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.
Claudin-18.2 Emerges as a Novel Therapeutic Target in GI Malignancies
May 24th 2023CLDN18.2 has become a promising target for the treatment of patients with digestive malignancies, such as gastric cancer, gastroesophageal junction cancer, esophageal cancer, and pancreatic cancer, because of its limited expression in healthy tissues and abnormal overexpression in a range of malignancies.
Milademetan Plus ONC201 Could Represent Synergistic Combination in MDM2-overexpressing Solid Tumors
May 24th 2023Ilyas Sahin, MD, details the preclinical findings from the study and highlighted how these data could help inform future studies for the treatment of patients with MDM2-overexpressing solid tumors.
Ribociclib/Fulvestrant Combo Generates PFS Improvement in Metastatic Breast Cancer
May 23rd 2023Ribociclib plus switch endocrine therapy induced a statistically significant progression-free survival benefit compared with placebo plus switch endocrine therapy in patients with hormone receptor–positive, HER2-negative, metastatic breast cancer.
China’s NMPA Accepts sNDA for Toripalimab Plus Chemo in Advanced TNBC
May 23rd 2023The National Medical Products Administration has accepted the supplemental new drug application seeking the approval of toripalimab in combination with nab-paclitaxel in patients with untreated metastatic or recurrent triple-negative breast cancer and a PD-L1 combined positive score of at least 1.
SPEECH Conference Highlights Multiplicity of Ongoing Efforts in Cancer Care Equity
May 23rd 2023Young investigators, fellows, and medical students recently gathered at the Temple University Lewis Katz School of Medicine in Philadelphia, Pennsylvania, to network and share exciting research aimed at addressing disparities in the dissemination of cancer care at the 5th Annual Regional Synergistic Partnership for Enhancing Equity in Cancer Health Conference and Retreat.
Sintilimab/Axitinib Combo Shrinks FH-Deficient RCC Tumors
May 23rd 2023Xingming Zhang, MD, discusses unmet needs in fumarate hydratase–deficient renal cell carcinoma; shares key efficacy, safety, and quality of life findings from a phase 2 trial of sintilimab plus axitinib; and elaborates on the next steps for this research, including an analysis of biomarkers and potential resistance mechanisms.
FDA Grants Priority Review to Lumisight Optical Imaging Agent for Breast Cancer Detection
May 23rd 2023The FDA has granted priority review to a new drug application seeking the approval of the optical imaging agent Lumisight for use in patients with breast cancer, according to an announcement from Lumicell, Inc.
Advances Across Urothelial Carcinomas Highlight Need for Shared Decision-making
May 23rd 2023As longer-term data read out for established regimens in urothelial cancer and up-and-coming therapeutics inch toward approval, optimizing treatment approaches relies on buy-in from multidisciplinary teams and patients.
GEN-002 Plus Avelumab Shows Promise as Third-line Option in PD-L1+ Gastric Cancer
May 22nd 2023The combination of GEN-002 and avelumab elicited responses in patients with advanced gastric or gastroesophageal junction adenocarcinoma, according to findings from an interim analysis of an ongoing phase 2 trial.
Milademetan Fails to Meet PFS End Point in Dedifferentiated Liposarcoma
May 22nd 2023Treatment with milademetan did not lead to a statistically significant improvement in progression-free survival compared with trabectedin in patients with dedifferentiated liposarcoma, failing to reach the primary end point of the phase 3 MANTRA trial.
Cabozantinib Plus Nivolumab and Ipilimumab Provides PFS Benefit in Advanced RCC
May 20th 2023The addition of cabozantinib to nivolumab and ipilimumab led to improved progression-free survival vs nivolumab and ipilimumab alone in patients with treatment-naïve advanced renal cell carcinoma; however, the rate of grade 3/4 adverse effects with the triplet was 79%.
Analysis Determines Predictive Biomarkers for Lenalidomide Survival Benefits in Mantle Cell Lymphoma
May 19th 2023Polymorphic alleles of ABCB1 or VEGF were predictive of lenalidomide efficacy in patients with mantle cell lymphoma who received lenalidomide maintenance after autologous stem cell transplant.
AEGEAN Trial Demonstrates Benefit and Viability of Novel Perioperative Treatment Approach in NSCLC
May 19th 2023John V. Heymach, MD, PhD, expands on the efficacy of perioperative durvalumab in the AEGAN trial, the significance of this unique approach for the non–small cell lung cancer treatment paradigm, and future research examining opportunities to build on or intensify the benefit achieved with this regimen.
FDA Approves Epcoritamab for Relapsed/Refractory DLBCL
May 19th 2023The FDA has approved the first T-cell–engaging bispecific antibody, epcoritamab-bysp (Epkinly), for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after 2 or more lines of systemic therapies.
MAJIC-PV Trial Confirms Clinical Benefit of Ruxolitinib in Polycythemia Vera
May 19th 2023Treatment with ruxolitinib generated superior responses vs treatment with best available therapy in patients with hydroxycarbamide-intolerant or -resistant polycythemia vera, according to findings from the phase 2 MAJIC-PV trial.
Omidubicel Approval Represents Key Advance for Patients With Blood Cancers Requiring Transplant
May 19th 2023Mitchell E. Horwitz, MD, expands on key efficacy and safety data supporting the FDA approval of omidubicel, the significance of this decision for the blood cancer treatment paradigm, and the need for continued investigation of the agent in non-malignant disease and other patient subgroups.
Birtamimab Under Investigation in Mayo Stage IV AL Amyloidosis
May 19th 2023Morie A. Gertz, MD, discusses the limitations of the current Mayo Stage IV amyloidosis treatment landscape, the rationale for investigating birtamimab in this population, and the importance of raising awareness for the AFFIRM-AL trial.
Chinese Phase 3 Trial of Roxadustat in Non-Myeloid Malignancies Meets Primary End Point
May 18th 2023Roxadustat proved to be noninferior to recombinant erythropoietin alfa with regard to change in hemoglobin level from baseline to an average level during weeks 9 to 13 in patients receiving concurrent chemotherapy for non-myeloid malignancies in China, meeting the primary end point of an ongoing phase 3 trial.