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.
Key Markers in Gut Microbiome May Predict Skin-Related AEs With Nivolumab in Advanced Gastric Cancer
January 20th 2022The presence of Arthrobacter and fatty acid metabolism pathways in gut microbiomes may be linked to an increased risk of skin-related adverse events in patients with advanced gastric cancer who are receiving single-agent nivolumab.
Neoadjuvant Nivolumab/Ipilimumab Produces High pCR Rate in MSI/dMMR Oeso-Gastric Adenocarcinoma
January 20th 2022Neoadjuvant nivolumab plus ipilimumab followed by adjuvant nivolumab elicited a pathologic complete response rate of 59% in patients with resectable microsatellite instable or mismatch repair deficient oeso-gastric junction adenocarcinoma.
Trastuzumab Deruxtecan Upholds 40% Improvement in OS in HER2+ Advanced Gastric/GEJ Cancer
January 20th 2022Fam-trastuzumab deruxtecan-nxki demonstrated a 40% reduction in the risk of death compared with standard chemotherapy in patients with HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma.
Idecabtagene Vicleucel Approved in Japan for Relapsed/Refractory Multiple Myeloma
January 20th 2022The Japanese Ministry of Health, Labour, and Welfare has approved idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 3 therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have progressed on their last therapy or relapsed following their last therapy.
Sugemalimab Plus Chemo Significantly Improves Survival in Frontline Stage IV NSCLC
January 19th 2022The addition of the PD-L1 inhibitor sugemalimab to chemotherapy significantly improved overall survival compared with chemotherapy alone in the frontline treatment of patients with stage IV non–small cell lung cancer.
FDA Grants Fast Track Designation to Gedatolisib for Metastatic Breast Cancer
January 19th 2022The FDA has granted a fast track designation to gedatolisib for use as a potential therapeutic option in patients with hormone receptor–positive, HER2-negative metastatic breast cancer who experienced disease progression on CDK4/6 therapy.
Venetoclax Shows Impressive Activity in Relapsed/Refractory Waldenström Macroglobulinemia
January 19th 2022Venetoclax proved to be safe and highly active when used in patients with relapsed or refractory Waldenström macroglobulinemia, including those who previously received BTK inhibitors and those harboring CXCR4 mutations.
Investigators Navigate the Complicated Treatment Landscape of Chemotherapy-Induced Neutropenia
January 19th 2022Advances in the treatment of solid tumors and hematologic malignancies have resulted in the development of thera-peutic regimens that can be administered at various points in a patient’s care.
Novel Oncolytic Immunotherapy Aims to Address Unmet Therapeutic Need for Anti–PD-1 Refractory Tumors
January 19th 2022Investigators have taken strides to genetically engineer novel oncolytic immunotherapies that synergize with existing immunotherapies to maximize antitumor response in anti–PD-1 refractory tumors.
Durvalumab Plus Tremelimumab Improves OS in Unresectable HCC
January 18th 2022The combination of durvalumab and tremelimumab demonstrated a significant improvement in overall survival vs sorafenib as frontline therapy in patients with unresectable hepatocellular carcinoma, according to findings from the phase 3 HIMALAYA trial.
Durvalumab Plus Chemotherapy Improves Survival in Advanced Biliary Tract Cancer
January 18th 2022Treatment with the PD-L1 inhibitor durvalumab in combination with gemcitabine and cisplatin resulted in significantly improved overall survival vs placebo plus chemotherapy in patients with advanced biliary tract cancer.
SIMBA Therapy Encounters Barriers But Holds Promise for Neutropenia and Beyond
January 18th 2022Hope S. Rugo, MD, FASCO, Rita Nanda, MD, William J. Gradishar, MD, and Tiffany A. Traina, MD discuss the selective immunomodulating microtubule-binding agent plinabulin, plus several other novel chemoprotective therapies under exploration, including trilaciclib.
Accredited Program Makes Young Man’s CRC a Distant Memory
January 18th 2022Trevor Batey was enjoying the first years of marriage and his work as a truck driver when cancer put the brakes on his life. He was in his early 20s when he saw blood in his stool, had a colonoscopy, and was diagnosed with colorectal cancer.
FDA Grants Fast Track Designation to CYNK-101 for HER2+ Gastric/GEJ Cancers
January 18th 2022The FDA has granted a fast track designation to CYNK-101 in combination with standard frontline chemotherapy, trastuzumab, and pembrolizumab for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Luspatercept Under Exploration in Myeloproliferative Neoplasm–Associated Myelofibrosis
January 17th 2022The safety and efficacy of luspatercept vs placebo is under exploration in patients with myeloproliferative neoplasm–associated myelofibrosis who are receiving concomitant JAK2 inhibitor therapy and who require red blood cell transfusions, as part of the phase 3 INDEPENDENCE trial.
NHS Scotland Accepts Trastuzumab Deruxtecan for Use in HER2+ Metastatic Breast Cancer
January 17th 2022The Scottish Medicines Consortium has accepted fam-trastuzumab deruxtecan-nxki as a treatment option for adult patients with HER2-positive unresectable or metastatic breast cancer who have previously received 2 or more anti–HER2-based therapies.