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.
Sacituzumab Govitecan Improves PFS in Metastatic TNBC With Brain Metastases
December 11th 2020December 11, 2020 - Sacituzumab govitecan increased response rates and improved progression-free survival vs chemotherapy in patients with metastatic triple-negative breast cancer with stable brain metastases, although no overall survival improvement was observed.
ctDNA Emerges as a Biomarker for Response, Outcomes in High-Risk Early Breast Cancer
December 11th 2020December 11, 2020 - The presence of circulating tumor DNA following neoadjuvant chemotherapy with or without pembrolizumab was a biomarker for response and distant recurrence-free survival in patients with high-risk early-stage breast cancer.
EU Panel Recommends Tucatinib for Locally Advanced or Metastatic HER2+ Breast Cancer
December 11th 2020December 11, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to tucatinib in combination with trastuzumab and capecitabine for use in adult patients with HER2-positive, locally advanced or metastatic breast cancer who had received at least 2 previous anti-HER2 therapies.
Plinabulin/Pegfilgrastim Shows 53% Efficacy Rate in Preventing Profound Neutropenia
December 11th 2020December 11, 2020 - The combination of plinabulin and pegfilgrastim was 53% more effective in reducing the incidence of profound neutropenia compared with pegfilgrastim alone in patients undergoing chemotherapy, according to full findings of the phase 3 PROTECTIVE-2 trial.
Frontline Pembrolizumab Granted Positive EU Opinion in Metastatic MSI-H, dMMR CRC
December 11th 2020December 11, 2020 - The European Medicine Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for pembrolizumab monotherapy for the frontline treatment of adult patients with metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.
AI-Based Analysis Enhances Prediction of Best Responders for Trastuzumab Deruxtecan
December 11th 2020December 11, 2020 - Use of a novel HER2 quantitative continuous score was better able to provide an objective and quantitative assessment of HER2 expression to identify patients who are most likely to respond to fam-trastuzumab deruxtecan-nxki.
Oncolytic Viral Therapy: A Unique Approach to Explore in GI Cancers
December 11th 2020December 11, 2020 - Oncolytic viral therapy has been heavily investigated across oncology, but plenty of work still lies ahead to determine how this treatment approach can be applied in gastrointestinal malignancies.
GP2/GM-CSF Combo Elicits 100% DFS Rate in HER2 3+ Breast Cancer at 5 Years
December 11th 2020December 10, 2020 - The GP2 immunotherapy plus granulocyte-macrophage colony-stimulating factor demonstrated potent responses and a 100% disease-free survival in patients with HER2/neu 3–positive disease who received adjuvant trastuzumab.
FDA Advisory Committee Votes in Favor of COVID-19 Vaccine BNT162b2
December 10th 2020December 10, 2020 - The FDA's Vaccines and Related Biological Products Advisory Committee has voted 17-4 with 1 abstention to support the benefit-risk profile associated with the coronavirus disease 2019 vaccine BNT162b2.
Sacituzumab Govitecan Induces Clinical Benefit in Metastatic TNBC, Irrespective of Trop-2 Expression
December 10th 2020December 10, 2020 - The antibody-drug conjugate sacituzumab govitecan was found to induce clinical benefit over physician’s choice of therapy in patients with metastatic triple-negative breast cancer, irrespective of Trop-2 expression; however, greater efficacy was observed in those who had a medium or high Trop-2 score.
Ipatasertib/Paclitaxel Fails to Improve PFS in PIK3CA/AKT1/PTEN-Altered TNBC
December 10th 2020December 10, 2020 — The combination of ipatasertib and paclitaxel failed to show a significant improvement in progression-free survival vs placebo plus paclitaxel in patients with PIK3CA/AKT1/PTEN-altered locally advanced, unresectable or metastatic triple-negative breast cancer.
CTC Count Possible Biomarker for Using HER2-Directed Therapy in MBC
December 10th 2020December 10, 2020 - Favorable outcomes after treatment with the HER2-directed lapatinib were indicated by early declines in circulating tumor cell counts in patients with metastatic breast cancer who initially had HER2-negative primary tumors but positive HER2 CTCs.
Trilaciclib Before Chemotherapy Significantly Improves OS in Metastatic TNBC
December 10th 2020The administration of the CDK4/6 inhibitor trilaciclib before chemotherapy comprised of gemcitabine and carboplatin resulted in a significant improvement in overall survival in previously treated patients with metastatic triple-negative breast cancer.
BluePrint Subtyping Could be a Predictor of Pertuzumab Benefit in Early Breast Cancer
December 10th 2020December 10, 2020 - Patients with early breast cancer with a HER2 single-activated pathway determined by molecular subtyping using BluePrint assay, showed a trend for greater benefit with adjuvant pertuzumab therapy, according to an exploratory analysis of the data from the APHINITY trial.
Ki-67 Can Be Used to Select Abemaciclib for Patients With High-Risk Early Breast Cancer
December 10th 2020December 10, 2020 - Treatment with abemaciclib in combination with endocrine therapy significantly reduced the risk of invasive disease recurrence or death in patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer who had high Ki-67 tumors, suggesting that this feature can be used in conjunction with high-risk features to select patients for abemaciclib in the adjuvant setting.