Open-Label, phase 2 study of blinatumomab as second salvage therapy in adults with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma

Figures & data

Table 1. Demographics and baseline disease characteristics.

Characteristics	Patients (n = 41)
Median (range) age, years	56 (19–75)
Sex, n (%)
Men	28 (68)
Women	13 (32)
Race, n (%)
White	38 (93)
Black	1 (2)
Asian	1 (2)
Not reported	1 (2)
ECOG performance status, n (%)
0	19 (46)
1	18 (44)
2	3 (7)
Missing	1 (2)
Disease type, n (%)
Diffuse large B-cell lymphoma	34 (83)
Primary mediastinal (thymic) large B-cell lymphoma	4 (10)
High grade B-cell lymphoma with C-myc, Bcl-2, and/or Bcl-6 rearrangements	2 (5)
T-cell/histiocyte–rich large B-cell lymphoma	1 (2)
Disease stage, n (%)
I	1 (2)
II	4 (10)
IIE	3 (7)
III	10 (24)
IV	20 (49)
Missing	3 (7)
International Prognostic Index at study entry, n (%)
Low risk	15 (37)
Low-intermediate risk	11 (27)
High-intermediate risk	11 (27)
High risk	4 (10)
Disease status after first-line therapy, n (%)
Relapsed	13 (32)
Refractory	28 (68)
Response after first salvage, n (%)
NMR	5 (12)
PMR	9 (22)
PMD	27 (66)
Prior indolent lymphoma, n (%)	6 (15)
Extranodal disease, n (%)	25 (61)
Cell of origin determination, n (%)
Known	33 (81)
GCB	17 (42)
Non-GCB	16 (39)
Unknown^a	8 (20)
C-myc, Bcl-2, and Bcl-6 rearrangement, n (%)	9 (22)
Double hit,^b	5 (12)
Triple hit,^c	4 (10)
Double or triple expressor, n (%)	15 (37)

GCB: germinal center B cell–like.

a Reasons for no cytogenetics reporting included no cytogenetics or FISH reports in hospital records; data not available; and cell of origin determination not performed by IHC or gene expression profiles/arrays.

b Defined as rearrangement of C-myc and either Bcl-2 or Bcl-6.

c Defined as rearrangement of C-myc, Bcl-2, and Bcl-6.

Figure 1. Patient disposition. ^aOne patient with progressive disease also had an AE discontinuation event (superior vena cava occlusion). ^bDeath attributed to sepsis.

Table 2. Response and transplant realization.

Characteristics	Patients	Proportion (95% CI)
Best response after 12 weeks of treatment
Objective response rate (CMR + PMR)	15/41	37% (22–53)
CMR	9/41	22% (11–38)
PMR	6/41	15% (6–29)
NMR	5/41	12% (4–26)
PMD	12/41	29% (16–46)
Not performed^a	9/41	22%
Patients with HSCT	8/41	20%
Autologous HSCT	7/41	17% (7–32)
Allogeneic HSCT	1/41	2% (<1–13)
Patients with HSCT within 30 days of first response	5/41	12%
Patients with delayed or not done HSCT	35/41	85%
No CMR (PMR only)	4/41	10%
NMR or unknown	1/41	2%
PMD	17/41	42%
Toxicity/adverse event	4/41	10%
Patient preference	1/41	2%
Missing	1/41	2%
Other^b	8/41	20%

CI: confidence interval; CMR: complete metabolic response; HSCT: hematopoietic stem cell transplant; NMR: no molecular response; PMD: progressive metabolic disease; PMR: partial metabolic response.

a Reasons for missing post-baseline assessment were death (n = 5), withdrawn consent (n = 2), patient refusal (n = 1), and logistical issue (n = 1).

b Other includes more than 30 days to organize transplant (n = 2), logistical issue (n = 2), investigator decision (n = 1), initiated cycle 2 without transplant (n = 1), transplant 9 days after completion of cycle 2 (n = 1), and started another line of treatment without transplant (n = 1).

Figure 2. Response by baseline parameter.

Figure 3. Kaplan–Meier estimated overall survival.

Table 3. Summary of adverse events.

	Any grade	Grade ≥3
Patients with any treatment-emergent AE, n (%)	41 (100)	29 (71)
Patients with any treatment-emergent serious AE, n (%)	19 (46)	18 (44)
Patients with a fatal AE,^a n (%)	9 (22)
AEs occurring in ≥10% of patients, n (%)
Back pain	10 (24)	1 (2)
Pyrexia	10 (24)	1 (2)
Headache	9 (22)	0
Tremor	9 (22)	1 (2)
Peripheral edema	8 (20)	1 (2)
Confusional state	6 (15)	3 (7)
Constipation	6 (15)	0
Nausea	6 (15)	1 (2)
Abdominal pain	5 (12)	1 (2)
Anemia	5 (12)	3 (7)
Neutropenia	5 (12)	4 (10)
Arthralgia	4 (10)	1 (2)
Diarrhea	4 (10)	0
Fatigue	4 (10)	1 (2)
Hypoalbuminemia	4 (10)	1 (2)
Hypomagnesemia	4 (10)	0
Insomnia	4 (10)	0
Pain in extremity	4 (10)	2 (5)
Patients with neurologic events, n (%)	23 (56)	10 (24)
Headache	9 (22)	0
Tremor	9 (22)	1 (2)
Confusional state	6 (15)	3 (7)
Insomnia	4 (10)	0
Aphasia	3 (7)	2 (5)
Lethargy	2 (5)	0
Neurotoxicity	2 (5)	2 (5)
Oral paresthesia	2 (5)	0
Agitation	1 (2)	0
Anxiety	1 (2)	0
Depression	1 (2)	0
Dissociative amnesia	1 (2)	0
Dizziness	1 (2)	0
Dysesthesia	1 (2)	1 (2)
Dysarthria	1 (2)	0
Facial paresis	1 (2)	0
Hemiparesis	1 (2)	1 (2)
Hypoesthesia	1 (2)	0
Intention tremor	1 (2)	0
Oral paresthesia	1 (2)	0
Presyncope	1 (2)	0
Somnolence	1 (2)	0
Speech disorder	1 (2)	0
Tension headache	1 (2)	0
Vertigo	1 (2)	0

a Diffuse large B-cell lymphoma (n = 2), lymphoma (n = 1), non-Hodgkin lymphoma (n = 1), squamous cell carcinoma of the lung (n = 1), pancytopenia (n = 1), multiple organ dysfunction syndrome (n = 1), treatment-related sepsis (n = 1), and adult failure to thrive (n = 1).