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NEWS
Plus Therapeutics Presents Positive ReSPECT-LM Phase 1 Interim Data for Breast Cancer Patients with Leptomeningeal Metastases at the 2024 San Antonio Breast Cancer Symposium
Tuesday, 17th December at 7:30 am
Single intrathecal dose of Rhenium (186Re) Obisbemeda delivers favorable responses in cerebrospinal fluid circulating tumor cell count, imaging, and clinical evaluation
Both single-dose and multiple-dose expansion trials planned in 2025
AUSTIN, Texas, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (NASDAQ: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, presented data updating the progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM) with a specific focus on breast cancer patients. The data were presented at the 2024 San Antonio Breast Cancer Symposium on December 10-13.
The data were presented in a session titled "Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) for the Treatment of Leptomeningeal Metastases (LM): Update on Phase 1 Dose Escalation Study," by Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, San Antonio.
Key Highlights from the Presentation:
• Nine of 20 patients with LM primary breast cancer were treated and evaluable through five dose escalation cohorts, with the maximum tolerated dose yet to be reached
• Primary breast cancer biomarker status across the 9 patients were:
◦ ER positive/HER2 negative: n=3
◦ HER2 positive: n=2
◦ Triple negative: n=4
• Patients received a single intrathecal dose of Rhenium (186Re) Obisbemeda, ranging from 6.6 to 66.14 mCi of radiation
• Only one dose-limiting toxicity (thrombocytopenia) was reported (Cohort 5)
• A linear increase in absorbed dose was observed from Cohorts 1 through 5, with an average absorbed dose of 253 Gy to the cranial subarachnoid space in Cohort 5
• Circulating tumor cell (CTC) and radiographic (MRI) response data were available for 8 of the 9 breast cancer patients with LM, and clinical response data were available for 7 of the 9 patients
◦ Best response rates (response only) were:
CTC: 88% (7/8)
MRI imaging: 25% (2/8)
Clinical: 29% (2/7)
◦ Clinical benefit rates (response and stable disease) were:
CTC: 100% (8/8)
MRI imaging: 75% (6/8)
Clinical: 71 % (5/7)
• Median overall survival for 9 breast cancer patients was 9 months, with 2 patients surviving beyond 600 days post-treatment
Next steps:
• Initiate ReSPECT-LM Phase 1b single-dose breast expansion cohort in Q1 2025 to further evaluate single-dose safety and efficacy of Rhenium (186Re) Obisbemeda
Tuesday, 17th December at 7:30 am
Single intrathecal dose of Rhenium (186Re) Obisbemeda delivers favorable responses in cerebrospinal fluid circulating tumor cell count, imaging, and clinical evaluation
Both single-dose and multiple-dose expansion trials planned in 2025
AUSTIN, Texas, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (NASDAQ: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, presented data updating the progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM) with a specific focus on breast cancer patients. The data were presented at the 2024 San Antonio Breast Cancer Symposium on December 10-13.
The data were presented in a session titled "Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) for the Treatment of Leptomeningeal Metastases (LM): Update on Phase 1 Dose Escalation Study," by Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, San Antonio.
Key Highlights from the Presentation:
• Nine of 20 patients with LM primary breast cancer were treated and evaluable through five dose escalation cohorts, with the maximum tolerated dose yet to be reached
• Primary breast cancer biomarker status across the 9 patients were:
◦ ER positive/HER2 negative: n=3
◦ HER2 positive: n=2
◦ Triple negative: n=4
• Patients received a single intrathecal dose of Rhenium (186Re) Obisbemeda, ranging from 6.6 to 66.14 mCi of radiation
• Only one dose-limiting toxicity (thrombocytopenia) was reported (Cohort 5)
• A linear increase in absorbed dose was observed from Cohorts 1 through 5, with an average absorbed dose of 253 Gy to the cranial subarachnoid space in Cohort 5
• Circulating tumor cell (CTC) and radiographic (MRI) response data were available for 8 of the 9 breast cancer patients with LM, and clinical response data were available for 7 of the 9 patients
◦ Best response rates (response only) were:
CTC: 88% (7/8)
MRI imaging: 25% (2/8)
Clinical: 29% (2/7)
◦ Clinical benefit rates (response and stable disease) were:
CTC: 100% (8/8)
MRI imaging: 75% (6/8)
Clinical: 71 % (5/7)
• Median overall survival for 9 breast cancer patients was 9 months, with 2 patients surviving beyond 600 days post-treatment
Next steps:
• Initiate ReSPECT-LM Phase 1b single-dose breast expansion cohort in Q1 2025 to further evaluate single-dose safety and efficacy of Rhenium (186Re) Obisbemeda
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