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.
COVID-19 Continues to Result in High Admission, Fatality Rates Among Patients With CLL
September 18th 2021COVID-19 continued to result in high admission and fatality rates among patients with chronic lymphocytic leukemia during the first 13 months of the pandemic, and although risk of severe infection was determined to be independent of age, CLL status, and treatment, being age 75 years or older was revealed to be a significant risk factor for death.
Goy Taps Into the True Potential of Precision Medicine in Oncology
September 18th 2021Current approaches to precision medicine in oncology have been fruitful, but require better integration and utilization of available resources to inform sustainable and effective drug development and clinical care, according to Andre Goy, MD.
Splicing Molecule Delays Leukemic Infiltration in CLL, Has Targeted Therapy Potential
September 17th 2021H3B-8800, a splicing molecule that binds to Splicing Factor 3b Subunit 1, has been shown to delay leukemic infiltration in a model of chronic lymphocytic leukemia using NOD-SCID interleukin-2 receptor gamma mice.
Toripalimab/Chemo Combo Elicits Survival Benefit in Frontline Esophageal Squamous Cell Carcinoma
September 17th 2021The addition of toripalimab to platinum-based chemotherapy demonstrated significantly improved survival outcomes in patients with advanced or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression.
Neoadjuvant Carboplatin Plus Paclitaxel, Without Veliparib, Improves pCR, EFS in TNBC
September 17th 2021The addition of carboplatin to neoadjuvant paclitaxel followed by doxorubicin and cyclophosphamide significantly improved pathological complete response rates and event-free survival in patients with treatment-naïve triple-negative breast cancer.
Olaparib Rechallenge Improves PFS in Relapsed Ovarian Cancer Previously Treated With PARP Inhibition
September 17th 2021Rechallenge with maintenance olaparib following response to platinum-based chemotherapy significantly improved progression-free survival in heavily pretreated patients with relapsed ovarian cancer, irrespective of BRCA status, according to results of the phase 3 OReO/ENGOT Ov-38 study.
Sintilimab Improves OS in Advanced ESCC, Gastric/GEJ Cancer
September 17th 2021Findings from a pair of studies presented at the 2021 European Society for Medical Oncology Annual Meeting showed that adding sintilimab to chemotherapy significantly improved overall survival compared with chemotherapy alone in patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma and those with unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma.
Pembrolizumab/Chemo Nears EU Approval for Select TNBC With PD-L1 CPS ≥10
September 17th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion of pembrolizumab plus chemotherapy in the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.
Zanubrutinib Approaches EU Approval for Waldenström Macroglobulinemia
September 17th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding the use of zanubrutinib in adult patients with Waldenström macroglobulinemia who have previously received at least 1 therapy or in the frontline treatment of patients who are not eligible for chemoimmunotherapy.
Nivolumab/Cabozantinib Combo Yields Efficacy Regardless of Prior Nephrectomy in RCC
September 17th 2021Nivolumab and cabozantinib demonstrated significant benefits in progression-free survival and objective response rate for patients with renal cell carcinoma regardless of whether they had a prior nephrectomy.
EU Panel Recommends Pralsetinib for RET Fusion+ Advanced NSCLC
September 17th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pralsetinib for use as a single agent in adult patients with RET fusion–positive advanced non–small cell lung cancer who did not receive prior RET inhibition.
Global Maximum-Tolerated Dose of Mobocertinib Found Tolerable in Japanese Patients With NSCLC
September 16th 2021Mobocertinib displayed a manageable safety profile across 40-mg, 120-mg, and 160-mg dose cohorts in Japanese patients with non–small cell lung cancer, which, when coupled with pharmacokinetic analysis, led to the determination of 160 mg as the maximum tolerated dose and recommended phase 2 dose for further study in this population.