Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

New Randomized Romidepsin vs Romidepsin/Pralatrexate RR PTCL P3

ClinicalTrials.gov Identifier: NCT01947140
The sponsor is Columbia University. It will recruit 102 pts w PFS as the primary endpoint. They are the ones currently running the P1/2 study for the same drug and indication; the P1 part of it was to determine the MTD; the P2 part to see if there is efficacy. The P1/2 was initially recruiting 57 pts and they increased it to 93. They must like what they see. While the P1/2 shows still recruiting, I'm sure it will close when the P3 starts recruiting. I was actually hoping we'd see results for the P1/2 at ASH 2017 so I guess regarding the P1/2 we'll get an abstract at ASCO 2018. Interim P1/2 data was presented at ASH last year. From abstract 1824

Twenty-two patients were evaluable for response, 1 patient is currently on therapy. The ORR in the total, non-PTCL and PTCL populations was 59%; 33% (no CR) and 77% respectively. Of the PTCL patients 4/13 (31%) achieved a CR, 6/13 (46%) achieved a PR, and 1 patient had stable disease. The mean duration of response (DOR) for all patients on the study (N=13) was 6.1 months (1.1 – 26.5), for the non-PTCL population (N=3) was 4.8 m (1.1-11) and for the PTCL population (N=10) was 6.55 months (range 1.6 – 26.5 +ongoing). The mean progression free survival (PFS) for all patients on study (N=26) was 4.8 m (.3 – 30.2), for the non-PTCL population (N=13) was 2.8 m (0.3-14.5), and for the PTCL population was 6.13 months (range 1.5 – 30.2 +ongoing).

My 2 cents from post 1566

Results were similar to the results presented 6 months earlier at ASCO. Note that this combo doesn’t work that well in B cell lymphomas. Seems like a completely different MoA in PTCLs as the vimeo.com/110122034 video noted and that’s why they will continue the Ph 2 (and now P3) part of the study in PTCL only.