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u/Careful-Ad-9700

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Another Direct Trial Comp for Gps, the SLS phase 3 AML remission maintenance immunotherapy, published this month.
▲ 37 r/biotech_stocks

Another Direct Trial Comp for Gps, the SLS phase 3 AML remission maintenance immunotherapy, published this month.

BAT for the SLS Phase 3 trial control arm, Aza +Ven MOS of 19 months for CR1 first remission patients.

362 Patient data: 19 months 17.3 months of remission vs Gps Phase 2 MOS of > 67.6 months in the same exact CR1 setting.

GPS MOS not yet reached and greater than > 67.6 months vs 19 months with BAT/ Aza VEN / BAT for the REGAL SLS Phase 3 Control arm patients.

Same First Remission CR1 setting absent transplant - AzaVEN MOS was 19 / Gps Phase 2 was >67.6.

And if you drill further into the data, to be equal you would have to subtract 1.7 months of average treatment time to get into transplant - the Remission duration is 17.3 months - the number to compare to 67.6.

https://preview.redd.it/hitjpu3m60jh1.png?width=1106&format=png&auto=webp&s=cbf063eb2e12e2a12f184481017e8e79ac85d5fc

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u/Careful-Ad-9700 — 8 days ago
▲ 91 r/SLS_Stock+1 crossposts

$SLS Immunotherapy: GPs Phase 2 Trial Result for First Remission (CR1) Patients > 67.6 Months of MOS compared the BAT Onureg at 24.7 months

Gps was tested in 4 phase 2 trials, all with exceptional results, including 2 trials for AML remission maintenance - the setting of the current phase 3 trial, that is about to report final results.

Gps Phase 2 MOS of 67.6 was not reached for CR1 Patients.

Gps Phase 2 statistically significant MOS of 21 months for CR2 patients, is the setting for the p3 trial.

The P3 survival data is known to be better than the p2,

based on the age difference - p2 was in an older than average 74 year old setting

based on the MRD Status - all the p2 patients were MRD+ harboring residual disease with a dire survival prognosis - should be 50 50 in the P3.

based on the Dosing regime - p2 patients only got a maximum of 12 gps treatments, in year 1 only, vs the p3 who'll get 15 gps treatments in year 1 and then an ongoing booster series every six weeks in year 2, and quarterly boosters in year 3 and beyond.

based on the unblinded IDMC Interim trial data, 80% immune response rate in tested Gps Phase 3 patients. 80% is better than the 64% IR rate in the p2. IR is directly correlated with increased survival.

Onureg was tested in combination with Venetoclax for CR1 Patients in the VIALE-M Phase 3 trial for remission maintenance - it failed.

there's more, but this is some of it.

https://www.reddit.com/r/sellasLifescience/s/sXtju99uA2 direct link to the Webcast Replay.

https://preview.redd.it/9ljs7s3cuyih1.png?width=1522&format=png&auto=webp&s=b326e32dcab501b13381883ce7bccb3aa0ca1518

u/Careful-Ad-9700 — 8 days ago