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.
Immunotherapy Combos, Novel Agents Hold Promise in Recurrent Ovarian Cancer
September 24th 2021Ritu Salani, MD, MBA, discussed the clinical rationale to evaluate combination strategies with immunotherapy in ovarian cancer, as well as novel agents in clinical development that could further influence the treatment paradigm.
Fixed-Dose Eniluracil Under Investigation in Advanced Refractory Gastrointestinal Cancers
September 23rd 2021Fixed-dose eniluracil is being evaluated with escalating doses of capecitabine in patients with advanced, refractory gastrointestinal cancers, or in advanced GI cancers who are intolerant to fluoropyrimidine chemotherapy, as part of an open-label, phase 1b dose-escalation trial.
Durvalumab Plus Olaparib or Cediranib Leads to Disease Stabilization in Leiomyosarcoma
September 23rd 2021Albiruni Ryan Abdul Razak, discusses the rationale for examining durvalumab with either olaparib or cediranib in patients with LMS, key data reported with this approach, and next steps for the phase 2 DAPPER study.
Belumosudil Expands Treatment Options for Chronic GVHD
September 23rd 2021Data from the phase 2 ROCKstar trial demonstrated that belumosudil induced clinically meaningful, durable responses in patients with chronic graft-vs-host disease, irrespective of previous treatment received, severity of disease, and number of organs involved.
Frontline Bevacizumab/Erlotinib Continues to Impress in EGFR-Mutated NSCLC
September 23rd 2021The addition of bevacizumab to erlotinib continued to provide a significant progression-free survival benefit over erlotinib alone when used in the frontline treatment of patients with EGFR-mutated, nonsquamous non–small cell lung cancer, according to data from the final analysis of the phase 3 BEVERLY trial.
TheraSphere Y-90 Plus Chemo Prolongs PFS, hPFS in Second-Line Metastatic CRC
September 23rd 2021The addition of TheraSphere™ Yttrium-90 Glass Microspheres to standard-of-care second-line chemotherapy in patients with colorectal cancer liver metastases led to a significant improvement in progression-free survival and hepatic PFS over chemotherapy alone, meeting both primary end points of the ongoing EPOCH trial.
FDA Authorizes AI-Based Software to Assist in Prostate Cancer Detection and Diagnosis
September 22nd 2021The FDA has authorized the marketing of Paige Prostate, an artificial intelligence–based software that was designed to help pathologists scan areas of the body for suspicious cancer as a supplement to the review of digitally-scanned slide images from prostate biopsies.
FDA Approval Sought for Betibeglogene Autotemcel for Transfusion-Dependent Beta-Thalassemia
September 22nd 2021A rolling submission of a biologic license application to the FDA has been completed for betibeglogene autotemcel for use in adult, adolescent, and pediatric patients with beta-thalassemia who require regular red blood cell transfusions, across all genotypes.
Acalabrutinib, Alone or With Obinutuzumab, Improves Quality-Adjusted Survival in Frontline CLL
September 22nd 2021Treatment with acalabrutinib as monotherapy or in combination with obinutuzumab improved quality-adjusted survival compared with chlorambucil plus obinutuzumab in patients with treatment-naïve chronic lymphocytic leukemia.
Real-World PFS Benefit Reported With Durvalumab Regimen in Unresectable Stage III NSCLC
September 21st 2021The median real-world progression-free survival with durvalumab was higher compared with the median progression-free survival reported in the durvalumab arm of the phase 3 PACIFIC trial in patients with stage III non–small cell lung cancer.
High HER2 Expression Is Linked With Improved Outcomes With Trastuzumab Deruxtecan in HER2+ mCRC
September 21st 2021Fam-trastuzumab deruxtecan-nxki led to improved responses in patients with higher HER2 expression at baseline, whereas responses were seen irrespective of RAS- and PIK3CA mutation status and blood tumor mutational burden levels in patients with HER2-positive, metastatic colorectal cancer.
Acalabrutinib Continues to Showcase Impressive Activity in Relapsed/Refractory MCL
September 21st 2021Michael Wang, MD, discusses the impact of acalabrutinib in patients with mantle cell lymphoma, the implications of the phase 2 ACE-LY-004 trial, and the challenges faced with treating those who harbor TP53 mutations.
Adavosertib Improves PFS in RAS-/TP53-Mutant Metastatic Colorectal Cancer
September 21st 2021Adavosertib demonstrated a 65% reduction in the risk of disease progression or death compared with active monitoring in patients with TP53-/RAS-mutant metastatic colorectal cancer following first-line chemotherapy.
Durvalumab Plus Chemotherapy Showcases Sustained OS Benefit in ES-SCLC
September 21st 2021The addition of durvalumab to platinum/etoposide chemotherapy continued to demonstrate an overall survival benefit over chemotherapy alone with a favorable safety profile in patients with extensive-stage small cell lung cancer.
Giredestrant Induces Greater Ki-67 Suppression Vs Anastrozole in ER+/HER2– Early Breast Cancer
September 21st 2021Giredestrant resulted in a greater relative reduction in Ki67 score from baseline to week 2 of a window of opportunity phase vs anastrozole in patients with estrogen receptor–positive, HER2-negative early breast cancer, according to results from an interim analysis of the phase 2 coopERA Breast Cancer trial.
Tailoring Therapy for Breast Cancer in 2021: Examining and Applying Clinical Lessons
September 21st 2021Personalized medicine has come to the forefront of breast cancer management, with genomic tools being utilized to avoid unnecessary chemotherapy in those with early-stage disease, PARP and PI3K inhibitors improving outcomes for those who harbor select mutations, and the emergence of highly active targeted agents shaking up the HER2-positive paradigm.
U2 Plus Pembrolizumab Shows Continued Efficacy at 5 Years in CLL and Richter’s Transformation
September 20th 2021The triplet combination of umbralisib, ublituximab, and pembrolizumab demonstrated durable responses with a tolerable safety profile in patients with relapsed/refractory chronic lymphocytic leukemia and Richter’s transformation.