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.
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.
Gene Expression Testing Varies Substantially by Region for Prostate Cancer
December 10th 2020December 10, 2020 — Despite gene expression tests helping health care professionals make optimal treatment decisions, testing varies by region for men with prostate cancer and could be related to socioeconomic status and patterns of prostate cancer care.
Trastuzumab Deruxtecan Continues to Show Impressive Outcomes in HER2+ Metastatic Breast Cancer
December 10th 2020December 10, 2020 - Fam-trastuzumab deruxtecan-nxki continued to showcase impressive signals of efficacy, including prolonged, durable responses and overall survival rates, as well as a tolerable safety profile in patients with HER2-positive metastatic breast cancer.
Ribociclib Continues to Showcase Significant Survival Benefit in HR+/HER2– Breast Cancer
December 10th 2020December 10, 2020 — The addition of ribociclib to endocrine therapy continued to significantly improve overall survival and delay subsequent chemotherapy compared with placebo, irrespective of endocrine partner in patients with hormone receptor–positive, HER2-negative breast cancer.
Disease Recurrence Similar Between Tamoxifen, Anastrozole in Postmenopausal Women With DCIS
December 10th 2020December 9, 2020 - Treatment with tamoxifen versus anastrozole did not yield any significant difference in terms of disease recurrence in postmenopausal women with locally excised ductal carcinoma in situ but understanding associated toxicities can inform care decisions.
Oral Paclitaxel/Encequidar Combo Improves Survival in Metastatic Breast Cancer
December 9th 2020December 9, 2020 - The combination of oral paclitaxel and encequidar led to an estimated 26.5% reduction in the risk of death compared with intravenous paclitaxel in patients with metastatic breast cancer, according to updated phase 3 findings of the KX-ORAX-001 trial.
AI-Digital Breast Cancer Risk Assessment Platform Accurately Classifies Low-Risk Recurrence Scores
December 9th 2020December 9, 2020 - The artificial intelligence–digital breast cancer risk discrimination platform PreciseDx was able to classify patients with Oncotype Dx low-risk recurrence scores with high accuracy using only hematoxylin and eosin stain images and limited clinical data.
Tumor Subtype Can Be a Prognostic Marker for Patients Treated with Ribociclib
December 9th 2020December 9, 2020 - Intrinsic tumor subtype was found to be associated with prognosis in patients with hormone receptor–positive, HER2-negative advance breast cancer who received the CDK4/6 inhibitor ribociclib.
Women Who Undergo Mastectomy with Reconstruction At Higher Risk for Chronic Controlled Substance Use
December 9th 2020December 9, 2020 - Among women who underwent a mastectomy plus reconstructive surgery, those who received a breast cancer diagnosis, received chemotherapy and were younger were reported to have a higher risk of new chronic controlled substance use.
Serial Circulating Tumor Cell Enumeration Predicts OS in Metastatic Breast Cancer
December 9th 2020December 9, 2020 - Follow-up circulating tumor cell assessments were confirmed to strongly predict overall survival outcomes in patients with metastatic breast cancer, when performed at a median of 29 days following treatment initiation.
Symptoms Under-Recognized in Patients Who Receive Radiotherapy After Lumpectomy
December 9th 2020December 8, 2020 - Oncologists widely under-recognize substantial symptoms in patients with breast cancer receiving radiotherapy after undergoing a lumpectomy, highlighting a need to improve symptom detection.
Abemaciclib Continues to Show Reduced Risk in iDFS in High-Risk Early HR+ Breast Cancer
December 9th 2020December 9, 2020 - The combination of abemaciclib and standard endocrine therapy showed a 28.7% reduction in the risk of invasive disease recurrence or death compared with endocrine therapy alone in patients with high-risk, early hormone receptor–positive, HER2-negative breast cancer.