Managing 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
Neoadjuvant SHR-1701 Increases Response, Resectability in Stage III Unresectable NSCLC
January 8th 2023Neoadjuvant treatment with SHR-1701 with or without chemotherapy followed by surgery or radiotherapy induced responses in more than half of patients with stage III unresectable non–small cell lung cancer and increased resectability in those assigned to definitive surgery.
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TAVT-45 Granules Show Equivalence to Abiraterone Tablets in Metastatic Prostate Cancer
January 5th 2023Abiraterone acetate granules for oral suspension demonstrated therapeutic equivalence and comparable safety to the original formulation of abiraterone acetate in patients with metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
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FDA Approval Sought for Cosibelimab in Advanced Cutaneous Squamous Cell Carcinoma
January 4th 2023A biologics license application has been submitted to the FDA seeking the approval of cosibelimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.
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FDA Grants Breakthrough Device Designation to OverC Multi-Cancer Detection Blood Test
January 4th 2023The FDA has granted a breakthrough device designation to the OverC Multi-Cancer Detection Blood Test for the early detection of cancers including esophageal, liver, lung, ovarian, and pancreatic in adults aged to 50 to 75 years with average risk.
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EMA Committee Advises Against Approval of Omburtamab for Neuroblastoma
January 3rd 2023The European Committee for Medicinal Products for Human Use has announced that it does not support the marketing authorization of omburtamab for the treatment of patients with central nervous system/leptomeningeal metastasis from neuroblastoma.
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PDS0101-Based Triplet Produces Prolonged OS in Refractory HPV+ Cancers
January 3rd 2023Treatment with PDS0101 plus the tumor-targeting IL-12 fusion protein M9241 and bintrafusp alfa elicited encouraging overall survival data in patients with checkpoint inhibitor–naïve and –refractory advanced human papillomavirus–positive anal, cervical, head and neck, vaginal, and vulvar cancer.
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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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