Table 2.

Median RFS and median OS in adult patients with R/R Ph-positive B-cell ALL treated with blinatumomab from pivotal studies.

Reference	Study name/descriptor	No. patients treated with blinatumomab	No. patients with CR/CRh (%)	Median RFS a , months (95% CI)	Median OS, months (95% CI)	Key safety results
Pivotal study
Martinelli et al. 36	ALCANTARA	45	16 (36.0)	6.7 (4.4–NE); 6.8 (4.4–NE) in patients who achieved CR/CRh + complete MRD response b ; 5.5 (3.6–NE) for patients younger than age 55 years; 6.7 (3.8–NE) for patients aged 55 years or older	7.1 (5.6–NE) with or without censoring for alloHSCT	The most common grade ⩾ 3 AEs were febrile neutropenia (26.7%), thrombocytopenia (26.7%), and anemia (17.8%). The incidence of grade ⩾ 3 CRS was 0% and grade ⩾ 3 neurologic AEs was 6.7%
Martinelli et al. 37	Final analysis of ALCANTARA	45	16 (35.6)	6.8 (4.4–NE)	9.0 (5.7–13.5) overall; 23.0 months (12.6–NE) in patients with CR/CRh	Grade ⩾ 3 AEs included febrile neutropenia (11.0%); elevated alanine aminotransferase (11.0%); no grade ⩾ 3 CRS (0%); neurologic grade ⩾ 3 AEs (13.0%)

^aMedian RFS was calculated in patients with CR/CRh. CR is defined as ⩽5% bone marrow and no evidence of disease, platelet count >100,000 per µL, and absolute neutrophil count >1000 per µL. CRh is defined as ⩽5% bone marrow blasts and no evidence of disease, platelet count of >50,000 per µL, and absolute neutrophil count of >500 per µL.

^bComplete MRD response was defined as no detectable PCR amplification of BCR-ABL1 genes (sensitivity ⩾10⁻⁵) as assessed by a central laboratory.

AE, adverse event; ALL, acute lymphoblastic leukemia; alloHSCT, allogeneic hematopoietic stem cell transplantation; CI, confidence interval; CR, complete remission with full hematologic recovery; CRh, complete remission with partial hematologic recovery; CRS, cytokine release syndrome; MRD, measurable residual disease; NE, not estimable; OS, overall survival; Ph, Philadelphia chromosome; RFS, relapse-free survival; R/R, relapsed / refractory.