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ASH 2022 | Phase I study of tinostamustine in pre-treated patients with R/R Hodgkin lymphoma

Anna Sureda, MD, PhD, Catalan Institute of Oncology, Duran I Reynals Hospital, Barcelona, Spain, discusses the early results of an expansion cohort from a Phase I study evaluating the safety and efficacy of tinostamustine in patients with relapsed/refractory classical Hodgkin lymphoma (R/R cHL; NCT02576496). Initial results showed that the drug was overall well tolerated, with thrombocytopenia as the most frequently observed adverse event (AE). In addition, the study reported an overall response rate (ORR) of 40% and a median progression-free survival (PFS) of 3.8 months. This interview took place at the 64th ASH Annual Meeting and Exposition congress in New Orleans, LA.

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Transcript (edited for clarity)

We presented a poster in the last ASH meeting looking at the safety and efficacy of tinostamustine in patients with relapsed/refractory classical Hodgkin’s lymphoma. These were the early results from an expansion cohort of a Phase I prospective clinical trial. I think that everybody knows that classical Hodgkin’s lymphoma is a highly curable hematological malignancy with first-line treatment strategies...

We presented a poster in the last ASH meeting looking at the safety and efficacy of tinostamustine in patients with relapsed/refractory classical Hodgkin’s lymphoma. These were the early results from an expansion cohort of a Phase I prospective clinical trial. I think that everybody knows that classical Hodgkin’s lymphoma is a highly curable hematological malignancy with first-line treatment strategies. For those patients that are primary refractory, or that relapse after this first-line treatment strategy, we usually take into consideration autologous stem cell transplantation, but in fact, those patients that failed at least two prior lines of therapies, they still constitute a big unmet medical need. Basically, the objective of this prospective clinical trial was to look at the potential role of tinostamustine in terms of efficacy and safety in this refractory/relapsed population of patients. Tinostamustine is a drug which is designed to improve the drug access to DNA strands, to induce, at the end of the day, DNA damage and counteract its repairing cancer cells.

In this analysis, we were basically looking at efficacy of tinostamustine evaluated by the overall response rate from cycle three, and the drug was given until disease progression or toxicity, and of course, the safety analysis. We presented the results of 20 patients, a young population of patients. 50% of them that had refractory disease, a heavily pretreated population of patients with a median number of five lines of prior therapy.

And if we start talking about the safety profile, I basically want to mention that the most frequent side effects or toxicity were hematological toxicity for these patients. The most important one, thrombocytopenia, then constituted one of the reasons why the drug had to be permanently discontinued in these patients, but we also observed anemia and leukopenia. We did not have any death related to treatment-related adverse events. And the other important adverse event that we have to take into consideration is the QT prolongation, which is one thing that is further analyzed in these patients.

If we talk about efficacy, the drug demonstrated to be really quite effective in this heavily pretreated population of patients with an overall response rate of 40%. Even in those patients that had failed a prior checkpoint inhibitor, which was basically the vast majority of them, the overall response rate was 38%. The median progression-free survival was around four months, independently of the fact if the patient had received yes or no prior checkpoint inhibition, and the median time to progression was around five months.

Basically, the conclusion of this analysis that hopefully will be soon published is that tinostamustine was really an effective drug in this heavily pretreated population of patients, that it was quite well-tolerated. We need to take into consideration thrombocytopenia, which was the most important side effect that led to treatment discontinuation and that, of course, there will be continued further analysis on tinostamustine in this population of patients.

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Disclosures

Takeda: Consultancy, Honoraria, Research Funding, Speakers Bureau; BMS/Celgene: Consultancy, Honoraria, Research Funding; MSD: Consultancy, Honoraria; Kite: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Jannsen: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; GenMab: Consultancy, Honoraria; Pierre Fabre: Consultancy, Honoraria; Astra Zeneca: Consultancy, Honoraria.