624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Clinical Studies in T/NK Cell Lymphoma
Emmanuel Bachy, Vincent Camus, Catherine Thieblemont, et al.
Authors Conclusion from the Abstract: The addition of romidepsin to CHOP did not improve PFS, the primary endpoint of the study, and response rates and OS appeared similar with the combination. The toxicity profile of Ro-CHOP was consistent with its phase Ib/II data, with no unexpected findings. The high rates of TEAEs with the addition of romidepsin hampered the ability to adequately administer 6 cycles of CHOP. Additional exploratory analyses to compare Ro-CHOP outcomes in specific patient subgroups are ongoing. The combination of CHOP plus romidepsin does not represent an advance in the standard of care for patients with previously untreated PTCL.
Jia Ruan, Alison J. Moskowitz, Neha Mehta-Shah, et al.
Authors Conclusion from the Abstract: This study provides the first demonstration that addition of hypomethylating agent oral azacitidine (CC486) to CHOP as initial therapy is feasible, safe, and induces high CR rate in PTCL-TFH subtype, with expected side effects. Although preliminary, the EOT CR to date exceeds the threshold of meeting study primary endpoint. Final efficacy data as well as response according to subtype and mutational profiling will be updated at ASH. This active combination will be further evaluated in the upcoming ALLIANCE/Intergroup randomized study A051902, comparing oral azacitidine-CHO(E)P with duvelisib-CHO(E)P against CHO(E)P in CD30 negative PTCL.
Neha Mehta-Shah, Ajitha Kommalapati, Stephanie Teja, et al.
Authors Conclusion from the Abstract: We present the largest series of HCT in TCL. In this dataset, HCT provided durable disease control for a significant portion of pts with relapsed or refractory or otherwise high risk TCL. Depth of response to therapy immediate prior to HCT was associated with PFS. Patients with AITL appeared to have a trend towards improved outcome with HCT compared to other common PTCL histologies. Patients with CTCL had a higher rate of relapse compared to PTCL subtypes, but OS was similar. MRD HCTs were associated with lower TRM. This data supports the curative potential of HCT in a patient group with otherwise poor survival and limited treatment options.
Yan Gao, MD, Huiqiang Huang, Xiaoxiao Wang, et al.
Authors Conclusion from the Abstract: PLM60 monotherapy yielded promising results for patients with R/R PTCL and ENKTCL with moderate toxicities. Further investigation of combination therapy is warranted.
Christiane Querfeld, Basem M. William, Lubomir Sokol, et al.
Authors Conclusion from the Abstract: BNZ-1, an IL-2, IL-9, and IL-15 inhibitor, may provide a novel treatment option for CTCL patients who relapsed or were refractory with conventional therapies with a favorable toxicity profile. The multifaceted approach of BNZ-1 leads to direct inhibition of malignant cells, activation of tumor immunity, and suppression of inflammation. Since BNZ-1 showed safety and efficacy in challenging rCTCL patient population, its further development in a phase 3 trial is planned.
Barbara Pro, Jonathan E. Brammer, Carla Casulo, et al.
Authors Conclusion from the Abstract: The DUV data observed to date show consistent response rates in a R/R PTCL pt population. The safety profile observed in PRIMO to date is consistent with the current safety profile of DUV. The mature dose-optimization phase results demonstrated a median DOR of 12.2 months for the 75 mg BID cohort. The preliminary results from the PRIMO dose-expansion cohort (75 mg BID followed by 25 mg BID dosing) show an ORR of 40 % and CR rate of 30% (6/20) by INV assessment. These data support continued evaluation of DUV as a treatment option for R/R PTCL. Updated data from the planned interim analysis after 40 pts enroll (occurred June 2020) will be presented.