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.
Cabozantinib Plus Atezolizumab Misses PFS End Point in Previously Treated Advanced RCC
March 7th 2023The combination of cabozantinib and atezolizumab did not significantly improve progression-free survival over cabozantinib alone in patients with locally advanced or metastatic clear cell or non–clear cell renal cell carcinoma who progressed during or following checkpoint inhibition, missing the primary end point of the phase 3 CONTACT-03 trial.
Incyte to Discontinue Phase 3 LIMBER-304 Trial of Parsaclisib Plus Ruxolitinib in Myelofibrosis
March 6th 2023The phase 3 LIMBER-304 trial evaluating parsaclisib plus ruxolitinib in patients with myelofibrosis will be discontinued after results of a preplanned interim analysis indicated that the study is unlikely to meet its primary end point of targeted reduction in spleen volume in the intent-to-treat population.
FDA Approves Biosimilar Pegfilgrastim-cbqv for Febrile Neutropenia
March 6th 2023The FDA has approved a single-dose, prefilled autoinjector presentation of pegfilgrastim-cbqv (Udenyca), which is a biosimilar of pegfilgrastim that is given the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
Trastuzumab Deruxtecan Meets ORR End Point in HER2-expressing Advanced Solid Tumors
March 6th 2023The antibody-drug conjugate trastuzumab deruxtecan met the prespecified target for objective response rate and demonstrated durable responses in heavily pretreated patients with HER2-expressing advanced solid tumors in the phase 2 DESTINY-PanTumor02 trial.
Real-World Outcomes With Sacituzumab Govitecan Match ASCENT in Single-Center Study
March 5th 2023In a single-center study, investigators assessed real-world outcomes in patients with metastatic metastatic triple-negative breast cancer treated with the antibody-drug conjugate sacituzumab govitecan-hziy.
Miami Breast Keynotes Highlight the Call to Action for Advocacy Efforts in Breast Cancer
March 4th 2023Lindsay Avner Kaplan and Nancy G. Brinker, the keynote speakers of the 40th Annual Miami Breast Cancer Conference, discuss the need to confront social determinants of health for patients and drive the public conversation and interpretation of personal and clinical stories in health care.
Treatment in HR+ Early Breast Cancer May be Best Guided by Risk of Recurrence
March 4th 2023After settling the debate of which patients with early-stage, hormone receptor–positive breast cancer require chemotherapy in addition to endocrine therapy, investigators have set their sights on determining whether ovarian function suppression can deliver the same effects of chemotherapy and when to recommend abemaciclib and olaparib.
SERMS, SERDS, and PROTEC Are Poised to Shake Up Treatments for ER+ Breast Cancer
March 4th 2023Novel selective estrogen receptor modulators, selective estrogen receptor degraders, and proteolysis-targeting chimera inhibitors have demonstrated early efficacy for patients with breast cancer who experience disease progression following CDK4/6 inhibitor treatment.
Progress in Treating Brain Metastases in Breast Cancer Puts Multidisciplinary Approaches Into Focus
March 4th 2023Brain metastases are a common complication in patients with breast cancer, and although systemic therapies for patients with HER2-positive disease have displayed promise in penetration of the blood-brain barrier, work remains for subsets of patients with central nervous system metastases.
I-SPY 2 Framework Could Represent the Future of Drug Development in Breast Cancer
March 3rd 2023By moving away from adjuvant- to neoadjuvant-based protocols, such as I-SPY, investigators may be better able to develop effective treatments for patients in less time by refining the understanding of who will benefit from therapy, enabling strategies with multiple pathway targets, and testing approaches earlier in the disease course.
ADC Developments in HER2– Breast Cancer Treatment Shake Up Paradigm
March 3rd 2023As additional antibody-drug conjugates continue to emerge for the treatment of patients with HER2-negative breast cancer, identifying optimal sequencing strategies and managing toxicities associated with these agents remain top priorities for their use, according to Hope S. Rugo, MD.
FDA Expands Abemaciclib Indication in HR+/HER2–, Node+, High-Risk Breast Cancer
March 3rd 2023The FDA approved an expanded indication for abemaciclib (Verzenio) in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer that is at a high risk of recurrence.
Miami Breast Cancer Conference Celebrates 40 Years
March 3rd 2023The agenda set for this year's Miami Breast Cancer Conference® has been shaped by the recent updates out of the 2022 San Antonio Breast Cancer Symposium, updates to guideline recommendations over the past year, and the influence of new indications and approvals across subtypes of breast cancer.
Enfortumab Vedotin Plus Pembrolizumab May Address Unmet Need in Advanced Urothelial Cancer
March 2nd 2023Jonathan E. Rosenberg, MD, discusses key safety and efficacy data from the EV-103 trial supporting supplemental biologics license applications seeking FDA approval of enfortumab vedotin plus pembrolizumab in patients with advanced urothelial cancer.
Mesenchymal Chondrosarcoma Is a Rare Sarcoma Subtype With Challenging Diagnosis
March 2nd 2023R. Lor Randall, MD, FACS, discusses the presentation and diagnosis of mesenchymal chondrosarcomas, the role of HEY1-NCoA2 gene fusions in the disease, and potential treatment options for this rare subgroup of patients.
SKCC’s Dr. Edith Mitchell Named Enterprise Vice President for Cancer Disparities
March 2nd 2023Edith P. Mitchell, MD, MACP, FCCP, FRCP, Director of the Center to Eliminate Cancer Disparities and Clinical Professor of Medicine and Medical Oncology, has been named Enterprise Vice President for Cancer Disparities at Jefferson Health’s Sidney Kimmel Cancer Center.