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.

FDA Approves Epcoritamab for Relapsed/Refractory DLBCL

May 19th 2023

The FDA has approved the first T-cell–engaging bispecific antibody, epcoritamab-bysp (Epkinly), for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after 2 or more lines of systemic therapies.

MAJIC-PV Trial Confirms Clinical Benefit of Ruxolitinib in Polycythemia Vera

May 19th 2023

Treatment with ruxolitinib generated superior responses vs treatment with best available therapy in patients with hydroxycarbamide-intolerant or -resistant polycythemia vera, according to findings from the phase 2 MAJIC-PV trial.

Georgia Cancer Center Awarded $2.3 Million Grant for Acute Myeloid Leukemia Research to Improve Patient Survival

May 19th 2023

Acute myeloid leukemia is a cancer that affects blood cells in the bone marrow- the spongy tissue inside certain bones where new blood cells are made.

Omidubicel Approval Represents Key Advance for Patients With Blood Cancers Requiring Transplant

May 19th 2023

Mitchell E. Horwitz, MD, expands on key efficacy and safety data supporting the FDA approval of omidubicel, the significance of this decision for the blood cancer treatment paradigm, and the need for continued investigation of the agent in non-malignant disease and other patient subgroups.

The Placebo: A Controversial Element of Randomized Cancer Clinical Trials

May 19th 2023

The potential effectiveness of employing placebo in cancer clinical investigation is not difficult to appreciate, but the use of this approach has been, and continues to be, controversial.

Birtamimab Under Investigation in Mayo Stage IV AL Amyloidosis

May 19th 2023

Morie A. Gertz, MD, discusses the limitations of the current Mayo Stage IV amyloidosis treatment landscape, the rationale for investigating birtamimab in this population, and the importance of raising awareness for the AFFIRM-AL trial.

Chinese Phase 3 Trial of Roxadustat in Non-Myeloid Malignancies Meets Primary End Point

May 18th 2023

Roxadustat proved to be noninferior to recombinant erythropoietin alfa with regard to change in hemoglobin level from baseline to an average level during weeks 9 to 13 in patients receiving concurrent chemotherapy for non-myeloid malignancies in China, meeting the primary end point of an ongoing phase 3 trial.

Link Between PSA Response and Survival Outcomes Supports Use of Darolutamide Plus ADT/Docetaxel as a SOC in mHSPC

May 18th 2023

Fred Saad, MD, FRCS, expands on the relationship between PSA responses and survival outcomes in the ARASENS trial, explained the use of 0.2 ng/mL as a standard cut off for undetectable PSA within this exploratory analysis, and discussed how this study elucidates future directions for research with triplet regimens in mHSPC.

Adjuvant Abemaciclib Provides Survival Benefit in Chinese Breast Cancer Population

May 18th 2023

Abemaciclib plus endocrine therapy delivered sustained survival benefits with a tolerable safety profile when used as adjuvant treatment in Chinese patients with high-risk, hormone receptor–positive, HER2-negative early breast cancer.

CG0070 Plus Pembrolizumab Produces Durable Responses in BCG-Unresponsive NMIBC

May 18th 2023

Roger Li, MD, discusses how the synergistic mechanism of pembrolizumab plus CG0070 could address unmet needs in BCG-unresponsive NMIBC, safety and efficacy data for the combination from the CORE-001 trial, and how those data support planned research efforts for CG0070 in this space.

Major Expansion Provides Best Cancer Care to Utah and Beyond

May 18th 2023

Huntsman Cancer Institute at the University of Utah, the only place in the region devoted to developing new treatments for cancer, announced the opening of the Kathryn F. Kirk Center for Comprehensive Cancer Care and Women’s Cancers.

FDA Grants Orphan Drug Designation to Rucosopasem for Pancreatic Cancer

May 18th 2023

The FDA has granted an orphan drug designation to rucosopasem manganese for the treatment of patients with pancreatic cancer.

Epcoritamab Could Provide Active and Accessible Treatment Option for R/R LBCL

May 18th 2023

Chan Cheah, MBBS, FRACP, FRCPA, DMSc, discusses key safety and efficacy data from the EPCORE NHL-1 trial that may serve to support the approval of epcoritamab in patients with relapsed or refractory large B-cell lymphoma, and highlighted ongoing research efforts seeking to further move the needle forward in this disease.

Elacestrant Highlights Promise of Oral SERDs in HR+/HER2– Metastatic Breast Cancer

May 18th 2023

Antoinette R. Tan, MD, MHSc, discussed the promise of oral SERDs as they continue to be developed for the treatment of patients with ER-positive, HER2-negative breast cancer, factors that inform treatment decisions following disease progression on a CDK4/6 inhibitor, and the growing role of antibody-drug conjugates across the breast cancer spectrum.

First-line Eftilagimod Alpha Plus Pembrolizumab Generates OS Benefit in PD-L1+ NSCLC

May 17th 2023

Eftilagimod alpha plus pembrolizumab provided an overall survival benefit over what has been reported with historical controls when given as first-line treatment in patients with non–small cell lung cancer and a PD-L1 tumor proportion score of at least 1%.

Encorafenib Plus Cetuximab/Binimetinib Displays Activity, Safety in BRAF V600E–mutant mCRC

May 17th 2023

Triplet therapy consisting of encorafenib, cetuximab, and binimetinib demonstrated activity and manageable safety as first-line treatment for patients with BRAF V600E–mutated metastatic colorectal cancer.

Genomic Testing Is Critical for Improved Personalized Medicine and Treatment Sequencing in Breast Cancer

May 17th 2023

Lida A. Mina, MD, discusses the evolving role of ADCs across breast cancer subtypes, current data on the use of CDK4/6 inhibitors in HR-positive, HER2-negative breast cancer, and the increased use of genomic testing and NGS to improve the sequencing of agents in triple-negative breast cancer.

Targeted Therapy Developed in FCS Clinical Trials Transforming Cancer Treatment For Adult Patients with Diffuse Large B-cell Lymphoma

May 17th 2023

Florida Cancer Specialists & Research Institute, LLC released a case study outlining the evolution of a newly FDA-approved first-line therapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma.

Optimizing CSCC Management Requires a Multifaceted Approach to Care

May 17th 2023

Sunandana Chandra, MD, MS, Anna C. Pavlick, DO, MSc, MBA, BSN, and Nikhil Khushalani, MD, discuss the importance of multidisciplinary care in CSCC and patient counseling regarding available therapies.

Osimertinib Plus Chemotherapy Improves PFS in EGFR+ Advanced NSCLC

May 17th 2023

The combination of osimertinib and platinum-based chemotherapy led to a statistically significant and clinically meaningful improvement in progression-free survival compared with osimertinib alone in patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR mutations.