ASCEND: Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL

[Jm954]

Take home message is that Acalabrutinib significantly improved PFS and that Idelalisib Plus Rituximab treatment was associated with a high level of serious adverse events compared to the other treatments.

310 patients were randomly assigned to acalabrutinib monotherapy (n = 155) or investigator’s choice (n = 155; I-R, n = 119; B-R, n = 36). Patients had received a median of two prior therapies (range, 1-10).

After a median follow-up of 16.1 months (range, 0.03-22.4 months), median PFS was significantly longer with acalabrutinib monotherapy (PFS not reached) compared with investigator’s choice (16.5 months [95% CI, 14.0 to 17.1 months]; hazard ratio, 0.31 [95% CI, 0.20 to 0.49]; P < .0001).

Estimated 12-month PFS was 88% (95% CI, 81% to 92%) for acalabrutinib and 68% (95% CI, 59% to 75%) for investigator’s choice.

Serious adverse events occurred in 29% of patients (n = 44 of 154) treated with acalabrutinib monotherapy, 56% (n = 66 of 118) with I-R, and 26% (n = 9 of 35) with B-R.

Deaths occurred in 10% (n = 15 of 154), 11% (n = 13 of 118), and 14% (n = 5 of 35) of patients receiving acalabrutinib monotherapy, I-R, and B-R, respectively.

CONCLUSION

Acalabrutinib significantly improved PFS compared with I-R or B-R and has an acceptable safety profile in patients with R/R CL

[Psmithuk]

Is it an option in the UK?

[Jm954 Administrator in reply to Psmithuk]

This trial isn't as far as I am aware, not sure I would take the chance of Idelasalib with its safety profile.

Acalabrutinib is available in the UK for first line treatment at the moment under a compassionate access scheme.

All the best

Jackie

[Psmithuk in reply to Jm954]

Thanks, Jackie - I meant Acalabrutinib, sorry I didn’t make it clear. Sounds very promising!

[morepork]

My NZ Haematologist indicated at least a year ago that they would not touch Idelalisib given that data.