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.
Adjuvant Nivolumab Approaches EU Approval for Select High-Risk Muscle-Invasive Urothelial Carcinoma
February 25th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab for use as an adjuvant treatment in adult patients with muscle-invasive urothelial carcinoma with a PD-L1 expression of at least 1% on tumor cells, who are at a high risk of recurrence following radical resection.
NCCN Guidelines List Ripretinib as Preferred Fourth-Line Option in Gastrointestinal Stromal Tumor
February 25th 2022Version 1.2022 of the National Comprehensive Cancer Network guidelines now include ripretinib as a category 1 fourth-line treatment option for patients with advanced gastrointestinal stromal tumor and as an additional TKI for consideration prior to surgery.
Real-World Study Shows Fast Uptake of Immunotherapy-Based Combinations in Frontline RCC
February 25th 2022The FDA approvals of immunotherapy-based combinations as frontline therapy led to a substantial increase in their use in patients with metastatic renal cell carcinoma in the community setting, leading to a greater use of TKI monotherapy as second- and third-line therapies.
Neoadjuvant Atezolizumab/Chemo Shows Encouraging Efficacy in Muscle-Invasive Bladder Cancer
February 24th 2022The addition of atezolizumab to neoadjuvant gemcitabine and cisplatin generated a high rate of non–muscle-invasive downstaging following radical cystectomy, which correlated with improved relapse-free survival and overall survival in patients with muscle-invasive bladder cancer, according to data from a phase 2 trial.
American Oncology Network and Cancer & Blood Specialists of Arizona Open New Flagstaff Office
February 24th 2022American Oncology Network, LLC, and its partner, Cancer & Blood Specialists of Arizona, are pleased to announce the opening of their new cancer center location in Flagstaff, Arizona, located at 77 W. Forest Avenue, Suite 301.
Nivolumab/Ipilimumab Shows Superior QOL in Advanced RCC
February 24th 2022The combination of nivolumab and ipilimumab led to superior quality of life compared with sunitinib in the frontline setting of patients with advanced renal cell carcinoma, according to results of a 5-year analysis from the CheckMate 214 trial.
Relapsed/Refractory Follicular Lymphoma Has a Bounty of Options in the Third Line
February 24th 2022Caron A. Jacobson, MD, MMSc, and a panel of experts, talk about the evolving landscape for patients with relapsed or refractory follicular lymphoma, plus data on PI3K inhibitors and CAR T-cell therapies.
Bavdegalutamide Showcases Early Activity in Metastatic Castration-Resistant Prostate Cancer
February 24th 2022The novel androgen receptor PROTAC degrader, bavdegalutamide, was found to be clinically active and tolerable with manageable adverse effects in patients with metastatic castration-resistant prostate cancer.
Sotorasib Shows Early Promise in Heavily Pretreated KRAS G12C–Mutated Advanced Pancreatic Cancer
February 23rd 2022Sotorasib had clinically meaningful activity in heavily pretreated patients with KRAS G12C–mutated advanced pancreatic cancer, according to findings from the phase 1/2 CodeBreaK 100 trial.
Addition of Bevacizumab to Ixabepilone Is Effective, Tolerable in Platinum-Resistant Ovarian Cancer
February 23rd 2022The combination of ixabepilone and bevacizumab significantly improved progression-free survival vs ixabepilone alone in the treatment of platinum-resistant ovarian cancer, according to data from the phase 2 trial published in the British Journal of Cancer.
Zanubrutinib Applications for CLL and MZL Accepted for Review in Europe
February 23rd 2022The European Medicines Agency has accepted for review 2 new indication applications for zanubrutinib as a therapeutic option for patients with chronic lymphocytic leukemia and for those with marginal zone lymphoma.
Niraparib Demonstrates Antitumor Activity in Heavily Pretreated mCRPC With BRCA Mutations
February 23rd 2022The PARP inhibitor niraparib elicited a meaningful overall response rate in patients with heavily pretreated metastatic castration-resistant prostate cancer and DNA repair gene defects, particularly those with BRCA alterations.
Frontline Checkpoint Inhibition Shows Potential in mRCC With Poor Performance Status
February 22nd 2022The combinations of nivolumab plus ipilimumab and pembrolizumab plus axitinib demonstrated comparable activity and safety as frontline treatment in patients with metastatic renal cell carcinoma and a performance status of 2 or greater, according to findings from a retrospective study.
MRD-Guided Treatment Approach Generates Excitement in Stage II to III Colon Cancer
February 22nd 2022The utilization of a circulating tumor DNA assay to detect the presence of minimal residual disease may provide an opportunity to better inform treatment decisions in patients with early-stage colon cancer.
KIN-2787 Looks to Fill Unmet Need in Class II/III BRAF-Altered Solid Tumors
February 22nd 2022Investigators hope to address the need for additional treatment options for patients with class II or class III BRAF-altered disease with KIN-2787, a next-generation, orally available, potent, and selective small molecule inhibitor.
Safety Review for OVATION 2 Trial Examining GEN-1 in Advanced Ovarian Cancer Has Positive Results
February 22nd 2022The Data Safety Monitoring Board for the ongoing phase 1/2 OVATION 2 trial has unanimously recommended that patients continue to receive treatment with the novel gene-mediated immunotherapy, GEN-1, at a dose of 100 mg/m2.
Investigators Explore Metformin to Prevent Cancers in Li-Fraumeni Syndrome Carriers
February 22nd 2022Individuals with Li-Fraumeni Syndrome, a rare hereditary condition, are at increased risk for a wide spectrum of malignancies, including breast cancer and sarcomas. Investigators are working to determine whether metformin, a drug indicated for diabetes and infertility caused by polycystic ovarian syndrome, can prevent cancers in LFS carriers.
FDA Approves FoundationOne CDx as Companion Diagnostic for Pembrolizumab in MSI-H Solid Tumors
February 21st 2022The FDA has given the green light to the FoundationOne CDx for use as a companion diagnostic that can be leveraged to identify patients with microsatellite instability high solid tumors who may be candidates to receive and derive benefit from pembrolizumab.
Tepotinib Approved in Europe for METex14-Altered Advanced NSCLC
February 21st 2022The European Commission has approved tepotinib for use as a single agent in adult patients with advanced non–small cell lung cancer harboring METex14 skipping alterations who require systemic therapy after prior treatment with immunotherapy and/or platinum-based chemotherapy.