Editor, OncLive®
Caroline Seymour is your initial point of contact for the OncLive® podcast, OncLive On Air™. She joined the company in 2018 as an assistant editor, with expertise in video production and print/digital publication. Email: cseymour@onclive.com
Olverembatinib Delivers Durable Responses in T315I-Mutant, TKI-Resistant CML, Ph+ ALL
December 23rd 2022Olverembatinib demonstrated sustained efficacy and reduced toxicity with longer follow-up in patients with TKI-resistant, T315I-mutant chronic myeloid leukemia in chronic phase and accelerated phase.
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FDA Approves FoundationOne® Liquid CDx as a Companion Diagnostic for TKIs in EGFR-Mutant NSCLC
December 21st 2022The FDA has approved the FoundationOne® Liquid CDx as a companion diagnostic to identify patients with non–small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R substitutions.
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Durvalumab Misses OS End Point in PEARL Trial in Advanced, PD-L1–High NSCLC
December 19th 2022Durvalumab monotherapy failed to elicit a statistically significant improvement in overall survival vs platinum-based chemotherapy as frontline treatment in patients with stage IV non–small cell lung cancer with at least 25% positivity of PD-L1 on tumor cells, or in a subgroup of patients at low risk of early mortality.
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European Commission Approves Trastuzumab Deruxtecan in Pretreated HER2+ Advanced Gastric/GEJ Cancer
December 19th 2022The European Commission has approved fam-trastuzumab deruxtecan-nxki as monotherapy for the treatment of patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
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Individualized Maintenance Niraparib Dosing Confers Favorable OS in Recurrent Ovarian Cancer
December 16th 2022The use of an individualized starting dose of niraparib led to a trend toward improved overall survival as maintenance therapy vs placebo in Chinese patients with platinum-sensitive, recurrent ovarian cancer regardless of germline BRCA mutation status, according to data from the phase 3 NORA trial.
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Trastuzumab Deruxtecan sNDA for HER2-Mutant Metastatic NSCLC Submitted for Review in Japan
December 15th 2022Daiichi Sankyo has filed a supplemental new drug application with Japan’s Ministry of Health, Labor, and Welfare for the use of fam-trastuzumab deruxtecan-nxki in adults with previously treated HER2-mutant unresectable advanced or recurrent non–small cell lung cancer.
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Thrombocytopenia Is Associated With Greater Symptom Burden in Myelofibrosis
December 14th 2022Low platelet counts were associated with a greater severity of disease-related symptoms compared with low hemoglobin in patients with myelofibrosis, according to findings from a retrospective analysis of the phase 3 PERSIST-1 and PAC203 trials.
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European Commission Approves Pluvicto for PSMA-Positive mCRPC
December 13th 2022The European Commission has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition, for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.
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FDA Accepts New Drug Application for the Radiopharmaceutical Imaging Kit EVG-001 for NETs
December 13th 2022The FDA has accepted a new drug application for EVG-001, a kit for the preparation of Gallium-68 DOTATOC injection, a radiopharmaceutical approved for imaging of neuroendocrine tumors using positron emission tomography.
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Examining Headway in AML and Multiple Myeloma at ASH 2022: Drs Braunstein and Erba
December 11th 2022OncLive® will be LIVE with OncLive® News Network: On Location at the 2022 ASH Annual Meeting. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across hematologic oncology during the conference.
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REGAL Trial Receives Green Light to Continue Testing Galinpepimut-S in AML
December 9th 2022The phase 3 REGAL trial evaluating galinpepimut-S in patients with acute myeloid leukemia will continue as planned without modifications following a recommendation from the Independent Data Monitoring Committee.
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Everolimus Plus Adjuvant Endocrine Therapy Fails to Improve iDFS, OS in HR+/HER2- Breast Cancer
December 7th 2022The addition of 1 year of everolimus to adjuvant endocrine therapy did not demonstrate a statistically significant improvement in invasive disease-free survival or overall survival in patients with high-risk, hormone receptor–positive, HER2-negative breast cancer.
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Pluvicto Improves rPFS in PSMA-Positive mCRPC
December 5th 2022Treatment with lutetium Lu 177 vipivotide tetraxetan led to a statistically significant and clinically meaningful improvement in radiographic progression-free survival following treatment with an androgen receptor pathway inhibitor in patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.
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FDA Grants Fast Track Designation to Pelareorep for Advanced/Metastatic Pancreatic Cancer
December 1st 2022The FDA has granted a fast track designation to pelareorep for use in combination with atezolizumab, gemcitabine, and nab-paclitaxel for the treatment of patients with advanced or metastatic pancreatic cancer.
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FDA Grants RMAT, Fast Track Designations to CB-010 in Relapsed/Refractory Non-Hodgkin Lymphoma
November 29th 2022The FDA has granted CB-010 a regenerative medicine advanced therapy designation for relapsed/refractory large B-cell lymphoma and a fast track designation for relapsed/refractory B-cell non-Hodgkin lymphoma.
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NICE Recommends Nivolumab/Chemo for HER2- Advanced Stomach and Esophageal Cancer
November 29th 2022The United Kingdom’s National Institute for Health and Care Excellence has issued final guidance recommending the use of nivolumab plus chemotherapy as a treatment option for patients with HER2-negative advanced stomach and esophageal cancer.
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DetermaIO Assay Helps Inform Benefit With Single-Agent Immunotherapy in Advanced NSCLC
November 22nd 2022The score of the 27-gene Determa immune-oncology assay demonstrated a correlation with overall survival and progression-free survival in patients with advanced non–small cell lung cancer treated with single-agent immunotherapy, regardless of performance status.
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Ivonescimab Receives Breakthrough Therapy Designation for IO-Resistant NSCLC in China
November 16th 2022The Center for Drug Evaluation of the China National Medical Products Administration has granted a breakthrough therapy designation to ivonescimab plus docetaxel for patients with locally advanced or metastatic non–small cell lung cancer who failed to respond to a prior PD-(L)1 inhibitor plus platinum-based doublet chemotherapy.
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FDA Approves First IHC Companion Diagnostic for Mirvetuximab Soravtansine in Ovarian Cancer
November 15th 2022The FDA has approved the VENTANA FOLR1 RxDx assay, the first immunohistochemistry companion diagnostic test to help identify patients with epithelial ovarian cancer who are eligible for treatment with mirvetuximab soravtansine-gynx.
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Targeting the ‘New Kids on the Block’ in NSCLC: EGFR Exon 20 and MET Exon 14 Skipping Mutations
November 14th 2022Investigators are harnessing comprehensive molecular profiling to detect new targets, optimize existing treatment regimens, and develop novel therapies for patients with EGFR and MET exon 20–insertion positive non–small cell lung cancer.
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