Targeted Oncology - Immunotherapy, Biomarkers, and Cancer …
During an in-person Community Case Forum event in Miami, Florida, Mike Cusnir, MD, discussed the ARANOTE study outcomes presented at ESMO 2024 and how they fit into the treatment paradigm for patients with metastatic hormone-sensitive prostate cancer. A phase 1 trial evaluating FSHR-targeting CAR T ...
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 ...
Antibody-Drug Conjugates Show Unique Advantage in Breast …
Nov 19, 2024 · Erika P. Hamilton, MD, director of breast cancer and gynecologic cancer research at the Sarah Cannon Research Institute, discusses antibody-drug conjugates (ADCs) in multiple types of breast cancer, and when to use these drugs in sequence.
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 …
FDA Grants B7-H3–Targeted ADC Breakthrough Status in …
5 days ago · About the ARTEMIS-002 Study. The ARTEMIS-002 study is evaluating the efficacy, safety, pharmacokinetics (PK), and immunogenicity of GSK’227 when used as a monotherapy for the treatment of patients with relapsed/refractory osteosarcoma and other sarcomas. 2 ARTEMIS-002 is a phase 2, open-label, multicenter trial which consists of 2 parts: phase 2a and 2b.
FDA Reviews NDA for Dordaviprone in H3K27M-Mutant Diffuse …
Jan 3, 2025 · The FDA is reviewing a new drug application (NDA) for dordaviprone (ONC201), a potential treatment for patients with recurrent H3K27M-mutant diffuse glioma.; Clinical data show a 20% overall response rate (ORR) and a median response duration (DOR) of 11.2 months, with manageable safety profiles observed across multiple trials and a compassionate use program.
FDA Approves Perioperative Nivolumab in Resectable NSCLC
Oct 3, 2024 · The FDA approved nivolumab (Opdivo) plus chemotherapy for operable non–small cell lung cancer (NSCLC) treatment. Data from the CheckMate 77T trial (NCT04025879) supports this approval.
FDA Clears Investigational New Drug Application for REC-4539 in …
4 days ago · The FDA cleared an investigational new drug (IND) application for a phase 1/2 clinical trial to investigate REC-4539. REC-4539 a potential best-in-classlysine-specific demethylase 1 (LSD1) inhibitor for small cell lung cancer (SCLC).; The initial clinical investigation will focus on SCLC and several other solid tumor indications.
BCL2 and cBTK Inhibitors Show Superior Outcomes in CLL/SLL
Dec 12, 2024 · Treatment sequences including covalent Bruton tyrosine kinase inhibitors (cBTKis) followed by B-cell lymphoma-2 (BCL2) inhibitors and anti-CD20 monoclonal antibodies (aCD20abs) are associated with better overall survival (OS) in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Adjuvant T-DM1 Continues to Outperform Trastuzumab in HER2 …
Dec 8, 2023 · After 8.4 years follow-up, T-DM1 (ado-trastuzumab emtansine; Kadcycla) led to improved overall survival (OS) and invasive disease-free survival (iDFS) over trastuzumab (Herceptin) in patients with HER2-positive early breast cancer that had residual invasive disease after neoadjuvant therapy, according to findings from the KATHERINE trial that were presented at the 2023 San Antonio Breast ...