The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Indirect Treatment Comparison Indicates Improved OS With Brexu-Cel in BTK Inhibitor–Exposed R/R MCL
October 30th 2023Brexucabtagene autoleucel demonstrated an improvement in overall survival vs standard of care therapy in patients with relapsed/refractory mantle cell lymphoma following prior exposure to a BTK inhibitor, according to data from an indirect treatment comparison of findings from the phase 2 ZUMA-2 trial and retrospective SCHOLAR-2 trial.
Dr Stephen D. Nimer Named Researcher of the Year
October 30th 2023BioFlorida, a statewide association for Florida’s life sciences industry, has named Stephen D. Nimer, MD, director of Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, “Researcher of the Year.”
FDA Grants Priority Review to Tovorafenib in Pediatric Relapsed/Progressive Low-Grade Glioma
October 30th 2023The FDA has granted priority review to a new drug application seeking the approval of tovorafenib monotherapy for the treatment of pediatric patients with relapsed or progressive low-grade glioma.
Postoperative ctDNA Status May Prognosticate DFS Outcomes in Resected CRC
October 30th 2023Postoperative circulating tumor DNA (ctDNA)–based minimal residual disease status demonstrated prognostic value for patients with stage I to IV resected colorectal cancer, showing that those with positive ctDNA after surgery have significantly lower disease-free survival outcomes at 24 months vs those who were ctDNA negative.
Social Determinants of Health Impact Survival Outcomes in Patients With Hematologic Malignancies
October 29th 2023Marisol Miranda-Galvis, DDS, MS, PhD, highlights the importance of understanding which social determinants of health have the greatest influence on treatment-related outcomes in patients with hematologic malignancies, expands on key variables identified in a systematic review of these disparities, and emphasizes the importance of continuing to implement new strategies to increase access to quality treatments.
Expanding Immunotherapy Armamentarium Propels Personalized HCC Treatment Approaches
October 28th 2023Richard Kim, MD, discusses the range of systemic treatment options available for patients with unresectable hepatocellular carcinoma and the importance of assessing patients for high-risk disease criteria before beginning any systemic treatment.
FDA Approves Toripalimab for Recurrent or Metastatic Nasopharyngeal Carcinoma
October 27th 2023The FDA has approved toripalimab-tpzi (Loqtorzi) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as monotherapy for the treatment of adult patients with recurrent, unresectable, or metastatic nasopharyngeal carcinoma with disease progression on or after platinum-containing chemotherapy.
MRD and ctDNA Could Shift into Larger Role to Guide Treatment Decisions in Breast Cancer
October 27th 2023Praveen Vikas, MBBS, discusses what is currently known regarding minimal residual disease testing in breast cancer, expanded on what still needs to be done to bring minimal residual disease and ctDNA testing to clinical practice, and highlighted the evolving treatment paradigm for patients with advanced hormone receptor-positive, HER2-negative breast cancer.
FDA Grants Fast Track Designation to ONCT-534 for Relapsed/Refractory mCRPC
October 27th 2023The FDA has granted fast track designation to the dual-acting androgen receptor inhibitor ONCT-534 for the treatment of patients with relapsed/refractory, metastatic castration-resistant prostate cancer that is resistant to approved androgen receptor pathway inhibitors.
Temple Health Wins Service Award for Colorectal Cancer Outreach, Prevention & Year-Round Excellence
October 27th 2023Temple Health was recently recognized with the American College of Gastroenterology’s Service Award for Colorectal Cancer Outreach, Prevention & Year-Round Excellence for its coordinated health campaign against colon cancer.
Early Trials of PRMT5 Inhibitors Leave Much to Be Desired, But Optimism Remains
October 27th 2023Despite the discovery of protein arginine methyltransferase 5 more than 20 years ago, interest in the potential oncogene as a treatment target for patients with hematologic and solid malignancies has increased in recent years with the advancement of multiple novel agents through preclinical and early-phase studies.
Ibrutinib/Bortezomib Combo Showcases Durable Efficacy in R/R MCL and High-Risk Features
October 26th 2023The combination of ibrutinib and bortezomib elicited durable responses in patients with relapsed or refractory mantle cell lymphoma and high-risk features such as a Ki-67 over 30%, blastoid or pleomorphic variant, p53 overexpression, and TP53 mutations and/or deletions.
FDA Accepts BLA Resubmission for N-803 in BCG-Unresponsive, High-Risk NMIBC In Situ
October 26th 2023The FDA has accepted the resubmission of a biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive, non–muscle-invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease.
Novel Frontline Combinations Influence Later-Line Treatment Strategies in SCLC
October 26th 2023While progress in outcomes has been greater in non–small cell lung cancer, recent advances, including molecularly targeted therapies against EGFR and ALK, checkpoint inhibitors that boost immune response, improved staging, and video-assisted surgery have all contributed to progress in treatment of all types of lung cancer, including in SCLC.
Vepdegestrant Continues to Show Tolerability, Activity in ER+/HER2- Advanced Breast Cancer
October 25th 2023Vepdegestrant continued to showcase clinical activity with favorable tolerability spanning all doses examined in heavily pretreated patients with estrogen receptor–positive, HER2-negative advanced breast cancer, according to updated dose-escalation data from a phase 1/2 study.
Venetoclax Monotherapy Leads to Responses, Genomic Changes in R/R CLL
October 25th 2023Jennifer A. Woyach, MD, elucidates the updated results generated from a phase 2 study of venetoclax monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) whose disease progressed on a prior B-cell receptor inhibitor, expanded on key findings from a genomic analysis from the study, and highlighted what these findings could mean for the CLL treatment paradigm.
Dr Nakamura on the Association Between MRD Negativity and DFS in Resected CRC
October 25th 2023Yoshiaki Nakamura, MD, PhD, discusses updated findings from an analysis of the association between circulating tumor DNA minimal residual disease status and disease-free survival in the GALAXY trial, an observational arm of the ongoing CIRCULATE-Japan trial in patients with resected colorectal cancer.
New Clinical Trials Test Innovative Ways To Preserve Muscle Mass During Metastatic Prostate Cancer
October 25th 2023The National Cancer Institute awarded investigators at Huntsman Cancer Institute a grant totaling more than $3 million to conduct a clinical trial to see if combining creatine monohydrate supplementation and resistance exercise training helps preserve muscle in people who have metastatic prostate cancer.
ImPrint Biomarker Predicts Immunotherapy Response in Patients With HR+/HER2– Breast Cancer
October 25th 2023Denise M. Wolf, PhD, discusses the methods used to conduct the I-SPY2 study and the implications that immune biomarkers could have on selecting treatment for patients with hormone receptor–positive, HER2-negative breast cancer in the future.