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Sponsored Project by the THE LONCAR INDEX: 2016 ASH Recap Highlighting the Latest Data In the CAR-T SpaceTicker(s): NVS, KITE, JUNO, CELG, BLUE
Name: Dr Stephan Grupp - MD/ PhD
Institution: University of Pennsylvania
- Director of the Cancer Immunotherapy Frontier Program, director of Translational Research for the Center for Childhood Cancer Research and medical director of the Stem Cell Laboratory
- Has led a group that performed a nationwide clinical trial establishing antibody-based immunotherapy as the new standard for care in neuroblastoma.
- Has received several awards throughout his career and is a member of a number of professional organizations including the International Society for Cell Therapy, American Pediatric Society, American Society of Hematology, American Society of Blood and Marrow Transplantation and more
This call is being provided 100% free through the generous financial support of our sponsor, The Loncar Cancer Immunotherapy Index. The Loncar Index tracks the stock market performance of 30 leading cancer immunotherapy companies. You can find out more and follow progress in real time by visiting www.loncarindex.com.
Please give us an update on the programs that you have been working on since the 2015 ASH program. Particularly the CTL019 ALL data you presented this year.Added By: joe_mccann
If Kite's ORR data at 6 months are broadly in line with that at 3 months, with no significant increase in tox, is KTE-C19 approvable on the dataset as it stands?
What other therapies in development do you see as competitive with CD19 CAR-Ts and would likely be used before CAR-Ts? Any bispecifics/ADCs/etc you are excited about?Added By: user8e79dc20
Can you comment on the ibrutinib+RCHOP trial that is ongoing? Do you think adding ibrutinib can produce more cures and therefore slowly eat away at the rrDLBCL population?Added By: user8e79dc20
The off-the-shelf CAR-Ts will eventually be killed by the patient's immune system - do you believe that CAR-T persistence is important for durability and how do you think this will affect the allo CAR-T programs?Added By: user8e79dc20
What other therapies in development are you excited about for B cell malignancies? Any bispecifics/ADCs/etc that could be used before CAR-Ts in DLBCL, ALL, etc?
Can you comment on the ibrutinib+RCHOP trials? Do you think that adding ibrutinib could produce more DLBCL cures and therefore reduce the number of rrDLBCL over time?
Any idea when these trials will read out?
What do you make of Kite's ASH presentation of the difference in response rates to KTE-C19 for DLBCL patients post ASCT versus chemo refractory DLBCL patients? For reference, Kite disclosed that the best response was 75% CR in post ASCT patients and 47% CR in chemo refractory patients. If this disclosure is sub-optimal, what disclosure would better illuminate what matters?Added By: user031d6e38
Do you believe the DLBCL market will be split two (Kite/Novartis) or three (+ Juno) ways?Added By: user8e79dc20
The Adaptimmune findings in Synovial Sarcoma show the absolute importance of Fludarabine for their NY-ESO TCR T-cell therapy in treatments. Will we always need this kind of harsh preconditioning in cell therapies to work or what other ways of durable T-cell transfer and expansion do you see?Added By: dhovekamp42
What new developments have there been in understanding the underlying causes of cytokine release and neurotoxicity?
Given data presented at ASH about antigen loss with CD22 and BCMA do you now think CAR-T relapse by antigen escape is a potentially bigger problem than we thought before?
How much of a concern is it that the constructs of KITE’s C-19 and JUNO’s JCar-15 (CD28/ γ-retrovirus) are the same vs. the clinical data itself. It seems given the relatively small N and uncertainty around JCAR015, is Kite’s program more at risk than CTL019 or JCAR17?
How was the mood at ASH this year compared to last year among professionals associated with the development of CAR-T therapies and science?Added By: joe_mccann
What new light did Shannon Maude's ASH update of the study of humanised CTL119 shed on retreatment of patients who relapse on CTL019? How does this compare against early data presented on the NCI's fully human CD19 CAR?
In your presentation of Eliana data you used n=44 as the denominator in the remission rate calculation, whereas the actual number of patients infused was 62. Which number will regulators (and payers) focus on when trying to determine the ITT population?
What does the durability of responses (in general) in Bluebird's anti-BCMA study need to be for that trial to be deemed a long-term success?
JCAR015 has made the entire CAR-T field toxic in the FDA's eyes. Discuss.
Do you anticipate CAR-T infusion will be administered at outpatient setting? Or do you think it will likely be administered during hospital stay? Which unit in hospital will likely handle patients with CAR-T administration?Added By: user40993375
Last year you talked about how CD28 produces a very hot t-cell and “very lovely peak” and then is gone vs. 4-1bb, but how that would impact outcomes wasn’t “separated out”. Can you revisit your thoughts on the differences between CD28 and 4-1bb now?
With the benefit of hindsight, should JCAR015's Rocket trial have been restarted after just 5 days in July?
In the Eliana trial you mentioned: five manufacturing failures in 81 patients enrolled vs. ZUMA-1’s slide of “99% manufacturing success rate” Are these both good enough for a strong commercial launch and approval?
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