Table 1.

Demographic features for pet dogs enrolled in SOC and SOC + IL-15.

	COTC022 SOC	COTC030 SOC + rhIL-15
Intent to treat population	N = 157	N = 37	P-value
Age in years (Median, range)	8.3 (1.4-15.6)	8 (2-12)	0.958
Weight (kg) (Median, range)	38.8 (25-94.5)	41.5 (26.4-74.6)	0.121
Sex
Castrated Male	83 (53%)	14 (37.8%)	0.184
Spayed Female	64 (41%)	20 (54%)
Intact Male	7 (4.5%)	1 (2.7%)
Intact Female	3 (1.5%)	2 (5.4%)
ALP Status
Normal	118 (75%)	30 (81%)	0.524
Elevated	39 (25%)	7 (19%)
Tumor Location
Proximal humerus	33 (21%)	11 (29.7%)	0.278
Non-proximal humerus	124 (79%)	26 (70.3%)
Distal Radius	57	14
Distal Tibia	27	5
Distal Femur	19	3
Proximal Tibia	9	1
Ulnar	4	1
Other	8	2
Intent-to-treat population
Started inhaled rhIL-15	NA	36 (97.3%)	0.248
Completed inhaled rhIL-15 a	NA	33 (89.2%)
Started carboplatin	149 (94.9%)	33 (89.2%)
Reason off study
Disease progression on study	52 (33.1%)	17 (45.9%)	0.322
Disease progression during follow-up period	69 (43.9%)	12 (32.4%)
Complicating disease/intercurrent illness	13 (8.2%)	2 (5.4%)
Follow-up period completed	9 (5.7%)	1 (2.7%)
Refused further treatment	6 (3.8%)	1 (2.7%)
Death on study	2 (1.2%)	1 (2.7%)
AEs/side effects	3 (1.9%)	3 (8.1%)

AE, adverse events.

^a3 of the 33 dogs missed between 1–3 doses of inhaled rhIL-15 but completed the majority of the treatment course.

^bClinical, imaging, or necropsy evidence.