Startseite Kongressberichte 2019 Annual Meeting of the American Society of Clinical Oncology 2019 Hematology ALL

Choice of Oral Presentations

ORAL PRESENTATIONS

Sumit Gupta, Cindy Wang, Elizabeth A. Raetz, Reuven J. Schore, et al.

Impact of asparaginase discontinuation on outcome in childhood ALL: A report from the Children's Oncology Group (COG)

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.

  AALL0331 AALL0232
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.

Efficacy and toxicity of pegaspargase and calaspargase pegol in childhood acute lymphoblastic leukemia/lymphoma: Results of DFCI 11-001.

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

 

 

POSTER PRESENTATION

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
InO 164 56 34.1 18.8 (14.7–NA)    
SC 162 93 57.4 3.9 (2.4–5.1)    
Never had HSCT         0.461 (0.283–0.752) 0.0001
InO 85 32 37.6 11.5 (6.8–23.0)    
SC 126 66 52.4 3.0 (2.1–5.0)    
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)    
SC 18 9 50.0 16.0 (12.3–NA)    

 

Marc Saul Schwartz, Deepa Jeyakumar, Lloyd Earl Damon, Gary J. Schiller, et al.

 
Methods: We are conducting a phase I/II multicenter trial to evaluate the safety and efficacy of blinatumomab with pembrolizumab in adults with R/R B-ALL and a high bone marrow lymphoblast percentage (NCT 03160079). The primary endpoint is ORR (CR+CRh) after 1-2 cycles with secondary endpoints of AEs, MRD-negative CR/CRh rate, 2-year DFS, 2-year OS, and allogeneic HCT rate. Exploratory studies are evaluating cytokine expression, PD-1 expression on T-cells, PD-L1 and PD-L2 protein expression on lymphoblasts, and T-cell populations at diagnosis and in response to therapy. Eligibility includes: adults with R/R CD19+ B-ALL after ≥ 1 prior line of therapy, R/R Ph+ B-ALL must fail a 2nd- or 3rd-generation TKI or be TKI intolerant, > 50% lymphoblasts on screening bone marrow sample. Blinatumomab is given by continuous IV at 9 mcg/day days 1-7 of cycle 1, 28 mcg/day days 8-28 of cycle 1, then at 28 mcg/day days 1-28 in subsequent cycles. Pembrolizumab 200 mg IV is given on days 15 and 36 of each 42-day cycle. Patients in CR/CRh after 1-2 cycles will complete 5 cycles. Patients not in CR/CRh after 2 cycles of therapy or progressing after Day 15 of cycle 1 go off study. CNS prophylaxis with IT methotrexate is given at screening and once per cycle. A phase I run-in of 3-6 patients precedes accrual of 18-21 patients for a target of 24. The study opened in July 2017 and 4 patients have been treated. No DLTs have occurred to date. Clinical trial information: NCT03160079