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.
Adjuvant Chemotherapy Fails to Improve PFS and OS in Locally Advanced Cervical Cancer
June 3rd 2021The administration of adjuvant carboplatin and paclitaxel following standard cisplatin-based chemoradiation failed to demonstrate an improvement in progression-free survival or overall survival in women with locally advanced cervical cancer, according to findings from the phase 3 OUTBACK trial.
CAR T-Cell Therapy Trial in Solid Tumors Halted Following 2 Patient Deaths
June 3rd 2021Tmunity Therapeutics, a clinical-stage biotherapeutics company, has halted the development of its lead CAR T-cell product following the deaths of 2 patients who were enrolled to a trial investigating its use in solid tumors.
Phase 2 Trial of Envafolimab With and Without Ipilimumab in Sarcoma to Continue
June 3rd 2021The phase 2 ENVASARC trial, which is examining the PD-L1 antibody envafolimab with and without ipilimumab in patients with undifferentiated pleomorphic sarcoma and myxofibrosarcoma, has been recommended by the Independent Data Monitoring Committee to continue as planned.
Selinexor/Dexamethasone Combo Approved in UK for Relapsed/Refractory Myeloma
June 2nd 2021The United Kingdom’s Medicines & Healthcare Products Regulatory Agency has granted conditional marketing authorization to the combination of selinexor and dexamethasone as a treatment for select patients with relapsed/refractory multiple myeloma.
Nivolumab/Ipilimumab Approved in Europe for Frontline Unresectable Malignant Pleural Mesothelioma
June 2nd 2021The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adults with unresectable malignant pleural mesothelioma.
Adjuvant Neoantigen Peptide Vaccine PGV-001 Shows Promise in Multiple Malignancies
June 2nd 2021A personalized adjuvant neoantigen peptide vaccine, PGV-001, was successfully synthesized and administered to patients across a wide range of malignancies who had a greater than 30% chance of disease recurrence.
NDA Resubmitted to FDA for Pedmark in Prevention of Cisplatin-Induced Ototoxicity in Solid Tumors
June 1st 2021The new drug application seeking the approval of a unique formulation of sodium thiosulfate for the prevention of ototoxicity induced by cisplatin chemotherapy in patients aged 1 month to less than 18 years of age with localized, nonmetastatic solid tumors has been resubmitted to the FDA.
FDA Approves Companion Diagnostic for Sotorasib in KRAS G12C–Mutated Advanced NSCLC
June 1st 2021The FDA has approved the Guardant360 CDx assay as a companion diagnostic for tumor mutation profiling to identify patients with locally advanced or metastatic non–small cell lung cancer whose tumors harbor the KRAS G12C mutation and may derive benefit from sotorasib.
Loncastuximab Tesirine Provides Alternative for Broad Range of Patients With DLBCL
June 1st 2021Loncastuximab tesirine-lpyl (Zynlonta) exhibited significant clinical activity, including impressive response rates with tolerable safety, as a single agent in adult patients with relapsed/refractory large B-cell lymphoma that failed prior established therapies.
COVID-19 Vaccination Hesitancy Finds Echo in Cancer Care
June 1st 2021Although the COVID-19 vaccine rollout is unprecedented in speed and scope, the process of postapproval surveillance has been shown to be robust and should serve as a source of reassurance to the public regarding the effectiveness of the initial and follow-up review process.
Neoadjuvant Cemiplimab Induces Tumor Necrosis in Resectable HCC
June 1st 2021Parissa Tabrizian, MD, MSc, discusses the rationale for evaluating cemiplimab in the neoadjuvant setting for patients with resectable hepatocellular carcinoma, the results of the trial, and next steps planned to identify optimal clinical end points that correlate with survival benefit.
Cabozantinib Plus Atezolizumab Shows Promise in High-Risk Castration-Resistant Prostate Cancer
May 31st 2021The combination of cabozantinib plus atezolizumab was found to elicit encouraging response rates, disease control, and acceptable safety in patients with metastatic castration-resistant prostate cancer who had previously received enzalutamide and/or abiraterone acetate.
Prevalence of Precancerous CRC Lesions Warrants Screening in Younger Population
May 29th 2021A significant incidence of advanced neoplasia and colorectal cancer was identified in individuals between the ages of 45 and 49 years, emphasizing the importance of adhering to recent recommendations from the United Services Preventive Services Task Force to lower the CRC screening age from 50 to 45 years.