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Showing 2451 - 2500FDA Approves Pembrolizumab for Some Patients With PD-L1–Positive Esophageal Cancer
On July 30, the U.S. Food and Drug Administration (FDA) approved the programmed cell death protein 1 inhibitor pembrolizumab (Keytruda) as monotherapy for the treatment of patients with recurrent locally advanced or metastatic esophageal cancer whose tumors express programmed cell death ligand 1...
FDA Pipeline: Designation in CLL, New Drug Application in GIST, New Prostate Ablation System Receives 510(k) Clearance
Recently, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to acalabrutinib in chronic lymphocytic leukemia (CLL), accepted a new drug application for avapritinib in some types of gastrointestinal stromal tumors (GIST), and granted 501(k) clearance to market the...
Olaparib/Temozolomide Shows Activity in Patients With Relapsed Small Cell Lung Cancer
Small cell lung cancer accounts for approximately 15% of all lung cancers and has high metastatic potential and poor clinical outcomes. While untreated small cell lung cancers are usually highly sensitive to cytotoxic chemotherapy—with response rates of between 50% and 70%—patients...
Highlights in Geriatric Hematology From the ASH Annual Meeting & Exposition
GUEST EDITOR Geriatrics for the Oncologist is guest edited by Stuart M. Lichtman, MD, FACP, FASCO, and developed in collaboration with the International Society of Geriatric Oncology (SIOG). Dr. Lichtman is an Attending Physician at Memorial Sloan Kettering Cancer Center, Commack, New York, and...
Polatuzumab Vedotin-piiq for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
On June 10, 2019, the CD79b-directed antibody-drug conjugate polatuzumab vedotin-piiq was granted accelerated approval for use in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified,...
Treatment Update on Selected Non-Hodgkin Lymphomas
As part of The ASCO Post’s coverage of the 2019 ASCO Annual Meeting, featured here are four abstracts from different clinical trials evaluating newer treatments for Waldenström’s macroglobulinemia and T-cell lymphomas. Waldenström’s Macroglobulinemia ABSTRACT 7509: Outcomes with bendamustine plus ...
Novel Therapeutics on the Horizon for Treating Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy-induced peripheral neuropathy is a major clinical problem, and better therapies are needed for both its treatment and prevention. According to Charles Loprinzi, MD, a medical oncologist at the Mayo Clinic in Rochester, Minnesota, to devise better preventive and treatment approaches,...
Notable Presentations at ASCO 2019 Included Studies in Sarcoma, Lymphoma, Myeloma, and Breast and Kidney Cancers
The 2019 ASCO Annual Meeting featured a wealth of presentations on important topics. In addition to our regular news coverage of the meeting, we present below some highlights of other studies that add to our knowledge base for treatment of various cancers. Olaratumab in Soft-Tissue Sarcoma...
How an Innovative AI-Based Smartphone Application Is Addressing Patients’ Palliative Care Needs
GUEST EDITOR Addressing the evolving needs of cancer survivors at various stages of their illness and care, Palliative Care in Oncology is guest edited by Jamie H. Von Roenn, MD, FASCO. Dr. Von Roenn is ASCO’s Vice President of Education, Science, and Professional Development. During the 2019...
BEACON CRC: Encorafenib/Binimetinib/Cetuximab Improves Survival in BRAF V600E–Mutated Metastatic Colorectal Cancer
The three-drug combination of encorafenib (a BRAF inhibitor), binimetinib (a MEK inhibitor), and cetuximab (an EGFR inhibitor) significantly improved overall survival in patients with BRAF-mutated metastatic colorectal cancer, according to the results of the phase III BEACON CRC clinical trial....
AI May Improve Efficiency and Accuracy of Digital Breast Tomosynthesis
Artificial intelligence (AI) may improve the efficiency and accuracy of an advanced imaging technology used to screen for breast cancer, according to a study published by Conant et al in Radiology: Artificial Intelligence. Digital breast tomosynthesis is an advanced method for cancer...
FDA Approves Pembrolizumab for Some Patients With PD-L1–Positive Esophageal Cancer
On July 30, the U.S. Food and Drug Administration (FDA) approved the programmed cell death protein 1 inhibitor pembrolizumab (Keytruda) as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed ...
FDA Approves Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer
On July 30, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa) for the treatment of nonmetastatic castration-resistant prostate cancer. Approval was based on the ARAMIS study, a multicenter, double-blind, placebo-controlled clinical trial of 1,509 patients with...
Brief Update on Clinical Trials of New Treatments in Gastrointestinal Cancers
The 2019 ASCO Annual Meeting provided attendees with an abundance of clinically relevant abstracts in gastrointestinal cancers. Briefly featured here are clinical trial updates on pembrolizumab in the second-line treatment of hepatocellular carcinoma (KEYNOTE-240 trial), laparoscopic vs open...
Update on Newer Treatments in Non-Hodgkin Lymphomas
As part of The ASCO Post’s coverage of the 2019 ASCO Annual Meeting, featured here are summaries of five abstracts of different clinical trials evaluating newer treatments for follicular and marginal zone lymphomas as well as diffuse large B-cell lymphoma. Follicular and Marginal Zone Lymphomas...
FDA Grants Accelerated Approval to Selinexor in Combination With Dexamethasone in Pentarefractory Multiple Myeloma
On July 3, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two ...
Study Highlights on Novel Agents and Supportive Care Strategies in Prostate Cancer
In addition to our regular coverage of major news stories from the 2019 ASCO Annual Meeting, here is an additional roundup of important studies related to prostate cancer. ARAMIS: Darolutamide and Quality of Life Darolutamide, a next-generation androgen receptor antagonist, significantly prolonged...
Is Heterogeneity Within HER2-Positive Tumors Clinically Relevant?
Breast cancers that display heterogeneity of HER2 expression may represent a distinct subset of HER2-positive breast cancer that is associated with lower rates of pathologic complete response, according to a phase II study from Dana-Farber Cancer Institute. This trial evaluated HER2 heterogeneity...
Two Pivotal Studies in Breast Cancer Report Further Analyses
At the 2019 ASCO Annual Meeting, two pivotal breast cancer trials reported final or additional analyses: one confirmed the negative results seen in earlier reports,1 and the other supported a new survival benchmark.2 KRISTINE: Neoadjuvant T-DM1/Pertuzumab Sara A. Hurvitz, MD, of the David Geffen...
Study Finds Immune-Related Adverse Events Herald Benefit With Adjuvant Pembrolizumab in Melanoma
In the EORTC 1325/KEYNOTE-054 trial of adjuvant pembrolizumab in patients with stage III melanoma, recurrences were reduced by 44% in the immunotherapy arm, vs placebo, but this benefit increased to a 63% reduction in risk among patients developing an immune-related adverse event on treatment.1...
FDA Approves Daratumumab in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
On June 27, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received...
Brentuximab Vedotin in Untreated Systemic Anaplastic Large-Cell Lymphoma and CD30-Expressing Peripheral T-Cell Lymphomas
On November 16, 2018, brentuximab vedotin was approved for use in combination with chemotherapy for previously untreated systemic anaplastic large-cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCLs), including angioimmunoblastic T-cell lymphoma and PTCL–not otherwise...
FDA Grants Breakthrough Therapy Designation to Pembrolizumab Plus Lenvatinib in Advanced HCC
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the programmed cell death protein 1 inhibitor pembrolizumab in combination with the multiple kinase inhibitor lenvatinib for the potential first-line treatment of patients with advanced unresectable...
Neoadjuvant Chemotherapy Duration and Obesity May Be Associated With Increased Risk of Lymphedema in Some Women With Breast Cancer
In a cohort study reported in JAMA Surgery, Armer et al found that longer duration of neoadjuvant chemotherapy and increasing body mass index (BMI) were associated with increased risk of lymphedema in women with node-positive breast cancer who received neoadjuvant chemotherapy and axillary...
AACR Immune Cell Therapies: Early Study Results Suggest Activity of Multiantigen T-Cell Therapy in Patients With Pancreatic Cancer
Findings from a small phase I study investigating a nonengineered, multiantigen-specific T-cell therapy for the treatment of pancreatic cancer has found that the therapy had clinical activity and was safe and well tolerated. The early results suggest that the immune cell therapy may provide a...
Fragility Analysis of Phase III Trials Supporting FDA Approval of Anticancer Drugs
In an analysis reported in The Lancet Oncology, Del Paggio and Tannock found that many phase III trials supporting U.S. Food and Drug Administration (FDA) approval of anticancer drugs have a low fragility index—a measure of how many people in a study would have had to have a different outcome ...
FDA Approves First-Line Ivosidenib for IDH1-Mutated AML
On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...
ESMO World GI 2019: BEACON CRC: Encorafenib/Binimetinib/Cetuximab Improves Survival in BRAF V600E–Mutated Metastatic Colorectal Cancer
The three-drug combination of encorafenib, binimetinib, and cetuximab significantly improved overall survival in patients with BRAF-mutated metastatic colorectal cancer, according to results of the phase III BEACON CRC clinical trial. These findings were presented by Kopetz et al at the European...
FDA Grants Accelerated Approval to Selinexor in Combination With Dexamethasone in Pentarefractory Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two...
Actively Recruiting Clinical Trials for Muscle-Invasive and Non–Muscle-Invasive Bladder Cancers
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical research trials for both muscle-invasive and non–muscle-invasive bladder cancers. The studies listed here are evaluating the safety and efficacy of combinations of chemotherapy and...
APACT Trial: Nab-paclitaxel/Gemcitabine vs Gemcitabine Alone in Adjuvant Treatment of Pancreatic Cancer
The largest adjuvant trial in pancreatic adenocarcinoma, the global phase III APACT trial, evaluated the combination of adjuvant nab-paclitaxel/gemcitabine vs gemcitabine monotherapy in patients with resected pancreatic cancer. Results of the study were reported by Margaret A. Tempero, MD, of the...
SOPHIA Trial Tests Margetuximab in Heavily Pretreated Patients With HER2-Positive Metastatic Breast Cancer
In the phase III SOPHIA trial of 536 heavily pretreated patients with HER2-positive metastatic breast cancer, the novel anti-HER2 antibody margetuximab plus chemotherapy led to significant improvements in progression-free survival, response, and clinical benefit compared with...
Study Shows Benefit With Pazopanib in Treatment of Carcinoid Tumors
Pazopanib significantly improved progression-free survival by 47% in patients with progressive carcinoid tumors, in a prospective randomized phase II trial presented at the 2019 ASCO Annual Meeting.1 “With these results, Alliance A021202 becomes the first randomized study to show that the vascular...
Expert Point of View: Jordan Berlin, MD
Jordan Berlin, MD, the Ingram Professor of Cancer Research and Professor of Medicine at Vanderbilt University Medical Center, Nashville, discussed the FOxTROT study at the oral session. “FOxTROT did reach its targeted hazard ratio, but the bottom line is the P value did not quite make it to where...
Study Supports Neoadjuvant Chemotherapy in Operable Colon Cancer
For patients with operable colon cancer, neoadjuvant chemotherapy resulted in numerous benefits in the FOxTROT trial but did not reach target significance for the primary endpoint. The study was presented at the 2019 ASCO Annual Meeting by Matthew T. Seymour, MD, of the University of Leeds School...
Targeting FOLFOXIRI Plus Bevacizumab to a Metastatic Colorectal Cancer Subset
In a population of patients with metastatic colorectal cancer deemed to be at high risk by the presence of circulating tumor cells (CTCs), first-line treatment with FOLFOXIRI plus bevacizumab improved progression-free survival by about 3 months, compared with modified FOLFOX plus bevacizumab,...
Pexidartinib for Advanced Tenosynovial Giant Cell Tumors
In the phase III ENLIVEN trial reported in The Lancet, Tap et al found that the colony-stimulating factor 1 inhibitor pexidartinib produced responses in patients with advanced tenosynovial giant cell tumors (TGCTs) not amenable to surgical resection. Study Details In the double-blind portion of...
Neoadjuvant Immunotherapy May Benefit Patients With Early-Stage NSCLC
Neoadjuvant immunotherapy had encouraging activity and demonstrated favorable safety in patients with resectable early-stage non–small cell lung cancer (NSCLC), according to two studies presented at the 2019 ASCO Annual Meeting.1,2 This approach has the potential to boost the survival rate in...
NALA Trial: Neratinib Plus Capecitabine Shows Benefit in Metastatic Breast Cancer
In the global phase III NALA trial, treatment of metastatic HER2-positive breast cancer with neratinib plus capecitabine significantly improved progression-free survival, delayed the time to intervention for central nervous system disease, and showed a trend toward improved overall survival vs...
CLEOPATRA End-of-Study Analysis in Metastatic Breast Cancer: 37% Alive at 8 Years
The end-of-study analysis of the landmark CLEOPATRA trial shows that 37% of patients with HER2-positive metastatic breast cancer are still alive at 8 years, according to principal investigator Sandra M. Swain, MD, FACP, FASCO, Associate Dean for Research Development at Georgetown University Medical ...
Extended Follow-up From the National Lung Screening Trial Reported
Early detection and treatment through screening with low-dose computed tomography (LDCT) has been investigated as a potential means of reducing lung cancer mortality for more than 2 decades. In 2011, a large U.S. study—the randomized National Lung Screening Trial (NLST)—reported a 20%...
15-ICML: Adding Lenalidomide to R-CHOP in Newly Diagnosed DLBCL
In the phase II ECOG-ACRIN 1412 trial, presented by Nowakowski et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 006), researchers sought to compare the addition of lenalidomide to R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) vs...
FDA Pipeline: Applications Accepted in Gynecologic Cancers, Targeted Therapies
Recently, the U.S. Food and Drug Administration (FDA) accepted a new drug application for niraparib in the treatment of certain pretreated gynecologic cancers; granted Fast Track designation to a T-cell product; accepted investigational new drug applications for a myelopreservation agent and an...
FDA Approves Daratumumab in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed, Transplant-Ineligible Patients With Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received approval ...
15-ICML: Final Data From ALCANZA: Brentuximab Vedotin for CD30-Positive CTCL
Final analyses from the ALCANZA study, a phase III trial investigating brentuximab vedotin vs physician’s choice for the treatment of CD30-positive cutaneous T-cell lymphoma (CTCL), were presented by Horwitz et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract...
15-ICML: ROBUST Trial Examines Efficacy of Lenalidomide/R-CHOP in Previously Untreated ABC-Type DLBCL
The ROBUST trial compared the addition of lenalidomide to R-CHOP (rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone) vs placebo/R-CHOP in previously untreated, prospectively selected, CD20-positive patients with activated B-cell–like (ABC)-type diffuse large B-cell...
Noninferiority Trial Establishes Chemoradiotherapy Regimen as ‘First Standard of Care for HPV-Positive Oral Cancer’
A noninferiority phase III trial, previously reported in The Lancet, has established the standard of care in human papillomavirus (HPV)-related oral cancer, according to Andy M. Trotti, MD, a radiation oncologist at Moffitt Cancer Center in Tampa, Florida. Data from the NRG Oncology RTOG 1016 trial ...
Two Studies Question the Role of Continuous LHRH Antagonists in Metastatic Castration‑Resistant Prostate Cancer
In the field of prostate cancer, the use of androgen-deprivation therapy (ADT) in men with metastatic castration-resistant prostate cancer is received wisdom. When experts are asked why ADT is continued once the disease has figured out how to evade hormone suppression, the answer invariably is...
Fixed-Duration Venetoclax Plus Obinutuzumab as First-Line Treatment in Older Patients With CLL Who Have Comorbidities
A fixed-duration regimen of venetoclax plus obinutuzumab demonstrated superior progression-free survival, complete response rates, and minimal residual disease (MRD) negativity compared with chlorambucil plus obinutuzumab as first-line therapy for older patients with chronic lymphocytic leukemia...
Expert Point of View: Charles Drake, MD, PhD
IN A SEPARATE interview with The ASCO Post, Charles Drake, MD, PhD, commented on the clinical implications of the ENZAMET and TITAN trials, as well as studies of apalutamide, abiraterone acetate, and docetaxel used in metastatic hormone-sensitive prostate cancer. Dr. Drake is Director of...
