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Showing 251 - 300FDA Grants Approval to New Bispecific Antibody for NSCLC and Pancreatic Adenocarcinoma
On December 4, 2024, the U.S. Food and Drug Administration granted accelerated approval to the HER2 × HER3 bispecific antibody zenocutuzumab-zbco (Bizengri) for adults with the following types of lung and pancreatic cancers: advanced, unresectable, or metastatic non–small cell lung cancer (NSCLC)...
Prior Authorization Delays May Lead to Severe Consequences for Patients With Cancer
A recent nationwide survey has confirmed that prior authorization may cause treatment delays, abandoned treatments, hospitalizations, and deaths among patients with cancer, according to an executive summary published by the American Society for Radiation Oncology (ASTRO). The findings may reinforce ...
Temozolomide Plus Radiotherapy for Low-Grade Gliomas
Based on the phase III E3F05 trial, conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), the combination of radiation therapy and temozolomide appeared to be more effective than radiotherapy alone in the treatment of low-grade gliomas. The trial followed 172 patients for more than 10...
Study Highlights From MD Anderson Researchers
Here are some highlights of clinical trials presented at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting by researchers from The University of Texas MD Anderson Cancer Center. They include breakthroughs in cancer care, updates in clinical research, and efforts in cancer...
AI and the Future of Lung Cancer Screening: Still Room for Improvement
“Artificial intelligence [AI] will be used in all aspects of [lung cancer] screening…, and it continues to get better,” commented topic overview speaker David F. Yankelevitz, MD, Professor of Radiology at the Icahn School of Medicine at Mount Sinai, New York, at the Quantitative Imaging Workshop...
Understanding the Link Between Obesity and Cancer
Worldwide, more than a billion people have obesity—including 650 million adults, 340 million adolescents, and 39 million children1—a rate that has nearly doubled since 1980.2 In the United States alone, about two out of three adults are overweight or have obesity, and one out of three have...
Adding Chemoradiation in Perioperative Gastric Cancer Treatment Improves Pathologic Response Rates Without Survival Benefit
Adding chemoradiation to perioperative chemotherapy improves pathologic complete response rates in patients with resectable gastric cancer but does not extend overall survival, according to data presented at the European Society for Medical Oncology (ESMO) Congress 20241 and published...
In Treatment of Transplant-Ineligible Myeloma, Addition of Isatuximab Improves Outcomes
In the phase III IMROZ trial, the addition of the anti-CD38 monoclonal antibody isatuximab-irfc to bortezomib, lenalidomide, and dexamethasone (VRd) was more effective than VRd alone as initial therapy in patients ≤ 80 years with newly diagnosed multiple myeloma ineligible for transplant,...
Toripalimab Plus Chemotherapy in First-Line Therapy for Extensive-Stage Small Cell Lung Cancer
In a Chinese phase III trial (EXTENTORCH) reported in JAMA Oncology, Cheng et al reported that the addition of the immunoglobulin G4 PD-1–blocking antibody toripalimab to first-line chemotherapy with etoposide plus cisplatin or carboplatin (EP) improved progression-free survival among patients with ...
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...
Could SARS–CoV-2 Be an Oncogenic Agent and Cancer Initiator?
It’s not news that some viruses, including human papillomavirus, human immunodeficiency virus, Epstein-Barr, and hepatitis B, can cause or accelerate the development of cancer. But a recent story in The Washington Post about rare cancers being diagnosed in individuals who had previously been...
Daratumumab Induction Regimen in Transplant-Ineligible Patients Newly Diagnosed with Multiple Myeloma
In the phase III CEPHEUS trial,1 the achievement of undetectable measurable residual disease (or MRD negativity)—the primary endpoint—was met by 61% of patients with transplant-ineligible or deferred newly diagnosed multiple myeloma treated with the monoclonal antibody daratumumab plus bortezomib, ...
Ramucirumab/Paclitaxel as Switch Maintenance in Advanced HER2-Negative Gastric/Gastroesophageal Junction Cancer
In an Italian phase III study (ARMANI) reported in The Lancet Oncology, Randon et al found that switch maintenance with ramucirumab/paclitaxel was associated with significantly improved progression-free survival vs continuation of first-line oxaliplatin-based chemotherapy in patients with advanced...
Evidence-Based Recommendations and Knowledge Gaps Regarding Cardio-Oncology
A recent report highlighted evidence-based recommendations for the prevention, detection, and management of cancer therapy–related cardiovascular toxicity and cardiovascular events in patients with cancer, as well as knowledge gaps. Select considerations are summarized herein. “The European Society ...
MRD-Guided Chemotherapy Intensification After Induction in Fit Older Patients With AML
As reported in the Journal of Clinical Oncology by Russell et al, the NCRI AML18 trial has shown survival benefit with treatment intensification in fit older patients with measurable residual disease (MRD)-positive response after first induction for acute myeloid leukemia (AML). Study Details In...
Radiotherapy With Durvalumab or Cetuximab in Locoregionally Advanced Head and Neck Cancer With Contraindication for Cisplatin
As reported in The Lancet Oncology by Mell et al, the phase II/III NRG-HN004 trial of radiotherapy with durvalumab or cetuximab in patients with locoregionally advanced head and neck squamous cell carcinoma and contraindications for cisplatin was stopped for futility during phase II; the phase III...
Overall Survival Not Improved With Maintenance Niraparib in Advanced Ovarian Cancer
The final overall survival analysis of the phase III PRIMA trial found no survival benefit for maintenance niraparib over placebo in advanced ovarian cancer. However, the PARP inhibitor continued to exert a sustained progression-free survival benefit, investigators reported at the European Society...
Prognostic Factors in Limited-Stage SCLC Treated With Escalated Radiotherapy Doses
In a study reported in JAMA Network Open, Farris et al identified prognostic factors in patients with limited-stage small cell lung cancer (SCLC) receiving radiotherapy at two dose schedules in the CALGB 30610–RTOG 0538 trial. Study Details In the trial, 638 patients were randomly assigned between...
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...
Glofitamab or Rituximab Plus Gemcitabine/Oxaliplatin in Relapsed/Refractory DLBCL
As reported in The Lancet by Abramson et al, the phase III STARGLO trial has shown significantly improved overall survival with glofitamab plus gemcitabine/oxaliplatin vs rituximab plus gemcitabine/oxaliplatin in patients with transplant-ineligible relapsed or refractory diffuse large B-cell...
Adding Temozolomide to Radiation Therapy May Improve Survival in Adults With Low-Grade Gliomas
Both radiation and temozolomide may have meaningful single-modality antitumor activity against slow-growing, low-grade gliomas, according to recent findings presented by Schiff et al at the 2024 Society for Neuro-Oncology Annual Meeting (Abstract LTBK-07) and simultaneously published in...
Nodal Burden and Recurrence in Patients With Breast Cancer With Residual Isolated Tumor Cells After Neoadjuvant Chemotherapy
In a retrospective study (OPBC-05/ICARO) reported in the Journal of Clinical Oncology, Giacomo Montagna, MD, MPH, of Memorial Sloan Kettering Cancer Center, New York, and colleagues found that nodal burden in patients with breast cancer with residual isolated tumor cells after neoadjuvant...
Novel Hypofractionated Proton-Beam Therapy for Older Patients With Newly Diagnosed Glioblastoma
In a phase II trial reported in The Lancet Oncology, Vora et al found that short-course hypofractionated proton-beam therapy guided by 3,4-dihydroxy-6-[F-18]fluoro-L-phenylalanine (F-18–DOPA) positron-emission tomography (PET) and contrast-enhanced MRI produced good outcomes in patients aged ≥ 65...
Patient With Metastatic NSCLC and Brain Metastasis
This is Part 3 of First-Line Immunotherapy for Metastatic NSCLC: Special Populations and Unmet Needs, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Roy Herbst, Charu Aggarwal, and Karen Reckamp discuss the first-line...
KEYNOTE-811: Pembrolizumab Combination in First-Line Setting Improves Overall Survival in Gastric Cancer
In the final per-protocol analysis of the phase III KEYNOTE-811 trial, an overall survival benefit was shown by adding the PD-1 inhibitor pembrolizumab to trastuzumab and chemotherapy in treatment-naive, unresectable, HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.1...
Trial Updates in Stage III Melanoma Solidify the Neoadjuvant Use of Immunotherapy as the Current Standard of Care
Neoadjuvant therapy for patients with resectable stage III melanoma has recently emerged as a better approach than resection plus adjuvant therapy. At the European Society for Medical Oncology (ESMO) Congress 2024, updates of pivotal neoadjuvant studies demonstrated the long-standing benefit of...
PEACE-3: Enzalutamide Plus Radium-223 Significantly Improves Survival in Metastatic Castration-Resistant Prostate Cancer
Initial analysis from the PEACE-3 trial suggests that the addition of radium-223 dichloride to enzalutamide could offer a promising new first-line treatment option for patients with metastatic castration-resistant prostate cancer, according to data presented by lead study author, Silke Gillessen,...
ADRIATIC Trial: Durvalumab Consolidation Extends Survival in Limited-Stage Small Cell Lung Cancer
Consolidation therapy with the PD-1 immune checkpoint inhibitor durvalumab is set to become the new global standard of care for patients with limited-stage small cell lung cancer (SCLC), according to groundbreaking data presented at the European Society for Medical Oncology (ESMO) Congress 2024.1...
HIMALAYA: 5-Year Analysis Confirms Survival Benefit of STRIDE Regimen in Hepatocellular Carcinoma
An updated overall survival analysis of the phase III HIMALAYA study, now at 5 years, confirms the benefit for the STRIDE regimen of the monoclonal antibodies durvalumab plus tremelimumab in unresectable hepatocellular carcinoma.1 [The STRIDE regimen consists of a single priming dose of...
LEAP-012: Combination of Therapies Extends Progression-Free Survival in Intermediate-Stage Hepatocellular Carcinoma
The combination of the VEGF tyrosine kinase inhibitor lenvatinib, the PD-1 inhibitor pembrolizumab, and transarterial chemoembolization (TACE) significantly improved progression-free survival in patients with intermediate-stage hepatocellular carcinoma (HCC) compared with TACE alone, according to...
T-DXd of Benefit in Patients With Breast Cancer and Brain Metastases
Late-breaking findings from the phase IIIb/IV, open-label DESTINY-Breast12 trial support the use of the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) in patients with HER2-positive metastatic breast cancer and brain metastases who have experienced disease progression on at least...
Overall Survival Analysis Confirms Pembrolizumab Regimen as Standard of Care for Triple-Negative Breast Cancer
For women with early-stage triple-negative breast cancer, KEYNOTE-522 changed the treatment paradigm several years ago. Support for neoadjuvant use of the PD-1 inhibitor pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, was bolstered by the positive overall survival analysis...
HypoG-01 Trial: Reducing the Treatment Time for Breast Cancer Nodal Irradiation
A 3-week moderately hypofractionated radiotherapy regimen has been found to be noninferior to the 5-week fractionation when irradiating nodal areas in patients with breast cancer, according to data presented at the European Society for Medical Oncology (ESMO) Congress 2024.1 The 5-year results of...
I-SPY2.2: Dato-DXd Plus Durvalumab Yields High Pathologic Response Rate in Breast Cancer Subset
In the neoadjuvant I-SPY2.2 trial, a treatment strategy including the antibody-drug conjugate datopotamab deruxtecan (Dato-DXd), partnered with the PD-L1 inhibitor durvalumab, yielded a high pathologic complete response rate, especially in immune-positive and ‘all-negative’ subtypes.1...
Highlights From the ESMO Congress 2024
The European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona featured several groundbreaking trials with the potential to significantly influence clinical practice. These studies highlighted the benefits of new combination immunotherapy strategies and innovative approaches in the...
Trastuzumab Duocarmazine in Previously Treated HER2-Positive Metastatic Breast Cancer
The studies summarized below were reported online over the past month in The ASCO Post, generating a high number of visitors. For comprehensive reviews of these studies and more, visit ASCOPost.com. Trastuzumab Duocarmazine in Previously Treated HER2-Positive Metastatic Breast Cancer In the phase...
Cancer Has Plagued My Family
My twin brother and I were adopted at 18 months old, so I don’t know the medical history of our biological parents and family. But for certain, cancer has played an integral—and heartbreaking—role in my life. Both of my adoptive parents were diagnosed with genitourinary cancers at relatively early ...
CARMEN-LC03: Tusamitamab Ravtansine vs Docetaxel in Previously Treated Advanced Nonsquamous NSCLC
The multicenter phase III -CARMEN-LC03 trial did not meet its dual primary endpoints of progression-free and overall survival with the CEACAM5-directed antibody-drug conjugate tusamitamab ravtansine vs standard chemotherapy with docetaxel in previously treated patients with advanced nonsquamous...
Information-Blocking Proposal Helps Protect Reproductive Health Information, Patient Preferences
The Association for Clinical Oncology (ASCO) submitted comments to the Office of the National Coordinator for Health Information Technology in response to the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed...
Perioperative Toripalimab in Locoregionally Advanced Nasopharyngeal Carcinoma
Hai-Qiang Mai, MD, of the Department of Nasopharyngeal Carcinoma at Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues reported their findings from a single-center phase II trial in The Lancet Oncology.1 They found that the addition of perioperative toripalimab to concurrent...
Addition of Hyperthermic Intraperitoneal Chemotherapy to Surgery for Recurrent Ovarian Cancer
Based on results from the ongoing multicenter phase III CHIPOR trial, which were reported in The Lancet Oncology Jean-Marc Classe, MD, PhD, Head of the Oncological Surgery Department at the Institut de Cancérologie de l’Ouest, Saint Herblain, France, and colleagues, the addition of hyperthermic...
Novel p53-MDM2 Inhibitor Plus Ribociclib Demonstrates Anticancer Activity in Liposarcoma Subset
The p53-MDM2 inhibitor siremadlin given with the CDK4/6 inhibitor ribociclib showed activity in a subset of patients with well-differentiated/dedifferentiated liposarcomas enrolled in the biology-driven adaptive phase II MEGAMOST Ribociclib/HDM201 basket trial.1 MEGAMOST was designed to evaluate...
Novel EGFR Inhibitor Firmonertinib Shows Activity in Rare Subtype of NSCLC
Firmonertinib (AST2818; formerly furmonertinib), a novel EGFR inhibitor, has shown activity and tolerability in patients with advanced non–small cell lung cancer (NSCLC) harboring EGFR P loop and aC-helix compressing (PACC) mutations, according to data presented at the International Association for ...
FDA Grants Accelerated Approval to Zanidatamab-hrii for Previously Treated Unresectable or Metastatic HER2-Positive Biliary Tract Cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to zanidatamab-hrii (Ziihera), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test. The FDA also approved ...
Outcomes of Immune Checkpoint Inhibitor Treatment for Cancer in Black vs White Patients in the U.S. VHA System
In a retrospective cohort study reported in The Lancet Oncology, Sean Miller, MD, of Veterans Affairs Ann Arbor Healthcare System, and colleagues found that immune checkpoint inhibitor treatment for cancer had similar efficacy and reduced toxicity in Black patients vs White patients in the U.S....
Pooled Analysis of Long-Term Outcomes With Nivolumab With or Without Ipilimumab in Advanced Melanoma
Georgina V. Long, PhD, MBBS, FRACP, of Melanoma Institute Australia and Royal North Shore and Mater Hospitals, The University of Sydney, and colleagues shared their findings from a pooled analysis of long-term outcomes in advanced melanoma reported in the Journal of Clinical Oncology.1 They found...
Project Facilitate: 5 Years of Progress, Outreach, and Service
OCE Insights is developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Lieutenant Commander Mitchell Chan, PharmD, BCPS, Team Lead and Clinical Analyst, Lieutenant Cameron Wilson, PharmD, BCPS, BCCCP, ...
Is There a Role for Neoadjuvant Chemotherapy in HR-Positive, HER2-Negative Early Breast Cancer?
Question: Based on NATALEE and monarchE data, is there still a need for neoadjuvant chemotherapy in hormone receptor (HR)-positive, HER2-negative early breast cancer? Answer: In monarchE trial, the CDK4/6 inhibitor abemaciclib combined with endocrine therapy demonstrated long-term efficacy in...
Determining the Optimal First-Line Management of Advanced Classical Hodgkin Lymphoma
“While clinical trials emphasize improvement in cure rates for patients with advanced classical Hodgkin lymphoma, an important goal is reducing the potential long-term effects of treatment,” commented Iris Isufi, MD, of the Smilow Cancer Hospital and Yale Cancer Center, New Haven, Connecticut, and ...
4-Year Asian Subpopulation Data From the CheckMate 816 Trial of Neoadjuvant Nivolumab Plus Chemotherapy in Resectable NSCLC
Neoadjuvant chemotherapy with vs without the PD-1 inhibitor nivolumab conferred a higher pathologic complete response rate and long-term event-free survival benefit in Asian patients with resectable non–small cell lung cancer (NSCLC), according to the global phase III CheckMate 816 trial. At the...
