Replimune’s Post

After promising Phase IIb 24-week data with povorcitinib, Incyte unveiled 52-week data indicating greater improvement with longer-term therapy and plans to initiate a Phase III trial. https://lnkd.in/gqVsZf3y

We're proud to share that JAMA Neurol has published the results of batoclimab (HBM9161) phase 3 clinical trial, which examined the efficacy and safety of batoclimab, a fully human anti-FcRn mAb, in patients with generalized myasthenia gravis (gMG).   In this randomized clinical trial, batoclimab demonstrated sustained efficacy evaluated by MG-ADL (Myasthenia Gravis Activities of Daily Living), QMG (Quantitative Myasthenia Gravis) and other outcome measures. The results also revealed that batoclimab was safe and well tolerated in gMG patients.   With these groundbreaking data, batoclimab is expected to set a new benchmark for the treatment of gMG and bring benefit to patients in need.   Read more: https://lnkd.in/g35nqKf4 #gMG #HarbourBioMed

This trial of ibrutinib/venetoclax in CLL, recently published in the NEJM, does some interesting things.  It uses an MRD-guided approach to determine when patients could stop therapy, and has a fixed duration of treatment for ibrutinib.  However, FCR and chlorambucil are the punching bags of CLL, and it's crazy to me that in 2023 we still consider this as standard of care in clinical trials.  I'm not surprised ibrutinib/venetoclax showed a PFS benefit with a trend towards OS benefit, when compared to FCR.  Any BTK or BCL2 inhibitor would do that. The trial did add on ibrutinib later on as a third arm, but the primary outcome for that arm, MRD negativity, is not a clinically relevant outcome.  In addition, if they wanted to look at MRD negativity, they should have compared ibrutinib/venetoclax to venetoclax or venetoclax/obintuzumab, not ibrutinib.  I support the use of MRD-guided therapy and fixed duration therapy in clinical trials for CLL, but we have to compare apples to apples, not whatever this is. #venclexta #imbruvica #cll https://lnkd.in/djcHf2pd

In case you missed it, you can watch our BioIndustry Association (BIA) and RNID webinar discussing clinical trials of hearing therapeutics and sharing learnings relevant to those working in other novel therapeutic areas. 👇 #clinicaltrials #hearingloss

Really useful workshop yesterday, jointly held by the FDA and the International Myeloma Society. Huge progress has been made in treating patients in recent years. Future therapies are focusing much more on specific patient populations, with clinical trials being designed accordingly. Beyond thinking in terms of prior lines of therapy, it’s useful to assess by refractory state, to what classes of drug patients are no longer responsive. https://lnkd.in/eXZVaysq Karen Clegg #InternationalMyelomaSociety

Want to stay up to date with all the latest in the world of cardio metabolic therapeutics and clinical data? Head on over to the CMF, where we have just posted our latest detailed slide decks. This month includes a systematic review and meta-analysis of randomised controlled trials (n=6) reporting safety outcomes in elderly patients with T2D treated with SGLT2i’s by Rigato, et al. Read the detailed slide deck and get all the latest insights for only on the #CMF: https://ow.ly/qhmu50PFjC1

Seeking the latest insights from the world of clinical #PsA therapy? Our latest slide decks are now live over on the #IMIDforum including a recent paper by Coates L, et al. Here, the authors explored the trajectory of, and factors contributing to, achievement of individual criteria of MDA in patients with active PsA treated with guselkumab. They found that higher baseline domain scores, older age, worse fatigue, and increased body mass index were significant predictors of longer time to achieve MDA. Read our detailed slide deck for the latest research in #PsA therapeutics now, completely free, on the #IMIDforum: https://ow.ly/vwgC50R4b8q