Performing Timely Testing in Novel Brain Cancer Therapy Development
Shwetal Mehta, PhD, highlights novel brain cancer drug development procedures in the clinical lab and pre-clinical arms of the Ivy Brain Tumor Center.
FDA Receives NDA for TAR-200 in BCG-Unresponsive High-Risk NMIBC
Data from the phase 2b SunRISe-1 study support the NDA for TAR-200 in patients with BCG-unresponsive high-risk non–muscle-invasive bladder cancer with CIS.
Sasanlimab Plus BCG Boosts Event-Free Survival in High-Risk NMIBC
FDA Clears Investigational New Drug Application for R-5780 in Solid Tumors
The RISE R-5780-01 trial will evaluate the safety and tolerability of R-5780 in patients with melanoma, basal cell carcinoma, or squamous cell carcinoma.
Ponsegromab Reduces Symptoms Linked to Cancer Cachexia, Elevated GDF-15
Patients in the ponsegromab group had significantly greater weight gain and physical activity than those in the placebo arm in a phase 2 trial.
Low ctDNA Levels are Prognostic of Outcomes in Early-Stage Lung Adenocarcinoma
The NeXT Personal platform identified minuscule amounts of ctDNA that were found to be predictive of OS and RFS outcomes in patients with lung adenocarcinoma.
High Immunoglobulin Expression Shows Long-Term Survival in Breast Cancer
Data support the IGG signature, especially its key gene subset, as a potential marker of sustained antitumor activity in breast cancer.
Aggressive End-of-Life Care More Likely in ICD Users with Advanced Cancers
Nearly half of patients with an ICD had a device programming encounter near the end of life, which could present an opportunity to discuss goals of care.
Lete-cel Earns FDA Breakthrough Therapy Designation in Pretreated MRCLS
In the IGNYTE-ESO trial, letetresgene autoleucel elicited an ORR of 43%, a median PFS of 7.7 months, and a median DOR of 12.2 months in those with MRCLS.
AI-Supported Mammography Screening Leads to Increased Breast Cancer Detection Rate
The use of artificial intelligence led to a higher rate of breast cancer detection as an improvement for mammography screening compared with standard detection methods.
Using Biopsies to Inform Response Characteristics in Kidney Cancer
Observing changes in the tumor microenvironment before and after a biopsy may elucidate how kidney cancer cells interact with immune cells.
Adjuvant Cemiplimab Boosts DFS in Cutaneous Squamous Cell Carcinoma
Investigators of the phase 3 C-POST trial will continue to follow up with patients and assess the key secondary end point of overall survival.
FDA Grants Orphan Drug Designation to ELC-100 in Pancreatic NETs
Investigators are assessing treatment with ELC-100 among patients with pancreatic neuroendocrine tumors as part of a phase 1/2 trial.
Dato-DXd Receives Priority Review in Pretreated EGFR-Mutated mNSCLC
The FDA accepted a BLA for Dato-DXd based on data from the TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01 trials.
LOAd703 Receives FDA Fast Track Designation for Pancreatic Cancer
The decision follows safety data from the phase 1/2 LOKON001 trial evaluating LOAd703 in advanced pancreatic ductal adenocarcinoma.
Novel Immunotherapy Trials May Drive Progress in Kidney Cancer Field
Various kidney cancer trials have combined agents such as A2a receptor inhibitors with immunotherapy backbones to potentially improve treatment outcomes.
SABCS 2024 Data Show ‘Great Steps Forward’ in Breast Cancer Care
Paolo Tarantino, MD, and Matteo Lambertini, MD, PhD discuss findings related to CDK4/6 inhibitors and antibody drug conjugates presented at SABCS 2024.
XMT-1660 Earns Fast Track Designation for HER2–Low/Negative Breast Cancer
The World Health Organization has approved emiltatug ledadotin as XMT-1660’s international nonproprietary name.
Novel IRAK1/4 Inhibitor Receives FDA Orphan Drug Designation in MDS
Phase 1b data support the potential benefits of R289 as a treatment for patients with lower-risk myelodysplastic syndrome.
Topical Gel Significantly Improves EGFR Inhibitor-Related Skin Toxicity
All patients who received HT-001 in the phase 2a CLEER-001 trial showed significant skin toxicity improvements by 6 weeks.
Enfortumab Vedotin Combo Approved in China for Advanced Bladder Cancer
The approved combination of enfortumab vedotin and pembrolizumab provides an alternative to chemotherapy for patients in China.
Kidney Cancer Research Consortium Efforts May Improve Treatment Outcomes
Leveraging novel agents, innovative clinical trial designs, and correlative studies may improve the treatment of patients with kidney cancer.
MaaT013 Elicits Durable Responses in Acute Graft-vs-Host Disease
Efficacy findings reveal that the phase 3 ARES study evaluating MaaT013 met its primary end point of gastrointestinal overall response rate.
Belzutifan/Cabozantinib Elicits Promising Activity in Clear Cell RCC
Safety data from the phase 2 LITESPARK-003 trial evaluating belzutifan/cabozantinib in renal cell carcinoma show no treatment-related deaths.
Elinzanetant Reduces The Frequency of Hot Flashes in HR+ Breast Cancer
Elinzanetant met all primary and secondary end points when compared with placebo in patients with HR-positive breast cancer in the phase 3 OASIS-4 trial.
Invikafusp Alfa Earns FDA Fast Track Designation in Locally Advanced CRC
Phase 1 data support the fast track designation for invikafusp alfa in advanced colorectal cancer with high tumor mutational burden.
Acute Mind-Altering Effects of Psilocybin Managed With Clinician Oversight
Sympathomimetic effects related to psilocybin may preclude use among patients with coronary artery disease or those with a high risk of stroke.
Integrating PAP into Comprehensive Cancer Care for Mental Health
Psilocybin-assisted psychotherapy may be integrated into pre-existing behavioral health aspects of comprehensive cancer treatment.
FDA Grants BBO-8520 Fast Track Designation for KRASG12C-Mutant mNSCLC
The decision was supported by efficacy findings from the phase 1 ONKORAS-101 trial, which evaluated the therapy in KRASG12C non–small cell lung cancer.
Subcutaneous Isatuximab Shows Noninferior ORR, C Trough in R/R Myeloma
Subcutaneous isatuximab yields noninferior results vs intravenous isatuximab when paired with pomalidomide and dexamethasone in the phase 3 IRAKLIA trial.
