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.
NKX019 Showcases Manageable Safety, Early Activity in R/R B-cell Non-Hodgkin Lymphoma
July 27th 2023The allogeneic natural killer cell therapy NKX019 was found to have an acceptable toxicity profile and to induce deep and durable responses in patients with relapsed or refractory B-cell non-Hodgkin lymphomas.
Social Determinants of Health Correlate With Lower CRC Screening Rates
July 26th 2023Isabelle Franklin discusses the effects of social determinants of health on rates of colorectal cancer screening, expands on how these social determinants of health could affect a patient’s likelihood of adhering to screening guidelines, and highlights ways to potentially address these barriers to screening.
Expanding Definitions of HER2 Expression Mediate the Role of ADCs in Breast Cancer
July 26th 2023Erika P. Hamilton, MD, discusses the role of trastuzumab deruxtecan in HER2-positive and HER2-low breast cancer; the evolution of CDK4/6 inhibitors in hormone receptor–positive disease; and how genetic testing can match patients with personalized therapies and support further precision medicine research.
mRNA-4157 Plus Pembrolizumab Under Further Investigation in Phase 3 Trial in High-Risk Melanoma
July 26th 2023The combination of mRNA-4157 and pembrolizumab will be further evaluated as an adjuvant treatment option for patients with resected, high-risk, stage IIB to IV melanoma in the phase 3 V940-001 trial.
NCCN Adds Flotufolastat F 18 Injection to Clinical Practice Guidelines for Prostate Cancer
July 26th 2023The National Comprehensive Cancer Network has added flotufolastat F 18 injection to its Clinical Practice Guidelines in Oncology for positron emission tomography of prostate-specific membrane antigen–positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy.
FDA Clears Investigational New Drug Application for TCR-NK Cell Therapy in Multiple Myeloma
July 26th 2023The FDA has issued a ‘safe to proceed’ for the investigational new drug application enabling a phase 1 study evaluating NY-ESO-1 TCR/IL-15 NK, a first-in-class engineered T-cell receptor natural killer cell therapy for patients with relapsed/refractory multiple myeloma.
Birtamimab Pushes the Needle in AL Amyloidosis
July 26th 2023Findings from an analysis of treatment patterns for patients with systemic amyloid light chain amyloidosis have demonstrated that several unmet needs exist, including timely diagnosis and limited survival outcomes for patients with advanced disease.
Sugemalimab Plus Chemotherapy Yields Statistically Significant Improvement in OS and PFS in NSCLC
July 26th 2023Sugemalimab plus chemotherapy demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival vs placebo plus chemotherapy for the first-line treatment of patients with stage IV non–small cell lung cancer irrespective of PD-L1 expression level and tumor pathological type.
Treatment Sequencing Clarifications May Spur NSCLC Therapeutic Evolutions
July 25th 2023Angel Qin, MD, contextualizes the non–small cell lung cancer ADAURA trial, in which patients with EGFR-mutated non–small cell lung cancer who received adjuvant therapy with osimertinib achieved a 5-year overall survival rate of 85% vs 73% in those who received placebo.
First-Line Rivoceranib Plus Camrelizumab Improves Survival in Unresectable HCC
July 25th 2023Treatment with the combination of rivoceranib and camrelizumab led to a statistically significant and clinically meaningful benefit in progression-free survival and overall survival compared with sorafenib in previously untreated patients with unresectable hepatocellular carcinoma.
Gilead Discontinues Phase 3 ENHANCE Trial of Magrolimab/Azacitidine in Higher-Risk MDS
July 25th 2023The phase 3 ENHANCE trial evaluating the first-line combination of magrolimab and azacitidine vs placebo plus azacitidine in patients with higher-risk myelodysplastic syndrome has been discontinued due to futility at a planned analysis.
GI Cancer Research Lends Insight Into the Future of Chemotherapy Combinations and Sequencing
July 24th 2023Mark Lewis, MD, discusses the contested designs of the NorPACT-1 trial and NAPOLI 3 trial; where trastuzumab deruxtecan falls in the HER2-positive metastatic colorectal cancer treatment paradigm; and how the PROSPECT trial results can improve quality of life for patients with rectal cancer.
Loncastuximab Tesirine BLA Receives Priority Review in China for Relapsed/Refractory DLBCL
July 24th 2023The China National Medical Products Administration has accepted and granted priority review to the biologics license application seeking the approval of loncastuximab tesirine-lpyl for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma following at least 2 prior lines of systemic therapy.
Axatilimab Meets ORR End Point in Chronic GVHD After 2 or More Prior Lines of Therapy
July 24th 2023The anti–CSF-R1 antibody axatilimab generated responses in adult and pediatric patients with chronic graft-vs-host disease who received 2 or more prior lines of therapy, meeting the primary end point in all cohorts of patients in the phase 2 AGAVE-201 trial.
FDA Approves Companion Diagnostic for Quizartinib in FLT3-ITD+ AML
July 24th 2023The FDA has approved the LeukoStrat CDx FLT3 Mutation Assay for use as a companion diagnostic to select patients with FLT3-ITD–positive acute myeloid leukemia who may be eligible to receive treatment with quizartinib (Vanflyta).1
CHMP Advises Against Adagrasib Approval for KRAS G12C–Mutant Advanced NSCLC
July 24th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the conditional marketing authorization application for adagrasib for the treatment of patients with KRAS G12C–mutated advanced non–small cell lung cancer.
Evaluating Toxicities of Antineoplastic Drug Therapeutics: Is It Time for a Critical Review?
July 24th 2023An evaluation of the utility of a cancer therapeutic in a clinical trial is determined through metrics that define 2 distinctive features of an antineoplastic strategy: efficacy and toxicity. Although that may be an oversimplification, the aim of such therapy is to improve clinical outcomes.