4SC AG has presented data of a set of biomarkers and their possible utility for stratification of patient populations analyzed in the clinical Phase II SAPHIRE study with its anti-cancer compound resminostat in patients with relapsed/refractory Hodgkin’s lymphoma (HL) at the 17th Congress of the European Hematology Association (EHA) in Amsterdam, The Netherlands from 14-17 June 2012.
The poster will be presented at the Hogdin's lymphoma session, Friday, 15 June 2012, from 5:45-7:00 pm (CEDT) and will report new data on the correlation of resminostat plasma levels and its pharmacodynamic effect on a set of biomarkers, including HDAC enzyme inhibition and the level of critical plasma proteins such as TARC.
Furthermore, based on expression analysis of a set of marker genes regulated by resminostat, the identification and potential of certain gene expressions to serve as either additional pharmacodynamic markers or to qualify as biomarkers for patient stratification or prediction of clinical response to resminostat will be discussed.
Dr. Bernd Hentsch, Chief Development Officer, commented: “Our biomarker analysis program has resulted in the identification of novel gene expressions that may serve as tools for the identification of those HL patients who could have a higher chance of obtaining a clinical benefit from resminostat treatment. This approach now opens the opportunity to target resminostat therapy more effectively to this patient group. Furthermore, we are applying this biomarker program to all our target indications, including HCC and CRC, in order to also explore possible stratification opportunities for those patients.”
The final efficacy data of the SAPHIRE study evaluating resminostat monotherapy in relapsed and/or refractory Hodgin's lymphoma patients had been presented at last year’s ASH conference.
The study met the primary efficacy endpoint with an overall response rate (ORR) of 35.3% and a clinical benefit in 55.9% of these heavily pretreated patients together with a very clean safety and tolerability profile.
The open-label, single-arm, international study evaluated safety, pharmacokinetics, biomarkers, and efficacy of resminostat monotherapy treatment in 34 patients with advanced HL.
Patients enrolled in the trial had either relapsed after high dose chemotherapy and/or autologous stem cell transplantation (ASCT) or had become refractory to treatment, and had on average received 6 prior treatments.