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
FDA Approves Label Updates to Include New Data for Axi-Cel in LBCL, Zanubrutinib in CLL
December 22nd 2023The FDA has approved label updates for zanubrutinib to include data from the ALPINE trial in relapsed/refractory chronic lymphocytic leukemia, and axicabtagene ciloleucel to include findings from the primary overall survival analysis of the ZUMA-7 trial in relapsed/refractory large B-cell lymphoma.
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sBLA and NDA Submitted to FDA for Amivantamab and Lazertinib in EGFR-Mutant NSCLC
December 21st 2023A supplemental biologics license application and new drug application seeking the approval of amivantamab plus lazertinib as frontline therapy for the treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations have been submitted to the FDA.
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The combination of pembrolizumab and lenvatinib failed to produce a statistically significant improvement in progression-free survival and overall survival vs platinum-based chemotherapy with carboplatin and paclitaxel as frontline therapy in patients with advanced or recurrent endometrial cancer whose disease in mismatch repair proficient/not microsatellite instability–high or mismatch repair deficient.
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Ide-Cel Wins Japanese Approval in Early Relapsed/Refractory Multiple Myeloma
December 14th 2023Idecabtagene vicleucel has received marketing and manufacturing approval in Japan for its supplemental new drug application in patients with relapsed/refractory multiple myeloma who have received at least 2 prior lines of therapy.
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DZD8586 Demonstrates Responses Across Dose Levels in B-Cell Non-Hodgkin Lymphoma
December 13th 2023DZD8586 showcased antitumor activity and favorable safety with limited grade 3 or greater treatment-emergent adverse effects in patients with heavily pretreated B-cell non-Hodgkin lymphoma, according to preliminary findings from a pooled analysis of two ongoing phase 1 trials.
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Taking Trial Data to the Clinic in MPN and CLL From ASH 2023: Drs Rogers, Brown, and Shammo
December 13th 2023OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 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 oncology during the conference.
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D-VRd Improves PFS in Newly Diagnosed, Transplant-Eligible Multiple Myeloma
December 12th 2023Induction therapy with subcutaneous daratumumab followed by autologous stem cell transplant, daratumumab, bortezomib, lenalidomide, and dexamethasone consolidation and daratumumab/lenalidomide maintenance prolonged progression-free survival in patients with newly diagnosed, transplant-eligible multiple myeloma.
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Looking at the Latest Data in Multiple Myeloma and Lymphoma From ASH 2023: Drs Landgren and Saeed
December 12th 2023OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 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 oncology during the conference.
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Making the Most of New Data in MPN, Leukemia, and GVHD From ASH 2023: Drs Ponce and Hobbs
December 11th 2023OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 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 oncology during the conference.
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MRD-Guided Ibrutinib Plus Venetoclax Improves Survival in Treatment-Naive CLL
December 10th 2023Ibrutinib plus venetoclax, given at a duration determined by minimal residual disease, improved progression-free survival and overall survival vs fludarabine, cyclophosphamide, and rituximab in patients with treatment-naive chronic lymphocytic leukemia.
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Orca-T Demonstrates Feasibility in Older Patients With Hematologic Malignancies
December 10th 2023The use of Orca-T with myeloablative chemotherapy conditioning had comparable safety and efficacy in younger and older patients with hematologic malignancies, according to data from a phase 1b study.
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Neoadjuvant Nivolumab Plus Carboplatin/Paclitaxel Elicits High pCR Rates in Early-Stage TNBC
December 8th 2023Neoadjuvant nivolumab and non–anthracycline containing chemotherapy produced promising pathologic complete response rates regardless of whether nivolumab was administered before or during treatment with carboplatin and paclitaxel in patients with stage I to IIB triple-negative breast cancer.
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Nivolumab Plus Ipilimumab Improves PFS in Newly Diagnosed Metastatic Colorectal Cancer
December 7th 2023The combination of nivolumab and ipilimumab led to a statistically significant and clinically meaningful improvement in progression-free survival per blinded independent central review compared with investigator’s choice of chemotherapy as frontline therapy in patients with metastatic colorectal cancer.
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FDA Approves Pirtobrutinib for Previously Treated CLL/SLL
December 1st 2023The FDA has granted an accelerated approval to pirtobrutinib for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL2 inhibitor.
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The FDA has granted fast track designation to zotatifin for use in combination with fulvestrant and abemaciclib as second- or third-line therapy for the treatment of patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer with disease progression following treatment with endocrine therapy and a CDK4/6 inhibitor.
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Nadofaragene Firadenovec Induces Durable Activity in High-Risk, BCG-Unresponsive NMIBC With CIS
November 29th 2023Nadofaragene firadenovec-vncg led to encouraging rates of high-grade recurrence-free survival and overall survival in patients with high-risk, BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
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Telisotuzumab Vedotin Meets Clinical End Points in LUMINOSITY Trial in Previously Treated NSCLC
November 29th 2023Telisotuzumab vedotin produced meaningful response rates and other clinically relevant outcomes in patients with c-Met protein overexpressed, EGFR wild-type, advanced or metastatic nonsquamous non–small cell lung cancer.
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CHMP Supports Approval of Subcutaneous Atezolizumab for All Current IV Indications
November 14th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of subcutaneous atezolizumab for all indications in which the intravenous formulation is approved, including certain types of lung, liver, bladder, and breast cancer
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Research Aims to Make Inroads With CAR T-Cell Therapy in Advanced RCC
November 11th 2023Although not immediately practice changing, CAR T-cell therapy has the potential to become a standard of care for patients with advanced renal cell carcinoma following progression on checkpoint inhibitors and VEGF inhibitors.
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Multimodal Care Marks the Past, Present, and Future of Localized Breast Cancer Management
November 10th 2023Improvements in screening, systemic therapy, and precision medicine have reduced breast cancer mortality and morbidity, and further progress will hinge on the use of ctDNA and CTCs for disease monitoring, continued development of novel antiestrogenic agents, and movement of ADCs and immunotherapy into expanded settings and indications.
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The FDA has updated the current indication for pembrolizumab plus trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma to those whose tumors express PD-L1 with a CPS of 1 or more.
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Frontline Pyrotinib Plus Trastuzumab and Docetaxel Improves PFS in HER2+ Metastatic Breast Cancer
November 8th 2023The addition of pyrotinib to trastuzumab and docetaxel led to a significant improvement in progression-free survival compared with placebo plus trastuzumab and docetaxel in patients with newly diagnosed, HER2-positive metastatic breast cancer.
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Indirect Treatment Comparison Indicates Improved OS With Brexu-Cel in BTK Inhibitor–Exposed R/R MCL
October 30th 2023Brexucabtagene autoleucel demonstrated an improvement in overall survival vs standard of care therapy in patients with relapsed/refractory mantle cell lymphoma following prior exposure to a BTK inhibitor, according to data from an indirect treatment comparison of findings from the phase 2 ZUMA-2 trial and retrospective SCHOLAR-2 trial.
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OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 ESMO Congress. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.
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Frontline Amivantamab Plus Lazertinib Bests Osimertinib in Advanced EGFR+ NSCLC
October 23rd 2023The combination of amivantamab and lazertinib reduced the risk of disease progression or death by 30% compared with osimertinib alone as frontline therapy for patients with advanced non–small cell lung cancer harboring classical EGFR sensitizing mutations.
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