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leukemia

Bruton’s Tyrosine Kinase Inhibitor Yields High Overall Response Rates in del(17p) CLL and SLL

In findings of the SEQUOIA trial and updated results of the AU-003 trial,1,2 zanubrutinib, a Bruton’s tyrosine inhibitor (BTK), was shown to produce high overall response rates for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), even in the presence of...

immunotherapy
lymphoma

Combination Brentuximab Vedotin, Nivolumab Explored in First-Line, Salvage Therapies for Patients With Hodgkin Lymphoma

Two separate studies are investigating brentuximab vedotin plus nivolumab combination therapy for adults with Hodgkin lymphoma: one as first-line therapy and another as salvage therapy for relapsed/refractory classic disease, according to data presented at the 2019 Annual Meeting & Exposition...

immunotherapy
leukemia

Expert Point of View: Howard J. Weinstein, MD, and Robert A. Brodsky, MD

Commenting on the Children’s Oncology Group AALL1331 study, Howard J. Weinstein, MD, Chief of Pediatric Hematology­Oncology at Massachusetts General Hospital for Children and Harvard Medical School in Boston, said: “These are very promising results for children, adolescents, and young adults who...

immunotherapy
leukemia

Blinatumomab Post-reinduction Consolidation Improves Event-Free, Overall Survival vs Chemotherapy in Young Patients With B-Cell ALL

Among children, adolescents, and young adults with B-cell acute lymphoblastic leukemia (ALL), the bispecific T-cell engager blinatumomab improved event-free survival and overall survival, compared with standard chemotherapy, as post-reinduction consolidation therapy at first relapse prior to...

hematologic malignancies
leukemia
multiple myeloma
lymphoma
immunotherapy

Conference Highlights From the 2019 American Society of Hematology Annual Meeting & Exposition

More than 25,000 specialists in hematology from over 115 countries attended the 61st American Society of Hematology (ASH) Annual Meeting & Exposition held last December in Orlando. The conference featured a stunning array of 4,900 abstracts with impressive new data in the treatment of multiple...

pancreatic cancer

Expert Point of View: Andrea Wang-Gillam, MD, PhD

Andrea Wang-Gillam, MD, PhD, Clinical Director of the GI Oncology Program and Director of Developmental Therapeutics at Washington University in St. Louis, was the invited discussant of SEQUOIA and HALO 109-301. She tried to make sense of the two negative studies of pegylated agents in advanced...

pancreatic cancer

Two Novel Pegylated Agents Fail in Metastatic Pancreatic Cancer

Two novel treatments once thought to hold promise in the treatment of metastatic pancreatic cancer have not proved to be effective in phase III trials, investigators reported at the 2020 Gastrointestinal Cancers Symposium. When combined with standard chemotherapy, a pegylated form of human...

breast cancer
immunotherapy

Addition of Pembrolizumab to Neoadjuvant Chemotherapy in Early-Stage HER2-Negative Breast Cancer

As reported in JAMA Oncology by Rita Nanda, MD, and colleagues, findings from the ongoing phase II I-SPY 2 trial indicated that the addition of pembrolizumab to standard neoadjuvant chemotherapy improved pathologic complete response rates in patients with high-risk stage II/III HER2-negative breast ...

lymphoma
lung cancer
gastrointestinal cancer
breast cancer
head and neck cancer
immunotherapy

FDA Pipeline: Priority Reviews in Lymphoma, Lung Cancer, GIST, and Breast Cancer

This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents in lymphoma, lung cancer, gastrointestinal stromal tumors, and breast cancer, and granted Fast Track designation to a first-in-class radioenhancer hafnium oxide nanoparticle in head and neck cancer. Priority...

gastroesophageal cancer

PANGEA Trial Shows Personalized Antibody Selection May Improve Outcomes in Gastroesophageal Cancer

A personalized approach to selecting antibody therapy for patients with newly diagnosed stage IV gastroesophageal adenocarcinoma resulted in a 1-year overall survival rate of 66% and a median overall survival of 16.4 months in the PANGEA study (see Table 1).1 The study used a novel clinical...

kidney cancer
immunotherapy

ASCO-SITC 2020: Ilixadencel/Sunitinib vs Sunitinib Alone in Synchronous Metastatic Kidney Cancer

In a study presented by Lindskog et al at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium (Abstract 11), researchers found ilixadencel, a cell-based allogeneic off-the-shelf product, in combination with sunitinib produced a higher objective response rate than sunitinib alone in patients with...

gynecologic cancers

Is There a Future Role for Secondary Cytoreductive Surgery in the Treatment of Recurrent Ovarian Cancer?

In a recent issue of The New England Journal of Medicine, Coleman et al released the results from the GOG-0213 trial, a multicenter, randomized prospective trial that compared secondary cytoreduction followed by chemotherapy with chemotherapy alone in women with platinum-sensitive recurrent ovarian ...

breast cancer

Triple-Negative Breast Cancer Responds to Novel Therapy

The phase II KEYNOTE-890 trial is a small but interesting study in patients with inoperable advanced triple-negative breast cancer. After one injection of intratumoral tavokinogene telseplasmid, a plasmid encoding the proinflammatory cytokine interleukin-12 (IL-12), followed by electroporation and...

breast cancer
immunotherapy

Neoadjuvant and Adjuvant Pembrolizumab Improves Pathologic Complete Response Rate in Triple-Negative Breast Cancer

The addition of pembrolizumab to neoadjuvant and adjuvant chemotherapy achieves higher rates of pathologic complete response compared with placebo in patients with triple-negative breast cancer, according to results of the phase III KEYNOTE-522 trial presented at the 2019 San Antonio Breast Cancer...

lymphoma
immunotherapy
symptom management

Early Steroid Use May Reduce Toxicity With CAR T-Cell Therapy

In patients with large B-cell lymphoma undergoing chimeric antigen receptor (CAR) T-cell therapy with axicabtagene ciloleucel, earlier-than-usual intervention with corticosteroids and tocilizumab may reduce the incidence of severe cytokine-release syndrome, according to the findings of a...

Selected ASH Abstracts on Myelodysplastic Syndromes

To complement The ASCO Post’s continued comprehensive coverage of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel therapies for myelodysplastic syndromes (MDS), including the...

breast cancer

Real-World Use of Palbociclib and Abemaciclib Explored in Two Studies Based on Electronic Health Records Database

Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors are changing the landscape of the treatment of hormone receptor (HR)-positive/HER2-negative breast cancer. Three CDK4/6 inhibitors are approved by the U.S. Food and Drug Administration—ribociclib, palbociclib, and abemaciclib—as first- or...

leukemia
lymphoma

Two Clinical Trials Show Zanubrutinib Achieves High Response Rates in del(17p) CLL and SLL

The Bruton’s tyrosine kinase inhibitor (BTK) zanubrutinib continues to achieve high overall response rates for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), even in the presence of high-risk cytogenetics, according to findings from two different trials...

lung cancer
immunotherapy

Pooled Analysis of Body Mass Index and Overall Survival With Immune Checkpoint Inhibitor Therapy in NSCLC

In a study reported in JAMA Oncology, Kichenadasse et al found that high body mass index was associated with improved overall survival in patients with advanced non–small cell lung cancer (NSCLC) treated with atezolizumab. As noted by the investigators, there are data showing that high BMI is...

head and neck cancer
pain management

Gabapentin and Methadone for Patients Undergoing Treatment of Head and Neck Cancer

With nearly all patients who undergo treatment for cancer of the head and neck experiencing oral mucositis, effective pain control is one of the main goals of physicians and care teams. Looking to provide more effective relief for patients—while also reducing the need for opioid painkillers—a team...

issues in oncology

Ringing a Bell on the Last Day of Radiation Therapy: Helpful or Harmful?

Some patients with cancer celebrate the end of a course of radiation or chemotherapy by ringing a bell. Indeed, many patients say they love the graduation-like ceremony and the sense of closure it gives them. However, a study published by Williams et al in the International Journal of Radiation...

pancreatic cancer

‘Unprecedented’ Responses to Cisplatin/Gemcitabine in BRCA-Mutated Advanced Pancreatic Cancer

As first-line treatment of patients with pancreatic ductal adenocarcinoma and a germline BRCA/PALB2 mutation, cisplatin plus gemcitabine yielded high response rates and encouraging survival, establishing this doublet as a standard approach in this subset of patients, according to Eileen M....

Expert Point of View: A. Jo Chien, MD

The formal discussant of this abstract on the ATEMPT trial, A. Jo Chien, MD, Associate Professor at UCSF’s Helen Diller Comprehensive Cancer Center, San Francisco, said that a median follow-up of 3-years is relatively short for this trial, considering about 75% of patients had hormone...

breast cancer
immunotherapy

Study Reports Similar Efficacy but No Less Toxicity With Adjuvant T-DM1 vs Taxane/Trastuzumab in Early Breast Cancer

The antibody-drug conjugate ado-trastuzumab emtansine (T-DM1) failed to show improved safety when compared with paclitaxel plus trastuzumab as adjuvant therapy in patients with stage 1 HER2-positive breast cancer. These results of the randomized, phase II ATEMPT trial were presented at the 2019 San ...

multiple myeloma
prostate cancer
lung cancer
hepatobiliary cancer
immunotherapy

FDA Pipeline: Priority Reviews in Multiple Myeloma, Prostate Cancer

Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for multiple myeloma and prostate cancer; gave Fast Track designation to a targeted gene therapy for lung cancer; granted Orphan Drug designation to a combination therapy for hepatocellular...

sarcoma

FDA Approves Tazemetostat for Epithelioid Sarcoma

On January 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. “Epithelioid sarcoma accounts...

breast cancer

APHINITY Update Supports Benefit of Pertuzumab-Based Triplet in Early HER2-Positive, Node-Positive Breast Cancer

Six-year follow-up of the APHINITY trial found a modest, but not statistically significant, overall survival benefit for the addition of pertuzumab to chemotherapy plus trastuzumab vs chemotherapy/trastuzumab as adjuvant therapy in patients with early HER2-positive breast cancer. The benefit was...

Expert Point of View: Virginia Kaklamani, MD, Steven Vogl, MD, Gary Lyman, MD, MPH, and Ginny Mason, BSN

For several breast cancer experts interviewed by The ASCO Post, the phase III oral paclitaxel study and the drug itself had some limitations. Virginia Kaklamani, MD, of UT Health San Antonio, moderator of a press briefing, thought that the dosing process and the 11 pills or so per day was a...

breast cancer

Oral Paclitaxel Outperforms Intravenous Formulation in Phase III Trial

In the first reported phase III study of an oral taxane, an investigational oral form of paclitaxel yielded a higher overall response rate and produced less neuropathy than standard intravenous paclitaxel, researchers reported at the 2019 San Antonio Breast Cancer Symposium.1 “Oral paclitaxel...

breast cancer

Partial-Breast Irradiation Favored Over Whole-Breast in Early Breast Cancer

Patients with early breast cancer with small, node-negative tumors can safely be treated with accelerated partial-breast irradiation using intensity-modulated radiotherapy. According to the 10-year median follow-up of the randomized phase III APBI IMRT Florence trial, recurrence rates were low and...

leukemia
geriatric oncology

Oral CC-486 Maintenance Therapy Extends Survival in Older Patients With AML

Use of CC-486—an investigational oral form of azacitidine—as maintenance therapy significantly improved overall survival and relapse-free survival in older patients with newly diagnosed acute myeloid leukemia (AML) who were in remission following induction chemotherapy with or without consolidation ...

leukemia

ADMIRAL Trial: More Than Standard Chemotherapy Needed for FLT3-Mutant Advanced AML

The important ADMIRAL trial, reported by Perl et al in The New England Journal of Medicine1 and reviewed in this issue of The ASCO Post, shows the efficacy of a specific FLT3 inhibitor in patients with advanced acute myeloid leukemia (AML) and enhances the era of personalized medicine in leukemia. ...

breast cancer

Breast Cancer Chemoprevention Effect Maintained Long After Stopping Anastrozole Therapy

For postmenopausal women at high risk for developing breast cancer—largely based on family history—anastrozole taken for 5 years maintained a preventive effect for at least an additional 7 years after stopping the drug in the IBIS-II trial, which included nearly 4,000 subjects. Women randomly...

breast cancer

FDA Grants Breakthrough Therapy Designation to Tucatinib in Combination Therapy for HER2-Positive Breast Cancer

Seattle Genetics recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tucatinib, in combination with trastuzumab and capecitabine, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast...

breast cancer
immunotherapy

Tucatinib Combination Extends Survival in HER2-Positive Metastatic Breast Cancer, Including Patients With Brain Metastases

For patients with progressing HER2-positive metastatic breast cancer previously treated with trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1), no single regimen is an established standard of care. More than 50% of these patients will develop brain metastasis, and thus far, treatments...

cns cancers

Everolimus/Octreotide Shows Antitumor Activity in Recurrent Meningioma

According to the results from the small phase II CEVOREM trial, a targeted combination of the mTOR inhibitor everolimus and the somatostatin agonist octreotide showed antitumor activity in patients with recurrent meningioma not amenable to any type of surgery or radiotherapy. These findings were...

issues in oncology

Optimizing Metabolic Discoveries

Obesity is a leading cause of cancer, and researchers are working to learn more about the biology behind the body’s metabolism and the promotion of cancer growth. “While we know that physical activity and a balanced diet are generally healthy, we don’t yet have the data to make personalized...

breast cancer

Extended Letrozole Boosts Disease-Free Survival in 10-Year Update of NSABP B-42 Trial

“In the 10-year analysis of the NSABP B-42 trial, the effect of extended treatment with 5 years of letrozole on disease-free survival persisted and reached statistical significance. There was no significant improvement in overall survival with letrozole, but letrozole continued to provide a...

immunotherapy
lymphoma

Brentuximab Vedotin Plus Nivolumab in Hodgkin Lymphoma

The combination of brentuximab vedotin and nivolumab is making headway as first-line therapy for older adults with Hodgkin lymphoma and as salvage therapy for adults with relapsed or refractory classic Hodgkin lymphoma, according to separate studies presented at the 2019 Annual Meeting &...

skin cancer
immunotherapy

Immune-Related Adverse Events and Recurrence-Free Survival With Adjuvant Immunotherapy vs Placebo in Stage III Melanoma

In an analysis of the EORTC 1325/KEYNOTE-054 trial of adjuvant pembrolizumab vs placebo in stage III melanoma reported in JAMA Oncology, Alexander M.M. Eggermont, MD, PhD, and colleagues found that patients treated with pembrolizumab who experienced immune-related adverse events had improved...

breast cancer

Mixed Results With Weekly Nab-paclitaxel, Denosumab in Primary Breast Cancer

A weekly schedule of nab-paclitaxel as part of neoadjuvant chemotherapy significantly improved pathologic complete response compared with nab-paclitaxel given 2 weeks out of every 3 weeks (2/3) in patients with primary breast cancer, with a greater magnitude of benefit in patients with...

lung cancer

Entrectinib in Advanced ROS1 Fusion–Positive NSCLC

As reported in The Lancet Oncology by Alexander Drilon, MD, and colleagues, an integrated analysis of three phase I/II trials has shown high activity of the TRK and ROS1 inhibitor entrectinib in ROS1 fusion-positive non–small cell lung cancer (NSCLC). This analysis supported the August 2019 U.S....

leukemia
immunotherapy

Expert Point of View: Howard J. Weinstein, MD

Commenting on the blinatumomab study, Howard J. Weinstein, MD, Chief of Pediatric Hematology-Oncology at Massachusetts General Hospital for Children and Harvard Medical School in Boston, said: “These are very promising results for children, adolescents, and young adults who have had a first...

immunotherapy
leukemia

Blinatumomab Outperforms Chemotherapy as Post-Reinduction Consolidation Therapy in Younger Patients With B-Cell ALL

Blinatumomab was superior to standard chemotherapy in children, adolescents, and young adults at the first relapse of B-cell acute lymphoblastic leukemia (ALL) as post-reinduction consolidation therapy prior to hematopoietic stem cell transplant (HSCT), according to the results of a late-breaking...

multiple myeloma

Selected Abstracts on New Therapies for Newly Diagnosed Multiple Myeloma

To complement The ASCO Post’s comprehensive coverage of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel therapeutic regimens including the monoclonal antibody daratumumab in combination ...

leukemia

ADMIRAL Trial: Gilteritinib Improves Overall Survival in Relapsed or Refractory FLT3-Mutated AML

As reported in The New England Journal of Medicine by Alexander E. Perl, MD, of Abramson Cancer Center, University of Pennsylvania, and colleagues, the phase III ADMIRAL trial showed improved overall survival with the oral FMS-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib vs salvage...

solid tumors
genomics/genetics

Entrectinib in Advanced or Metastatic NTRK Fusion–Positive Solid Tumors

As reported in The Lancet Oncology by George D. Demetri, MD, and colleagues, integrated analysis of three phase I/II trials has shown high levels of activity of the tropomyosin receptor kinase (TRK) inhibitor entrectinib in advanced NTRK fusion–positive solid tumors. This analysis supported the...

bladder cancer
immunotherapy

FDA Approves PD-1 Inhibitor for BCG-Unresponsive, High-Risk Non–Muscle Invasive Bladder Cancer

Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have...

head and neck cancer

T-DM1 Shows Activity in HER2-Amplified Salivary Gland Cancer in Small Patient Sample of NCI-MATCH

The antibody-drug conjugate ado-trastuzumab emtansine (T-DM1) showed activity in HER2-amplified salivary gland tumors, according to data published by Jhaveri et al in Annals of Oncology. The publication is for ‘Arm Q,’ which is one of nearly 40 single-arm phase II treatments in the NCI-Molecular...

bladder cancer
immunotherapy

JAVELIN Bladder 100 Study of Avelumab for Urothelial Cancer Meets Primary Endpoint

The phase III JAVELIN Bladder 100 trial met its primary endpoint of overall survival at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy and who were randomly...

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