Giovanni Martinelli1, Nicolas Boissel2, Patrice Chevallier3, Oliver Ottmann4, Nicola Gökbuget5, Alessandro Rambaldi6, Ellen K Ritchie7, Cristina Papayannidis8, Catherine A Tuglus9, Joan D Morris9, Anthony Stein10. 1. IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy. Electronic address: giovanni.martinelli@irst.emr.it. 2. Université Paris Diderot, Institut Universitaire d'Hématologie, EA-3518, AP-HP, University Hospital Saint-Louis, Paris, France. 3. Centre Hospitalier Universitaire Nantes, Nantes, France. 4. Division of Cancer and Genetics, Department of d'Haematology, Cardiff University, Cardiff, United Kingdom. 5. University Hospital, Goethe University, Frankfurt, Germany. 6. Department of Oncology-Hematology, Università degli Studi di Milano e Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy. 7. Weill Cornell Medical College and New York-Presbyterian Hospital, New York, NY, United States. 8. Institute of Hematology "L. and A". Seràgnoli, University Hospital S. Orsola-Malpighi, Bologna, Italy. 9. Amgen Inc., Thousand Oaks, CA, United States. 10. Gehr Family Center for Leukemia Research, City of Hope, Duarte, CA, United States.
Abstract
AIM: To evaluate long-term durability of blinatumomab, a BiTE® (bispecific T-cell engager) molecule, in adults with relapsed/refractory (R/R) Philadelphia chromosome-positive (Ph+) B-cell precursor acute lymphoblastic leukaemia (ALL). METHODS: In this final analysis of an open-label, single-arm, phase 2, multicentre ALCANTARA study (NCT02000427), adults (age ≥18 years) with Ph+ ALL who had relapsed or were refractory to at least one TKI were included. The primary endpoint was the proportion of patients who achieved complete remission (CR)/CR with partial haematologic recovery (CRh) during the first two cycles of blinatumomab treatment. RESULTS: The final analysis included 45 patients who completed the study between 3rd January 2014 and 6th January 2017, of which 16 (35.6%; 95% CI, 21.9%-51.2%) achieved CR/CRh within the first two blinatumomab cycles. After a median follow-up of 16.1 months, median relapse-free survival (RFS) was 6.8 (95% CI, 4.4-not estimable [NE]) months. Median overall survival (OS) was 9.0 (95% CI, 5.7-13.5) months with a median follow-up of 25.1 months. Median OS in patients with CR (19.8 [95% CI, 12.1-NE] months) was greater than in those without CR (6.0 [95% CI, 2.9-7.1] months). Of 16 patients with CR/CRh, 14 achieved complete minimal residual disease (MRD) response; the median duration of complete MRD response was 9.7 (95% CI, 5.2-NE) months. Treatment-related adverse events were consistent with those previously reported. CONCLUSION: Long-term durability of responses to blinatumomab was demonstrated in patients with R/R Ph+ ALL.
AIM: To evaluate long-term durability of blinatumomab, a BiTE® (bispecific T-cell engager) molecule, in adults with relapsed/refractory (R/R) Philadelphia chromosome-positive (Ph+) B-cell precursor acute lymphoblastic leukaemia (ALL). METHODS: In this final analysis of an open-label, single-arm, phase 2, multicentre ALCANTARA study (NCT02000427), adults (age ≥18 years) with Ph+ ALL who had relapsed or were refractory to at least one TKI were included. The primary endpoint was the proportion of patients who achieved complete remission (CR)/CR with partial haematologic recovery (CRh) during the first two cycles of blinatumomab treatment. RESULTS: The final analysis included 45 patients who completed the study between 3rd January 2014 and 6th January 2017, of which 16 (35.6%; 95% CI, 21.9%-51.2%) achieved CR/CRh within the first two blinatumomab cycles. After a median follow-up of 16.1 months, median relapse-free survival (RFS) was 6.8 (95% CI, 4.4-not estimable [NE]) months. Median overall survival (OS) was 9.0 (95% CI, 5.7-13.5) months with a median follow-up of 25.1 months. Median OS in patients with CR (19.8 [95% CI, 12.1-NE] months) was greater than in those without CR (6.0 [95% CI, 2.9-7.1] months). Of 16 patients with CR/CRh, 14 achieved complete minimal residual disease (MRD) response; the median duration of complete MRD response was 9.7 (95% CI, 5.2-NE) months. Treatment-related adverse events were consistent with those previously reported. CONCLUSION: Long-term durability of responses to blinatumomab was demonstrated in patients with R/R Ph+ ALL.
Authors: Camila Ordóñez-Reyes; Juan Esteban Garcia-Robledo; Diego F Chamorro; Andrés Mosquera; Liliana Sussmann; Alejandro Ruiz-Patiño; Oscar Arrieta; Lucia Zatarain-Barrón; Leonardo Rojas; Alessandro Russo; Diego de Miguel-Perez; Christian Rolfo; Andrés F Cardona Journal: Pharmaceutics Date: 2022-06-11 Impact factor: 6.525