AssAssertio Holdings Inc (ASRT)

[dcaf7]

From the abstract
The primary endpoint was the time to recovery of absolute neutrophil counts (ANC) from nadir to ? 1.5×109/L in C1. Secondary endpoints included incidence of SN (ANC < 0.5×109/L) and FN (ANC < 1.0×109/L and temperature of > 38.3 oC or 2 consecutive readings ?
38.0 oC over 2 hours), duration of SN (DSN), and incidence of neutropenic complications, including use of antibiotics and/or hospitalizations.
Results: A total of 53 pts (mean [SD] age: 62.7 [11.9] years; female: 100%) from 13 sites across the US, were enrolled (White: 62.3%; Black or African American: 9.4%; others: 28.3%). Pts were relatively healthy (ECOG 0, 52.8% [n = 28] patients; ECOG 1, 47.2% [n =
25] patients). Efficacy in C1 was evaluable in 49 patients. Mean (SD) time to ANC recovery was 1.8 (1.1) days. Incidence of SN was 46.9% (n = 23) and mean (SD) DSN was 0.8 (1.0) days. Incidence of FN was 2% (n = 1). No neutropenic complications were observed during the study. Safety was assessed in all 53 patients who received at least 1 dose of eflapegrastim. Overall, 43 patients (81.1%) experienced any TEAE of musculoskeletal pain. Common musculoskeletal-related TEAEs experienced by ? 10% of patients were bone pain (52.8%; n = 28); back pain (26.4%; n = 14), arthralgia or pain in extremity (17.0%; n = 9 for each); and myalgia (13.2%; n = 7). No deaths were reported during the study.
Conclusions: These findings suggest that administration of eflapegrastim on the same day as TC chemotherapy may be advantageous in reducing the time to ANC recovery and related complications in pts with ESBC. The AEs observed in this study were consistent with those
generally observed in pts receiving TC and other GCSF products.