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.
Perioperative Nivolumab Plus Chemotherapy Improves EFS in Resectable NSCLC
September 22nd 2023Neoadjuvant treatment with nivolumab plus platinum-based chemotherapy, followed by surgery and adjuvant nivolumab monotherapy, generated a statistically significant and clinically meaningful improvement in event-free survival vs neoadjuvant chemotherapy plus placebo, followed by surgery and adjuvant placebo, in patients with resectable stage IIA to IIIB non–small cell lung cancer.
Novel Targets Could Expand CAR T-Cell Therapy and Bispecific Antibody Options in Myeloma
September 22nd 2023Ajai Chari, MD, discusses selecting between CAR T-cell therapies and bispecific antibodies in multiple myeloma, expands on the factors that can help inform these decisions, and highlights the need for additional data to help inform sequencing and potential combinations for these therapies.
Continued CRC Research Informs Later-Line Disease Management
September 21st 2023Howard S. Hochster, MD, highlights key updates in CRC research and management from the 2023 ASCO Annual Meeting, including findings from the phase 2/3 PROSPECT trial, long-term follow-up data from the phase 3 PRODIGE 23 trial, and results of the phase 3 NeoCol study.
Ifinatamab Deruxtecan Demonstrates Robust Efficacy, Acceptable Safety in SCLC
September 21st 2023Melissa L. Johnson, MD, spotlights the early-phase investigation of ifinatamab deruxtecan in advanced solid tumors, discusses the efficacy and safety of the agent in patients with small cell lung cancer, and emphasizes how results from a subgroup analysis support its continued investigation.
Multiple Myeloma: The Black Community, Disparities & Clinical Trials
September 21st 2023The incidence of multiple myeloma, a rare and incurable cancer of a person’s plasma cells that fight infection and disease, is more than two times higher in Black people compared to white people according to the American Cancer Society’s 2022-2024 Cancer Facts & Figures for African American/Black People.
MWTX-003 Wins FDA Fast Track Designation for Polycythemia Vera
September 21st 2023The FDA has granted fast track designation to the investigational, anti-TMPRSS6 monoclonal antibody, MWTX-003 (DISC-3405), for use in the treatment of patients with polycythemia vera, according to an announcement from Disc Medicine, Inc.
Luspatercept Provides Frontline Alternative to ESAs For Lower-Risk MDS and Anemia
September 21st 2023Uwe Platzbecker, MD, discusses the efficacy and safety data from the COMMANDS trial that supported the approval, and the next steps planned for luspatercept’s investigation in patients with lower-risk MDS who are transfusion independent.
Triplets With Azacitidine/Venetoclax Aim to Improve Responses in AML
September 21st 2023Courtney D. DiNardo, MD, MSCE, discusses ongoing investigations of triplet regimens with an azacitidine/venetoclax backbone for the treatment of patients acute myeloid leukemia and highlights the unmet needs that remain in older and high-risk subgroups within this patient population.
FCR Retains Curative Potential in Young Patients With Favorable CLL Biology
September 20th 2023John Seymour, AM, MBBS, FRACP, FAHMS, PhD, discusses the characteristics of patients with CLL who may benefit from FCR, how genetic testing can provide key insights into individual patient disease patterns, and treatment sequencing options after progression on FCR.
Second-Line Regorafenib Demonstrates Safety in Advanced HCC, Irrespective of Prior Treatment
September 20th 2023Second-line treatment with regorafenib displayed safety in patients with advanced hepatocellular carcinoma who were not eligible for treatment on the phase 3 RESORCE trial, according to data from the phase 2 REGAIN trial.
European Commission Approves Elacestrant for Pretreated, ESR1+, ER+/HER2– Breast Cancer
September 20th 2023The European Commission has approved elacestrant for the treatment of postmenopausal women and men with estrogen receptor–positive, HER2-negative, locally advanced, or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least 1 line of endocrine therapy including a CDK4/6 inhibitor.
Thoracic Clinical Expert Looks at Optimal Ways to Translate Data Into Practice
September 20th 2023As oncogene-driven therapies move into clinical practice, it is paramount that clinicians have the tools and understanding to integrate the latest evidence for the appropriate treatment of patients with lung cancer.
Ongoing Research Aims to Address Further Questions on Fixed-Duration Therapy in CLL
September 20th 2023Alessandra Ferrajoli, MD, discusses the continued investigation of fixed-duration therapy as a frontline approach for patients with CLL, highlights both the pros and cons of this strategy, and touches on the unanswered questions regarding fixed-duration therapy that ongoing research aims to address.
FDA Approval Sought for Frontline Tislelizumab in Locally Advanced or Metastatic ESCC
September 19th 2023The FDA has accepted for review a biologics license application seeking the approval of tislelizumab for use in the frontline treatment of patients with unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma.
Tislelizumab Approved in Europe for Advanced ESCC After Platinum-Based Chemotherapy
September 19th 2023The European Commission has approved tislelizumab monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.
First-line Toripalimab Plus Sorafenib Elicits Responses in Unresectable Hepatocellular Carcinoma
September 19th 2023The addition of toripalimab to standard-of-care sorafenib in the frontline setting demonstrated preliminary efficacy and tolerability in patients with unresectable hepatocellular carcinoma.
FDA Grants Priority Review to Belzutifan in Previously Treated Advanced RCC
September 19th 2023The FDA has granted priority review to the supplemental new drug application seeking the approval of belzutifan for the treatment of previously treated patients with advanced renal cell carcinoma following immune checkpoint and anti-angiogenic therapies.
Data for Luspatercept Highlight Evolving Treatment Landscape in Lower-Risk MDS
September 19th 2023Uwe Platzbecker, MD, discusses how the FDA approval of luspatercept for the treatment of anemia in patients who have not had prior treatment with erythropoiesis-stimulating agent and may require regular red blood cell transfusions could change the sequencing of agents for this patient population.
EMA Grants PRIME Designation to Iopofosine I-131 for Waldenström Macroglobulinemia
September 19th 2023The European Medicines Agency has granted Priority Medicines designation to iopofosine I-131 for use in patients with Waldenström macroglobulinemia in patients who previously received at least 2 treatment regimens.