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.
Continued Development of Targeted Therapies Aims to Address Unmet Needs in CRC
May 9th 2023John L. Marshall, MD, discusses the identification of targetable subsets of patients with advanced CRC, unmet needs that remain to be addressed for patients with advanced CRC, and the continued need for a multidisciplinary approach in treating patients across the gastrointestinal cancer spectrum.
International Study Shows Many Younger Women with Breast Cancer Can Safely Have a Baby
May 9th 2023A new study published today in the New England Journal of Medicine found that for young women with hormone receptor-positive breast cancer, pausing endocrine therapy to pursue a pregnancy did not raise the short-term risk that the disease will recur.
MANIFEST-2 Study of Pelabresib Plus Ruxolitinib Completes Enrollment in Myelofibrosis
May 9th 2023Enrollment to the phase 3 MANIFEST-2 trial, which is examining the safety and efficacy of pelabresib plus ruxolitinib vs ruxolitinib alone in patients with JAK inhibitor–naïve myelofibrosis, has completed and topline findings are anticipated by the end of 2023.
REGN5459 Demonstrates Early Promise in Heavily Pretreated Multiple Myeloma
May 9th 2023Attaya Suvannasankha, MD, discusses the unique mechanism of action of REGN5459, the early efficacy and safety of the immunotherapy in heavily pretreated patients with relapsed/refractory multiple myeloma, and opportunities for further exploration.
China Approves Zanubrutinib in Previously Untreated CLL/SLL and Waldenström Macroglobulinemia
May 8th 2023China’s National Medical Products Administration has approved 2 supplemental new drug applications of zanubrutinib for use in treatment-naïve adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma and Waldenström macroglobulinemia.
Interval Cytoreductive Surgery After Chemo Boosts Survival in Stage IV Epithelial Ovarian Cancer
May 8th 2023Liat Hogen, MD, FRCSC, discussed the potential benefit for cytoreductive surgery in patients with initially unresectable stage IV epithelial ovarian cancer and the implications of findings from this retrospective analysis on future clinical decisions.
GD2-CART01 Elicits Clinical Activity, Tolerability in Pediatric R/R Neuroblastoma
May 8th 2023The investigational CAR T-cell therapy GD2-CART01 showed preliminary antitumor activity and safety in pediatric patients with relapsed or refractory high-risk neuroblastoma, according to data from a phase 1/2 trial.
Sintilimab Plus Chemo With or Without IBI305 Provides PFS Benefit in EGFR TKI–Pretreated EGFR+ NSCLC
May 8th 2023The combination of sintilimab and chemotherapy with or without the bevacizumab biosimilar IBI305 produced a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with EGFR-mutated, nonsquamous non–small cell lung cancer who progressed after treatment with an EGFR TKI.
Oncologists Prepare to Bridge Knowledge Gap on Clinical Trial Outcomes With Patients
May 8th 2023When patients with cancer are asked to be participants in a clinical trial, they are informed that a primary purpose of the investigative effort is to develop objectively valid, generalizable information that may be of value to patients with the same malignancy or benefit researchers in the development of future studies.
Emerging Data Help Steer CDK4/6 Inhibitor Choice in HR+/HER2– Breast Cancer
May 8th 2023Karen S. Anderson, MD, PhD, discusses emerging data and role for CDK4/6 inhibitors in the treatment of patients with hormone receptor–positive, HER2-negative breast cancer, along with the growing use of antibody-drug conjugates across the breast cancer spectrum and updates in triple-negative breast cancer.
Pembrolizumab Could Delay Radical Cystectomy in BCG-unresponsive, High-risk NMIBC
May 7th 2023Eric A. Singer, MD, discusses the findings from cohort B of KEYNOTE-057 and explains why systemic therapy with pembrolizumab could be beneficial for patients with Bacillus Calmette-Guérin–unresponsive, high-risk, papillary-only non–muscle invasive bladder cancer who hope to avoid radical cystectomy.
TAR-200 Monotherapy Displays Early Efficacy in BCG-Unresponsive NMIBC
May 5th 2023Sia Daneshmand, MD, discusses the rationale for investigating TAR-200 for the treatment of patients with Bacillus Calmette-Guérin-unresponsive, high-risk non–muscle-invasive bladder cancer, expands on the preliminary efficacy and safety data from the SunRISe-1 trial, and more.
Jumping Genes in Cancer Cells Open Door to New Immunotherapies
May 5th 2023Research from Washington University School of Medicine in St. Louis suggests that transposable elements in various cancers potentially may be used to direct novel immunotherapies to tumors that don’t typically respond to immune-based treatments.
FDA Grants 501K Clearance to Bladder EpiCheck for Surveillance in NMIBC
May 5th 2023The FDA has granted 510K clearance to Bladder EpiCheck for use as a noninvasive method for surveillance of tumor recurrence in previously diagnosed patients with non–muscle invasive bladder cancer, in conjunction with cystoscopy.
IRAK-4 Inhibitor CA-4948 May Enhance Immunotherapeutic Outcomes in Melanoma With Brain Metastases
May 5th 2023Bently Doonan, MD, discusses how CA-4948 can penetrate the blood-brain barrier and interact with the tumor microenvironment, and how this approach may open doors for patients with melanoma who have brain metastases.
Aumolertinib Plus SRT Elicits Responses in Intracranial Oligometastatic EGFR+ NSCLC
May 4th 2023Administration of aumolertinib until intracranial oligoprogression, followed by salvage stereotactic radiation therapy, produced central nervous system responses with acceptable tolerability in patients with intracranial oligometastatic EGFR-mutant non–small cell lung cancer.
Gedatolisib, Fulvestrant, and Palbociclib Triplet Under Investigation in HR+/HER2– Breast Cancer
May 4th 2023The combination of gedatolisib and fulvestrant with or without palbociclib is under evaluation in the phase 3 VIKTORIA-1 trial for the treatment of patients with PIK3CA-mutated or wild-type hormone receptor–positive/HER2-negative breast cancer who have previously progressed on first-line therapy.