Phase 3 Trial of Tumor-Treating Fields for NSCLC Impresses at Interim Analysis
April 15th 2021Interim analysis of the phase 3 LUNAR trial led to a data monitoring committee recommendation to reduce the trial sample size due to strongly positive results gathered from the current patient population treated with tumor-treating fields.
Higher Cutoff by FoundationOne CDx for TMB May Determine Atezolizumab Success
April 13th 2021In an analysis of a cohort of patients treated with atezolizumab in the myPathway trial, a tumor mutational burden cutoff of 16 mutations per megabase or higher was key for achieving durable responses in various solid tumors.
FDA Grants Priority Review to Tisotumab Vedotin for Recurrent/Metastatic Cervical Cancer
April 12th 2021Based on results of the phase 2 innovaTV 204 trial, the FDA granted priority review to tisotumab vedotin as a potential therapy for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Real-World Evidence Supports Efficacy of Palbociclib Plus Letrozole in HR+/HER2– Breast Cancer
April 9th 2021An analysis of real-world outcomes in a cohort of patients treated in mostly community settings showed that palbociclib plus letrozole improved both progression-free and overall survival in women with hormone receptor–positive, HER2-negative metastatic breast cancer.
Umbralisib Activity, Safety in Indolent Lymphomas Demonstrated in Phase 2b Trial
April 6th 2021Data that led to the approval of umbralisib in patients with indolent non-Hodgkin lymphoma— including follicular lymphoma and marginal zone lymphoma—indicates favorable activity of the therapy versus other available PI3K inhibitors.
Investigational RET Inhibitor TPX-0046 Show Preliminary Clinical Activity in NSCLC, MTC
April 6th 2021In a dose-finding trial, TPX-0046 elicited responses in patients with non–small cell lung cancer and medullary thyroid cancer who were naïve to prior tyrosine kinase inhibitors and whose tumors harbored alterations in RET.
Long-Term OS Data for Olaparib Maintenance in Ovarian Cancer Show Clinically Meaningful Boost
April 5th 2021With more than 5 years of follow-up, results from the SOLO2 trial of olaparib maintenance in relapsed, high-grade serous or endometrioid ovarian cancer, including primary peritoneal or fallopian tube cancer, were reported and showed superiority of the agent over placebo.
Avelumab Plus Chemotherapy Fails in HNSCC Phase 3 Trial, Raises Future Research Questions
April 2nd 2021Despite the success of immune checkpoint blockade in the treatment of recurrent or metastatic head and neck squamous cell carcinoma, the use of the PD-L1 inhibitor avelumab failed to prolong progression-free survival for patients with locally advanced disease.
Whole-Genome Sequencing May Improve Prognosis Accuracy for AML/MDS Versus Traditional Cytogenetics
April 1st 2021According to a single-institution study of patients with a known or suspected diagnosis of AML or MDS, whole-genome sequencing may provide better predictive ability of patients’ risk status than traditional methods.
Genetic Alterations in CTCs May Be Associated With Androgen Receptor Response in mCRPC
March 31st 2021The presence of certain genetic alterations in circulating tumor cells in patients with metastatic castration-resistant prostate cancer were associated with response or resistance to AR inhibitors, according to a recent study.
FDA Grants Fast Track Designation to Investigational Anthracycline Annamycin for STS Lung Metastases
March 30th 2021The agent annamycin, which offers the potential to fulfill unmet medical needs of traditional anthracyclines, has been granted fast track designation for the treatment of soft tissue sarcoma lung metastases.
FDA Issues Complete Response Letter for Pembrolizumab as Neoadjuvant Therapy in Early TNBC
March 30th 2021The FDA’s Oncologic Drugs Advisory Committee voted in favor of waiting for additional event-free survival data to become available before making a regulatory decision regarding a biologics license application for pembrolizumab in early triple-negative breast cancer.