Vivek Patel, MD

Hey #medtwitter Here are the basics on unequal randomization in trials Why should we do 1:1 instead of 2:1 or 3:1 in phase 3 RCTs? 🧵

@OncBrothers @mshadman @OncUpdates @BijoyTelivala @NicoGagelmann @nihardesai89 @FadiHaddad_MD @RenoHemonc @DanilovLab @Othman_Al_Sawaf @gellc @tarsheen2 @PallawiTorkaMD 1. Either fine. AMPLIFY no MRD rules. 2. MRD is prognostic but no good data that it's predictive for treatment. Most patients in FLAIR who were MRD negative got it in 18 months so more maybe not worth it (some got I+V 6 yrs) 3. 12 months. Limited data. BTK receptor NGS

Ahhh… tell me more (please 🙏🏽🙏🏽): 1. Out of the available options, which one do you use frequently (SEQOIA or AMPLIFY…? What helps you make that decision) 2. I know you said the role of MRD is unclear… but what if it is positive…? 3. Do we have long term/mature data on relapse/refractory disease after BTKi + BCL2i? Resistant patterns? How do we decide if this progression is double refractory or can we re-challenge… time frame?

This is the algorithm for reference during our discussion with @mshadman on CLL! #HemeTwitter #OncTwitter #MedTwitter @OncUpdates #lymsm

@OncBrothers @mshadman @OncUpdates @BijoyTelivala @NicoGagelmann @nihardesai89 @FadiHaddad_MD @RenoHemonc @DanilovLab @Othman_Al_Sawaf @gellc @tarsheen2 @PallawiTorkaMD Yeah I’m using it currently for my patients. Very well tolerated and great quality of life for them

@vpatelmd @mshadman @OncUpdates @BijoyTelivala @NicoGagelmann @nihardesai89 @FadiHaddad_MD @RenoHemonc @DanilovLab @Othman_Al_Sawaf @gellc @tarsheen2 @PallawiTorkaMD Completely agree that these are now part of the conversations with our patients (had a chance to touch on this during the actual conversation). Waiting for official approval to add this to the algorithm! Are you using this commonly now in your practice?

@graham74GC Important data. I think we should learn from our solid tumor colleagues (escalation didn’t work) and start with de escalation approaches for MRD negative patients. Escalation trials also important but Hodgkin should stick to the RATHL mantra first given age of our patients

Herrera et al - ctDNA in S1826 • 97% ctDNA + baseline • clearance at C3D1 assoc with PFS • within pos pts, those with minor ⬇️ assoc with esp poor outcomes • EOT ctDNA detection also assoc with poor outcomes CtDNA ripe for response adapted trials. #18ICML #ICML25 #lymsm

🚨Hot off the press: A simultaneous publication in @JCOOP_ASCO alongside @vpatelmd’s presentation highlighting the 1st cluster randomized study evaluating podcasts for heme/onc education! The outcome: @TheFellowOnCall and @TwoOncDocs should be included for h/o fellow education!

@MediHumdani Had a very similar patient recently and gave lupron + Nivo-AVD after sending patient to discuss urgently with cardio oncology and fertility clinic. Risk too high and fertility preservation reasonable with this regimen

#Lymphoma management question: 22 YOF; advanced stage classic Hodgkin. Large pericardial effusion, w/o tamponade (yet): Best course of action regarding fertility? -Pericardiocentesis/steroids +/-Nivo/ovarian stimulation for ovaCryo [3wk minimum] vs - Lupron + NivoAVD now

@AaronGoodman33 We adopted E1910 protocol. Very similar to 10403 other than higher dauno dose in induction and no capizzi MTX in IM which we weren’t doing for most adult patients and were opting for HD MTX

@graham74GC Heavy pre treatment with chemo, BTK, and ven may be driving the NRM. Earlier use in TP53 mutated and blastoid might mitigate some of this

🇬🇧 real world data Brexucel RR Mantle cell lymphoma • 119 approved, 83 infused • PD / manufacturing failure main reasons for non-infusn • ORR/CRR 87%/ 81% • med PFS (infused) 21mo • NRM 6/12/24mo 6/15/25% (infn mainly) Active agent but NRM concerning onlinelibrary.wiley.com/doi/10.1002/he…

@graham74GC @dgermain21 @Fer_martinmoro @RossK11 @michaelwangmd I also think if the goal is to maximize quality of life then a fixed duration of the BTK should be evaluated. I’d like to see BR/HiDAC vs. BR alone followed by R maintenance +/- fixed duration BTK inhibitor given results of TRIANGLE. Mandated BTK at progression in control

@dgermain21 @Fer_martinmoro @RossK11 @michaelwangmd Just to add - it’s a positive study for PFS the primary EP which is great. But in my mind the sequential or concurrent BTKi question is not definitively answered.

Acalabrutinib will move to frontline with benda-ritu in mantle cell #lymphoma pts aged ≥65! (ECHO trial) Trend in better OS against benda-ritu when Covid19 deaths are censored! (benefit not seen in SHINE trial with ibrutinib as BTKi) By @michaelwangmd at LBA Session #EHA2024

@graham74GC Seems doubtful in this high risk population but the question remains about earlier. 40% had CAR and most relapsed within 6 months of last therapy

Extended FU of epcoritamab PhII R/R DLBCL. Big question: are we curing patients with bispecifics? 65 pts had CMR out of 157 In those 65, durable benefit clearly seen BUT are we curing anyone? From shape of curve.... I'm not sure! #EHA24 #lymsm

Conquer cancer awardee Morgan Zenner @VUMC_Medicine Multicenter analysis of the impact of late ICAHT after CART for large B cell lymphoma Not associated with severe infection or survival outcomes. Stop by poster 24 to learn more! Thanks to Peter Reidell @UCCancerCenter

@graham74GC Some patients can get Nivo-AVD and still work a relatively normal schedule. Same likely can’t be said about this regimen. The best next step is to compare the two in a randomized trial while capturing quality of life data

This is such a powerful regimen. 94% 4y PFS is incredible. In places thay use escBEACOPP (& which fund it) this will be the new standard. The question is how far it will extend into ABVD / AVD-N using areas. US colleagues - will you use it do you think?

Really proud of two of my mentees receiving @ConquerCancerFd merit awards! Ronak Mistry for our innovative heme/onc med ed research and Morgan Zenner for our work in CART @CathyEngMD @VUMC_Medicine @jordanberlin5 @benhopark @VUMCMedicineRes @rmistry91

@ManniMD1 @End_myeloma @Amyloid_Planet @Phhersh @BijoyTelivala @VincentRK @RahulBanerjeeMD @Abdallah81MD @Drjhoffmanmiami @rajshekharucms @AaronGoodman33 @OncBrothers @Rfonsi1 @karmanoscancer Another thought I’ve had is the idea of anti-CD38 “sensitive” or “resistant” similar to platinums in aggressive small cell cancers. If we are trying to sequence therapies at relapse, I wonder if we prevent selection for CD38 resistant clones by deferring dara maintenance

@End_myeloma @Amyloid_Planet @Phhersh @BijoyTelivala @VincentRK @RahulBanerjeeMD @Abdallah81MD @Drjhoffmanmiami @rajshekharucms @AaronGoodman33 @OncBrothers @Rfonsi1 @karmanoscancer Great points, Dr Costa. Broadly speaking, the curves for Dara-VTd-transplant-Obs look fairly similar to Dara-VRd- transplant-Dara-len too. Current maint over-treating standard risk, and not enough for ultra- high risk.

60 IgAMM- RISS-3, 17 p minus 6 Quad ind- Auto- Day100 marrow - NED Maintainece? @ManniMD1 @VincentRK @RahulBanerjeeMD @Abdallah81MD @Drjhoffmanmiami @rajshekharucms @AaronGoodman33 @OncBrothers @Rfonsi1

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Receiving emails like this 💯 Thanks to all our listeners! We’re so excited to be on this journey with you!

@rajshekharucms @ManniMD1 @BrunoPaiva_UNAV @End_myeloma I need to look at it more closely but you could look at effect modification of time to MRD and cytogenetics. If there’s a significant interaction, then it may be driven more in the standard risk patients

@ManniMD1 Fascinating analysis by @BrunoPaiva_UNAV’s group. If I am not mistaken, @End_myeloma had similar finding in MASTER where ultra-high risk pts took longer to get to MRD-negativity, esp 10^-6. Perhaps the disconnect with older data due to superior depth of MRD in this study?

What I found surprising in this study is that longer time to achieve MRD neg was a predictor for "unsustained" MRD neg I see the opposite in my clinic routinely High-risk patients achieve MRD negativity (usually at 10^-5) quite routinely/early- only to relapse shortly after.

@majorajay @dgermain21 @Eddie_Cliff The spearman correlation will also find non linear associations so the change in PFS is correlated to OS but not necessarily 1:1

PFS as a surrogate for OS in CLL #ASH23: - 4237 pts from pooled GCLLSG trials, 75% tx with CIT - correlation higher for targeted therapies - EOT MRD also correlated with OS? Would love input of trial gurus @dgermain21 @Eddie_Cliff #lymsm ash.confex.com/ash/2023/webpr…

@dgermain21 @samyamshon @Eddie_Cliff @propublica @DusetzinaS @amarkelkar Huge problem and for the most part is just wasting more money and significantly impacting patient quality of life

@samyamshon @Eddie_Cliff @propublica @DusetzinaS @vpatelmd @amarkelkar We literally do the same and hope they have regular Medicare since it’s the fastest to approve, usually same week. Some payers demand 21 business days (!!!) between completion of pretesting and authorization decision, only after which can you go to apheresis…

The human face of this problem propublica.org/article/priori… This is a two part problem: CAR T is too expensive (more on this soon), AND insurers should not put profits over people in cases like this Courtesy @propublica @DusetzinaS cc @dgermain21 @vpatelmd @amarkelkar #ASH23

Here are my slides on a talk I gave on why there is no association between most auto-immune diseases and MGUS. And why previous studies were flawed/claimed erroneous associations. All credit to the amazing @iStopMM for this. tinyurl.com/ky9smm3e @SarahSchaferMD #mmsm