Dr. Scarlett has done a great job differentiating...

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biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Dr. Scarlett has done a great job differentiating...

Post by biopearl123 » Wed Dec 09, 2020 11:20 pm

Dr. Scarlett's job just got a lot harder. He did a great job differentiating Imetelstat from Luspatercept and showing where in the treatment scheme Imetelstat is likely to be placed. Now with the new Constellation data it appears we have further competition from an oral agent that (PIII in first line starting now w and w/o Rux in combo) has also been tested not only in front line but also in Rux failures. This is an oral drug that has been shown to reverse fibrosis, improve anemia, symptoms etc. The company is looking at testing in PV and ET. We have seen stellar results in ET from Dr. Boerlacher. Imetelstat of course is IV and it is likely that Constellation's drug will be tried in R/R patients before getting to Imetelstat even if off label. I have not seen any evidence that this drug actually targets the malignant clone and CSC itself but there is clearly translational data and bone marrow fibrosis reversal not to mention profound spleen and symptom effects. This is why IMHO Geron stock is stuck. It looks like Imetelstat is being slowly relegated to the position of drug of last resort. Yes the upcoming MF study has a strong chance of showing prolongation of life and that is important and yes the Constellation drug is being looked at only for front line right now but the landscape is changing and Dr. Scarlett will need to find a convincing way to provide clarity and differentiation. It may lie in reducing the risk of transformation to AML but we shall see. No doubt he will get a lot of questions. bp

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: Dr. Scarlett has done a great job differentiating...

Post by biopearl123 » Wed Dec 09, 2020 11:27 pm

"Our" Dr. Mascarenhas has described this drug as representing a paradigm shift (sound familiar?) and one that is simple to use (oral agent).

Edward
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Joined: Sun Nov 22, 2020 5:46 am

Re: Dr. Scarlett has done a great job differentiating...

Post by Edward » Thu Dec 10, 2020 12:23 am

Yeah, I’m getting deeply concerned to be honest. I don’t doubt that imetelstat can still get approval, but it seems like the commercial prospects are shrinking, the wait is still very long, and there won’t be much encouraging news to boost the stock in the meantime. Hard to make an argument that this is the best place to park your money for the next two to three years.

I still hold onto hope that the unique impact of imetelstat could make it so widely applicable in various cancers that the breadth of use will make up for not being the go-to treatment in any one indication. But that sounds like a decade-long mission.

Austin417
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Joined: Wed Oct 31, 2018 9:57 pm

Re: Dr. Scarlett has done a great job differentiating...

Post by Austin417 » Thu Dec 10, 2020 10:44 pm

Recent article that considers imetelstat as part of a "sequence of treatments" with other drugs: https://ascopubs.org/doi/full/10.1200/JCO.20.02964

"If imetelstat's safety and efficacy results are sustained and it gains a regulatory nod, one could envision a treatment algorithm for transfusion-dependent, patients with lower-risk MDS that starts with ESAs and moves onto imetelstat with its every 4-week dosing schedule, followed by luspatercept in those with ring sideroblasts with its every 3-week dosing schedule (or the opposite, depending on where the relative balance of safety and efficacy falls for each drug; patient preference for less frequent intravenous treatment versus more frequent subcutaneous injections; or on the results of follow-up luspatercept studies in those without ring sideroblasts, or upfront v ESAs). Eventual lack or loss of efficacy from these two drugs could be followed by lenalidomide in patients with the del(5q) karyotypic abnormality (or off-label in those without del(5q)), followed by hypomethylating agents.

Indeed, one could envision a therapeutic future for MDS in which we carefully plan our sequence of treatments over the years, and one in which the clinical trials supporting those treatments actually showed that our therapies allowed patients to live longer, instead of merely diminishing their transfusion needs for isolated periods of time."

biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

Re: Dr. Scarlett has done a great job differentiating...

Post by biopearl123 » Fri Dec 11, 2020 12:18 am

Nice find, Austin, thanks for sharing.

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