CBM588 May Improve Clinical Outcomes in Metastatic RCC
Analysis of 2 phase 1 trials compared gut biome diversity between standard of care with or without CBM588 in patients with metastatic renal cell carcinoma.
27 CARDIAC-STAR: Prevalence of Cardiovascular (CV) Comorbidities in Hormone Receptor–Positive/ Human Epidermal Growth Factor Receptor 2–Negative (HR+/HER2–) Metastatic Breast Cancer (mBC)
ODAC Votes in Favor of New Perioperative NSCLC Trial Design Proposals
Members agreed that perioperative regimen NSCLC trial designs should clarify the contribution of treatment during adjuvant and neoadjuvant therapy.
Ozuriftamab Vedotin Gains FDA Fast Track Designation for Recurrent SCCHN
Multiple confirmed responses in a phase 2 trial support the FDA designation for the experimental therapy in squamous cell carcinoma of the head and neck.
Creating Confidence While Climbing the Ranks in the Lymphoma Field
“Sometimes you have to be a little more assertive and a little louder, and you have to step up to the front,” Julie M. Vose, MD, MBA, said.
28 Enhancing the Interpretation of Real-World Quality of Life (QoL) in Patients With Hormone Receptor– Positive/Human Epidermal Growth Factor Receptor 2–Negative (HR+/HER2-) Advanced Breast Cancer (ABC) Enrolled in the POLARIS Trial
Novel CAR T-Cell Therapy Receives FDA RMAT Status in Advanced Thyroid Cancer
Results from a phase 1 trial evaluating the CAR T-cell therapy, AIC100, in relapsed/refractory thyroid cancer support the FDA’s RMAT designation.
FDA Accepts Resubmitted BLA for Remestemcel-L in Pediatric SR-aGVHD
The agency has set a Prescription Drug User Fee Act date of January 7, 2025, for its decision on approving remestemcel-L in this patient population.
Flexible Monitoring for CAR T-Cell Therapy May Improve Treatment Access
Following rare CRS and ICANS incidence following CAR T-cell therapy, investigators propose a reduced 2-week monitoring period with extensions as needed.
Telomere-Targeting Agent Demonstrates Tolerability in Advanced NSCLC
As of data cutoff, 6 patients with NSCLC in the phase 2 THIO-101 trial are receiving ongoing treatment with THIO plus cemiplimab after 12 months.
Nintedanib Does Not Significantly Improve PFS in Thyroid Cancer
An observed extension in progression-free survival with nintedanib vs placebo did not warrant continued development of the therapy for thyroid cancer.
FDA Gives Positive Feedback on Phase 3 Eftilagimod Alfa NSCLC Trial Design
Feedback from a Type C meeting signals the end of preparatory regulatory interactions for the phase 3 TACTI-004 trial’s design in metastatic NSCLC.
New Data Recommend Continuous Monitoring of Lymphedema for Breast Cancer
Findings from the PREVENT study show that bioimpedance spectroscopy use may reduce progression to chronic lymphedema compared with tape measure use.
Tool Combining Genomics, AI May Predict Future Prostate Cancer Recurrence
A combined genomic and histological analysis within trial datasets demonstrates a sound tumor evaluation strategy for patients with prostate cancer.
Successful/Safe Pregnancies Deemed Possible Following Allogeneic Transplant
After allogeneic hematopoietic cell transplantation, pregnancies could be carried out and were successful.
FDA Clears New Drug Application for ZW191 in FR⍺+ Ovarian Cancer, NSCLC
Preclinical data support the potential anti-tumor activity and tolerability of a novel FR⍺ topoisomerase I inhibitor in ovarian cancer and NSCLC.
EMA Validates Application for Nivolumab/Ipilimumab in Liver Cancer Type
Survival results from the phase 3 CheckMate –9DW trial support the application for the combination therapy in treating hepatocellular carcinoma.
Exploring New Possibilities in Kidney Cancer Detection and Therapy
Experts discuss findings related to liquid biopsy profiling, later-line immunotherapy, and CDK4/6 inhibitor efficacy presented at the 2024 KCRS meeting.
FDA Grants SLS009 Rare Pediatric Disease Designation in Pediatric AML
SLS009 is a highly selective CDK9 inhibitor that is being studied in an ongoing phase 1/2 trial for patients with hematologic malignancies.
29 ELEVATE: A Phase 1b/2, Open-Label, Umbrella Study Evaluating Elacestrant in Various Combinations in Patients (pts) With Estrogen Receptor–Positive (ER+), HER2-Negative (HER2–) Locally Advanced or Metastatic Breast Cancer (mBC)
30 Datopotamab Deruxtecan (Dato-DXd) vs Chemotherapy in Previously-Treated Inoperable or Metastatic Hormone Receptor–Positive, HER2-Negative (HR+/HER2–) Breast Cancer (BC): Primary Results From the Randomised Phase 3 TROPION-Breast01 Trial
FS-1502 Demonstrates Promising Antitumor Activity in HER2+ Breast Cancer
Two dose-limiting toxicities were observed, and the maximum tolerated dose was not reached in a study evaluating FS-1502 safety, tolerability, and efficacy.
Factoring Multidisciplinary Care Into IORT for Pancreatic Cancer
Experts from Vanderbilt University Medical Center emphasize gathering a second opinion to determine if a tumor is resectable in patients with pancreatic cancer.
EMA Accepts Application for Belantamab Mafodotin in R/R Multiple Myeloma
Data from DREAMM-7 and DREAMM-8 support the marketing authorization application for the belantamab mafodotin combinations in multiple myeloma.
FDA Discourages Accelerated Approval of Botensilimab/Balstilimab Combo in R/R MSS CRC
The recommendation was made following mid-stage, end-of-phase 2 data for the botensilimab/balstilimab combination, which yielded lower responses in patients.
Applying The IORT Technique to a Pancreatic Cancer Case
Experts from Vanderbilt University Medical Center discuss the use of intraoperative radiation therapy in a 64-year-old patient with pancreatic cancer.
MET-Targeted MFGI, Spectroscopy May Detect Papillary Thyroid Cancer
Phase 1 data show that EMI-137 enabled MFGI and spectroscopy differentiation between papillary thyroid cancer–afflicted tissue and healthy thyroid tissue.
BLA Accepted for Tabelecleucel in EBV+ Lymphoproliferative Disease
The drug developers of tabelecleucel are seeking approval of the treatment for patients with EBV-positive post-transplant lymphoproliferative disease.
FDA Gives Dendritic Cell Vaccine Fast Track Status for Pancreatic Cancer
The overall survival benefit seen with DOC1021 in a phase 1 trial of glioblastoma support the fast track status decision for the agent.
Mitazalimab Combo Shows Lasting Responses in Metastatic Pancreatic Cancer