Bernie Marini
3.9K posts
@Berninini
https://t.co/ZI0sU4f13q Clinical Pharmacist Specialist #Heme #Leukemia. @UMichPharmacy Dad. Girls Hockey & Lacrosse Coach. Views my own
I know some have become experts at clinical appraisal and clinical trial critique. It’s important to have this dialogue and it helps physicians and patients understand the drawbacks of a given trial. But my advise to young investigators is to best not to make it your primary academic output. Secondly, when critiquing it’s also worthwhile remembering that the investigators of trials may also fully aware of the issues but there are many barriers and often we have to choose between not doing a trial at all versus compromising. Perfect trials are not common; we can usually find some fault with almost all trials. So we must strive to avoid rudeness and condescension. Third, try if possible to lead a clinical trial or at least get engaged with someone who leads trials and get a feel for the various stakeholders who have veto power during trial design, and more importantly the various competing priorities for what the trial seeks to accomplish, it will be easier to understand why a specific control arm was chosen, or a why a specific endpoint was chosen, even though you may think they are the wrong ones.
Yes 3/4 of these AML patients had high risk disease, in which past observational studies have shown CR rates of only 20-40% with traditional 7+3 With PARADIGM, we see higher response rates, and superior, statistically significant event-free survival with a plateau, favoring venetoclax/HMA over 7+3 “Tossing out” is too strong a phrase, but I would say prudent refinement with more targeted venetoclax-based approaches in high risk AML, reserving 7+3 backbone in the following subtypes: NPM1 CBF FLT3 MLL RAD monoblastic disease Since the end goal for these fit, high risk individuals has to be allo transplant, patients getting venetoclax/HMA were more likely to be bridged accordingly than those who received 7+3 (61% vs 40%) #ASH25
RIP 7+3 (1973-2025)? Why PARADIGM Doesn't Deliver the Eulogy. Listen to our take on the #PARADIGM #Plenary from #ASH25 @ajperissinotti @Berninini open.spotify.com/episode/5pO9pc…
I’m not a leukemia AML doc. So Im struggling to understand this. The PARADIGM study is a randomized phase II, not phase III. Are these results with Aza/Ven vs 7+3 sufficient to be considered paradigm changing to toss out decades of practice? What am I missing? What are the caveats for community practice? #ASH25 @DrHKantarjian @sanamloghavi @MikkaelSekeres @beatalleukemia
🔥 Aza-Ven just outperformed 7+3 in fit AML. Yes, you read that right. #ASH25 This is the PARADIGM moment: the so-called less intensive regimen delivered better survival, fewer grade 3+ events, and lower early mortality in IC-eligible AML. 🧬 Arms 🔵 IC (7+3 or CPX-351) 🟠 Aza-Ven 📈 Event-Free Survival Aza-Ven 14.6 mo vs 6.15 mo for IC (P=0.0021). 1-year EFS: 53.4% vs 36%. Adjusted HR: 0.66. 💥 Safety advantage Infections: 20.8% vs 15.1% Bleeding: 6.3% vs 1.3% 60-day mortality: 4.7 percent vs 0 percent (QOL and hospital days also significantly better) 🧩 Responses Higher OR and CCR with Aza-Ven. More patients successfully bridged to HCT. 🎯 Takeaway For functionally fit, IC-eligible, FLT3-WT intermediate or adverse risk AML, Aza-Ven is emerging as the more effective and safer bridge to transplant. #OncoTwitter #MedTwitter #AML @OncoAlert @myesmo @esmo_open @ASCO
