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.
Rising Standards in Regulatory Decisions Highlight Challenges in Drug Development in Lung Cancer
February 6th 2023If the FDA’s Oncologic Drugs Advisory Committee meeting held on February 10, 2022, was any indication, the days of applying foreign single country or region data to support regulatory approval are gone; instead, regulatory decisions are headed toward the need for regional consistency through multiregional clinical trials, which could help the United States overcome the persistent underrepresentation of racial and ethnic minorities in drug development.
PD-1 Inhibitor Combinations, Alternative Therapeutic Approaches Are Moving the Needle in NSCLC
February 6th 2023As more agents are evaluated either in addition to or following PD-1/PD-L1 inhibitors, more information may be learned about how best to leverage alternate biomarkers, according to Marina C. Garassino, MD.
RaDaR Assay Predicts Patient Response to Immunotherapy in Stage III Bladder Cancer
February 6th 2023The RaDaR assay successfully identified the patients with locoregionally advanced urothelial cancer most likely to benefit from treatment with ipilimumab and nivolumab in findings from the second cohort of the phase 1b/2a NABUCCO trial.
Investigators Seek Simpler Solution to Treatment Resistance in Esophageal Cancer
February 6th 2023Although the incidence, location, and histology of esophageal cancer vary globally, patients in the Western World typically develop esophageal cancer in the distal esophagus or at the gastroesophageal junction.
WHO Outlines New Framework for Early Detection and Management of Breast Cancer
February 3rd 2023The World Health Organization has released new framework guidelines with the goal of saving 2.5 million lives from breast cancer by 2040 through a combination of early detection, timely diagnosis, and comprehensive management.
Post-Transplant KRd Maintenance May Allow for Superior Outcomes in Newly Diagnosed Multiple Myeloma
February 3rd 2023Andrzej Jakubowiak, MD, PhD, highlighted several key studies that influenced the development and design of the ATLAS trial, introduced conclusions from the initial efficacy data, and discussed how ongoing analysis could further contextualize and inform post-transplant treatment approaches in multiple myeloma.
FDA Approves Sacituzumab Govitecan for Pretreated HR+/HER2– Metastatic Breast Cancer
February 3rd 2023The FDA has approved sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.
MOUNTAINEER-03 Propels Progress in Metastatic HER2+ CRC
February 3rd 2023The MOUNTAINEER-03 trial is designed to evaluate the efficacy of tucatinib and trastuzumab plus modified leucovorin calcium, fluorouracil, and oxaliplatin, compared with standard-of-care, first-line therapy for metastatic HER2-positive colorectal cancer.
Docetaxel Added to Radiation Provides DFS, OS Benefit in Cisplatin-Ineligible HNSCC
February 2nd 2023Radiation plus docetaxel improved disease-free survival and overall survival vs radiation alone in patients with head and neck squamous cell carcinoma unsuitable for cisplatin-based chemoradiation, regardless of patients’ prespecified prognostic groups, according to findings from a phase 2/3 trial.
NRG/RTOG 1112 Trial Highlights Benefit of Adding SBRT to Sorafenib in Locally Advanced HCC
February 2nd 2023Laura Dawson, MD, FRCPC, discusses data from the NRG/RTOG 1112 trial examining the addition of stereotactic body radiation therapy to sorafenib, the implications of the data for the locally advanced hepatocellular carcinoma treatment paradigm, and next steps for research.
Combinations Targeting EGFR and KRAS G12C May Advance NSCLC Treatment
February 2nd 2023Timothy Burns, MD, PhD, discusses the evolution of EGFR-targeted non–small cell lung cancer treatments, the importance of delineating small cell lung cancer subtypes, and the advantages of continued antibody-drug conjugate development across all areas of lung cancer.
MRI-Guided SBRT Could Represent Safer, More Precise Radiotherapy Option for Prostate Cancer
February 2nd 2023Amar U. Kishan, MD, discusses the safety results of MRI-guided SBRT compared with the current standard of care, highlights the benefits of using an MRI to guide radiation for patients with prostate cancer, and explains other areas where MRI-guided SBRT could explored.
More Frequent CT Scans Not Associated with Improved Outcomes After Lung Cancer Surgery
February 2nd 2023A new study by researchers at Washington University School of Medicine in St. Louis found that undergoing more frequent computed tomography scans was not associated with improved outcomes following lung cancer surgery.
Immunotherapy Propels Urothelial Carcinoma Treatment Advances
February 2nd 2023Stephanie A. Berg, DO, highlights ongoing urothelial cancer clinical trials; the role of single-agent immunotherapy and combinations in this disease; and the importance of future research that prioritizes and guides individualized patient care.
Breast Cancer Expert Focuses on Decoding Biomarkers
February 2nd 2023For Kevin Kalinsky, MD, MS, director of breast medical oncology at the Winship Cancer Institute of Emory University in Atlanta, Georgia, his work on the RxPONDER trial serves as one of a few accomplishments for which he is grateful that have impacted clinical care.
NCCN Adds Neratinib to New Metastatic Breast Cancer Guidelines
February 1st 2023In recommendations released January 27, 2023, the National Comprehensive Cancer Network now advises physicians to consider neratinib for patients with HER2-negative metastatic breast cancer, regardless of estrogen receptor status, with activating mutations in the HER2 gene as detected by next-generation sequencing of tumor tissue or circulating tumor DNA.
Neoadjuvant Chemo Reduces 2-Year Risk for Residual, Recurrent Disease by 28% in Colon Cancer
February 1st 2023Six weeks of preoperative oxaliplatin-fluoropyrimidine chemotherapy did not increase perioperative morbidity in patients with radiologically staged T3-4, N0-2, M0 colon cancer, according to findings from the international phase 2/3 FOxTROT trial.
Mutation Status Drives PARP Inhibitor Investigation and Treatment in mCRPC
February 1st 2023Atish D. Choudhury, MD, PhD, discussed the significance of these trials within the metastatic castration-resistant prostate cancer treatment landscape, highlighted investigative PARP inhibitor combinations, and emphasized the need for further research in this area to determine which patients are most likely to benefit from certain therapies based on their molecular profiles.
Three-Drug Combination Therapy Effective in Patients with High-Risk CLL, Trial Shows
February 1st 2023A three-drug combination that sent chronic lymphocytic leukemia into deep remissions in a broad group of patients in a clinical trial is highly effective in patients with high-risk forms of the disease, a new, phase 2 clinical trial led by Dana-Farber Cancer Institute investigators indicates.