All Oncology News

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.

Dostarlimab Plus Chemo Provides OS Benefit in Primary Advanced or Recurrent Endometrial Cancer

October 30th 2023

The addition of dostarlimab to carboplatin plus paclitaxel followed by dostarlimab monotherapy significantly improved overall survival compared with placebo plus chemotherapy followed by placebo in adult patients with primary advanced or recurrent endometrial cancer.

Vimseltinib Improves 25-Week ORR Vs Placebo in TGCT

October 30th 2023

Vimseltinib elicited a statistically significant and clinically meaningful improvement in 25-week overall response rate vs placebo in patients with tenosynovial giant cell tumor that was not amenable to surgery.

Indirect Treatment Comparison Indicates Improved OS With Brexu-Cel in BTK Inhibitor–Exposed R/R MCL

October 30th 2023

Brexucabtagene 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 2023

BioFlorida, 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 2023

The 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 2023

Postoperative 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 2023

Marisol 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 2023

Richard 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 2023

The 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.

Exploratory Analyses Show Trastuzumab Deruxtecan Elicits Consistent Intracranial Responses in HER2-Mutated NSCLC With Brain Metastases

October 27th 2023

Pooled findings from exploratory analyses of the phase 2 DESTINY-Lung01 and DESTINY-Lung02 trials showed that different doses of fam-trastuzumab deruxtecan-nxki elicited similar intracranial responses in patients with HER2-mutated non–small cell lung cancer who had treated or untreated brain metastases at baseline.

MRD and ctDNA Could Shift into Larger Role to Guide Treatment Decisions in Breast Cancer

October 27th 2023

Praveen 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 2023

The 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.

EMA Accepts Marketing Authorization Application for Mirvetuximab Soravtansine in FRα+, Platinum-Resistant Ovarian Cancer

October 27th 2023

The European Medicines Agency has accepted a marketing authorization application seeking the approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Temple Health Wins Service Award for Colorectal Cancer Outreach, Prevention & Year-Round Excellence

October 27th 2023

Temple 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 2023

Despite 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 2023

The 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.

Datopotamab Deruxtecan Elicits Antitumor Activity in Pretreated NSCLC With Actionable Genomic Alterations

October 26th 2023

Datopotamab deruxtecan elicited encouraging responses in patients with heavily pretreated non–small cell lung cancer harboring actionable genomic alterations.

FDA Accepts BLA Resubmission for N-803 in BCG-Unresponsive, High-Risk NMIBC In Situ

October 26th 2023

The 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.

Patient and Disease Characteristics Serve as Key Factors Behind Treatment Considerations in Advanced RCC

October 26th 2023

Vitaly Margulis, MD, expands on the factors to consider when treating patients with advanced RCC and how these could help inform the selection of immunotherapy-based combinations in the frontline setting.

Further Research Is Needed to Maximize Efficacy of Current Treatment Options in Hematologic Malignancies

October 26th 2023

Ricardo D. Parrondo, MD, highlights the current use of covalent BTK inhibitors in chronic lymphocytic leukemia, potential roles for the non-covalent BTK inhibitor pirtobrutinib, and the importance of future research on time-limited treatment options for patients with newly diagnosed chronic lymphocytic leukemia.