Choice of Oral Presentations
Sumit Gupta, Cindy Wang, Elizabeth A. Raetz, Reuven J. Schore, et al.
Conclusions: Discontinuation of ASP doses is associated with significantly inferior EFS and must be balanced against the risks of ASP re-challenge. Our results also illustrate the potentially severe consequences of EA shortages. Prescribed pegasparagase doses.
|Rapid early responders||2-6||5-7|
|Slow early responders||11||9-11|
Lynda M. Vrooman, Traci M. Blonquist, Jeffrey G. Supko, Sarah K. Hunt, et al.
Conclusions: Every 3-week SC-PEG had similar EFS, OS, safety profile, and NSAA compared with every 2-week SS-PEG. The high NSAA observed for both preparations suggest dosing strategies can be further optimized. These data informed FDA approval of SC-PEG for pediatric pts. Clinical trial information: NCT01574274
Bijal D. Shah, Michael Russell Bishop, Olalekan O. Oluwole, Aaron Logan, et al.
End of phase I results of ZUMA-3, a phase 1/2 study of KTE-X19, anti-CD19 chimeric antigen receptor (CAR) T cell therapy, in adult patients (pts) with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL).
Conclusions: KTE-X19 dosing and safety mgmt have been successfully refined by testing 3 cell doses and evaluating a new AE mgmt guideline with altered corticosteroids/tocilizumab use for NE/CRS. Pivotal Phase 2 is ongoing at the 1 × 106 dose with rAE mgmt. Clinical trial information: NCT02614066
Elias Jabbour, Matthias Stelljes, Anjali S. Advani, Daniel J. DeAngelo, et al.
Time from randomization to first subsequent induction/salvage therapy (ST) in patients with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) treated with inotuzumab ozogamicin (InO) in the phase 3 INO-VATE trial.
Conclusions: In this study, treatment with InO provided the benefit of extended TST, effectively allowing patients a longer time period until an ST was needed in both patients who proceeded to as well as those who did not proceed to HSCT. Clinical trial information: NCT01564784
|Total, N||Had ST, n||% (n/N)||TST, median (95% CI), months||HR (97.5% CI)||1-sided P|
|Overall||0.336 (0.228–0.494)||< 0.0001|
|Never had HSCT||0.461 (0.283–0.752)||0.0001|
|Had HSCT directly after study treatment||0.477 (0.184–1.233)||0.0370|
|InO||70||15||21.4||NA (KM curve > 50%, median not reached)|
Marc Saul Schwartz, Deepa Jeyakumar, Lloyd Earl Damon, Gary J. Schiller, et al.