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Showing 1801 - 1850SIMPLIFY Trials: JAK Inhibitor Yields Long-Term Survival Benefit and Transfusion Independence in Myelofibrosis
Treatment with the novel JAK inhibitor momelotinib led to long-term overall survival and sustained transfusion independence in patients with intermediate- or high-risk myelofibrosis, according to updates from the SIMPLIFY-1 and SIMPLIFY-2 trials presented at the 2020 American Society of Hematology...
Novel Insights Into Multiple Myeloma
“Knowledge has a beginning but no end.” —Geeta Iyengar To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are three abstracts selected from the meeting proceedings focusing on novel therapies for...
Expert Point of View: Rachna T. Shroff, MD
Invited discussant of the ClarIDHy trial, Rachna T. Shroff, MD, Associate Professor of Medicine, University of Arizona, and Chief of GI Medical Oncology at the University of Arizona Cancer Center, said positive findings for ivosidenib support the notion that “biliary cancer is a perfect example of...
ClarIDHy Trial: IDH1 Inhibitor Ivosidenib Benefits Survival in Cholangiocarcinoma
Ivosidenib, an inhibitor of isocitrate dehydrogenase 1 (IDH1), improved overall survival by almost 3 months in previously treated patients with advanced IDH1-mutated cholangiocarcinoma, compared with placebo, researchers of the global phase III ClarIDHy trial reported at the 2021 Gastrointestinal...
Bruce E. Johnson, MD, on Evolving Challenges in Lung Cancer Drug Development
Bruce E. Johnson, MD, of Dana-Farber Cancer Institute, offers his expert perspective on single-arm drug approvals for targeted agents between 2016 and 2020, the need for biomarker testing, and the societal costs of drug development (Abstract PL04.03).
CheckMate 274: Adjuvant Nivolumab May Improve Disease-Free Survival in Patients With Muscle-Invasive Urothelial Carcinoma
Treatment with the immunotherapy nivolumab with or without cisplatin-based chemotherapy following radical surgery significantly improved disease-free survival in patients with muscle-invasive urothelial carcinoma, irrespective of their PD-L1 status, according to a study that will be presented by...
Reduced-Dose Intensity-Modulated Radiation Therapy for HPV-Associated Oropharyngeal Carcinoma
In the phase II NRG Oncology HN002 trial reported in the Journal of Clinical Oncology, Sue S. Yom, MD, PhD, and colleagues found that a reduced-dose intensity-modulated radiation therapy (IMRT) regimen for human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma satisfied...
MURANO Trial: Venetoclax Plus Rituximab Achieves Durable Progression-Free Survival in Resistant CLL
Patients with relapsed or refractory chronic lymphocytic leukemia (CLL) treated with the combination of fixed-duration venetoclax/rituximab had a longer overall survival and progression-free survival at 5 years compared with those treated with bendamustine/rituximab, according to a 5-year analysis...
Lisocabtagene Maraleucel Approved by FDA for Patients With Relapsed or Refractory Large B-Cell Lymphoma
On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (Breyanzi) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not...
FDA Grants Accelerated Approval to Umbralisib for Treatment of Marginal Zone and Follicular Lymphomas
On February 5, the U.S. Food and Drug Administration granted accelerated approval to umbralisib (Ukoniq), a kinase inhibitor including PI3K-delta and CK1-epsilon, for the following indications: Adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior...
FDA Update: Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate, Statement on Product Development to Address Virus Variants
On February 4, the U.S. Food and Drug Administration (FDA) announced the scheduling of a meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the request for emergency use authorization for a COVID-19 vaccine from Janssen Biotech Inc. Additionally, Acting...
Two ADAURA Analyses Support the Use of Osimertinib in Patients With Surgically Resected NSCLC
Two presentations based on data from the ADAURA clinical trial advanced previous research that demonstrated improved disease-fee survival outcomes for patients with surgically resected non–small cell lung cancer (NSCLC) receiving osimertinib, while also maintaining quality of life. The data were...
Nivolumab Monotherapy Improves Survival in Patients With Relapsed Malignant Mesothelioma
In patients with relapsed malignant mesothelioma, treatment with single-agent nivolumab led to a significant improvement in both overall and progression-free survival in the phase III CONFIRM trial. These findings were presented by Dean A. Fennell, FRCP, PhD, Professor and Chair of Thoracic Medical ...
Addition of Abatacept to Acute Graft-vs-Host Disease Prophylaxis
In a phase II trial (ABA2) reported in the Journal of Clinical Oncology, Watkins et al found that the addition of T-cell costimulation blockade with abatacept to calcineurin inhibitor (CNI)/methotrexate (MTX)–based graft-vs-host disease prophylaxis resulted in reduced rates of acute graft-vs-host...
FDA Pipeline: Priority Reviews for Immunotherapies in Gastric Cancers, Anal Cancer
The U.S. Food and Drug Administration (FDA) recently granted Priority Review to nivolumab as either adjuvant or first-line therapy in several types of gastric cancers, as well as to a novel PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal. The FDA also...
A Tale of Two CDK4/6 Inhibitors in Early Breast Cancer
The primary outcome analysis of the phase III monarchE trial, an update of previous data, continued to show significant benefit for abemaciclib in the adjuvant setting, reducing the risk for invasive disease recurrence by 28.7%. Meanwhile, the first results of the phase III PENELOPE-B trial of...
Expert Point of View: Marlise Luskin, MD
Commenting on this trial, Marlise Luskin, MD, of Dana-Farber Cancer Institute, Boston, explained that the treatment of AML in older adults remains a particular challenge for leukemia clinicians. “Although many older patients eligible for intensive induction chemotherapy achieve complete remission,...
Oral Azacitidine Is Noninferior to Placebo for Health-Related Quality of Life in AML
Health-related quality of life was sustained in patients taking oral azacitidine (also known as CC-486) compared with placebo in patients with acute myeloid leukemia (AML), according to results of the phase III QUAZAR AML-001 trial reported at the 2020 American Society of Hematology (ASH) Annual...
Expert Point of View: Suzanne Lentzsch, MD, PhD
IFM 2009 showed that autologous stem cell transplant (ASCT) combined with lenalidomide, bortezomib, and dexamethasone (RVd) results in a significantly better progression-free survival than RVd alone in newly diagnosed patients with myeloma.1 “The data favor immediate ASCT, as transplant resulted in ...
Long-Term Follow-up of IFM 2009 Confirms Benefit of Front-Line Transplant in Myeloma
The benefit of autologous transplantation in newly diagnosed multiple myeloma has been confirmed by follow-up of the IFM 2009 trial, reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition by Aurore Perrot, MD, PhD, Assistant Professor of Hematology at the Cancer...
Ipatasertib Plus Paclitaxel Falters in Advanced Triple-Negative Breast Cancer Phase III Trial
The combination of ipatasertib plus paclitaxel failed to improve progression-free survival in PIK3CA/AKT1/PTEN-altered locally advanced, unresectable or metastatic triple-negative breast cancer, according to results from cohort A of the phase III IPATunity130 trial, presented at the 2020 San...
Adding Entinostat to Exemestane Fails to Overcome Aromatase Inhibitor Resistance in Advanced Breast Cancer
The histone deacetylase inhibitor (HDAC) entinostat, added to exemestane, failed to overcome endocrine therapy resistance in advanced breast cancer, according to the E2112 phase III trial conducted by the ECOG-ACRIN Cancer Research Group. Results showed that overall survival was not improved by the ...
KEYNOTE-355: Pembrolizumab Plus Chemotherapy Improves Progression-Free Survival in PD-L1–Enriched Advanced Triple-Negative Breast Cancer
Pembrolizumab plus chemotherapy improved progression-free survival vs chemotherapy alone as first-line treatment of advanced or metastatic triple-negative breast cancer, according to the results of KEYNOTE-355.1 Progression-free survival was significantly improved with pembrolizumab plus...
Anastrozole vs Tamoxifen to Prevent DCIS Recurrence: Key Difference May Be Side-Effect Profile
If your patient were an older woman opting for hormonal therapy after surgically excised ductal carcinoma in situ (DCIS), which hormonal agent would you recommend for the prevention of disease recurrence: tamoxifen or anastrozole? According to long-term follow-up of the large, randomized IBIS...
Oral Taxanes Moving Forward in Metastatic Breast Cancer
Positive results have now been reported in phase III trials of two oral taxanes in the treatment of metastatic breast cancer. At the 2020 San Antonio Breast Cancer Symposium, treatment with tesetaxel and reduced-dose capecitabine resulted in an improvement in progression-free survival of about 3...
Unexpected Survival Benefit Reported With Trilaciclib in Metastatic Triple-Negative Breast Cancer
The intravenous administration of trilaciclib, the first-in-class reversible inhibitor of cyclin-dependent kinase 4/6 (CDK4/6), given with chemotherapy, led to a significant improvement in overall survival in previously treated patients with metastatic triple-negative breast cancer, compared with...
FDA Approves Nivolumab Plus Cabozantinib for Advanced Renal Cell Carcinoma
On January 22, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) and cabozantinib (Cabometyx) as first-line treatment for patients with advanced renal cell carcinoma. CheckMate 9ER Efficacy was evaluated in CheckMate 9ER, a randomized, open-label trial in...
Allogeneic Hematopoietic Cell Transplantation in Acute Leukemias and Myelodysplastic Syndromes
To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on the use of allogeneic hematopoietic cell transplantation (allo-HCT) in the...
Belantamab Mafodotin-blmf in Multiple Myeloma: Number of Prior Treatments No Hindrance to Efficacy
A post hoc analysis of the phase II DREAMM-2 trial showed single-agent belantamab mafodotin-blmf to be efficacious and tolerable in patients with relapsed or refractory multiple myeloma treated with at least three prior therapies, investigators reported at the 2020 American Society of Hematology...
Bemarituzumab Plus Chemotherapy Improves Outcomes in Advanced Gastric/Gastroesophageal Junction Cancer
Gastric cancer has a new target: fibroblast growth factor receptor 2b (FGFR2b). Targeting FGFR2b with bemarituzumab plus chemotherapy led to clinically meaningful and statistically significant improvements in progression-free survival, overall survival, and response rates in the randomized phase II ...
Does Cabozantinib Reduce Tumor Volume and Pain in Patients With NF1?
Results of a phase II trial showed that cabozantinib, a multiple tyrosine kinase receptor inhibitor, reduces tumor volume and pain in patients with the genetic disorder neurofibromatosis type 1 (NF1). These findings were published by Fisher et al in Nature Medicine. “This is the second class of...
IDH Inhibitor Ivosidenib Improves Overall Survival in Previously Treated Patients With Cholangiocarcinoma: ClarIDHy Trial
Ivosidenib, an inhibitor of isocitrate dehydrogenase 1 (IDH1), improved overall survival by almost 3 months compared with placebo in previously treated patients with advanced IDH1-mutated cholangiocarcinoma. Researchers presented results from the global phase III ClarIDHy trial at the 2021...
FDA Grants Accelerated Approval to Daratumumab Plus Hyaluronidase-fihj for Newly Diagnosed Light Chain Amyloidosis
On January 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to daratumumab plus hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis. ANDROMEDA Trial Efficacy was evaluated in ...
FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Previously Treated Patients With HER2-Positive Gastric Cancers
On January 15, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen....
FDA Approves Crizotinib for Children and Young Adults With Relapsed or Refractory Systemic ALK-Positive ALCL
On January 14, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori) for pediatric patients aged 1 year and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of crizotinib have not been ...
Subcutaneous Daratumumab Meets Primary Endpoint in APOLLO Trial in Myeloma
The first phase III study to evaluate the subcutaneous form of daratumumab has met its primary endpoint, investigators of the APOLLO trial reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.1 The triplet of daratumumab, pomalidomide, and low-dose dexamethasone ...
FDA Pipeline: Two Reviews in NSCLC, Plus Prescribing Information Update for Darolutamide
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to lorlatinib in ALK-positive non–small cell lung cancer (NSCLC) and Breakthrough Therapy designation to the combination of tiragolumab plus atezolizumab in NSCLC with high PD-L1 expression. The FDA also updated the...
FDA Issues Emergency Use Authorization for Second COVID-19 Vaccine
On December 18, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the second vaccine for the prevention of COVID-19 caused by SARS-CoV-2. The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the United States for use in...
Selected ASH Abstracts on Novel Treatments of Polycythemia Vera
To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are three abstracts selected from the meeting proceedings focusing on novel therapies for polycythemia vera. For full details of these study...
FDA Approves Adjuvant Osimertinib for EGFR-Mutated NSCLC
On December 18, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso) for adjuvant therapy after tumor resection in patients with non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as...
Intratumoral Injections May Boost Neoadjuvant Response in Resectable Melanoma
Studies reported at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting, which was held virtually, showed promise for the use of intratumoral injections of novel immunotherapies in treating advanced, resectable melanoma. In the 3-year interim analysis of a global phase II randomized...
Expert Point of View: Laura Dawson, MD
Laura Dawson, MD, Professor of Radiation Oncology at the University of Toronto and Princess Margaret Cancer Centre, viewed these initial study results as “a strong signal with high promise.” “Radiation therapy improves local control and delays local disease progression in patients with pancreatic...
Novel Radiomodulation Approach With Dismutase Mimetic Plus SBRT in Resectable Pancreatic Cancer
Pancreatic cancer is one of the most aggressive, lethal malignancies, and life-extending treatments represent a critical unmet need. A pilot study suggests a potential way forward for patients with nonmetastatic unresectable or borderline resectable pancreatic cancer may be a combination of...
Ruxolitinib Improves Outcomes in Patients With Steroid-Refractory or Steroid-Dependent Graft-vs-Host Disease
Ruxolitinib was superior to best available therapy in achieving efficacy as determined by best overall response and duration of response, with acceptable safety in adolescents and adults with steroid-dependent or steroid-refractory chronic graft-vs-host disease effects. These findings were shown in ...
Naxitamab for High-Risk Neuroblastoma in Bone or Bone Marrow
On November 25, 2020, naxitamab-gqgk (Danyelza) was granted accelerated approval for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone...
Expert Point of View: C. Kent Osborne, MD
C. Kent Osborne, MD, Founding Director of the Dan L. Duncan Comprehensive Cancer Center and the Dudley and Tina Sharp Chair for Cancer Research, Baylor College of Medicine, Houston, said in a press briefing that the results of the study were clear, but the explanation for the findings is less so....
Initial Therapy for Asymptomatic Follicular Lymphoma: Start With Watch and Wait or Rituximab
For patients with indolent follicular lymphoma, generally take a conservative approach to treatment unless the patient is symptomatic, advised John P. Leonard, MD, Executive Vice-Chair of Weill Department of Medicine at Weill-Cornell Medicine/NewYork-Presbyterian, New York.1 “Prognostic scores are...
2020 FDA Approvals of Drugs for Cancer Treatment
Over the past year (January to December 2020), the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and new indications for older therapeutic agents used in oncology and hematology. A brief review of new approvals appears here. For complete prescribing information for ...
Transplant May Improve Survival in Older Patients With High-Risk Myelodysplastic Syndrome, Study Reports
Stem cell transplants are not frequently offered to older patients with high-risk myelodysplastic syndromes (MDS). According to a study from the Blood and Marrow Transplant Clinical Trials Network (BMTCTN 1102), these patients may indeed achieve a survival benefit from stem cell transplant. As...
FDA Approves Selinexor for Refractory or Relapsed Multiple Myeloma
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor (Xpovio) in combination with bortezomib (Velcade) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The FDA granted selinexor accelerated...
