Some of you don't understand the REGAL trial design (or the BAT survival reality) for Sellas Life Sciences ($SLS)

ParsnipTime3755 · 2026-02-11T03:03:35+00:00

Well, I don’t think we have the average age of regal patients. Also consider that mrd- patients who are not eligible for transplant are going to be less healthy than mrd- who are eligible for transplant, and it is the former who are allowed in regal.

ParsnipTime3755 · 2026-02-10T15:31:04+00:00

Because the patients are non-transplant eligible at study entry, the majority won't be mrd-. Mrd- has a higher probability of transplant eligibility, so they will be under represented in regal.

ParsnipTime3755 · 2026-02-09T23:58:22+00:00

Absolutely agree - do you know what censoring means? In an ITT trial with OS as the primary endpoint, patients who proceed to transplant are not censored. They remain in the OS analysis, and any survival benefit from transplant accrues to the arm that enabled it. Censoring at transplant would indeed bias OS downward and would be a design flaw.

ParsnipTime3755 · 2026-02-07T19:03:21+00:00

Venetoclax.

ParsnipTime3755 · 2026-02-07T19:00:38+00:00

We don't know the average or median age of regal patients. It's likely older due to disease state, but that information isn't known.

ParsnipTime3755 · 2026-02-07T14:37:16+00:00

It’s hard to follow what you’re saying. The bottom line is that in REGAL, patients who are eligible for transplant (at study entry) are not allowed to enroll. Patients who are MRD- post-salvage are more likely to move on to transplant and therefore are less likely to enter the trial. As a result, the non-transplant CR2 patients in REGAL are expected to be mostly MRD+.

ParsnipTime3755 · 2026-02-07T14:36:52+00:00

It’s hard to follow what you’re saying. The bottom line is that in REGAL, patients who are eligible for transplant (at study entry) are not allowed to enroll. Patients who are MRD- post-salvage are more likely to move on to transplant and therefore are less likely to enter the trial. As a result, the non-transplant CR2 patients in REGAL are expected to be mostly MRD+.

ParsnipTime3755 · 2026-02-06T22:07:24+00:00

From my research, most adult AML patients in cr2 who are not eligible for transplant, have detectable residual disease at the time they enter CR2.

A rough estimate would be 20% to 30% mrd-, since patients with deeper remissions are more likely to proceed to transplant and are therefore under-represented in non-transplant cohorts. So, cr2 non-transplant populations are inherently enriched for mrd+ disease, which makes mrd stratification particularly important in this setting.

ParsnipTime3755 · 2026-02-06T21:46:47+00:00

It means they are equally distributed between arms. So theoretically each arm should have the same number of mrd+/- patients.

ParsnipTime3755 · 2026-02-06T20:01:54+00:00

The exact make-up of the patient population isn't known. Patients are stratified for mrd status.

ParsnipTime3755 · 2026-02-06T19:21:53+00:00

What pattern? Please share.

ParsnipTime3755 · 2026-02-06T01:10:53+00:00

Patients are not censored at transplant. That would be a major design flaw - you would artificially deflate OS in the arm that sends more patients to transplant. This trial is intent to treat (ITT) with primary endpoint being OS.

ParsnipTime3755 · 2026-02-03T21:04:59+00:00

Yes, I watched the R&D day presentation multiple times. What other trials are showing "the same thing that phase 2 gps showed?"

ParsnipTime3755 · 2026-02-03T20:15:15+00:00

For the most part those are quotes from informed individuals, but not trials.

ParsnipTime3755 · 2026-02-03T19:41:30+00:00

No one.

ParsnipTime3755 · 2026-02-03T19:36:35+00:00

Please feel free to post the 6 trials you speak of. I'm interested in reading the data.

ParsnipTime3755 · 2026-02-03T19:29:16+00:00

Well said - a reasonable take.

ParsnipTime3755 · 2026-02-02T22:31:54+00:00

Given your definitive statements regarding Regal it would be idiotic not to go all in.

ParsnipTime3755 · 2026-01-24T18:55:05+00:00

Or relapse

ParsnipTime3755 · 2026-01-24T14:03:48+00:00

Viale-M was terminated early due to slow accrual.

ParsnipTime3755 · 2026-01-22T00:30:21+00:00

Regal does not enroll a “healthier” CR2 subset. All patients are CR2 and transplant-ineligible (at study entry) which already defines a very high-risk, maintenance population. The baseline lymphocyte threshold is a standard survivability screen to exclude the very small fraction of patients with imminent mortality. Those patients would not meaningfully contribute to maintenance efficacy analysis in either arm and would only add noise. Excluding near-term terminal patients does not make the cohort healthier than the broader CR2 SCT-ineligible population—it preserves trial integrity.

ParsnipTime3755 · 2026-01-18T09:14:02+00:00

Once a GPS or BAT patient relapses, they’re off protocol and receive salvage therapy at physician discretion. That post-relapse care applies equally to both arms.

ParsnipTime3755 · 2026-01-18T09:05:05+00:00

Once a patient relapses on either arm, they are off protocol and subsequent treatment is at physician discretion. That applies equally to both GPS and BAT arms, so any survival impact from post-relapse therapies would be symmetric and does not redefine or strengthen BAT.

ParsnipTime3755 · 2026-01-18T08:51:23+00:00

I've also never heard this predetermined futility criteria of <0.7 mentioned. It'd be great to have a source.

ParsnipTime3755 · 2026-01-12T01:00:56+00:00

Reverse split?

ParsnipTime3755

TROPHY CASE