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Findings from the expansion of a phase 1 study of tinostamustine in patients with relapsed/refractory (R/R) Hodgkin Lymphoma (HL) will be presented at the 2021 ASH Annual Meeting & Exposition.

Tinostamustine is a developing therapy designed to improve drug access to DNA strands, induce DNA damage, and counteract DNA repair in cancer cells. A dose-escalation study supported the drug’s efficacy and tolerability in patients with R/R HL. This study, published in Blood, examined the safety, efficacy, and pharmacokinetics of tinostamustine, specifically in patients with R/R HL who were heavily pre-treated.

Patients with R/R HL were recruited to the expansion cohort if they had sufficiently responded to tinostamustine, had previously received at least two lines of therapy, and did not have another standard, clinically beneficial therapy available. With this criteria, 14 patients were included in the study.

Study participants received the recommended phase 2 dose of the drug according to their baseline platelet count on day 1 of a 21-day treatment cycle. The researchers used data of overall response rates, survival outcomes, and adverse events (AEs) to evaluate the safety and efficacy of tinostamustine.

The study’s results demonstrated that tinostamustine was well tolerated, and no unexpected AEs occurred. There were treatment-emergent adverse events (TEAEs), mostly hematological and gastrointestinal issues, including thrombocytopenia, neutropenia, anemia, lymphopenia, nausea, and vomiting.

Serious TEAEs occurred in 35.7% of patients and included thrombocytopenia and infusion-related reaction. While 33.3% of patients discontinued treatment due to TEAEs, there were no fatal TEAEs, and the overall response rate for treatment was 36%.

The researchers concluded that tinostamustine seems to be a well-tolerated and efficacious therapy in patients with R/R HL. A call to action is made to continue researching this novel treatment in a larger cohort [1].

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[1] Ghesquieres, H., Pinto, A., Sureda, A., Tournilhac, O., Morschhauser, F., Janik, T., & Zinzani, P. L. (2021). Safety and efficacy of tinostamustine in heavily pre-treated patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL). Blood, 138(Supplement 1), 2472. https://doi.org/10.1182/blood-2021-148483