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.
REGN5459 Delivers Dose-Dependent Responses in Relapsed/Refractory Myeloma
April 17th 2023The BCMA- and CD3-directed bispecific antibody REGN5459 led to fast onset, deep, and dose-dependent responses sustained over time, with a high frequency of manageable low-grade cytokine release syndrome in patients with relapsed/refractory multiple myeloma.
Selective CDK2 Inhibitor Undergoes Investigation in CCNE1-High Tumors
April 17th 2023Preclinical data have demonstrated activity of a novel, small molecule CDK2 inhibitor INCB123667 in CDK2/cyclin E1 expressing cell lines prompting investigators to initiate a phase 1 study, and the agent may fill an unmet need for patients with cancers with primary or acquired CDK4/6 resistance.
FDA Accepts sBLA for Ide-cel in Triple-class Exposed Relapsed/Refractory Myeloma
April 17th 2023The FDA has accepted a supplemental biologics license application seeking the approval of idecabtagene vicleucel for the treatment of adult patients with relapsed and refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Perioperative Durvalumab Plus Neoadjuvant Chemo Improves pCR, EFS in Resectable NSCLC
April 16th 2023Perioperative durvalumab plus neoadjuvant platinum-based chemotherapy demonstrated a statistically significant improvement in pathologic complete response and event-free survival vs placebo plus chemotherapy in patients with resectable non–small cell lung cancer.
Adjuvant mRNA-4157 Plus Pembrolizumab Improves RFS in Resected High-Risk Melanoma
April 16th 2023mRNA-4157 in combination with pembrolizumab improved recurrence-free survival compared with pembrolizumab alone when used as an adjuvant treatment in patients with resected high-risk melanoma, regardless of tumor mutational burden.
Pembrolizumab Plus Cisplatin/Gemcitabine Extends OS in Advanced Biliary Tract Cancer
April 16th 2023Pembrolizumab plus cisplatin and gemcitabine produced a statistically significant and clinically meaningful improvement in overall survival vs placebo plus cisplatin and gemcitabine in previously untreated patients with advanced biliary tract cancer, according to data from the phase 3 KEYNOTE-966 trial.
Adjuvant Atezolizumab Plus Bevacizumab Significantly Improves RFS in High-risk HCC
April 16th 2023Adjuvant treatment with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) resulted in a statistically significant and clinically meaningful improvement in recurrence-free survival vs active surveillance in patients with a high risk of hepatocellular carcinoma recurrence following curative-intent resection or ablation.
MOUNTAINEER and DESTINY-CRC01 Trials Expand Second-Line Options for HER2+ mCRC
April 15th 2023Alaa Muslimani, MD, discusses the significance of the phase 2 DESTINY-CRC01 and MOUNTAINEER-03 trials on HER2-positive metastatic colorectal cancer treatment in the second line, efforts to expand the use of these agents in earlier disease settings, and the need for more robust clinical data and larger investigations for this population.
Risk Classification, Mutational Analysis Are Key in Informing AML Management
April 14th 2023During an OncLive® workshop titled Key Updates in the Management of Acute Myeloid Leukemia and Their Application in Clinical Practice, moderated by Naval Daver, MD, faculty reviewed updates to the classification of acute myeloid leukemia and its effects on the treatment paradigm and provided insight on the management of adverse-risk and secondary acute myeloid leukemia.
Chief of Urologic Oncology Addresses Young Men’s Common Concerns about Testicular Cancer
April 14th 2023Though testicular cancer can impact males of any age, it generally affects men in their 20s and 30s. The average age at the time of diagnosis of testicular cancer is about 33, according to the American Cancer Society.
Intermittent Dosing Helps Mitigate Thrombocytopenia Associated With Milademetan in Sarcomas
April 14th 2023Thrombocytopenia is a common adverse effect associated with treatment with the MDM2 inhibitor milademetan in patients with sarcomas and other solid tumors, and the effects of thrombocytopenia can be mitigated with an intermittent dosing schedule and managed with dose interruptions or reductions.
Neoadjuvant Chemoimmunotherapy Combination Is Active and Tolerable in Ovarian Cancer
April 13th 2023Jung-Yun Lee, MD, PhD, discusses the TRU-D trial within the context of prior negative trials to emphasize the need for more effective therapies in advanced-stage ovarian cancer, highlights key findings from TRU-D, and elaborates on future steps for this research.
FDA Accepts sBLA for Pembrolizumab Plus Chemotherapy in Advanced Gastric/GEJ Adenocarcinoma
April 13th 2023The FDA has accepted for review a supplemental biologics license application for pembrolizumab plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
TIGIT Remains a Tempting Target for Immunotherapy Combinations, Despite Setbacks
April 13th 2023Despite a high-profile clinical disappointment, the TIGIT immune checkpoint remains an important target for anticancer therapy, with research programs testing novel agents moving forward in non–small cell lung cancer and a range of other tumor types.
Practice-Changing Trials Expand Armamentarium and Improve Guidance in Advanced Breast Cancers
April 13th 2023Several landmark trials have led to FDA approval milestones across all breast cancer subtypes in the past 5 years, each continuing to change the navigation of treatment approaches in clinical practice.