancer Therapies in Paris. In addition, young adults could be included in ...

skin cancer
immunotherapy

AACR 2019: Diet May Influence Gut Microbiome and Response to Immunotherapy

Among patients with melanoma treated with anti–programmed cell death protein 1 (PD-1) immunotherapy, consumption of a high-fiber diet was associated with higher gut microbiome diversity and better response to treatment, according to data presented by Spencer et al at a presscast in advance of ...

breast cancer
immunotherapy

Addition of Pembrolizumab to Trastuzumab in PD-L1–Positive, Trastuzumab-Resistant, HER2-Positive Breast Cancer

In the phase II portion of a phase Ib/II trial reported in The Lancet Oncology, Loi et al found evidence of activity of pembrolizumab plus trastuzumab in programmed cell death protein ligand 1 (PD-L1)-positive, trastuzumab-resistant, HER2-positive advanced breast cancer. Study Details In the...

kidney cancer
immunotherapy

2019 GU Cancers Symposium: First-Line Pembrolizumab Plus Axitinib vs Sunitinib in Advanced Renal Cell Carcinoma

As reported at the 2019 Genitourinary Cancers Symposium (Abstract 543) and in The New England Journal of Medicine, Rini et al found significant benefits in overall and progression-free survival with the combination of pembrolizumab plus axitinib vs sunitinib in the first-line treatment of advanced...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Addition of First-Line Ramucirumab to Cisplatin and Fluoropyrimidine in Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

In the phase III RAINFALL trial reported in The Lancet Oncology, Fuchs et al found no apparent benefit of the addition of the VEGFR-2 inhibitor ramucirumab to first-line cisplatin and fluoropyrimidine treatment in metastatic gastric or gastroesophageal junction adenocarcinoma. Study Details The...

prostate cancer
immunotherapy

2019 GU Cancers Symposium: CheckMate 650: Nivolumab and Ipilimumab in Metastatic, Castration-Resistant Prostate Cancer

Some patients with metastatic prostate cancer respond to a combination of immune checkpoint inhibitors after treatment with hormonal therapy and chemotherapy has not been successful in treating their disease, according to early results from the phase II CheckMate 650...

skin cancer
immunotherapy

FDA Approves Adjuvant Pembrolizumab for Melanoma

On February 15, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with melanoma with lymph node involvement following complete resection. Approval was based on the phase III EORTC1325/KEYNOTE-054 trial, a randomized, double-blind,...

kidney cancer
immunotherapy

2019 GU Cancers Symposium: JAVELIN Renal 101: Avelumab Plus Axitinib vs Sunitinib for Advanced Kidney Cancer

A combination of two drugs could become a new standard first-line treatment for patients with metastatic kidney cancer, according to results from the JAVELIN Renal 101 trial presented at the 2019 Genitourinary Cancers Symposium (Abstract 544) and simultaneously published in The New England...

health-care policy
immunotherapy

CMS Proposes Medicare Coverage With Evidence Development for CAR T-Cell Therapy

Today, the Centers for Medicare & Medicaid Services (CMS) proposed coverage of U.S. Food and Drug Administration (FDA)–approved chimeric antigen receptor (CAR) T-cell therapy under its “coverage with evidence development” paradigm. Currently, there is no national...

head and neck cancer
kidney cancer
immunotherapy

FDA Pipeline: Priority Reviews in Renal Cell Carcinoma and Head and Neck Cancer

Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews: Pembrolizumab in Combination With Axitinib as First-Line Treatment for Advanced Renal Cell Carcinoma Today, the FDA accepted and granted Priority Review for a new supplemental biologics license...

skin cancer
immunotherapy

First-Line Pembrolizumab in Advanced Merkel Cell Carcinoma

In a phase II trial (Cancer Immunotherapy Trials Network-09/Keynote-017) reported in the Journal of Clinical Oncology, Nghiem et al found that first-line pembrolizumab produced a high response rate in patients with advanced Merkel cell carcinoma. In the multicenter trial, 50 adult patients who had ...

immunotherapy

Steven A. Rosenberg, MD, PhD, Awarded the 2019 Szent-Györgyi Prize

The 2019 Szent-Györgyi Prize for Progress in Cancer Research will be awarded to Steven A. Rosenberg, MD, PhD, of the Center for Cancer Research (CCR) at the National Cancer Institute (NCI). The prize, awarded annually by the National Foundation for Cancer Research (NFCR), recognizes Dr....

kidney cancer
immunotherapy

2019 GU Cancers Symposium: KEYNOTE-426: Pembrolizumab Plus Axitinib vs Sunitinib in Advanced Renal Cell Carcinoma

Results from the randomized, phase III KEYNOTE-426 clinical trial show that first-line therapy with a combination of pembrolizumab and axitinib extended both overall survival (OS) and progression-free survival (PFS) for patients with clear cell metastatic renal cell carcinoma compared with the...

multiple myeloma
immunotherapy

FDA Approves Daratumumab Split-Dosing Regimen

The U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for daratumumab (Darzalex), a CD38-directed antibody, providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. The approval is based on...

immunotherapy

Immunotherapy in Patients With HIV Infection and Advanced Cancer

A study published by Cook et al in JAMA Oncology focused on whether treatment with checkpoint inhibitors is both safe and effective in patients with advanced cancer who are also human immunodeficiency virus (HIV)-positive. Because checkpoint inhibitors manipulate the immune system, the concern has...

immunotherapy

Machine Learning Identifies Multiple Underlying Factors Predicting Response to Immunotherapy

A research team is using a branch of artificial intelligence known as machine learning to better target immunotherapy to those who will benefit. In a recent study published by Leiserson et al in PLOS One, the team used data from a clinical trial of patients with bladder cancer to...

skin cancer
immunotherapy

Real-World Treatment Impact of Newer Agents on Survival of Patients With Metastatic Melanoma

The approval of several new agents for metastatic melanoma in the past several years has led to changes in how the disease is treated and managed. Treatments such as the programmed cell death protein 1 (PD-1) inhibitors pembrolizumab, ipilimumab, and nivolumab; BRAF inhibitors; and MEK inhibitors...

gynecologic cancers
immunotherapy

Avelumab in Recurrent or Refractory Ovarian Cancer

In phase Ib results from the JAVELIN Solid Tumor Trial reported in JAMA Oncology, Disis et al found that avelumab produced durable responses in some patients with recurrent or refractory ovarian cancer. In the study, an expansion cohort of 125 women with advanced disease who had received...

lung cancer
immunotherapy

Lung-MAP Precision Medicine Trial Expands

The Lung Cancer Master Protocol (Lung-MAP), the first precision medicine trial in lung cancer supported by the National Cancer Institute (NCI), is undergoing a major expansion to include patients with all non–small cell lung cancers (NSCLCs). The trial previously tested treatments for people ...

skin cancer
immunotherapy

How Effective Is Talimogene Laherparepvec Injection in Metastatic Melanoma?

Injection of a genetically modified virus that induces the body’s own immune cells to attack metastatic melanoma effectively treated almost 40% of patients with tumors that could not be surgically removed, according to findings published by Louie et al in the Journal of the American...

lung cancer
immunotherapy

Nivolumab or Nivolumab Plus Ipilimumab in Relapsed Malignant Pleural Mesothelioma

In a French phase II trial reported in The Lancet Oncology, Scherpereel et al found evidence of activity with nivolumab or the combination of nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma. Study Details In the open-label, noncomparative trial, 125 patients...

lung cancer
immunotherapy

Avelumab in Previously Treated Advanced Unresectable Mesothelioma

In a phase Ib trial reported in JAMA Oncology, Hassan et al found that the anti–programmed cell death ligand 1 antibody avelumab produced durable responses and a high rate of disease control in some patients with advanced unresectable mesothelioma progressing after platinum and pemetrexed...

sarcoma
immunotherapy

Results Reported From the Phase III ANNOUNCE Trial of Olaratumab in Soft-Tissue Sarcoma

The recently reported results of ANNOUNCE, the phase III study of olaratumab in combination with doxorubicin in patients with advanced or metastatic soft-tissue sarcoma, did not confirm the clinical benefit of olaratumab in combination with doxorubicin as compared to doxorubicin, a...

solid tumors
immunotherapy

Overall Survival in Men and Women Receiving Immune Checkpoint Inhibitors for Advanced Cancers

In a systematic review and meta-analysis reported in JAMA Oncology, Wallis et al found no difference in overall survival benefit in women vs men receiving immune checkpoint inhibitor treatment for advanced solid tumors. The authors noted that a prior analysis had suggested men derived a greater...

kidney cancer
immunotherapy

Patient-Reported Outcomes With Nivolumab Plus Ipilimumab vs Sunitinib in Advanced Renal Cell Carcinoma

As reported in The Lancet Oncology by Cella et al, patient-reported outcomes were better with nivolumab plus ipilimumab vs sunitinib in the phase III CheckMate 214 trial among patients with intermediate- or poor-risk advanced renal cell carcinoma. The ongoing trial showed significantly improved...

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