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
HER3+ CTC Count May Affect Responses to Patritumab Deruxtecan in Pretreated Advanced Breast Cancer
June 1st 2023Higher baseline HER3-positive circulating tumor cell count at baseline and reduction following treatment initiation was associated with a higher likelihood of deriving an early response with patritumab deruxtecan in patients with hormone receptor–positive or HER2-low advanced breast cancer.
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EMA Recommends Approval of Neoadjuvant Nivolumab/Chemotherapy in Resectable NSCLC
May 26th 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab as neoadjuvant therapy in combination with platinum-based chemotherapy for patients with resectable non–small cell lung cancer at high risk of recurrence and tumor cell PD-L1 expression of at least 1%.
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NCCN Guidelines Endorse FES PET for Workup of Recurrent/Metastatic ER+ Breast Cancer
May 25th 2023The National Comprehensive Cancer Network Guidelines now recommend the use of 18F-Fluorestradiol positron emission tomography in certain circumstances during the systemic staging workup for patients with recurrent or metastatic for estrogen receptor–positive breast cancer.
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NCCN Guidelines List Ropeginterferon Alfa-2b as Preferred Treatment in Polycythemia Vera
May 24th 2023The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology have been revised to include ropeginterferon alfa-2b-njft as a preferred treatment option for patients with high- and low-risk polycythemia vera, irrespective of treatment history.
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ECLIPSE PV Trial Begins Ropeginterferon Alfa-2b Dosing in Polycythemia Vera
May 15th 2023The first patients have been dosed in the phase 3b ECLIPSE PV trial, which is evaluating an accelerated dosing schedule of ropeginterferon alfa-2b-njft for the treatment of patients with polycythemia vera.
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Preoperative treatment with atezolizumab, epirubicin, trastuzumab, and pertuzumab led to improved rates of pathologic complete response and decreased residual cancer burden compared with trastuzumab, pertuzumab, and chemotherapy alone in patients with early-stage HER2-positive breast cancer, according to findings from the randomized phase 2 ATHENE trial.
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Treatment with trastuzumab deruxtecan resulted in lower exposure-adjusted incidence rates per patient-year of treatment-emergent adverse effects compared with treatment of physician’s choice in patients with HER2-low unresectable and/or metastatic breast cancer, according to safety analysis from the phase 3 DESTINY-Breast04 trial.
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Mirvetuximab Soravtansine Improves PFS, OS in FRα+ Platinum-Resistant Ovarian Cancer
May 3rd 2023Mirvetuximab soravtansine-gynx led to a clinically meaningful and statistically significant improvement in progression-free survival, overall survival, and objective response rate vs single-agent chemotherapy in patients with platinum-resistant ovarian cancer whose tumors express high levels of folate receptor alpha, according to topline findings from the phase 3 MIRASOL trial.
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Iptacopan Meets Primary End Point of APPOINT-PNH Trial in Paroxysmal Nocturnal Hemoglobinuria
April 26th 2023Iptacopan elicited improved hemoglobin levels measuring at least 2 g/dL higher vs baseline, leading to transfusion independence after 24 weeks in approximately 92.2% of patients with complement inhibitor–naïve paroxysmal nocturnal hemoglobinuria.
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The European Medicines Agency has validated a type II variation for potential approval of dostarlimab in combination with carboplatin and paclitaxel for the treatment of patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.
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Leaked data from an abstract scheduled to be presented at the 2023 EHA Hybrid Congress showed that ciltacabtagene autoleucel demonstrated a 74% reduction in the risk of disease progression or death compared with standard therapy in patients with relapsed/refractory multiple myeloma who received 1 to 3 prior lines of therapy.
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The combination of PARP and ATR inhibition with olaparib and ceralasertib was tolerable but showed limited efficacy in pediatric patients with advanced malignancies harboring DNA replication stress and DNA repair deficiencies, according to findings from arm N of the phase 1/2 AcSé-ESMART trial.
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REGN5459 Delivers Dose-Dependent Responses in Relapsed/Refractory Myeloma
April 17th 2023The BCMA- and CD3-directed bispecific antibody REGN5459 led to fast onset, deep, and dose-dependent responses sustained over time, with a high frequency of manageable low-grade cytokine release syndrome in patients with relapsed/refractory multiple myeloma.
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Perioperative Durvalumab Plus Neoadjuvant Chemo Improves pCR, EFS in Resectable NSCLC
April 16th 2023Perioperative durvalumab plus neoadjuvant platinum-based chemotherapy demonstrated a statistically significant improvement in pathologic complete response and event-free survival vs placebo plus chemotherapy in patients with resectable non–small cell lung cancer.
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FDA Accepts sBLA for Pembrolizumab Plus Chemotherapy in Advanced Gastric/GEJ Adenocarcinoma
April 13th 2023The FDA has accepted for review a supplemental biologics license application for pembrolizumab plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
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FDA Grants Orphan Drug Designation to Osemitamab for Pancreatic Cancer
April 10th 2023The FDA has granted an orphan drug designation to osemitamab for the treatment of patients with pancreatic cancer, marking the second ODD for the agent following its initial designation in 2021 for use in those with gastric and gastroesophageal junction cancer.
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FDA Accepts BLA for Trastuzumab Biosimilar in HER2+ Breast Cancer, Gastric/GEJ Cancer
April 5th 2023The FDA has accepted a biologics license application for the HLX02, a proposed trastuzumab biosimilar, as adjuvant therapy for patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
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FDA Accepts sNDAs for Encorafenib and Binimetinib in BRAF V600E–Mutant NSCLC
April 4th 2023The FDA has accepted for review supplemental new drug applications for the combination of encorafenib and binimetinib for the treatment of patients with metastatic non–small cell lung cancer harboring a BRAF V600E mutation, as detected by an FDA-approved test.
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The use of 4 cycles of chemotherapy plus durvalumab with or without tremelimumab-actl was associated with improved or sustained response and similar toxicity compared with chemotherapy alone as frontline therapy in patients with metastatic non–small cell lung cancer, according to post hoc exploratory findings from the phase 3 POSEIDON trial.
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Liso-cel Receives European Approval Recommendation for Relapsed/Refractory LBCL
March 31st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of lisocabtagene maraleucel for the treatment of select patients with large B-cell lymphoma who relapsed within 12 months from completion of or developed refractory disease to frontline chemoimmunotherapy.
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