Medizinische Klinik und Poliklinik II, Würzburg, Bayern, Germany
Max Topp , Anthony Selwyn Stein , Gerhard Zugmaier , Hervé Dombret , Monika Brueggemann , Massimiliano Bonifacio , Xiaoyu Dong , Hagop M. Kantarjian , Ralf C. Bargou , Nicola Gökbuget
Background: In BCP-ALL, blinatumomab has demonstrated efficacy in two phase 2 trials: MT 103 -203 (Gökbuget et al, Blood 2017) in minimal residual disease (MRD) and MT 102 – 211 in relapsed/refractory (R/R) disease (Topp et al Lancet Oncology 2104). We describe the long-term outcomes after blinatumomab followed by HSCT. Methods: Survival after blinatumomab and HSCT in continuous complete remission (CCR) was evaluated. In the MRD trial, 116 patients between Nov 2010 and Feb 2014 were treated with blinatumomab; in the R/R trial, 189 patients between Jan 2012 and Oct 2013 were treated. Follow up in both trials continued through 2017. Results: Most patients with HSCT in CCR in the MRD trial were >35 yrs of age whereas those in the R/R trial were younger (Table). After follow up of at least 3 yrs in the MRD trial of patients ≤35 yrs, 16/26 (62%) were alive with HSCT vs 2/9 (22%) for non-HSCT; in patients >35 yrs, 19/48 (40%) and 13/27 (48%) were alive with HSCT and for non-HSCT, respectively. Median overall survival (OS) from HSCT was not reached in patients ≤35 yrs in either trial (Table). Conclusions: These results suggest that in transplant-eligible patients in CCR, HSCT following blinatumomab is a potential option. Clinical trial information: NCT01466179, NCT01207388
MT 103 -203 N=74b n (%) | MT 103 -211 N=34 n (%) | |
---|---|---|
Characteristics | ||
Age, n (%), yrs | ||
≤35 | 26 (35) | 19 (56) |
>35 to 55 | 29 (39) | 9 (26) |
>55 | 19 (26) | 6 (18) |
Median (range) | 43 (18, 67) | 31 (18, 65) |
Donor | ||
Related, n (%) | 19 (26)a | 8 (23) |
Unrelated, n (%) | 53 (72) | 23 (68) |
Matched, n (%) | 20 (27) | 9 (26) |
Unmatched | 23 (31) | 10 (29) |
Unknown, n (%) | 6 (8) | 3 (9) |
Cord | 4 (5) | 1 (3) |
Unknown, n (%) | 2 (3) | 3 (9) |
Conditioning regimen | ||
Myeloablative | 32 (43) | 15 (44) |
Reduced intensity/nonmyeloablative | 35 (47) | 12 (35) |
Unknown | 7 (20) | 7 (21) |
100-day mortality after HST, n (%)c | 5 (7) | 4 (12) |
Outcomes | ||
Median OS from HSCT, months | ||
Age ≤35 yrs | NE | NE |
Age >35 yrs | 25.7 | 15.9 |
Median RFS from HSCT, months | ||
Age ≤35 yrs | NE | 16.4 |
Age >35 yrs | 15.5 | 15.9 |
NE, not estimable. a 1 haploidentical. b 74 patients received on-study HSCT in CR; Ph+ and patients not in CR at treatment start excluded. c No VOD-related deaths. Study Sponsored by Amgen.
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