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ImMix Biophma在IMS第20届年会上宣布在NXC-201临床试验中对第9名复发/难治性AL淀粉样变性患者的完全缓解
2023-10-03 21:16
- 100% (9/9) overall response rate and 67% (6/9) complete response rate (MRD 10-5) observed in heavily pre-treated patients with daratumumab relapsed/refractory AL Amyloidosis as of the September 20, 2023 data cutoff
- 100% (4/4) overall response rate and 75% (3/4) complete response rate observed in t(11;14) relapsed/refractory AL Amyloidosis
- Best responder duration of response was 19.2 months with response ongoing; median follow-up of 7.3 months (range: 2.5 – 16.5 months) as of the data cutoff date of September 20, 2023
- ImmixBio plans to submit a BLA for FDA approval in AL Amyloidosis once 40 patients are treated with NXC-201
- The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate
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