All Oncology News

Two novel antibody-drug conjugates, HS-20089 and SGN-B7H4V, targeting the highly expressed immune checkpoint ligand B7-H4 have demonstrated manageable safety profiles and shown anti-tumor activity in first-in-human dose-escalation portions of phase 1 trials and will move forward to the next portions of the studies.

The FDA has granted a fast track designation to SLS009 for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma.

The FDA has lifted the clinical hold placed on a phase 1 trial evaluating XMT-2056 monotherapy in patients with HER2-high or -low advanced or recurrent solid tumors.

VAL-083 did not improve efficacy compared with standard-of-care approaches in patients with glioblastoma.

The FDA has granted breakthrough therapy designation to furmonertinib for use as a potential therapeutic option in patients with previously untreated, locally advanced or metastatic nonsquamous non–small cell lung cancer harboring EGFR exon 20 insertion mutations.

Igor Astsaturov, MD, PhD, has been appointed inaugural holder of the Paul F. Engstrom Professorship in Oncology.

A closer look at some of the approaches being used across The US Oncology Network to improve patient access can provide helpful insight into how practices can meet the growing need for their services.

Apar Kishor Ganti, MD, discusses molecular targets to test for in lung cancer; treatment approaches for small cell lung cancer; and immunotherapy options for patients with metastatic non–small cell lung cancer in the frontline setting and beyond.

The European Medicines Agency has validated a type II variation application for the first-line combination of nivolumab and cisplatin-based chemotherapy for adult patients with unresectable or metastatic urothelial carcinoma.

The addition of dostarlimab to carboplatin plus paclitaxel followed by dostarlimab monotherapy significantly improved overall survival compared with placebo plus chemotherapy followed by placebo in adult patients with primary advanced or recurrent endometrial cancer.

Vimseltinib elicited a statistically significant and clinically meaningful improvement in 25-week overall response rate vs placebo in patients with tenosynovial giant cell tumor that was not amenable to surgery.

Brexucabtagene autoleucel demonstrated an improvement in overall survival vs standard of care therapy in patients with relapsed/refractory mantle cell lymphoma following prior exposure to a BTK inhibitor, according to data from an indirect treatment comparison of findings from the phase 2 ZUMA-2 trial and retrospective SCHOLAR-2 trial.

BioFlorida, a statewide association for Florida’s life sciences industry, has named Stephen D. Nimer, MD, director of Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, “Researcher of the Year.”

The FDA has granted priority review to a new drug application seeking the approval of tovorafenib monotherapy for the treatment of pediatric patients with relapsed or progressive low-grade glioma.

Postoperative circulating tumor DNA (ctDNA)–based minimal residual disease status demonstrated prognostic value for patients with stage I to IV resected colorectal cancer, showing that those with positive ctDNA after surgery have significantly lower disease-free survival outcomes at 24 months vs those who were ctDNA negative.

Marisol Miranda-Galvis, DDS, MS, PhD, highlights the importance of understanding which social determinants of health have the greatest influence on treatment-related outcomes in patients with hematologic malignancies, expands on key variables identified in a systematic review of these disparities, and emphasizes the importance of continuing to implement new strategies to increase access to quality treatments.

Richard Kim, MD, discusses the range of systemic treatment options available for patients with unresectable hepatocellular carcinoma and the importance of assessing patients for high-risk disease criteria before beginning any systemic treatment.

The FDA has approved toripalimab-tpzi (Loqtorzi) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as monotherapy for the treatment of adult patients with recurrent, unresectable, or metastatic nasopharyngeal carcinoma with disease progression on or after platinum-containing chemotherapy.

Pooled findings from exploratory analyses of the phase 2 DESTINY-Lung01 and DESTINY-Lung02 trials showed that different doses of fam-trastuzumab deruxtecan-nxki elicited similar intracranial responses in patients with HER2-mutated non–small cell lung cancer who had treated or untreated brain metastases at baseline.

Praveen Vikas, MBBS, discusses what is currently known regarding minimal residual disease testing in breast cancer, expanded on what still needs to be done to bring minimal residual disease and ctDNA testing to clinical practice, and highlighted the evolving treatment paradigm for patients with advanced hormone receptor-positive, HER2-negative breast cancer.

The FDA has granted fast track designation to the dual-acting androgen receptor inhibitor ONCT-534 for the treatment of patients with relapsed/refractory, metastatic castration-resistant prostate cancer that is resistant to approved androgen receptor pathway inhibitors.

The European Medicines Agency has accepted a marketing authorization application seeking the approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Temple Health was recently recognized with the American College of Gastroenterology’s Service Award for Colorectal Cancer Outreach, Prevention & Year-Round Excellence for its coordinated health campaign against colon cancer.

Despite the discovery of protein arginine methyltransferase 5 more than 20 years ago, interest in the potential oncogene as a treatment target for patients with hematologic and solid malignancies has increased in recent years with the advancement of multiple novel agents through preclinical and early-phase studies.

The combination of ibrutinib and bortezomib elicited durable responses in patients with relapsed or refractory mantle cell lymphoma and high-risk features such as a Ki-67 over 30%, blastoid or pleomorphic variant, p53 overexpression, and TP53 mutations and/or deletions.

Datopotamab deruxtecan elicited encouraging responses in patients with heavily pretreated non–small cell lung cancer harboring actionable genomic alterations.

The FDA has accepted the resubmission of a biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive, non–muscle-invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease.

Vitaly Margulis, MD, expands on the factors to consider when treating patients with advanced RCC and how these could help inform the selection of immunotherapy-based combinations in the frontline setting.

Ricardo D. Parrondo, MD, highlights the current use of covalent BTK inhibitors in chronic lymphocytic leukemia, potential roles for the non-covalent BTK inhibitor pirtobrutinib, and the importance of future research on time-limited treatment options for patients with newly diagnosed chronic lymphocytic leukemia.

Ontada®, a McKesson business dedicated to leveraging oncology real-world data and evidence, clinical education, and provider technology, was awarded a competitive contract with the U.S. Food and Drug Administration to advance the use of real-world data in the U.S. community oncology setting.