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.
huCART19-IL8 Proves Safe and Elicits Durable Responses in CAR T–Pretreated R/R Lymphoma
July 3rd 2023huCART19-IL8 had acceptable safety and induced durable responses in patients with lymphoma who were refractory or relapsed following second-generation CD19-targeted CAR T-cell therapies, according to data from a first-in-human phase 1 trial.
FOLFOX Produces Varying Toxicity Profile vs Chemoradiation in Rectal Cancer
July 1st 2023Lower rates of diarrhea and overall bowel dysfunction were reported with the use of neoadjuvant fluorouracil and oxaliplatin vs neoadjuvant pelvic chemoradiation with fluorouracil (5FCURT) in patients with locally advanced rectal cancer. However, lower rates of other toxicities were reported in patients treated with 5FCURT.
FDA Grants Breakthrough Therapy Designation to Zenocutuzumab for NRG1+ Pancreatic Cancer
June 30th 2023The FDA has granted breakthrough therapy designation to zenocutuzumab for use as a potential therapeutic option in patients with advanced unresectable or metastatic NRG1 fusion–positive pancreatic cancer after disease progression on previous systemic therapy or who have no satisfactory alternative options available.
Ropeginterferon Alfa-2b Produces Responses, Safety in Prefibrotic Primary Myelofibrosis
June 30th 2023Harry Gill, MD, discusses the rationale for exploring ropeginterferon alfa-2b as a potential treatment option for patients early myelofibrosis and expands on the efficacy and safety data observed in the phase 2 study.
Avutometinib/Defactinib Combo Generates Early Efficacy Signals in Low-Grade Serous Ovarian Cancer
June 30th 2023Bradley J. Monk, MD, FACS, FACOG, discusses the rationale for investigating avutometinib plus defactinib in patients with low-grade serous ovarian cancer, key findings from RAMP 201, and how this research may influence the ovarian cancer treatment paradigm going forward.
Durvalumab Plus Tremelimumab Elicits Clinically Meaningful, 4-Year OS Advantage in Advanced HCC
June 30th 2023Durvalumab plus a single priming dose of tremelimumab led to continued clinically meaningful overall survival benefit at 4 years compared with sorafenib in patients with previously untreated, unresectable hepatocellular carcinoma not eligible for localized therapy.
Intra-arterial Gemcitabine Improves OS in Locally Advanced Pancreatic Cancer
June 29th 2023Treatment with intra-arterial gemcitabine led to an improvement in overall survival compared with continued treatment with intravenous gemcitabine plus nab-paclitaxel in patients with locally advanced pancreatic cancer following sequential treatment with IV gemcitabine, nab-paclitaxel, and radiotherapy.
Neoadjuvant Nivolumab/Chemo Wins EU Approval for Resectable PD-L1+ NSCLC
June 29th 2023The European Commission has approved nivolumab in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable non–small cell lung cancer at high risk of recurrence with tumor cell PD-L1 expression of at least 1%.
NOX-A12 Plus Bevacizumab and Radiotherapy Shows Sustained Survival in Glioblastoma
June 29th 2023The addition of the CXCL12 inhibitor NOX-A12 to standard frontline therapy with radiation and bevacizumab led to an overall survival rate of 83% at a median follow-up of 15 months in patients with glioblastoma.
Development of FHD-286 Monotherapy Will Not Continue in Metastatic Uveal Melanoma
June 29th 2023Although the highly potent, selective, allosteric, oral, small molecule BRG1/BRM inhibitor FHD-286 elicited signs of clinical activity and safety as monotherapy in patients with metastatic uveal melanoma in the dose-escalation portion of a phase 1 trial, further development in this indication will not be pursued.
FDA Grants Fast Track Status to Quaratusugene Ozeplasmid Plus Atezolizumab in ES-SCLC
June 29th 2023The FDA has granted fast track designation to the combination of quaratusugene ozeplasmid and atezolizumab as maintenance therapy in patients with extensive-stage small cell lung cancer whose disease did not progress after receiving initial standard treatment with atezolizumab and chemotherapy.
Repotrectinib NDA Under NMPA Review for Locally Advanced or Metastatic ROS1+ NSCLC
June 28th 2023The National Medical Products Administration in China has accepted for review a new drug application seeking the approval of repotrectinib for use in adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.
Galinpepimut-S Plus Nivolumab Provides Survival Benefits With Acceptable Safety in Mesothelioma
June 28th 2023The combination of galinpepimut-S and nivolumab provided positive survival outcomes with an acceptable safety profile in patients with malignant pleural mesothelioma who were refractory to or relapsed after at least 1 line of standard treatment.
Epcoritamab Elicits an ORR of 82% in Relapsed/Refractory Follicular Lymphoma
June 28th 2023Epcoritamab elicited a confirmed overall response rate of 82% by independent review committee assessment in patients with relapsed or refractory follicular lymphoma who received 2 or more prior systemic treatments, which exceeded the prespecified threshold for efficacy in the phase 1/2 EPCORE NHL-1 trial.
Novel CD19xCD3 Bispecific Antibody May Expand Second-Line Options in Follicular Lymphoma
June 28th 2023Ryan Jacobs, MD, expands on the initial efficacy and safety data seen with TNB-486, the need for more data on treatment-related CRS to improve toxicity management, and next steps planned for the investigation of this and other bispecific antibodies in relapsed/refractory follicular lymphoma.
Fixed-Duration Mosunetuzumab Elicits Durable Responses in R/R Follicular Lymphoma
June 27th 2023Fixed-duration treatment with single-agent mosunetuzumab resulted in a high complete response rate by end of treatment in patients with relapsed or refractory follicular lymphoma, according to updated data from the phase 2 GO29781 trial.
Quizartinib Plus Chemotherapy Improves EFS, RFS in Newly Diagnosed FLT3-ITD–Negative AML
June 27th 2023Pau Montesinos, MD, PhD, discusses the preliminary results of the QUIWI trial, expands on the potential implications for the use of quizartinib plus chemotherapy in newly diagnosed patients with FLT3-ITD–negative acute myeloid leukemia, and details the next steps for this study and future research.