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Showing 51 - 1002019 ASCO-SITC: Combined Targeting of TIM-3 and PD-L1 Immune Checkpoint Pathways in Advanced Relapsed or Refractory Solid Tumors
A phase Ia/Ib trial was launched in order to evaluate the safety of LY3321367, an anti–T-cell immunoglobulin domain and mucin domain–containing molecule-3 (TIM-3) antibody, administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in...
TAT 2019: Use of the Lung Immune Prognostic Index in Stratifying Outcomes in Patients Treated With Immune Checkpoint Inhibitors
The Lung Immune Prognostic Index (LIPI) calculated prior to the initiation of treatment may be used to stratify patients with diverse tumor types into groups that significantly associate with outcome following immune checkpoint inhibitor therapy, according to a retrospective study presented at the...
FDA Pipeline: Priority Reviews in Solid Tumors and Lymphoma; Plus an sNDA in Acute Myeloid Leukemia
Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews and accepted a supplemental new drug application: Priority Review for Entrectinib in NTRK Fusion–Positive Solid Tumors and Metastatic, ROS1-Positive NSCLC This week, the FDA accepted new drug...
Craig R. Nichols, MD, on Testicular Cancer Cases: Should They Be Discussed With High-Volume Centers?
Craig R. Nichols, MD, of the Testicular Cancer Commons and the SWOG Group Chair's Office, discusses the superior outcomes obtained at high-volume centers, the impracticality of referring all patients to such centers, and the international efforts to develop virtual collaborations on salvage...
Stefanie C. Fischer, MD, on Nonseminoma: Outcomes After Adjuvant Bleomycin/Etoposide/Cisplatin
Stefanie C. Fischer, MD, of Manchester Cancer Research Centre and The Christie NHS Foundation Trust, discusses an international retrospective analysis of the rare clinical scenario of men relapsing after adjuvant treatment with bleomycin/etoposide/cisplatin for clinical stage I nonseminoma...
FDA Pipeline: Treatments for Tenosynovial Giant Cell Tumor and Pancreatic Cancer, Plus a Statement on Breast Implant–Associated Lymphoma
The U.S. Food and Drug Administration (FDA) recently granted the following designations and applications and also issued a statement: Priority Review for Pexidartinib in Tenosynovial Giant Cell Tumor The FDA has accepted a new drug application (NDA) and granted Priority Review for pexidartinib...
Impact of Stereotactic Ablative Radiotherapy on Survival for Patients With Advanced Cancers
The first report from a phase II, multicenter clinical trial has found that a newer, more aggressive form of radiation therapy—stereotactic ablative radiation—can extend long-term survival for some patients with stage IV cancers, while maintaining their quality of life. The study was...
ASCO Clinical Cancer Advances 2019 Names Advance of the Year: Progress in Treating Rare Cancers
Over the past year, major research advances provided new treatment options for patients with rare, difficult-to-treat cancers. In recognition of these achievements, ASCO named “Progress in Treating Rare Cancers” as the Advance of the Year. To continue the forward momentum, ASCO also...
2019 GI Cancers Symposium: Pembrolizumab in Pretreated, Advanced Neuroendocrine Tumors
Findings from the phase I KEYNOTE-028 trial, which studied pembrolizumab in a number of solid tumors, showed activity of the immunotherapy in some patients with heavily pretreated neuroendocrine tumors. Now, a phase II basket trial—KEYNOTE-158—is studying the efficacy and safety of...
Common Markers of Tumor Hypoxia Found Across Cancer Types
Unlike healthy tissues, tumors thrive in low-oxygen environments, often acquiring the ability to resist treatment and spread to other sites in the body. Despite being a well-known cause of therapy resistance and metastasis, the impact of hypoxia on tumor cells is poorly understood. Researchers have ...
FDA Pipeline: Designations for Treatments of Graft-vs-Host-Disease, Colorectal Cancer, Pancreatic Cancer, and More
The U.S. Food and Drug Administration (FDA) recently issued the following new designations and clearances: Fast Track Designation for Itolizumab for the Treatment of Acute Graft-vs-Host Disease The FDA granted Fast Track designation to itolizumab for the treatment of acute graft-vs-host ...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
EORTC-NCI-AACR: Investigational Anti-HER2 Therapy in HER2-Expressing Solid Tumors
An antibody that binds simultaneously to two distinct regions of the HER2 receptor to block the growth of cancer cells has shown antitumor activity in a number of cancers, including those of the esophagus, stomach, and bowel. Updated results from a phase I clinical trial of the treatment, called...
FDA Approves Larotrectinib for Solid Tumors With NTRK Gene Fusions
On November 26, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to larotrectinib (Vitrakvi) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, whose...
NCRI 2018: HiLo Trial: Rate of Thyroid Cancer Recurrence After Adjuvant Lower-Dose Radiation
Patients with thyroid cancer whose disease is at low risk of returning can be treated safely with a smaller amount of radiation following surgery, according to results from the HiLo trial presented by Wadsley et al at the 2018 National Cancer Research Institute (NCRI) Cancer Conference (Abstract...
Transcription Factors TP63 and SOX2 in Squamous Cell Carcinoma Progression
Squamous cell carcinomas (SCCs) are malignancies arising from squamous epithelium of various organs, such as esophagus, head and neck, lung, and skin. Previous studies demonstrated that two master transcription factors, TP63 and SOX2, effect genomic activation in SCCs. Now, researchers from...
FDA Grants Breakthrough Therapy Designation to LOXO-292 for RET Fusion–Positive Thyroid Cancer
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with advanced RET fusion–positive thyroid cancer who require systemic therapy, have had disease progression following...
2018 ASTRO: Phase I Trial of SBRT for Oligometastatic Disease With Multiple Metastases
The phase I NRG Oncology clinical trial BR001 tested the hypothesis that stereotactic body radiotherapy (SBRT) could be used safely in patients with oligometastatic disease characterized by multiple metastases. Results from the trial indicate that using SBRT is safe as treatment for patients with 2 ...
2018 ASTRO: SABR-COMET: Stereotactic Ablative Radiation Therapy for Oligometastatic Tumors
In the first randomized, phase II clinical trial of its kind, researchers have shown that an aggressive form of high-precision radiation therapy can increase survival in patients with oligometastatic tumors. These findings were presented by Palma et al in the plenary session at the 60th Annual ...
David Palma, MD, PhD, on Oligometastatic Tumors: Results From the SABR-COMET Trial
David Palma, MD, PhD, of the London Health Sciences Centre, discusses study findings on improvement in survival following stereotactic ablative radiation for oligometastatic tumors (Presentation 5 in PL 01).
Lalan S. Wilfong, MD, on Metastatic Solid Tumors: Limiting Low-Value Care
Lalan S. Wilfong, MD, of Texas Oncology, discusses reducing the use of a white blood cell growth factor treatment in advanced and incurable solid tumors for patients treated at a community oncology practice.
Bacterial Therapy Tolerable, Shows Early Activity in Patients With Advanced Solid Tumors
A phase I clinical trial investigating the use of bacterial Clostridium novyi-NT spores as an injectable monotherapy had manageable toxicities and showed early clinical efficacy in patients with treatment-refractory solid tumor malignancies, according to data presented at the CRI-CIMT-EATI-AACR...
FDA Grants Breakthrough Therapy Designation to LOXO-292 for Treatment of Lung and Thyroid Cancers
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation to LOXO-292, a selective RET inhibitor, for: the treatment of patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC) who require systemic therapy and have had...
FDA Warns of Increased Risk of Cancer Relapse With Long-Term Use of Azithromycin After Allogeneic Stem Cell Transplant
The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin should not be given on a long-term basis to prevent the inflammatory lung condition bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell...
FDA Approves Iobenguane I-131 for Rare Adrenal Gland Tumors
On July 30, the U.S. Food and Drug Administration (FDA) approved iobenguane I-131 (Azedra) injection for adult and pediatric patients (12 years and older) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic...
FDA Clears Expanded Indication of Scalp-Cooling System
Paxman’s advanced scalp-cooling system has now been cleared by the US Food and Drug Administration (FDA) for use during treatment of patients with solid tumors. The system is now indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors such as...
2018 ASCO: Pexidartinib in Tenosynovial Giant Cell Tumor
The phase III ENLIVEN study showed a statistically significant 39% overall response rate at week 25 based on central review of magnetic resonance imaging (MRI) scans using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (the primary endpoint) for patients treated with oral...
Apostolia-Maria Tsimberidou, MD, PhD, on Precision Medicine: Results From the IMPACT Study
Apostolia-Maria Tsimberidou, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses findings on clinical outcomes, including long-term survival, according to the pathway targeted and treatment period (Abstract LBA2553).
2018 ASCO: Genomic Study Finds Lynch Syndrome Is Common Among Patients With MSI-High Tumors
A genomic study of more than 15,000 tumor samples showed that people who have tumors with high microsatellite instability (MSI-H)—a genomic marker associated with a large number of genetic mutations in the tumor—are more likely to have Lynch syndrome, a hereditary condition that...
2018 ASCO: IMPACT Trial Matches Treatment to Genetic Changes in the Tumor to Improve Survival Across Multiple Cancer Types
Researchers conducted a retrospective analysis of consecutive, prospectively molecularly profiled patients with advanced cancer who participated in a large, personalized medicine trial. They found that using molecular tests of tumors to select targeted therapy resulted in slower cancer growth and...
FDA Accepts Larotrectinib New Drug Application and Grants Priority Review
The U.S. Food and Drug Administration (FDA) has accepted a new drug application (NDA) and granted Priority Review for larotrectinib in the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. ...
FDA Grants Fast Track Designation to Debio 1347 for Unresectable or Metastatic Tumors With a Specific FGFR Gene Alteration
Debiopharm International SA (Debiopharm) recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Debio 1347, an inhibitor of fibroblast growth factor receptors 1, 2, and 3 (FGFR1–3), for the treatment of patients with unresectable or...
FDA Approves Dabrafenib/Trametinib Combination for BRAF-Positive Anaplastic Thyroid Cancer
Today, the U.S. Food and Drug Administration approved dabrafenib (Tafinlar) and trametinib (Mekinist), administered together, for the treatment of unresectable, metastatic, BRAF V600E mutation–positive anaplastic thyroid cancer. Anaplastic thyroid cancer accounts for about 1% to 2% of all...
FDA Grants Orphan Drug Designation to BN-Brachyury for the Treatment of Chordoma
On May 2, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to the cancer vaccine BN-Brachyury for the treatment of chordoma. Chordoma is a rare type of cancer that develops along the spine, with presentation occurring at one of three main sites: sacrum, mobile spine, or...
Update Regarding Tazemetostat Clinical Program
On April 23, Epizyme, Inc, announced that U.S.-based enrollment of new patients into tazemetostat clinical trials is temporarily on hold. Following a safety report of a pediatric patient who developed a secondary lymphoma, the U.S. Food and Drug Administration (FDA) issued a partial clinical hold...
AACR 2018: Dual Inhibition of IDO1 and PD-L1 Safe in Patients With Advanced Solid Tumors
Treatment combining the IDO1 inhibitor epacadostat and the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) was found to be safe in patients with advanced solid tumors, with safety data similar to treatment with durvalumab alone, according to data presented from the ongoing...
AACR 2018: Selective Inhibitor Shows Early Promise in Patients With RET-Altered Cancers
BLU-667, a next-generation inhibitor that selectively targets the oncogenic receptor tyrosine kinase RET, was well tolerated and had broad clinical benefit in patients with advanced cancer that had progressed on previous therapies, including multikinase inhibitor therapy. Proof-of-concept data from ...
Comprehensive Genomic-Profiling Assay FoundationOne CDx Is Commercially Available
On March 30, Foundation Medicine announced that FoundationOne CDx, the first U.S. Food and Drug Administration (FDA)-approved comprehensive genomic-profiling assay for all solid tumors incorporating multiple companion diagnostics, is now available in the United States. FoundationOne CDx is a...
SSO 2018: Is Low-Volume Disease in the Sentinel Node After Neoadjuvant Chemotherapy an Indication for Axillary Dissection?
Frozen section evaluation of sentinel lymph nodes after neoadjuvant chemotherapy has a higher false-negative rate than in the primary surgical setting, particularly for small tumor deposits. However, it is unknown whether similar false positive rates occur after chemotherapy. Researchers led by...
EAU 2018: Study Finds a Quarter of Penile Cancer Patients Do Not Receive Recommended Treatment
A major international survey has found that around a quarter of patients with penile cancer are not receiving the recommended treatment, and that these patients had half the survival rate of those who were treated according to guidelines. The study, presented at the European Association of Urology...
Testicular Cancer Survivors and Adequate Screening for Long-Term Heart Disease
Testicular cancer is the most common cancer in young men. The majority of patients are cured of their disease, but a newly published study shows many remain at risk for later complications from chemotherapy or other treatments. The study, published by Zaid et al in JNCCN –Journal of the...
Poorer Socioeconomic Status May Predict Lower Survival in Patients With Anal Cancer
Patients with lower income have a significantly reduced chance of surviving anal cancer, according to a new study led by investigators at NYU Langone Health’s Perlmutter Cancer Center published by Lin et al in the journal Cancer. The study shows that both overall and...
AACR 2018: Prior Chemotherapies May Impair Pediatric Patients’ Ability to Develop Effective CAR T Cells
Pediatric patients with solid tumors may have poor quality T cells compared to patients with leukemia, and certain chemotherapies were detrimental to the T cells and their potential to become chimeric antigen receptor (CAR) T cells, according to data presented during a media preview for the...
TAT 2018: EXPRESS Study Explores the Genomic Landscape of Patients Achieving an 'Exceptional' Response to Targeted Therapy
The level of genomic alterations in genes associated with the oncogenesis of specific solid tumor types is being investigated in patients that have demonstrated an exceptional response to currently approved targeted therapies, researchers announced at the International Congress on Targeted...
FDA Approves sBLA Updating Nivolumab Dosing Schedule Across Indications
On March 6, Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the nivolumab (Opdivo) dosing schedule to include 480 mg infused every 4 weeks for a majority of approved indications. This approval will ...
Study Shows Need for Early Supportive Care in Patients Diagnosed With Uveal Melanoma
In a study published by Williamson et al in JAMA Ophthalmology, University of California, Los Angeles, (UCLA) researchers found that nearly all patients diagnosed with uveal melanoma had a number of unmet psychological and health information needs, particularly during the first 3 months after their ...
Jeffrey M. Holzbeierlein, MD, on Penile, Urethral, and Testicular Cancers: Abstract Roundup
Jeffrey M. Holzbeierlein, MD, of the University of Kansas Medical Center, summarizes key abstracts on long-term sexual function in germ cell tumor survivors, sentinel node biopsy in clinical stage I testicular cancer, the impact of Medicaid expansion on diagnosis and management of patients with...
Linda Mileshkin, MBBS, on Solid Tumors: Early Treatment Study Results
Linda Mileshkin, MBBS, of the Peter MacCallum Cancer Centre, discusses phase Ib trial findings on the anti–PD-1 monoclonal antibody BGB-A317 in combination with the PARP inhibitor BGB-290 in advanced solid tumors.
Jeffrey M. Lemons, MD, on Solid Tumors: Safety Data on SBRT and Immunotherapy
Jeffrey M. Lemons, MD, of the University of Chicago, discusses early safety and efficacy findings from a small study on pembrolizumab and multiorgan-site ablative stereotactic body radiotherapy in patients with advanced solid tumors (Abstract 20).
Updated SCOUT Trial Data Demonstrate Response to Larotrectinib in TRK Fusion Cancers
At the Special Conference on Pediatric Cancer Research, convened in Atlanta by the American Association for Cancer Research, investigators announced updated clinical data from the larotrectinib (LOXO-101) pediatric phase I SCOUT trial. Bayer and Loxo Oncology are jointly developing larotrectinib,...
