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Showing 251 - 300FDA 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 ...
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 ...
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...
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....
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...
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 ...
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...
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 ...
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...
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...
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...
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 ...
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...
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...
Eric Jonasch, MD, on Kidney Cancer: A Year in Review
Eric Jonasch, MD, of The University of Texas MD Anderson Cancer Center, discusses major findings over the past 12 months in kidney cancer, including combination immunotherapies and trends in surgical oncology.
Matthew A. Gubens, MD, on Non–Small Cell Lung Cancer: New Immunotherapy Strategies in the NCCN Guidelines
Matthew A. Gubens, MD, of the UCSF Helen Diller Family Comprehensive Cancer Center, discusses recent updates to the NCCN Guidelines in non–small cell lung cancer, including the use of pembrolizumab as a single agent or in combination based on PD-L1 status, treatment selection in squamous and...
Jyoti D. Patel, MD, on Stage III Non–Small Cell Lung Cancer: A Look at New Systemic Treatments
Jyoti D. Patel, MD, of the University of Chicago, discusses immunotherapy for locally advanced NSCLC, selecting patients for these treatments, and the potential toxicities of combination therapies.
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...
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...
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 ...
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...
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 ...
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...
Stefan O. Ciurea, MD, on Infusing High Doses of Natural Killer Cells: An Enhanced Antitumor Effect
Stefan O. Ciurea, MD, of The University of Texas MD Anderson Cancer Center, discusses the enhanced antitumor effect and lower viral reactivation that result from high doses of natural killer cells infused after haploidentical transplantation, with no excess graft-vs-host disease, a low relapse rate ...
G. Travis Clifton, MD, on Breast Cancer and Disease Recurrence: Final Analysis From a Study of Nelipepimut-S, GM-CSF, and Trastuzumab
G. Travis Clifton, MD, of Brooke Army Medical Center, discusses phase IIb trial findings on nelipepimut-S plus GM-CSF with trastuzumab vs trastuzumab alone to prevent recurrences of high-risk, HER2 low-expressing breast cancer (Abstract 1).
Nicholas Vogelzang, MD, on Urothelial Cancer: Results From a Trial on Lenvatinib Plus Pembrolizumab
Nicholas Vogelzang, MD, of the Comprehensive Cancer Centers of Nevada, discusses phase Ib/II findings on pembrolizumab and lenvatinib given to 20 patients with metastatic transitional cell carcinoma of the bladder who had received no prior checkpoint inhibitor therapy (Abstract 11).
Kim A. Margolin, MD, on Promising Immunotherapy Strategies
Kim A. Margolin, MD, of City of Hope, summarizes a session she co-chaired on combination immunotherapies, locoregional therapies, systemic therapies, and enhancing natural killer cells.
Madhav V. Dhodapkar, MBBS, on Cancer Vaccines: Emerging Trends
Madhav V. Dhodapkar, MBBS, of Emory University, summarizes a session he co-chaired on emerging approaches for vaccines, personalized/neoantigen vaccines, and mutation-targeted immunotherapy for diffuse midline gliomas.
Nicolas Guibert, MD, PhD, on Non–Small Cell Lung Cancer: Predicting Response to PD-1 Inhibitors With cfDNA
Nicolas Guibert, MD, PhD, of Toulouse University Hospital, discusses a simple algorithm built to predict durable outcomes of patients with advanced non–small cell lung cancer that has been treated with immunotherapy. He notes that early changes in circulating tumor DNA burden may also predict...
Elizabeth A. Mittendorf, MD, PhD, on Breast Cancer Immunotherapy: Building on Recent Successes
Elizabeth A. Mittendorf, MD, PhD, of Dana-Farber Cancer Institute, discusses the encouraging data on atezolizumab plus nab-paclitaxel in the first-line setting for metastatic triple-negative breast cancer, and the potential benefits of combining immune checkpoint inhibitors with targeted treatment...
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...
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...
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...
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...
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...
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...
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 ...
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 ...
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...
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...
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...
Sumit K. Subudhi, MD, PhD, on Prostate Cancer: Results From the CheckMate 650 Trial on Nivolumab and Ipilimumab
Sumit K. Subudhi, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses the initial results from a phase II study of nivolumab plus ipilimumab in the treatment of metastatic castration-resistant prostate cancer (Abstract 142).
Rana R. McKay, MD, on Renal Cell Carcinoma: Results From a Trial on Atezolizumab and Bevacizumab
Rana R. McKay, MD, of the University of California, San Diego, discusses phase II study findings on atezolizumab and bevacizumab in non–clear cell renal cell carcinoma and clear cell renal cell carcinoma with sarcomatoid differentiation (Abstract 548).
Laurence Albiges, MD, PhD, on Renal Cell Carcinoma: Results From the NIVOREN GETUG-AFU 26 Study on Nivolumab
Laurence Albiges, MD, PhD, of Gustave Roussy, discusses findings on the safety and efficacy of nivolumab used in a “real world” prospective study on metastatic renal cell carcinoma (mRCC). This research was conducted after nivolumab was approved for the treatment of mRCC following failure of one or ...
Toni K. Choueiri, MD, on Renal Cell Carcinoma: Trial Results on Avelumab Plus Axitinib vs Sunitinib
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discusses a subgroup analysis from the JAVELIN Renal 101 study on outcomes for avelumab plus axitinib vs sunitinib in advanced renal cell carcinoma (Abstract 544).
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...
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,...
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...
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...
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...
