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.
Phase 1 Trial Set to Explore Efficacy and Safety of KB-0742 in Solid Tumors
June 16th 2023Brian Van Tine, MD, PhD, discusses key considerations for understanding the biology of MYC, the rationale for the phase 1 study of KB-0742 in MYC-amplified or -overexpressed relapsed or refractory solid tumors, and patient characteristics that may signal their eligibility for participation in this trial.
FDA Approves Glofitamab-gxbm for Relapsed/Refractory DLBCL
June 16th 2023The FDA has approved glofitamab-gxbm (Columvi) for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy.
Duvelisib Demonstrates Higher Activity in Angioimmunoblastic Peripheral T-Cell Lymphoma
June 15th 2023Treatment with duvelisib led to a high response rate in patients with peripheral T-cell lymphoma, with activity favoring patients with PTCL not otherwise specified and angioimmunoblastic T-cell lymphoma.
Gedatolisib Triplet Shows Early Efficacy in Previously Untreated ER+/HER2– Breast Cancer
June 15th 2023The addition of gedatolisib to palbociclib and letrozole produced durable responses with comparable safety to that observed with palbociclib and letrozole alone in treatment-naïve patients with estrogen receptor-positive, HER2-negative advanced breast cancer.
Real-World Analysis Supports Use of Brexu-Cel in Relapsed/Refractory MCL
June 15th 2023The real-world efficacy and safety of brexucabtagene autoleucel were similar to the outcomes seen in the phase 2 ZUMA-2 trial, regardless of patients’ treatment history, according to results from a real-world subgroup analysis of patients with relapsed/refractory mantle cell lymphoma.
FDA Accepts sNDA for Frontline NALIRIFOX in Metastatic Pancreatic Ductal Adenocarcinoma
June 14th 2023The FDA has accepted a supplemental new drug application seeking approval of the NALIRIFOX regimen comprised of irinotecan liposome injection plus 5-fluorouracil, leucovorin, and oxaliplatin as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma.
Frontline Pembrolizumab Plus Lenvatinib Has Antitumor Activity in Non–clear Cell RCC
June 14th 2023The first-line combination of lenvatinib and pembrolizumab elicited durable responses with a manageable safety profile in patients with non–clear cell renal cell carcinoma, according to findings from the phase 2 KEYNOTE-B61 trial.
Phase 1 Trial of SC-DARIC33 in Pediatric R/R CD33+ AML on Hold After Serious Grade 5 AE
June 14th 2023The phase 1 PLAT-08 trial investigating SC-DARIC33 in pediatric and young-adult patients with relapsed/refractory CD33-positive acute myeloid leukemia has been paused following the report of a grade 5 serious adverse effect.
One-stage Synovectomy Does Not Lead to Worse Outcomes in D-TGCT of the Knee
June 14th 2023R. Lor Randall, MD, FACS, discusses the standard treatment approach for patients with diffuse-type tenosynovial giant cell tumor, the results of the retrospective cohort study evaluating 1- vs 2-stage synovectomies in these patients, and the importance of having additional treatment options for this patient population.
FDA Greenlights Companion Diagnostic for Encorafenib Plus Cetuximab in BRAF V600E+ mCRC
June 13th 2023The FDA has approved FoundationOne CDx for use as a companion diagnostic to determine patients with BRAF V600E–mutated metastatic colorectal cancer who may be candidates to receive encorafenib in combination with cetuximab.
Polatuzumab Vedotin Substitution in R-mini-CHOP Does Not Worsen High-Grade Toxicities in DLBCL
June 13th 2023Using polatuzumab vedotin instead of vincristine in a reduced-dose regimen of rituximab, cyclophosphamide, doxorubicin, and prednisone was not found to increase grade 3/4 hematologic toxicities, infection risk, or neuropathy in elderly patients with untreated diffuse large B-cell lymphoma.
Brentuximab Vedotin Plus Nivolumab/Chemo Elicits 98% ORR in Early-Stage Classical Hodgkin Lymphoma
June 13th 2023Frontline treatment with the combination of brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine led to an overall response rate of 98% and a complete response rate of 93% in patients with early-stage, classical Hodgkin lymphoma.
Domvanalimab-Based Combinations Generate Clinically Meaningful Responses in NSCLC
June 13th 2023The combination of the TIGIT inhibitor domvanalimab and the A2R antagonist etrumadenant enhances the clinical activity of the PD-1 inhibitor zimberelimab when administered as triplet therapy in patients with PD-L1–high, metastatic non–small cell lung cancer.