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.
SAR439859 Achieves On-Target Activity in Metastatic ER+ Breast Cancer
December 28th 2020December 28, 2020 - The investigational selective estrogen receptor degrader SAR439859 elicited clinical, on-target activity in patients with heavily pretreated estrogen receptor–positive, HER2-negative metastatic breast cancer, even in the presence of multiple resistance mechanisms.
Student Loan Debt, Immigration Status Often Drive Career Decisions for Fellows
December 26th 2020Investigators from Indiana University decided to study some of the factors influencing career plans for physicians, focusing on current fellows and recent graduates of the hematology and medical oncology specialty in the United States.
Nivolumab Plus Temozolomide/Radiotherapy Misses OS End Point in Glioblastoma Multiforme
December 23rd 2020December 23, 2020 — Nivolumab in combination with temozolomide and radiation treatment failed to result in a statistically significant improvement in overall survival in patients with newly diagnosed glioblastoma multiforme with MGMT promoter methylation following surgical resection of the tumor.
Fixed-Dose Pertuzumab/Trastuzumab Combo Approved in Europe for HER2+ Breast Cancer
December 23rd 2020December 23, 2020 - The European Commission has approved the fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase, to be administered via a subcutaneous injection in the treatment of patients with early and metastatic HER2-positive breast cancer.
Allogeneic SCT Benefits Children and Adolescents With Relapsed Anaplastic Large Cell Lymphoma
December 23rd 2020December 23, 2020 — Findings from the International, Prospective ALCL-Relapse trial showed that allogeneic SCT after reinduction chemotherapy can lead to survival improvements in children and adolescents with high-risk relapsed or refractory anaplastic large cell lymphoma, provide more insight into how to treat this population.
FDA Updates Ibrutinib Label to Include Long-Term Waldenström Macroglobulinemia Data
December 23rd 2020December 23, 2020 - The FDA has updated the prescribing information for ibrutinib to include safety and efficacy data for the agent in combination with rituximab in the treatment of patients with Waldenström macroglobulinemia.
Idasanutlin Induces Responses in Polycythemia Vera, but GI AEs Lead to Frequent Dose Interruptions
December 22nd 2020December 22, 2020 - Idasanutlin, an investigational MDM2 antagonist that leads to increased p53 activity, led to hematologic responses in about two-thirds of patients with hydroxyurea-resistant polycythemia vera, but was associated with frequent discontinuation.
N-803 Plus BCG Elicits 72% CR in BCG-Unresponsive, High-Grade Non-Muscle Invasive Bladder Cancer
December 22nd 2020December 22, 2020 — Intravesical Bacillus Calmette-Guerin in combination with N-803 was found to induce a complete response rate of 72% in patients with non-muscle invasive bladder cancer in high-risk carcinoma in situ disease, meeting the primary end point of the phase 2/3 QUILT 3.032 trial.
Early MRD Monitoring in Younger Patients With MCL Posttransplant Predicts Outcomes
December 22nd 2020December 22, 2020 - Minimum residual disease negativity in the bone marrow and peripheral blood prior to autologous stem cell transplant predicts better progression-free survival and overall survival in younger patients with mantle cell lymphoma.
Gilteritinib/Azacitidine Fails to Significantly Improve OS in Newly Diagnosed FLT3+ AML
December 21st 2020December 21, 2020 — The addition of gilteritinib to azacitidine failed to significantly improve overall survival vs azacitidine alone in patients with newly diagnosed FLT3-mutated acute myeloid leukemia who were not eligible for intensive induction chemotherapy, failing to meet the primary end point of the LACEWING trial.
BLA Initiated for JZP-458 in Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
December 21st 2020December 21, 2020 - The submission of a biologics license application to the FDA has been initiated for JZP-458 for use as a component of a multiagent chemotherapy regimen in the treatment of adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.
ViPOR Regimen Is Safe, Shows Impressive Activity in Relapsed/Refractory DLBCL
December 21st 2020December 21, 2020 — The 5-drug regimen of venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide showed a tolerable safety profile and encouraging antitumor activity with complete responses in patients with relapsed/refractory diffuse large B-cell lymphoma.
FDA Approval Sought for Cilta-Cel in Relapsed/Refractory Multiple Myeloma
December 21st 2020December 21, 2020 - A rolling submission of the biologics license application for the BCMA-directed CAR T-cell product ciltacabtagene autoleucel for use in adults with relapsed/refractory multiple myeloma has been initiated to the FDA.