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SAKK 35/15: A PHASE I TRIAL OF OBINUTUZUMAB IN COMBINATION WITH VENETOCLAX IN PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA PATIENTS
Author(s) -
Stathis A.,
Mey U.,
Schär S.,
Hitz F.,
Pott C.,
Mach N.,
Krasniqi F.,
Novak U.,
Schmidt C.,
Hohloch K.,
Kienle D.,
Hess D.,
Moccia A.,
Unterhalt M.,
Eckhardt K.,
Hayoz S.,
Rossi D.,
Dirnhofer S.,
Ceriani L.,
Bertoni F.,
Buske C.,
Zucca E.,
Hiddemann W.
Publication year - 2019
Publication title -
hematological oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 44
eISSN - 1099-1069
pISSN - 0278-0232
DOI - 10.1002/hon.78_2629
Subject(s) - obinutuzumab , venetoclax , medicine , follicular lymphoma , lymphoma , gastroenterology , oncology , rituximab , leukemia , chronic lymphocytic leukemia
R-chemo vs 49% in R2). At diagnosis, 213/220 PB and 136/139 BM samples were (+) with a median of 0.0058 and 0.021 respectively. At W24, 98% and 78% of those pts have reached MR in PB and BM respectively. The MRD positivity in BM at W24 was significantly (p=.02) more frequently observed in pts receiving R-chemo (32% vs 15%), in those with beta2m ≥ 3 mg/L (55% vs 34%, p=.05), and in those with higher levels of molecular disease before treatment (median value ten times higher in pts with (+) MRD (PB=0.056 and BM=0.16) than in pts with (-) MRD (PB=0.0056 and BM=0.016), p= 0.03 and p=0.02 respectively). Multivariate analysis results showed that only R-Chemo arm (OR=3.4, p=.008) and beta2m ≥ 3 mg/L (OR=3.1, p=.014) were factors independently associated with an increased risk of MRD (+) in BM at W24. Achievement of MRD negativity at W24 in BM was significantly associated with an improved PFS (p=.011) (3-year PFS 85.3% vs 54.4% for pts with (+) MRD (figure). At W120 in pts with persisting clinical response, only 2/166 pts were MRD (+) in PB, and 11/99 in BM. Longer follow up is needed to evaluate the prognostic value of those positive samples. Conclusions: In agreement with the clinical results of RELEVANCE trial, our results show that an immunomodulatory induction treatment in first line FL can achieves high rate of MR in both blood and bone marrow; Achieving a complete MR at the end of induction was predicting a more favorable PFS.