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.
RP1 Plus Cemiplimab Misses Response End Points in Locally Advanced or Metastatic CSCC
December 14th 2023The combination of RP1 and cemiplimab provided a numerical, but not statistically significant, improvement in response rates vs cemiplimab alone in patients with locally advanced or metastatic cutaneous squamous cell carcinoma, missing the primary end points of the phase 2 CERPASS trial.
Ide-Cel Wins Japanese Approval in Early Relapsed/Refractory Multiple Myeloma
December 14th 2023Idecabtagene vicleucel has received marketing and manufacturing approval in Japan for its supplemental new drug application in patients with relapsed/refractory multiple myeloma who have received at least 2 prior lines of therapy.
Frontline IO/TKI Regimens Continue to Evolve in ccRCC
December 14th 2023Jaime R. Merchán, MD, discusses the evolution and current role of IO/TKI regimens in advanced RCC; highlights data from the phase 3 CLEAR and KEYNOTE-426 trials supporting the use of pembrolizumab-based regimens in untreated ccRCC; and speculates on how future biomarker-driven research could improve the benefit seen with these combinations in this disease.
Neoadjuvant KN026 Plus Docetaxel Demonstrates Early Activity in HER2+ Breast Cancer
December 14th 2023The novel bispecific antibody KN026 and docetaxel elicited responses with an acceptable toxicity profile when administered as neoadjuvant treatment in patients with HER2-positive early or locally advanced breast cancer.
Dostarlimab Plus Chemo Granted EU Approval for dMMR/MSI-H Endometrial Cancer
December 14th 2023The European Commission has granted marketing authorization to dostarlimab paired with carboplatin and paclitaxel in adults with dMMR/MSI-H primary advanced or recurrent endometrial cancer who are eligible to receive systemic treatment.
FDA Approves Eflornithine for Adult, Pediatric Patients With High-Risk Neuroblastoma
December 13th 2023The FDA has approved eflornithine (Iwilfin) as a treatment to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have achieved at least a partial response to prior multi-agent, multimodality therapy including anti-GD2 immunotherapy.
Responses With Pirtobrutinib Remain High Despite Acquired Resistance in Relapsed CLL/SLL
December 13th 2023Responses on the non-covalent BTK inhibitor pirtobrutinib remained high in patients with relapsed chronic lymphocytic leukemia who expressed frequent baseline BTK mutations, according to a genomic analysis of the phase 1/2 BRUIN trial.
T-DXd Continues to Show Robust CNS Activity in HER2+ Breast Cancer With Brain Metastases
December 13th 2023Javier Cortés, MD, PhD, expands on the importance of investigating the central nervous system activity of trastuzumab deruxtecan in patients with HER2-positive breast cancer and brain metastases; key efficacy data from the pooled analysis of the agent in the DESTINY-Breast01, -02 and -03 trials; and more.
DZD8586 Demonstrates Responses Across Dose Levels in B-Cell Non-Hodgkin Lymphoma
December 13th 2023DZD8586 showcased antitumor activity and favorable safety with limited grade 3 or greater treatment-emergent adverse effects in patients with heavily pretreated B-cell non-Hodgkin lymphoma, according to preliminary findings from a pooled analysis of two ongoing phase 1 trials.
Tafasitamab Quadruplet Shows Efficacy in Newly Diagnosed DLBCL
December 12th 2023The use of tafasitamab-cxix, lenalidomide, rituximab, and acalabrutinib in the first-line setting induced high responses in patients with newly diagnosed diffuse large B-cell lymphoma, with responders deriving benefit from subsequent treatment with cyclophosphamide, doxorubicin, vincristine, and prednisolone.
Pirtobrutinib Displays Activity in Relapsed/Refractory MCL Following Covalent BTK Inhibitor Therapy
December 12th 2023Pirtobrutinib demonstrated promising efficacy and a tolerable safety profile in heavily pretreated patients with relapsed/refractory mantle cell lymphoma who received prior therapy with a covalent BTK inhibitor.
BGB-16673 Delivers Responses With a Tolerable Safety Profile Across R/R B-Cell Malignancies
December 12th 2023The novel BTK degrader BGB-16673 was well tolerated; produced meaningful and rapid clinical responses; and demonstrated on-target effects in patients with relapsed/refractory B-cell malignancies.
D-VRd Improves PFS in Newly Diagnosed, Transplant-Eligible Multiple Myeloma
December 12th 2023Induction therapy with subcutaneous daratumumab followed by autologous stem cell transplant, daratumumab, bortezomib, lenalidomide, and dexamethasone consolidation and daratumumab/lenalidomide maintenance prolonged progression-free survival in patients with newly diagnosed, transplant-eligible multiple myeloma.
Ibrutinib Plus Venetoclax Confers PFS, Response Benefit in Relapsed/Refractory MCL
December 12th 2023Treatment with the oral BTK inhibitor ibrutinib in combination with venetoclax led to a statistically significant improvement in progression-free survival vs ibrutinib plus placebo in patients with relapsed/refractory MCL.
Financial Navigation Program May Alleviate Cost Burden Associated With Multiple Myeloma
December 12th 2023Utilization of a financial navigation program is feasible for reducing cost burden and improving quality of life in patients with multiple myeloma who are more likely to experience financial toxicity and have difficulty accessing appropriate resources and support services.
NX-2127 Elicits Responses With Manageable Safety in Heavily Pretreated B-cell Malignancies
December 12th 2023NX-2127 showcased early efficacy in the form of responses with an acceptable toxicity profile in patients with relapsed or refractory B-cell malignancies, according to data from the ongoing phase 1 NX-2127-001 trial.
Zanubrutinib Triplet Shows Early Promise in Treatment-Naive TP53-Mutant MCL
December 11th 2023The combination comprised of zanubrutinib, obinutuzumab, and venetoclax elicited high response rates and 2-year progression-free survival rates that compared favorably with historical outcomes achieved with chemoimmunotherapy in high-risk patients with previously untreated mantle cell lymphoma harboring TP53 mutations.