Perioperative Pembrolizumab Betters Survival in Stage III/IV Head …
Oct 8, 2024 · Perioperative pembrolizumab (Keytruda) led to improved event-free survival (EFS) in patients with stage III or IVA, resected head and neck squamous cell carcinoma (HNSCC), meeting the primary end point of the phase 3 KEYNOTE-689 study (NCT03765918). 1 “These results are substantial, as KEYNOTE-689 marks the first positive trial in 2 decades for patients with resected, locally advanced head ...
TMB and Gene Profiles Confirm Prognostic Value in TNBC
Dec 11, 2024 · Various biomarkers, including T-cell inflamed 18-gene expression profile, were positively prognostic for improved pathologic complete response (pCR) and event-free survival (EFS), with or without the addition of pembrolizumab (Keytruda; P ≤.001), according to findings from a prespecified, exploratory analysis of the KEYNOTE-522 study (NCT03036488) in high-risk, early triple-negative breast ...
Frontline Approaches in CML Headline 2025 Conference
Dec 18, 2024 · FRONTLINE TYROSINE KINASE inhibitor (TKI) therapy in chronic myelogenous leukemia (CML) has been well established, with 4 TKIs currently available: imatinib (Gleevec), dasatinib (Sprycel), bosutinib (Bosulif), and nilotinib (Tasigna). Current guidelines promote all 4 agents as viable options for the management of chronic phase (CP) CML. 1 Despite these agents’ overall success among patients ...
GLP-1 Agonists Poised to Impact Breast Cancer Care
Sep 25, 2024 · Recent trends have brought GLP-1 receptor agonists, including semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), to front of mind when discussing general weight loss. At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, multiple presentations focused on the weight loss aspect of GLP-1 agonists for patients with breast cancer.
6-Year Data Sustain Adjuvant Olaparib Benefit in BRCA1/2+, HER2 …
Dec 11, 2024 · Six-year results continued to show the clinically meaningful efficacy of adjuvant olaparib vs placebo in patients with BRCA1/2 mutation–positive, HER2-negative high-risk breast cancer, according to findings from the third pre-specified analysis of the phase 3 OlympiA trial (NCT02032823). 1. The analysis occurred at a median follow-up of 6.1 years (max, 9.6 years) and 2.6 years since the ...
FDA Grants Clearance for Phase 1b/2 Trial of SNB-101 in SCLC
6 days ago · The investigational new drug application for the nanoparticle drug SNB-101 has been cleared for small cell lung cancer treatment. The FDA has granted clearance to the investigational new drug application of SNB-101 in small cell lung cancer (SCLC) treatment. A phase 1b/2 clinical trial plans to ...
FDA Clears NMIBC Agent TYRA-300 for Phase 2 Trial
Jan 10, 2025 · TYRA-300 has gained an investigational new drug application from the FDA and will be further studied in the phase 2 SURF302 trial for patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer. The FDA cleared the investigational new drug (IND) application for TYRA-300 in low ...
FDA ODAC Finds Limited Benefit for Checkpoint Inhibitors in Low …
Sep 26, 2024 · In a 2 to 10 vote, the FDA’s Oncologic Drug Advisory Committee (ODAC) voted that the risk-benefit assessment is not favorable for the use of checkpoint inhibitors (CPIs) in first-line advanced HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma in patients with PD-L1 expression less than 1. 1 The ODAC discussed this question through data supporting the current approvals ...
Navtemadlin Monotherapy Shows Improvements in Hallmarks of …
Dec 8, 2024 · Navtemadlin (KRT-232), a novel p53 potentiating anticancer agent best-in-class MDM2 inhibitor, reduced biomarkers of disease severity in patients with relapsed or refractory (R/R) myelofibrosis (MF), suggesting the agent may …
T-DXd in ER+/HER2-Low Breast Cancer: Insights From DESTINY …
Dec 11, 2024 · Aditya Bardia, MD, MPH, FASCO, professor, department of medicine, division of hematology/oncology, director of translational research integration, UCLA Health Jonsson Comprehensive Cancer Center, Los Angeles, CA, discusses how fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) compares with physician’s choice of chemotherapy in estrogen receptor (ER)-positive/HER2-low breast cancer and how ...