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 Demonstrates Superiority Over T-DM1 in HER2+ Metastatic Breast Cancer
August 9th 2021Fam-trastuzumab deruxtecan-nxki significantly improved progression-free survival over ado-trastuzumab emtansine in patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane, meeting the primary end point of the phase 3 DESTINY-Breast03 trial.
Immunotherapy, Targeted Therapy, and Novel Strategies Progress Practice in GI Malignancies
August 9th 2021Data that were presented during the 2021 ASCO Annual Meeting shed light on new therapeutic strategies, and treatment considerations that are expanding the paradigms of gastrointestinal malignancies.
GEN-1 Plus Neoadjuvant Chemo Appears Active, Safe in Advanced Ovarian Cancer
August 8th 2021The addition of GEN-1 to standard-of-care neoadjuvant chemotherapy has shown preliminary safety and clinical activity and appears to have an impact on the tumor microenvironment in patients with advanced epithelial ovarian cancer.
ASCO 2021 Delivers Personalized Treatment Approaches Across Breast Cancer
August 6th 2021Refining treatment is not only a key aim of research in breast cancer but a greater possibility in the clinic with neoadjuvant and adjuvant PARP inhibitors, HER2 monoclonal antibodies, and greater stratification of genomic risk.
FDA Issues a Complete Response Letter for Eflapegrastim for Chemo-Induced Neutropenia
August 6th 2021The FDA has issued a complete response letter to Spectrum Pharmaceuticals regarding the biologics license application for eflapegrastimas a potential option for the management of chemotherapy-induced neutropenia.
Rusfertide Could Represent New Therapeutic Option in Polycythemia Vera
August 6th 2021Marina Kremyanskaya, MD, PhD, discussed the results of the phase 2 PTG-300-04 trial, which were presented at the European Hematology Association 2021 Virtual Congress, and the potential for rusfertide as a treatment option for patients with polycythemia vera.
Native American Ancestry Correlates With EGFR, KRAS Mutations in Lung Cancer
August 6th 2021An association has been found in Latin American patients with lung adenocarcinoma between Native American ancestry and somatic landscape, including EGFR, KRAS, and STK11 mutations, as well as tumor mutational burden.
FDA Grants Priority Review to Adjuvant Pembrolizumab for Stage II High-Risk Melanoma
August 5th 2021The FDA has granted priority review to a supplemental biologics license application for pembrolizumab for the use as an adjuvant treatment in adult and pediatric patients with stage IIB or IIC melanoma following complete resection.
Cemiplimab/Chemo Combo Significantly Improves OS Over Chemo Alone in Frontline Advanced NSCLC
August 5th 2021The combination of cemiplimab-rwlc plus platinum-doublet chemotherapy was found to significantly improve overall survival over chemotherapy alone in the frontline treatment of patients with advanced non–small cell lung cancer, meeting the primary end point of the phase 3 EMPOWER-Lung 3 trial.
FDA Grants Priority Review to Cabozantinib for Radioiodine-Refractory Differentiated Thyroid Cancer
August 5th 2021The FDA has granted a priority review designation to a supplemental new drug application for cabozantinib for the treatment of patients with differentiated thyroid cancer who have progressed after previous therapy and who are radioactive iodine refractory.
Investigators Look to Enhance Response With Novel Triplet in CLL
August 5th 2021Investigators of the phase 3 ULTRA-V trial are look-ing to leverage the synergistic capabilities of venetoclax for patients with chronic lymphocytic leukemia with the addition of the U2 regimen of ublituximab in combination with umbralisib.
Plinabulin Plus Docetaxel Significantly Improves OS in EGFR Wild-Type NSCLC
August 4th 2021The combination of plinabulin plus docetaxel resulted in a statistically significant improvement in overall survival vs docetaxel alone when used in the second- or third-line treatment of patients with EGFR wild-type, non–small cell lung cancer and measurable lung lesions.
Overcoming Treatment Barriers With Adjuvant Durvalumab in Unresectable Stage III NSCLC
August 4th 2021Benjamin H. Kann, MD, discusses the significance of the PACIFIC trial in patients with stage III NSCLC, existing barriers to treatment, and shared strategies to overcome common challenges faced in clinical practice.
Rini Remarks on Remaining Questions With Pembrolizumab/Axitinib in Frontline Advanced Clear Cell RCC
August 4th 2021At a median follow-up of 42.8 months, frontline pembrolizumab plus axitinib continued to yield improved outcomes over sunitinib in patients with advanced clear cell renal cell carcinoma.
Cardio-oncology Specialists Pave Optimal Treatment Path for Patients With Cancer
August 4th 2021The subspecialty of cardio-oncology has grown in recent years as improved cancer survival rates have expanded the population of long-term survivors with heightened risk of cardiovascular disease and drawn more attention to the need for preventive strategies and disease management.
Gandara Named Chief Medical Officer of International Society for Liquid Biopsy
August 4th 2021David R. Gandara, MD has been appointed chief medical officer of the International Society for liquid biopsy, an international non-profit organization dedicated to advancing the field of liquid biopsy in cancer diagnosis and management.
Optimal Sequencing and Treatment Intensity Remain the Focus of Treatment in HER2+ Breast Cancer
August 3rd 2021G. Thomas Budd, MD, discussed the promise of tailored treatment approaches in HER2-positive breast cancer, the utility of the combination of fixed-dose trastuzumab, pertuzumab, and hyaluronidase-zzxf via subcutaneous administration, and how sequencing could be further affected by drug development.