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.
Zanubrutinib Plus Obinutuzumab and Venetoclax Induces High Undetectable MRD Rate in CLL/SLL
June 22nd 2023Zanubrutinib plus obinutuzumab and venetoclax demonstrated lasting responses characterized by sustained progression-free survival and undetectable minimal residual disease in peripheral blood and bone marrow in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
Zanubrutinib Maintains PFS Benefit With Extended Follow-Up in Previously Untreated CLL/SLL
June 21st 2023Extended follow-up from the phase 3 SEQUOIA trial demonstrated that zanubrutinib maintained a progression-free survival benefit compared with bendamustine plus rituximab in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
FDA Grants Full Approval to Blinatumomab for MRD+ B-cell Precursor ALL
June 21st 2023The FDA has granted regular approval to blinatumomab (Blincyto) for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease of at least 0.1%
FDA Approval Sought for Imetelstat for Transfusion-Dependent Anemia in Select MDS
June 21st 2023A new drug application seeking the approval of imetelstat for use as a therapeutic option for transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndrome who have not responded to, lost response to, or were not candidates for erythropoiesis-stimulating agents has been submitted to the FDA.
Optimizing Treatment Patterns in Relapsed or Refractory Differentiated Thyroid Cancer
June 21st 2023A panel of head and neck cancer experts discussed the nuances of managing relapsed or refractory DTC with lenvatinib or sorafenib, as well as sequencing considerations with targeted therapies in the second-line setting and beyond for patients with relapsed or refractory disease.
Study Protocol Differences May Affect BTK Inhibitor Performance in R/R CLL
June 21st 2023Patients with relapsed/refractory chronic lymphocytic leukemia treated with ibrutinib in the phase 3 RESONATE trial achieved a significantly longer median progression-free survival compared with those in the phase 3 ALPINE trial, as well as a higher yet nonsignificant 2-year PFS estimate vs those in the phase 3 ELEVATE-RR trial.
Investigators to Explore Potential of LP-300 With Chemo in Never Smokers With Advanced Lung Cancer
June 20th 2023Joshua Eric Reuss, MD, discusses the enrollment criteria for the HARMONIC trial, the demonstrated safety and efficacy of LP-300, and potential benefits of the agent for never smokers with advanced non–small cell lung cancer.
Strides in GI Cancer Subsets Influence Advances
June 20th 2023Tanios S. Bekaii-Saab, MD, highlights the unmet needs in GI malignancies and discusses how interdisciplinary meetings, such as the 20th Annual Meeting of the International Society of Gastrointestinal Oncology, provide the framework for disseminating information and driving innovative advances.
Liso-Cel Elicits ORR of 97% in Relapsed/Refractory Follicular Lymphoma
June 19th 2023A single administration of lisocabtagene maraleucel provided deep and durable remissions when used as third-line treatment in patients with relapsed or refractory follicular lymphoma, including those with high-risk features.
Ibrutinib Plus Chemoimmunotherapy Fails to Improve PFS in Pretreated Follicular Lymphoma, MZL
June 19th 2023The addition of ibrutinib to bendamustine plus rituximab or R-CHOP did not lead to a statistically significant improvement in progression-free survival vs either chemoimmunotherapy regimen alone in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma.
DESTINY-CRC02 Trial Continues to Support the Use of T-DXd in HER2+ Metastatic CRC
June 19th 2023Kanwal Pratap Singh Raghav MBBS, MD, discusses data from DESTINY-CRC01 that supported the DESTINY-CRC02 trial, key efficacy and safety data from the trial, and the importance of identifying patients with HER2-positive CRC who may benefit from ADCs like T-DXd in clinical practice.
Determining the Optimal Use of Adjuvant Immunotherapy in Renal Cell Carcinoma
June 19th 2023Kidney and renal pelvis cancers are one of the 10 most common new malignant diagnoses in both men and women in the United States, with an estimated 52,360 new cases in men and 29,440 new cases in women per year.
Obe-Cel Demonstrates Durable, Safe Responses in Relapsed/Refractory B-ALL
June 18th 2023Claire Roddie, MD, discusses the rationale for investigating obecabtagene autoleucel in patients with relapsed/refractory B-cell acute lymphoblastic leukemia, details the key topline findings from the FELIX trial, and provides insights on unmet needs that remain for this patient population.
European Medicines Agency Validates MAA for Fruquintinib in Pretreated mCRC
June 16th 2023The European Medicines Agency has validated and accepted a marketing authorization application for priority review for fruquintinib for the treatment of adult patients with pretreated metastatic colorectal cancer.