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.
Durvalumab Plus Chemo Significantly Improves OS in Frontline Advanced Biliary Tract Cancer
October 25th 2021The combination of durvalumab and chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy alone when used in the first-line treatment of patients with advanced biliary tract cancer, meeting the primary end point of the phase 3 TOPAZ-1 trial.
Association of Community Cancer Centers Announces Annual Innovator Award Winners
October 25th 2021The Association of Community Cancer Centers (ACCC) today announced the winning programs for its eleventh annual ACCC Innovator Awards, spotlighting forward-thinking cancer care programs tackling challenges ranging from financial toxicity to telehealth advancements.
Children With Cancer At Higher Risk for Severe Illness from COVID-19
October 24th 2021Approximately 20% of pediatric patients with cancer infected with COVID-19 experienced severe illness and deaths due to the infection were proportionally higher in this patient population compared with the general pediatric population, providing evidence that children with cancer are at higher risk of developing severe illness from COVID-19.
Agenus Withdraws BLA for Balstilimab in Metastatic Cervical Cancer
October 22nd 2021The immuno-oncology company Agenus has made the decision to withdraw its biologic license application for the use of the PD-1 inhibitor balstilimab in patients with recurrent or metastatic cervical cancer who experienced disease progression on, or after, chemotherapy.
Oncopeptides Withdraws Melphalan Flufenamide Myeloma Indication in the United States
October 22nd 2021Oncopeptides AB has made the decision to withdraw the indication of melphalan flufenamide in combination with dexamethasone in select adult patients with relapsed or refractory multiple myeloma from the US market.
TAS-102 Plus Bevacizumab Misses PFS End Point in Frontline Unresectable Metastatic CRC
October 22nd 2021The frontline combination of trifluridine/tipiracil and bevacizumab was not found to result in a significant improvement in progression-free survival over capecitabine and bevacizumab in patients with unresectable metastatic colorectal cancer who are not eligible to receive intensive therapy, missing the primary end point of the phase 3 SOLSTICE trial.
Pembrolizumab/Chemo Approved in Europe for Select Locally Recurrent Unresectable or Metastatic TNBC
October 22nd 2021The European Commission has approved pembrolizumab plus chemotherapy for the frontline treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 expression combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.
FDA Approves Companion Diagnostic for Adjuvant Atezolizumab in Stage II to IIIA NSCLC
October 22nd 2021The FDA has approved the VENTANA PD-L1 assay to assist in identifying which adult patients with stage II to IIIA non–small cell lung cancer whose tumors have PD-L1 expression on 1% or more of tumor cells are eligible to receive adjuvant atezolizumab following surgery and platinum-based chemotherapy.
Mutational Status Is Associated With Time to First Treatment in Newly Diagnosed CLL
October 21st 2021The presence of at least 1 mutation captured by next-generation sequencing was associated with a shorter time to first treatment among patients with newly diagnosed chronic lymphocytic leukemia, particularly those with mutations in POT1, ATM, FBXW7, and MYD88 genes.
New Class of Radiopharmaceutical Therapy Makes Headway in Prostate Cancer
October 21st 2021Investigators have made great strides in the development of radiopharmaceuticals for prostate cancer diagnostics, culminating in recent FDA approvals for the first prostate-specific membrane antigen–targeted radioligands, gallium 68–PSMA-11 and piflufolastat F 18, for the detection of disease recurrence and metastatic lesions.
Pevonedistat Plus Ibrutinib Showcases Preliminary Efficacy and Tolerability in CLL and MCL
October 21st 2021The investigational NEDD8-activating enzyme inhibitor pevonedistat in combination with ibrutinib demonstrated high response rates with a tolerable safety profile in patients with relapsed/refractory chronic lymphocytic leukemia and mantle cell lymphoma.
Elacestrant Improves PFS Over SOC in ER+ Advanced or Metastatic Breast Cancer
October 20th 2021Elacestrant monotherapy improved progression-free survival over standard-of-care (SOC) treatment in patients with estrogen receptor–positive, HER2-negative breast cancer, including those whose tumors harbored ESR1 mutations, meeting the primary end points of the phase 3 EMERALD trial.
N-803 Plus Intravesical BCG Produces 57% DFS in BCG-Unresponsive Papillary Bladder Cancer
October 20th 2021Intravesical Bacillus Calmette–Guérin in combination with N-803 resulted in a 12-month disease-free survival rate of 57% in patients with BCG-unresponsive high-grade papillary non–muscle invasive bladder cancer, meeting the primary end point for cohort B of the phase 2/3 QUILT 3.032 trial.
Digital Health and Process Improvements Enhance Community-Based Patient Care
October 20th 2021A marked reduction in hospitalizations and emergency department visits are key metrics for value-based care programs. Quality improvement processes and electronic patient management systems may give practices a way to fully embrace these programs and remain mindful of cost while ensuring that patients receive high-quality care.