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Plus Therapeutics Announces Data From ReSPECT-LM Phase 1 Single Dose Escalation Trial Presented At The SNO/ASCo CNS Metastases Conference, Showing Reyobiq Is Feasible, With Manageable Safety Profile, And Shows Efficacy Signal For Leptomeningeal Metastases Patients
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Presented Data Highlights:

  • Radiographic and clinical response rate of 76% and 87%, respectively, through day 112
  • CSF tumor cell enumeration (TCE) assays (CNSide test) showed a maximum reduction over baseline of 100% at day 28
  • Five of the 7 patients with a TCE response >80% survived at least 1 year
  • RNA sequencing of LM cells showed early induction of apoptosis, with an innate immune response followed by an adaptive immune response by day 28
  • Median overall survival of 9 months across cohorts 1-4 (20 patients) months, comparing favorably with literature reports of ~4 months
  • No dose-limiting toxicity (DLT) was observed in cohorts 1-4, with 1 DLT in each of cohorts 5 and 6 of grade 4 cytopenia
  • The majority of adverse events across the trial were Grade 1 and 2
  • Mean absorbed dose to the cranial and spinal subarachnoid space was 272 Gy in cohort 6  
  • A recommended phase 2 single dose of 44.1 mCi was determined  
     
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