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.
Janku Highlights PFS Benefit With Dose-Escalated Ripretinib in Advanced GIST
December 15th 2020Filip Janku, MD, PhD highlighted a dose-escalated approach of ripretinib and how it yielded a progression-free survival benefit in patients with gastrointestinal stromal tumor across all lines of treatment in a phase 1 study.
Trastuzumab Deruxtecan Approaches EU Approval for HER2+ Metastatic Breast Cancer
December 15th 2020December 15, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2–based regimens.
Fixed-Dose Durvalumab Nears EU Approval for Unresectable NSCLC
December 15th 2020December 15, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for an additional dosing option of durvalumab, a fixed dose of 1500 mg every 4 weeks, in the approved indication of locally advanced, unresectable non–small cell lung cancer in adults whose tumors have a PD-L1 expression of at least 1% and who did not have progressive disease after platinum-based chemoradiation treatment.
TNBC Treatment Paradigm Advances With the Rise of Chemoimmunotherapy Combos
December 15th 2020Neelima Vidula, MD, highlights some of the pivotal trials evaluating immunotherapy combination regimens in triple-negative breast cancer, some of the challenges faced in practice, and areas for further exploration.
Overcoming Clinical Challenges Associated With TP53-Mutant MDS, AML
December 15th 2020TP53-mutant myelodysplastic syndromes and acute myeloid leukemia represent a molecularly distinct, poor-risk patient subgroup frequently associated with complex karyotypes, high propensity for relapse, and inferior overall survival.
Halmos Zeroes in on Year Ahead for Lung Cancer Treatment
December 15th 2020Balazs Halmos, MD discusses the year 2021 and how it will encompass a bigger focus on neoadjuvant and adjuvant trials, more novel molecular compounds for more select subgroups, and a migration of circulating tumor DNA into a more minimal residual disease–based setting.
Immunotherapy Finds a Foothold in Metastatic Bladder Cancer, But Frontline Challenges Remain
December 14th 2020The emergence of checkpoint inhibitors has transformed the second-line treatment of patients with metastatic bladder cancer. However, questions regarding the utility of immunotherapy in the frontline setting remain unanswered, leaving chemotherapy as the standard-of-care option.
Immunotherapy Finds a Role in Frontline Small Cell Lung Cancer and Mesothelioma
December 14th 2020Checkpoint inhibitors have failed to improve progression-free survival and overall survival as second-line therapy and maintenance therapy in small cell lung cancer, but this class of agents continue to show encouraging activity worthy of a paradigm shift up front.
PARP Inhibitors Pave the Way to Cure in Ovarian Cancer
December 14th 2020Following the results of the SOLO-1 trial, maintenance PARP inhibitors have become the standard of care for patients with BRCA-mutated ovarian cancer but overall survival data are needed to confirm their potentially curative benefit.
Neratinib Improves PFS in HER2+ Breast Cancer With Brain Metastases
December 14th 2020December 14, 2020 - The combination of neratinib and capecitabine showed a 34% reduction in the risk of disease progression or death compared with lapatinib and capecitabine in patients with HER2-positive breast cancer who had central nervous system metastases at baseline.
MSI-H GI and Endometrial Tumors Show High Immunogenicity With Frameshift Mutations
December 14th 2020December 14, 2020 - Microsatellite instability–high tumors in patients with endometrial, colorectal, and stomach carcinomas were found to be enriched in recurrent shared, immunogenic, tumor-specific frameshifts expressed on RNA and protein levels.
Biomarkers Drive ICIs in Colon Cancer
December 14th 2020December 14, 2020 - Immunotherapy agents have shown efficacy in malignant melanoma, kidney cancer, and non–small cell lung cancer, and investigators are examining the efficacy of checkpoint inhibitors in less immunogenic tumors such as colon cancer, particularly in tumors with high microsatellite instability and deficient mismatch repair genes.
Sacituzumab Govitecan Improves PFS in Metastatic TNBC With Brain Metastases
December 11th 2020December 11, 2020 - Sacituzumab govitecan increased response rates and improved progression-free survival vs chemotherapy in patients with metastatic triple-negative breast cancer with stable brain metastases, although no overall survival improvement was observed.
ctDNA Emerges as a Biomarker for Response, Outcomes in High-Risk Early Breast Cancer
December 11th 2020December 11, 2020 - The presence of circulating tumor DNA following neoadjuvant chemotherapy with or without pembrolizumab was a biomarker for response and distant recurrence-free survival in patients with high-risk early-stage breast cancer.
EU Panel Recommends Tucatinib for Locally Advanced or Metastatic HER2+ Breast Cancer
December 11th 2020December 11, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to tucatinib in combination with trastuzumab and capecitabine for use in adult patients with HER2-positive, locally advanced or metastatic breast cancer who had received at least 2 previous anti-HER2 therapies.
Plinabulin/Pegfilgrastim Shows 53% Efficacy Rate in Preventing Profound Neutropenia
December 11th 2020December 11, 2020 - The combination of plinabulin and pegfilgrastim was 53% more effective in reducing the incidence of profound neutropenia compared with pegfilgrastim alone in patients undergoing chemotherapy, according to full findings of the phase 3 PROTECTIVE-2 trial.
Frontline Pembrolizumab Granted Positive EU Opinion in Metastatic MSI-H, dMMR CRC
December 11th 2020December 11, 2020 - The European Medicine Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for pembrolizumab monotherapy for the frontline treatment of adult patients with metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.
AI-Based Analysis Enhances Prediction of Best Responders for Trastuzumab Deruxtecan
December 11th 2020December 11, 2020 - Use of a novel HER2 quantitative continuous score was better able to provide an objective and quantitative assessment of HER2 expression to identify patients who are most likely to respond to fam-trastuzumab deruxtecan-nxki.
Oncolytic Viral Therapy: A Unique Approach to Explore in GI Cancers
December 11th 2020December 11, 2020 - Oncolytic viral therapy has been heavily investigated across oncology, but plenty of work still lies ahead to determine how this treatment approach can be applied in gastrointestinal malignancies.