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.
Rituximab Plus Bendamustine Proves Promising in Young Patients With MCL
May 5th 2022The combination of bendamustine and rituximab plus autologous stem cell transplantation and maintenance rituximab was shown to be an effective first-line treatment with comparable outcomes to R-CHOP/R-DHAP plus ASCT and observation in young patients with transplant-eligible mantle cell lymphoma.
FDA Grants Regular Approval to Trastuzumab Deruxtecan for Select HER2+ Metastatic Breast Cancer
May 4th 2022The FDA has approved fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received an anti–HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within 6 months of therapy completion.
CG0070 Plus Nivolumab Under Investigation in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
May 4th 2022The safety and efficacy of the combination of the oncolytic immunotherapy CG0070 and nivolumab is under exploration as a potential therapeutic option in patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy, as part of the phase 1b CORE-002 trial.
FDA Grants Fast Track Status to HM43239 for FLT3-Mutated, Relapsed/Refractory AML
May 4th 2022The FDA has granted a fast track designation to the myeloid kinome inhibitor, HM43239, for use as a potential therapeutic option in patients with relapsed or refractory acute myeloid leukemia whose tumors harbor a FLT3 mutation.
ARO-HIF2 Lowers HIF2α Expression and Demonstrates Favorable Safety Profile in Clear Cell RCC
May 4th 2022The investigational RNA interference therapy, ARO-HIF2, reduced levels of hypoxia inducible factor-2 alpha expression and had acceptable tolerability when used in patients with clear cell renal cell carcinoma, according to data from the phase 1b AROHIF21001 trial.
Pembrolizumab With or Without Chemo Has Increased Efficacy With Increasing PD-L1 Expression in HNSCC
May 4th 2022Pembrolizumab with or without chemotherapy resulted in a numerically longer overall survival benefit vs cetuximab plus chemotherapy in patients with head and neck squamous cell carcinoma and a PD-L1 combined positive score (CPS) between 1 and 19, but did not improve survival in the subset with a PD-L1 CPS of less than 1.
Tucatinib Plus T-DM1 Represents Another Potential Therapy in High-Risk HER2-Positive Breast Cancer
May 3rd 2022Heather McArthur, MD, MPH, discusses key treatment developments in early-stage and metastatic HER2-positive breast cancer and triple-negative breast cancer, plus ongoing research at UT Southwestern Harold C. Simmons Comprehensive Cancer Center.
The Future of Frontline CLL Treatment Hinges on Chemotherapy-Free Approaches
May 3rd 2022Anthony Mato, MD, MSCE, discusses current data surrounding BTK inhibitors in chronic lymphocytic leukemia, the benefits of targeted therapies in this population, ways to begin addressing unmet needs, and the importance of improved clinical trial designs for varying patient populations.
FDA Issues Complete Response Letter to Toripalimab for Nasopharyngeal Carcinoma
May 2nd 2022The FDA is seeking the approval of toripalimab plus gemcitabine and cisplatin in the frontline treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma and for use as a monotherapy in the second-line and later treatment of those with recurrent or metastatic disease.
Very Low Dose Radiation Therapy Demonstrates Efficacy in Indolent Non-Hodgkin Lymphoma
May 2nd 2022Although it is not considered to be a standard of care for patients with indolent non-Hodgkin lymphoma, very low dose radiation therapy was found to have efficacy in the palliative setting and to allow for retreatment to the same field when needed.
Addition of Ublituximab/Umbralisib to Ibrutinib Produces High uMRD Rate in CLL
May 2nd 2022The time-limited combination of ublituximab and umbralisib plus ibrutinib resulted in an undetectable minimal residual disease rate of 77% in patients with chronic lymphocytic leukemia, according to findings from a phase 2 trial (NCT04016805)
Dana-Farber Cancer Institute and Lifespan Renew Strategic Alliance Agreement
May 2nd 2022Dana-Farber Cancer Institute and the Lifespan Cancer Institute have agreed to renew their strategic alliance to advance cancer treatment and research. Dana-Farber and the Lifespan Cancer Institute signed an initial agreement in 2017.