632: Chronic Myeloid Leukemia: Therapy: CML: New and Beyond

Hagop M. Kantarjian, Michael W. Deininger, Elisabetta Abruzzese, et al.

Authors Conclusion from the Abstract: In this analysis, comprising the largest patient population of CP-CML patients in a post-2G TKI setting, ponatinib shows high response rates and robust survival outcomes in patients who have failed 2G TKIs. With the response-adjusted dosing regimen in OPTIC (starting at 45 mg and reducing to 15 mg upon response), efficacy outcomes were consistent with that of PACE, while the overall incidences of AOEs and serious treatment emergent-AEs were lower; exposure-adjusted AOEs during the first 2 years were also lower. The ongoing OPTIC study is also evaluating lower starting doses of ponatinib (30 and 15 mg) and primary analysis of this study will provide a refined understanding of the benefit:risk profile of the 3 starting doses of ponatinib in CP-CML patients.

Monica Bocchia, Anna Sicuranza, Paola Pacelli, et al.

Authors Conclusion from the Abstract: After a sensible drop observed at 3 mos of any TKI treatment, CD26+LSCs are fluctuating and measurable at low level in most of pts (> 65%) even at 18 and 24 mos. We confirmed no correlation between the absolute number of persisting CD26+LSCs and BCR-ABL copies. However, pts with failure or suboptimal response showed the highest level of CD26+ at diagnosis. CD26+LSCs were found PD-L1+ in about half of 44 pts tested. At diagnosis higher CD26+LSCs number, PD-L1 positivity or both may correlate with a lower probability to achieve an optimal response; interim data of this first report will be presented; enrolment and follow up are ongoing.

Delphine Rea, Michael J. Mauro, Jorge E. Cortes, et al.

Authors Conclusion from the Abstract: The CANDID study represents the largest global cohort study to date characterizing COVID-19 in CML. Currently, the mortality rate from COVID-19 in evaluable CML patients is 13.7%. Factors associated with a higher mortality rate are age and imatinib therapy. Imatinib may represent a confounder as opposed to a true adverse prognostic predictor given the strong link between imatinib treatment and advanced age. Further case reports and longer follow up are needed to better ascertain independent risk factors, the impact of COVID-19, and the possible role that TKI type may play in this population.

Jorge E. Cortes, Timothy P. Hughes, Michael J. Mauro, et al.

Authors Conclusion from the Abstract: Asciminib 200 mg BID monotherapy continued to demonstrate a favorable safety profile and clinical efficacy in pts with CML-CP/AP harboring the T315I mutation, with durable MMR seen in almost half of the patients. Asciminib is a promising therapeutic option for pts with CML-CP/AP with T315I, including those for whom PON treatment has failed.

Qian Jiang,  Xiaojun Huang, Zi Chen, et al.

Authors Conclusion from the Abstract: HQP1351 has been shown highly efficacious in heavily TKI-pretreated patients with T315I-mutated CML-CP or CML-AP and was well tolerated. Registration: Clinicaltrials.gov identifier NCT03883087 (Study HQP1351-CC201) NCT03883100 (Study HQP1351-CC202).

Jorge E. Cortes, Tapan Saikia, Dong-Wook Kim, et al.

Authors Conclusion from the Abstract: Vodobatinib was evaluated over 9 escalating doses. Comparable and promising efficacy was noted in both PT (50% CCyR) and PN (67% CCyR) groups, meriting further study of vodobatinib as a potential new agent for treatment of previously treated CP-CML.