Welcome to another edition of "3 Things In Biotech," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Acceleron reaches for the gold in a pivotal trial
Disease: Low- to intermediate-risk myelodysplastic syndrome (MDS)
News: XLRN and CELG announced positive top-line data from their phase 3 MEDALIST trial, stating that their TGF-beta trapper luspatercept achieved a "highly statistically significant" improvement in the primary endpoint, which was transfusion independence at 8 weeks (you can learn more about this endpoint in another recent article of mine). Patients also experienced a greater rate of transfusion independence for at least 12 weeks within a 24-week period.
Looking forward: This news is sure to get Geron (GERN) shareholders talking, since they are currently wondering about the future of imetelstat in this indication. One thing is becoming clear: luspatercept is going to be moved toward approval, and with findings like these, it's likely they'll get it. It seems to me that we're going to see the full data readout at ASH 2018, and we'll get the application for approval sometime in late 2018 or 2019.
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Astellas codifies its prostate cancer results with a prestigious publication
Company: Astellas Pharma (OTCPK:ALPMY)
Disease: Prostate cancer
News: ALPMY published the findings of its phase 3 PROSPER study in the New England Journal of Medicine, detailing the use of enzalutamide plus androgen-deprivation therapy in men with non-metastatic prostate cancer that has begun to relapse, as indicated by increasing PSA levels. Enzalutamide led to an impressive 71% improvement in metastasis-free survival (39.6 vs. 17.7 months, HR 0.29) in addition to improving a variety of other endpoints.
Looking forward: Publication in this journal adds a lot of gravity to the findings that ALPMY demonstrated last year. And it solidifies the rationale for the FDA giving priority review to the supplemental application for approval. Why should you care about this readout as an investor? In a word: validation. Doctors are very busy people, and they don't always keep up with the latest in clinical data and management. Every new presentation and publication is like marketing for the drug sponsor. So we should be aware of it, too. This kind of publication will help ALPMY get enzalutamide into the clinic faster once it is approved.
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Cellectar signals that its aggressive lymphoma trial is going rather well.
Company: Cellectar Biosciences (CLRB)
Therapy: CLR 131
Disease: Diffuse large B-cell lymphoma (DLBCL)
News: CLRB announced that it will be expanding patient enrollment in the DLBCL cohort of its ongoing phase 2 trial involving its targeted phospholipid conjugate CLR 131. This announcement comes after the company found that the therapy exceeded the expected response rates, and as such it will be recruiting 30 more patients into the cohort.
Looking forward: Expanding enrollment here means that CLRB has an opportunity to get a clearer picture of the efficacy of this radiolabelled drug. Consider this is not the first cohort of patients to be expanded in recruitment, it would seem as though we're getting as strong an early signal as we can hope for at this stage of study. Still, there is quite a ways to go before we might see approval of this agent, and CLRB will need to find funding to make that happen.
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