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/Atezolizumab Combo Demonstrates Promising Clinical Activity in mCRC
February 18th 2022Thomas A. Abrams, MD, discusses the ongoing phase 1b COSMIC-021 trial examining cabozantinib/atezolizumab, the efficacy and safety demonstrated with the regimen in those with colorectal cancer, and the next steps for research
Continuous Enzalutamide After Progression Improves PFS in Patients with mCRPC
February 18th 2022Continuous enzalutamide plus docetaxel and prednisone elicited progression-free survival improvement vs placebo with docetaxel and prednisone in patients with metastatic castration-resistant prostate cancer who had previously progressed on enzalutamide alone
Darolutamide Plus ADT Boosts OS in Metastatic Castration-Sensitive Prostate Cancer
February 18th 2022The addition of darolutamide to androgen deprivation therapy and docetaxel generated better overall survival vs placebo with ADT and docetaxel in patients with metastatic castration-sensitive prostate cancer.
Frontline Niraparib Plus Abiraterone Improves rPFS in HRR Gene–Altered mCRPC
February 17th 2022The combination of niraparib and abiraterone acetate and prednisone led to a significant improvement in radiographic progression-free survival vs placebo plus abiraterone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations.
Olaparib/Abiraterone Combo Significantly Improves Radiographic PFS in mCRPC
February 17th 2022Olaparib in combination with abiraterone acetate led to a 34% reduction in the risk of radiographic disease progression or death compared with placebo and abiraterone as a first-line treatment for patients with metastatic castration-resistant prostate cancer, according to results of the phase 3 PROpel trial.
Apalutamide Outperforms Enzalutamide in mCSPC in Real-World Analysis
February 17th 2022A greater portion of patients with metastatic castration-sensitive prostate cancer achieved an early and deep prostate-specific antigen reduction from baseline of 90% or more when treated with apalutamide compared with enzalutamide.
FDA Grants Priority Review to Liso-cel for Second-Line Relapsed/Refractory LBCL
February 17th 2022The FDA has accepted and granted priority review to a supplemental biologics license application seeking the approval of the CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma in whom frontline therapy has failed.
Pelabresib Monotherapy Shows Benefit in JAK Inhibitor–Naïve Advanced Myelofibrosis
February 17th 2022Marina Kremyanskaya, MD, PhD, discusses the safety and efficacy of pelabresib in patients with myelofibrosis, additional data from the MANIFEST trial, and other efforts investigating the agent in this disease.
Eroglu Examines the Clinical Utility of ctDNA as an Emerging Biomarker for Melanoma Treatment
February 16th 2022Zeynep Eroglu, MD, discusses the potential of ctDNA as a noninvasive biomarker in melanoma, outlines different assays under development, and details potential opportunities to leverage ctDNA in treatment decision making.
FDA Places Clinical Hold on Phase 1 Trial Examining CAR T-cell Therapy LB1901 in T-cell Lymphoma
February 16th 2022The FDA has placed a clinical hold on a phase 1 trial evaluating the safety and efficacy of the autologous CAR T-cell product LB1901 as a potential therapeutic option in adult patients with relapsed or refractory T-cell lymphoma.
Checkpoint Inhibitor Changes Take Hold: Approval Standards Stir Debate
February 16th 2022the development of PD-1/PD-L1 immune checkpoint inhibitor therapy underwent a course correction in 2021, with the withdrawal of a range of indications due to study results that failed to reach thresholds for confirming clinical benefit.
FDA Grants Orphan Drug Designation to CYNK-101 for HER2+ Gastric/GEJ Cancers
February 15th 2022The FDA has granted an orphan drug designation to the off-the-shelf natural killer cell therapy CYNK-101 as a potential treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma.
FDA Approval Sought for Adagrasib in Previously Treated KRAS G12C–Mutated NSCLC
February 15th 2022The FDA has accepted a new drug application for the use of adagrasib in the treatment of patients with non–small cell lung cancer whose tumors harbor a KRAS G12C mutation and who have previously received at least 1 prior systemic therapy.
Novel CAR T-cell Therapy Obe-cel Under Exploration in Relapsed/Refractory B-Cell ALL
February 15th 2022The safety and efficacy of the CD19-targeted CAR T-cell therapy obecabtagene autoleucel in the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia as part of the phase 1/2 FELIX trial.
Advancing Therapies for Patients Through Clinical Research in Community Oncology Practices
February 15th 2022The survival rate for Americans diagnosed with several of the most common cancers has increased dramatically in the past nearly three decades, thanks in large part to scientific discoveries and treatment advances.