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.
Psilocybin May Help Alleviate Cancer-Related Depressive Symptoms
Psilocybin may help address a need for effective medication to aid those who have psychological challenges related to a serious cancer diagnosis.
Nivolumab/Cisplatin/Radiotherapy Improves DFS in Locally Advanced SCCHN
The phase 3 NIVOPOSTOP GORTEC 2018-01 trial shows that nivolumab added to radiotherapy and cisplatin had improved efficacy over SOC treatments in SCCHN.
FDA Gives Fast Track Designation to VGT-309 for Lung Tumor Visualization
Efficacy findings from a phase 2 trial demonstrated that abenacianine visualized lung tumor tissue and was well tolerated when used during surgery.
Novel Drug Receives FDA Breakthrough Therapy Designation for R/R Osteosarcoma
GSK5764227 yielded promising antitumor efficacy while showing no new safety signals in patients with relapsed/refractory osteosarcoma, the phase 2 ARTEMIS-002 trial found.
IMM-1-104 Regimens Yield Promising Activity in Pancreatic Cancer
Investigators of a phase 2a trial plan to include additional combination arms assessing treatment with IMM-1-104 across different patient populations.
Amivantamab/Lazertinib Show OS Improvement for mNSCLC Over Osimertinib
Results from the phase 3 MARIPOSA trial found that amivantamab plus lazertinib met the final pre-specified secondary end point of overall survival in NSCLC.
Early-Onset Colorectal Cancer Incidence Has Risen on Global Scale
Data suggest a need for international preventive strategies and educational efforts regarding the increasing incidence of early-onset colorectal cancer.
FDA Issues Guidance Considerations for Tissue Biopsies in Clinical Trials
According to the FDA, biopsies should be optional in clinical protocol when information will be used to evaluate only non-key secondary end points.
FDA Grants Orphan Drug Designation to Amezalpat in Hepatocellular Carcinoma
Data from a phase 1b/2 trial show improvements in overall survival with amezalpat plus atezolizumab/bevacizumab among patients with metastatic HCC.
FDA Grants Priority Review to Sunvozertinib for EGFR exon20 NSCLC
The WU-KONG1 trial found that sunvozertinib yielded a best ORR of 53.3% and a cORR of 44.9% in patients with NSCLC harboring EGFR exon20ins mutations.
