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.

Trastuzumab Deruxtecan sNDA for HER2-Mutant Metastatic NSCLC Submitted for Review in Japan

December 15th 2022

Daiichi Sankyo has filed a supplemental new drug application with Japan’s Ministry of Health, Labor, and Welfare for the use of fam-trastuzumab deruxtecan-nxki in adults with previously treated HER2-mutant unresectable advanced or recurrent non–small cell lung cancer.

Novel Targeted Immunotherapies Strengthen Frontline Treatment Strategies in Hodgkin Lymphoma

December 15th 2022

Joshua Brody, MD, discusses unmet needs in patient subgroups within Hodgkin lymphoma, recent advancements in the use of antibody-drug conjugates such as brentuximab vedotin and anti–PD-1 therapies in earlier lines of therapy, and future avenues for expanding the use of immunotherapy in this tumor type.

Emerging Agents Signal Promising Opportunities to Expand Treatment Options for CLL

December 15th 2022

Anthony Mato, MD, MSCE, discusses the relapsed refractory setting compared with the frontline setting and promising agents such as pirtobrutinib and zanubrutinib.

Updated EMERALD Data Support Oral SERD Elacestrant As a Potential Option for Metastatic Hormone Receptor–Positive Breast Cancer

December 14th 2022

The oral selective estrogen receptor degrader elacestrant has shown promise over standard second-line treatment, such as fulvestrant, for patients with metastatic hormone receptor–positive breast cancer.

New Clinical Tool for Clonal Hematopoiesis Identifies Patients at High Risk for Blood Cancer

December 14th 2022

A new clinical tool developed by a team of researchers led by the Dana-Farber Cancer Institute pinpoints which clonal hematopoiesis patients are at highest risk for cancer progression.

DZD1516 With CSF Penetration Has Antitumor Activity in Heavily Pretreated HER2+ Metastatic Breast Cancer

December 14th 2022

DZD1516, a reversible and selective HER2 TKI with full blood–brain barrier penetration led to tumor responses, including in patients with baseline central nervous system metastases, in a phase 1 study of patients with metastatic HER2-positive breast cancer.

Thrombocytopenia Is Associated With Greater Symptom Burden in Myelofibrosis

December 14th 2022

Low platelet counts were associated with a greater severity of disease-related symptoms compared with low hemoglobin in patients with myelofibrosis, according to findings from a retrospective analysis of the phase 3 PERSIST-1 and PAC203 trials.

Obe-cel Represents a Tolerable CAR T-cell Therapeutic Option in B-ALL

December 14th 2022

Elias Jabbour, MD, discusses the current and emerging roles of CAR T-cell therapy in B-ALL, emphasizes the importance of testing patients for MRD when determining CAR T-cell treatment strategies, and highlights how obe-cel, with its favorable safety profile, may address unmet needs related to CAR T-cell toxicities.

A New Take on Preclinical Drug Trials for Glioblastoma Treatment

December 14th 2022

The Ivy Brain Tumor Center at Barrow Neurological Institute in Phoenix, Arizona, is attempting to change the way preclinical studies are developed and conducted to assess the efficacy of drugs for glioblastoma multiforme.

Olutasidenib Elicits Durable Responses in IDH1-Mutant, Relapsed/Refractory AML

December 14th 2022

Olutasidenib monotherapy induced high complete response rates with a manageable toxicity profile in patients with relapsed/refractory acute myeloid leukemia harboring IDH1 mutations.

FDA Approves ctDx FIRST as Liquid Biopsy Companion Diagnostic Test for Adagrasib in Advanced NSCLC

December 14th 2022

The FDA has issued an accelerated approval for the Agilent Resolution ctDx FIRST assay for plasma as a companion diagnostic for adagrasib.

European Commission Approves Pluvicto for PSMA-Positive mCRPC

December 13th 2022

The European Commission has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition, for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.

BGB-11417 Alone or in Combination with Zanubrutinib Shows Early Efficacy in CLL/SLL

December 13th 2022

BGB-11417, when given alone or in combination with zanubrutinib, elicited encouraging responses and minimal residual disease negativity rates in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, according to preliminary data from a phase 1 trial.

HD-ASCT Demonstrates Improved PFS Vs Non-Myeloablative Chemoimmunotherapy in Primary CNS Lymphoma

December 13th 2022

Consolidation therapy with high-dose chemotherapy and autologous stem cell transplantation improved progression-free survival vs non-myeloablative chemoimmunotherapy in patients with primary central nervous system lymphoma.

BCMA/CD19 Dual-targeting CAR T-cell Therapy Shows 100% MRD Negativity Rate in Newly Diagnosed Multiple Myeloma

December 13th 2022

Among patients with newly diagnosed high-risk multiple myeloma, treatment with BCMA/CD19 dual-targeting FasTCAR-T Cells resulted in an overall response rate of 100%, with all treated patients evaluable for minimal residual disease showing minimal residual disease negativity to 12 months.

GVHD Prophylactic Regimen Improves 1-Year GRFS Vs Standard in Patients With Hematologic Malignancies Post-HCT

December 13th 2022

Administration of cyclophosphamide, tacrolimus, and mycophenolate mofetil improved 1-year GVHD relapse-free survival compared with tacrolimus plus methotrexate in patients with hematologic malignancies undergoing reduced intensity conditioning allogeneic hematopoietic cell transplantation.

Cilta-Cel Shows Efficacy and Tolerability in Multiple Myeloma, Potentially Filling Unmet Need in Early-Line Therapy

December 13th 2022

The CAR-T cell therapy ciltacabtagene autoleucel has expanded options for adult patients with relapsed/refractory multiple myeloma after 4 or more lines of prior therapy in the United States, and has continued to display promising efficacy in patients with multiple myeloma following early relapse.

FDA Accepts New Drug Application for the Radiopharmaceutical Imaging Kit EVG-001 for NETs

December 13th 2022

The FDA has accepted a new drug application for EVG-001, a kit for the preparation of Gallium-68 DOTATOC injection, a radiopharmaceutical approved for imaging of neuroendocrine tumors using positron emission tomography.

Olverembatinib Elicits Efficacy in US Patients With Ponatinib-Resistant, T315I-Mutant CML, and Ph-Positive ALL

December 13th 2022

Olverembatinib elicited encouraging responses and tolerability in US patients with ponatinib-resistant chronic myeloid leukemia, Philadelphia chromosome-positive acute lymphoblastic leukemia, and in patients with CML whose tumors have a T315I mutation.

Zanubrutinib PFS, ORR Is Superior to Ibrutinib for Relapsed/Refractory CLL/SLL

December 13th 2022

Treatment with zanubrutinib (Brukinsa) reduced the risk of progression or death by 35% compared with ibrutinib (Imbruvica) for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.