Citations 2
Safety and efficacy of pralsetinib in patients with advanced RET fusion-positive non-small cell lung cancer: Update from the ARROW trial.
Gainor, Justin F. , Griesinger, Frank , Thomas, Michael , Baik, Christina S. , Tan, Daniel Shao-Weng , Misch, Daniel, Garralda, Elena , Paz‐Ares, Luis , Kalemkerian, Gregory P. , Houvras, Yariv , Zalutskaya, Alena , Curigliano, Giuseppe , Subbiah, Vivek , Lee, Ki Hyeong , Kim, Dong‐Wan , Mazières, Julien , Liu, Stephen V. , Bowles, Daniel W. , Mansfield, Aaron S. , Zalutskaya, Alena A. , Wekken, Anthonie J. van der
Journal of Clinical Oncology | June 2, 2021 | Volume: 39 | Issue: 15_suppl | Pages: 9089-9089
10.1200/jco.2021.39.15_suppl.9089
9089 Background: RET fusions are targetable oncogenic drivers in 1–2% of non-small cell lung cancer (NSCLC). ARROW (NCT03037385) supported the US FDA approval of pralsetinib, a highly potent oral selective RET inhibitor for RET-altered NSCLC and thyroid cancer. Here, we present updated results for a larger population of patients with RET fusion–positive NSCLC enrolled in ARROW. Methods: ARROW is a phase 1/2 open-label study conducted at 84 sites in 13 countries. Phase 2 expansion cohorts included patients with RET fusion–positive NSCLC. Initially, all treatment-naïve patients were not candidates for platinum-based therapy, a requirement removed by protocol amendment in July 2019. Primary objectives are overall response rate (ORR; blinded independent central review [BICR] per RECIST v1.1), assessed for patients with baseline measurable disease, and safety. Results: Updated analyses were completed as of Nov 6, 2020 (data cut-off), for patients who initiated pralsetinib 400 mg QD by May 22, 2020 (enrollment cut-off). Efficacy results, including analyses for treatment-naïve patients enrolled after eligibility criteria were revised to allow candidates for platinum-based therapy, are shown in the Table. Conclusions: Pralsetinib showed rapid, potent, and durable clinical activity in patients with RET fusion-positive NSCLC (regardless of prior therapies), including poor prognosis patients not eligible for platinum-based therapy. Overall, pralsetinib was well-tolerated. These data highlight the need for RET testing early in the course of disease to identify candidates who may benefit from treatment with pralsetinib. Clinical trial information: NCT03037385. [Table: see text]
Anakinra usage in febrile infection related epilepsy syndrome: an international cohort
Lai, Yi‐Chen , Muscal, Eyal , Wells, Elizabeth, Shukla, Nikita , Eschbach, Krista , Kaliakatsos, Marios , Desai, Nevedita, Wickström, Ronny , Viri, Maurizio , Freri, Elena , Granata, Tiziana , Nangia, Srishti, Brunklaus, Andreas , Wainwright, Mark S. , Gorman, Mark , Stredny, Coral M. , Asiri, Abdurhman, Hundallah, Khalid , Payne, Eric T. , Koh, Sookyong , Carpenter, Jessica L. , Riviello, James J. , Wainwright, Mark S , Brunklaus, Andreas , Lai, Yi-Chen , Eschbach, Krista , Shukla, Nikita Malani , Lee, Ki Hyeong , Dilena, Robertino , Doja, Asif , Wirrell, Elaine
Annals of Clinical and Translational Neurology | December 4, 2020 | Volume: 7 | Issue: 12 | Pages: 2467-2474
AbstractFebrile‐infection related epilepsy syndrome (FIRES) is a devastating neurological condition characterized by a febrile illness preceding new onset refractory status epilepticus (NORSE). Increasing evidence suggests innate immune dysfunction as a potential pathological mechanism. We report an international retrospective cohort of 25 children treated with anakinra, a recombinant interleukin‐1 receptor antagonist, as an immunomodulator for FIRES. Anakinra was potentially safe with only one child discontinuing therapy due to infection. Earlier anakinra initiation was associated with shorter duration of mechanical ventilation, ICU and hospital length of stay. Our retrospective data lay the groundwork for prospective consensus‐driven cohort studies of anakinra in FIRES.