Event-free survival: TELESTO

Randomized trial of deferasirox versus placebo in lower IPSS risk MDS

Event-free survival

• Despite target enrollment being reduced by 2/3, making the study not powered to detect its endpoint,
• Despite half of placebo patients withdrawing from the study and subsequently receiving ICT,
• There was superior EFS in ICT patients, which became more apparent over time.

Conclusions: 1^st prospective, randomized study in Low/Int-1 IPSS risk MDS with IOL showing ICT provides clinical benefit; superior EFS.

• The safety profile was consistent with previous studies of DFX in MDS.
• The results support the use of ICT in Low/Int-1-risk MDS with IOL.

Comments:

• The use of ICT after study treatment discontinuation in 1/2 of placebo patients may have diluted OS & organ event differences.
• The mean age of TELESTO patients was 61 years, younger than in other analyses² & clinical practice (e.g. the mean ± SD age at TD in the Canadian analysis was 71.8 ± 11.3 years). This also could have diluted OS & organ event differences.
• Thus TELESTO may underestimate a clinical benefit of ICT in MDS.