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breast cancer

Award Recipients Announced for the 2024 San Antonio Breast Cancer Symposium

The San Antonio Breast Cancer Symposium (SABCS) and the American Association for Cancer Research (AACR), an SABCS cosponsor, will honor two researchers for their significant contributions to breast cancer research during the 2024 SABCS. 2024 AACR Distinguished Lectureship in Breast Cancer Research ...

breast cancer
immunotherapy

Updated Findings in Preventive Breast Cancer Vaccine Study

Researchers from Cleveland Clinic recently presented updated findings from a novel study of a vaccine aimed at preventing triple-negative breast cancer. The findings were presented at the Society for Immunotherapy of Cancer Annual Meeting.1 According to researchers, including principal...

gynecologic cancers

Lenvatinib/Pembrolizumab vs Chemotherapy in Advanced Endometrial Cancer

As reported in Journal of Clinical Oncology by Marth et al, the phase III European Network of Gynaecological Oncological Trial-en9/LEAP-001 study showed no significant differences in progression-free or overall survival with first-line lenvatinib/pembrolizumab vs chemotherapy in patients with...

cns cancers

Mirdametinib in Adults and Children With Symptomatic Neurofibromatosis Type 1–Associated Plexiform Neurofibroma

In a phase IIb trial (ReNeu) reported in the Journal of Clinical Oncology, Moertel et al found that the CNS-penetrant small molecule MEK1/2 inhibitor mirdametinib showed activity in adults and children with symptomatic neurofibromatosis type 1-associated plexiform neurofibroma (NF1-PN). Study...

head and neck cancer

Enfortumab Vedotin in Previously Treated Advanced Head and Neck Cancer

In a phase II trial (EV-202) reported in the Journal of Clinical Oncology, Swiecicki et al found that the antibody-drug conjugate enfortumab vedotin showed activity in heavily pretreated patients with recurrent or metastatic head and neck cancer (HNC). Study Details In the study, 46 patients who...

lung cancer

Tarlatamab-dlle for Previously Treated Extensive-Stage SCLC

On May 16, 2024, tarlatamab-dlle (Imdelltra) was granted accelerated approval for extensive-stage small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.1 Tarlatamab is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager. Supporting Efficacy...

gastroesophageal cancer

DKN-01 With Tislelizumab and Chemotherapy in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

In a phase IIa study (DisTinGuish) reported in the Journal of Clinical Oncology, Klempner et al found that use of the DKK1-neutralizing antibody DKN-01 in combination with tislelizumab and chemotherapy showed activity in the first-line treatment of patients with advanced gastric or gastroesophageal ...

sarcoma

Addition of Lenvatinib to Ifosfamide/Etoposide in Children and Young Adults With Relapsed Osteosarcoma

In a phase II study (OLIE) reported in JAMA Oncology, Gaspar et al found that the addition of lenvatinib to ifosfamide/etoposide did not significantly improve progression-free survival in children or young adults with relapsed or refractory osteosarcoma. Study Details In the global open-label...

bladder cancer

Early Results Show Novel Agent Has Clinical Activity in FGFR3-Driven Advanced Bladder Cancer

In a phase I clinical trial (SURF301) investigating the fibroblast growth factor receptor 3 (FGFR3) oral inhibitor TYRA-300 in patients with advanced bladder cancer, the drug showed early antitumor activity and produced lower rates of significant adverse events compared with pan-FGFR inhibitors....

legislation

Navigating Uncharted Waters in the Post-Chevron Sea Change

It is not often that the oncology community looks to the Supreme Court to forecast its future. In 2024, two decisions seemingly unrelated to health care were issued that are likely to have a monumental impact on oncology care delivery. The Court’s rulings—on June 28, Loper Bright Enterprises et ...

health-care policy

Creating a Culture of Diversity, Equity, and Inclusion: Why It Matters Clinically and Ethically

The National Comprehensive Cancer Network (NCCN) has always prided itself on its commitment to evidence-based, expert consensus–driven recommendations for cancer care, with a special focus on breaking down the barriers that contribute to disparities in outcomes across all patients with cancer. With ...

gynecologic cancers

Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer

On April 29, 2024, tisotumab vedotin-tftv (Tivdak) was granted regular approval for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.1 Tisotumab vedotin is a tissue factor–directed antibody and microtubule inhibitor conjugate. The agent was granted...

lung cancer

Addition of Pembrolizumab to Chemotherapy in EGFR TKI-Resistant, EGFR-Mutant, Metastatic Nonsquamous NSCLC

As reported in the Journal of Clinical Oncology by Yang et al, the phase III KEYNOTE-789 trial has shown no significant improvement in progression-free or overall survival with the addition of pembrolizumab to pemetrexed/platinum in EGFR tyrosine kinase inhibitor (TKI)-resistant, EGFR-mutant...

multiple myeloma
lymphoma

FDA Approves Ready-to-Use Version of Bortezomib for Subcutaneous Administration

The U.S. Food and Drug Administration (FDA) has approved a new presentation of bortezomib (Boruzu) for ready-to-use subcutaneous or intravenous administration. This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration. Bortezomib, a...

lymphoma

CAR T-Cell Therapy in Refractory Follicular Lymphoma

On May 15, 2024, lisocabtagene maraleucel (Breyanzi) was granted accelerated approval for adults with relapsed or refractory follicular lymphoma with two or more prior lines of systemic therapy.1 The agent is a CD19-directed genetically modified autologous T-cell immunotherapy. Supporting Efficacy...

leukemia

Menin Inhibitor in KMT2A-Rearranged Relapsed or Refractory Acute Leukemia

In a phase I/II study (AUGMENT-101) reported in the Journal of Clinical Oncology, Issa et al found that revumenib, an oral small-molecule inhibitor of the menin-lysine methyltransferase 2A (KMT2A) interaction, was active in patients with KMT2A-rearranged (KMT2A) relapsed or refractory acute...

legislation

SCOTUS Ruling Upends Country’s Regulatory Framework, Threatens to Complicate and Delay Health-Care Delivery

The Association for Clinical Oncology (ASCO) has serious concerns about the impact of the Supreme Court’s rulings in Loper Bright Enterprises v Raimondo and Relentless, Inc. v Department of Commerce on cancer care. These decisions overturned the “Chevron deference” or “Chevron doctrine,” a legal...

gynecologic cancers

Sacituzumab Govitecan in Advanced Endometrial Cancer

As reported in the Journal of Clinical Oncology by Alessandro D. Santin, MD, and colleagues, findings in the endometrial cancer cohort of the phase II multicohort TROPiCS-03 trial indicated activity of the Trop-2–directed antibody-drug conjugate sacituzumab govitecan-hziy in pretreated patients...

head and neck cancer

Recurrent/Metastatic HNSCC: Pembrolizumab Plus Carboplatin and Paclitaxel

As reported in the Journal of Clinical Oncology by Marcin Dzienis, MD, and colleagues, the phase IV KEYNOTE-B10 trial of pembrolizumab plus carboplatin and paclitaxel in the first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) showed that the regimen produced...

breast cancer

Early-Stage Breast Cancer: MammaPrint Prediction of Extended Letrozole Benefit

In an analysis from the NRG Oncology/NSABP B-42 trial reported in the Journal of Clinical Oncology, Priya Rastogi, MD, and colleagues found that the 70-gene MammaPrint assay findings did not predict the distant recurrence benefit of extended letrozole therapy vs placebo in patients with...

lung cancer
immunotherapy

Advanced NSCLC: Association of Intratumoral Escherichia With Overall Survival

In a study reported in the Journal of Clinical Oncology, Arielle Elkrief, MD, and colleagues found that detection of intratumoral Escherichia was associated with improved overall survival in patients with advanced non–small cell lung cancer (NSCLC) receiving single-agent immune checkpoint inhibitor ...

hematologic malignancies
supportive care

Chronic Graft-vs-Host Disease: Clinical Trial Updates

Chronic graft-vs-host disease, an immune-mediated disorder that follows allogeneic hematopoietic cell transplantation (allo-HCT), is characterized by debilitating tissue injury with inflammatory and fibrotic pathology leading to significant morbidity and mortality. Historically, the treatment of...

skin cancer

Advanced Melanoma: Efficacy of Monoclonal Antibody Doublet

In a phase I trial reported in the Journal of Clinical Oncology, Omid Hamid, MD, and colleagues found that the combination of the human lymphocyte activation gene-3 (LAG-3)-targeting monoclonal antibody fianlimab plus the PD-1–targeting monoclonal antibody cemiplimab-rwlc was active in patients...

health-care policy

ASCO: SCOTUS Ruling Upends Country’s Regulatory Framework, Threatens to Complicate and Delay Health-Care Delivery

The Association for Clinical Oncology (ASCO) has serious concerns about the impact of the Supreme Court’s rulings in Loper Bright Enterprises v Raimondo and Relentless, Inc. v Department of Commerce on cancer care. These decisions overturned the “Chevron deference” or “Chevron doctrine,” a legal...

gynecologic cancers

Mirvetuximab Soravtansine-gynx for FRα-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

On March 22, 2024, mirvetuximab soravtansine-gynx (Elahere) was granted regular approval for adult patients with folate receptor–alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment...

Lu-177 Dotatate for Pediatric Patients With Gastroenteropancreatic Neuroendocrine Tumors

On April 23, 2024, lutetium Lu-177 dotatate (Lutathera) was approved for pediatric patients 12 years and older with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.1 Lu-177 dotatate is a radiolabeled...

colorectal cancer

Previously Treated Metastatic Colorectal Cancer: Lenvatinib/Pembrolizumab vs Standard of Care

As reported in the Journal of Clinical Oncology by Akihito Kawazoe, MD, and colleagues, the final analysis of  the phase III LEAP-017 trial showed no significant overall survival benefit with lenvatinib plus pembrolizumab vs the standard of care in previously treated patients with mismatch...

lung cancer

Previously Treated Metastatic NSCLC: Sacituzumab Govitecan vs Docetaxel

As reported in the Journal of Clinical Oncology by Luis G. Paz-Ares, MD, PhD, and colleagues, the phase III EVOKE-01 trial has shown a numeric but not statistically significant improvement in overall survival with sacituzumab govitecan-hziy vs docetaxel in patients with metastatic non–small cell...

lung cancer

Tepotinib for Metastatic NSCLC With MET Exon 14–Skipping Alterations

On February 15, 2024, tepotinib (Tepmetko)-—a kinase inhibitor directed against MET, including variants with exon 14 skipping—was granted regular approval for patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping ...

gynecologic cancers

Advanced Ovarian Cancer: Adding Ruxolitinib to Front-Line Neoadjuvant Chemotherapy Plus Interval Debulking Surgery

In a phase I/II NRG Oncology Group study reported in the Journal of Clinical Oncology, Landen et al found that the addition of ruxolitinib to front-line paclitaxel/carboplatin neoadjuvant chemotherapy and interval debulking surgery improved progression-free survival in patients with stage III to IV ...

sarcoma

Doublet for Previously Treated Patients With Advanced Leiomyosarcoma

In a phase Ib study reported in the Journal of Clinical Oncology, Van Tine et al established the recommended phase II dose of oral unesbulin in combination with dacarbazine for patients with locally recurrent, unresectable or metastatic, relapsed or refractory leiomyosarcoma. Unesbulin is a small...

hepatobiliary cancer

Pembrolizumab/Chemotherapy for Advanced Biliary Tract Cancer

On October 31, 2023, pembrolizumab (Keytruda) was approved for use with ­gemcitabine/cisplatin in first-line treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.1 Supporting Efficacy Data Approval was based on the double-blind KEYNOTE-966 trial...

kidney cancer

Belzutifan in Previously Treated Advanced Renal Cell Carcinoma

On December 14, 2023, the hypoxia-inducible factor inhibitor belzutifan (Welireg) was approved for patients with unresectable locally advanced or metastatic clear cell renal cell carcinoma with disease progression on previous treatment with a PD-1 or PD-L1 inhibitor and a vascular endothelial...

gastroesophageal cancer

Bispecific Antibody Plus Chemotherapy Improves Survival in Patients With Gastric or Gastroesophageal Junction Cancer

Treatment with the first-in-class PD-1/CTLA-4 bispecific antibody cadonilimab plus XELOX (capecitabine, oxaliplatin) chemotherapy demonstrated a survival advantage for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma as first-line treatment, regardless of PD-L1...

breast cancer

Selective Targeting of PARP1 in Early-Phase Study Shows Activity in Breast Cancer

Saruparib, a first-in-class PARP1-­selective inhibitor, was reported to have favorable safety and anticancer activity in heavily pretreated patients with breast cancer harboring homologous recombination–repair (HRR) mutations, according to the results of the phase I/II PETRA study presented at the...

breast cancer

Dato-DXd in Advanced or Metastatic HR-Positive/HER2-Negative or Triple-Negative Breast Cancer

In the phase I TROPION-PanTumor01 trial reported in the Journal of Clinical Oncology, Aditya Bardia, MD, PhD, and colleagues found that the antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) was active in patients with locally advanced or metastatic hormone receptor...

colorectal cancer

Adagrasib Plus Cetuximab: Potential Option for KRAS G12C–Mutated Colorectal Cancer

Although KRAS was once considered an untargetable mutation, KRAS inhibitors are now approved for the treatment of KRAS-mutated non–small cell lung cancer (NSCLC) and are emerging as a potential option for the treatment of KRAS G12C–mutated colorectal cancer in combination with other therapies....

lymphoma

B-Cell Non-Hodgkin Lymphoma: Extended Follow-up With Mosunetuzumab

As reported in the Journal of Clinical Oncology by L. Elizabeth Budde, MD, PhD, and colleagues, extended follow-up of the dose-escalation phase of a phase I/II trial showed that the CD20 x CD3 T-cell–engaging bispecific antibody mosunetuzumab-axgb—given as an off-the-shelf fixed-duration outpatient ...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Bispecific Immune Checkpoint Inhibitor Improves Survival in Patients With Gastric Cancer, Regardless of PD-L1 Status

The PD-1/CTLA-4 bispecific antibody cadonilimab plus chemotherapy improved progression-free and overall survival in patients with untreated, HER2-negative, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer—including those with PD-L1–low tumors—compared with...

ASCO Congratulates 2024 Special Awards Recipients

ASCO and Conquer Cancer, the ASCO Foundation, will recognize researchers, patient advocates, philanthropists, teachers, and global oncology leaders who have reshaped cancer care around the world with the Society’s highest honors at the 2024 ASCO Annual Meeting. The 2024 Special Award Recipients...

kidney cancer

Belzutifan in Previously Treated Advanced Renal Cell Carcinoma

On December 14, 2023, the hypoxia-inducible factor inhibitor belzutifan (Welireg) was approved for patients with unresectable locally advanced or metastatic clear cell renal cell carcinoma with disease progression on previous treatment with a PD-1 or PD-L1 inhibitor and a vascular endothelial...

gynecologic cancers

Pembrolizumab With Chemoradiotherapy for FIGO 2014 Stage III–IVA Cervical Cancer

On January 12, 2024, pembrolizumab (Keytruda) was approved for use with chemoradiotherapy for treatment of patients with International Federation of Gynecology and Obstetrics (FIGO) 2014 stage III–IVA cervical cancer.1 Supporting Efficacy Data Approval was based on findings in the double-blind...

leukemia

FLT3-ITD–Mutated AML: Gilteritinib in Posttransplantation Maintenance

In the phase III MORPHO trial reported in the Journal of Clinical Oncology, Mark J. Levis, MD, PhD, and colleagues found that the FLT3 inhibitor gilteritinib showed activity as post–allogeneic hematopoietic cell transplantation (HCT) maintenance among patients with FLT3-ITD–mutated acute myeloid...

lung cancer

Repotrectinib for ROS1 Fusion–Positive Advanced NSCLC

On November 15, 2023, repotrectinib (Augtyro) was approved for locally advanced or metastatic ROS1 fusion–positive non–small cell lung cancer (NSCLC).1 This is the first U.S. Food and Drug Administration approval that includes patients with ROS1-positive NSCLC who have previously received a ROS1...

skin cancer

Adjuvant Pembrolizumab in Resected Stage IIB or IIC Melanoma

As reported in the Journal of Clinical Oncology by Jason J. Luke, MD, FACP, and colleagues, the final prespecified analysis of distant metastasis–free survival in the phase III KEYNOTE-716 trial showed continued benefit with adjuvant pembrolizumab vs placebo in patients with resected stage IIB or...

prostate cancer

Localized or Advanced Prostate Cancer: Short- or Longer-Term Relugolix Plus Radiotherapy

In an analysis reported in JAMA Oncology, Daniel E. Spratt, MD, and colleagues found that treatment with relugolix was associated with rapid achievement of sustained castration in patients with localized or advanced prostate cancer who were also receiving radiotherapy. Study Details The analysis...

breast cancer

Metastatic Triple-Negative Breast Cancer: Sacituzumab Govitecan vs Single-Agent Chemotherapy in Previously Treated Patients

As reported in the Journal of Clinical Oncology by Aditya Bardia, MD, MPH, and colleagues, final results of the phase III ASCENT trial showed continued superior progression-free and overall survival with sacituzumab govitecan-hziy, an anti–trophoblast cell surface antigen 2 (Trop-2) antibody-drug...

cns cancers

Novel Monotherapy in Recurrent H3 K27M–Mutant Diffuse Midline Glioma

In an analysis reported in the Journal of Clinical Oncology, Arrillaga-Romany et al found that single-agent ONC201 (dordaviprone), a first-in-class imipridone, showed activity in recurrent histone 3 (H3) K27M-mutant diffuse midline glioma. As noted by the investigators, “H3 K27M–mutant diffuse...

breast cancer

Adjuvant Olaparib for Germline BRCA1/2-Mutant, High-Risk HER2-Negative Early Breast Cancer: Patient-Reported Outcomes From the OlympiA Trial

In a patient-reported outcomes analysis from the phase III OlympiA trial reported in the Journal of Clinical Oncology, Patricia A. Ganz, MD, FASCO, and colleagues found no clinically important differences in fatigue—the outcome of primary interest—between adjuvant olaparib and placebo in patients...

myelodysplastic syndromes

MRD Markers and Outcomes in Patients With MDS After Stem Cell Transplant

In a Scandinavian study reported in the Journal of Clinical Oncology, Tobiasson et al found that individual-patient measurable residual disease (MRD) could be assessed by next-generation sequencing (NGS) and droplet digital polymerase chain reaction (ddPCR) to predict outcomes in patients with...

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