Spectrum Pharmaceutecals Inc (SPPI)

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New paper published, "Eflapegrastim Versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies".
https://www.e-crt.org/journal/view.php?doi=10.4143/crt.2022.987#
In a few words, "This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population."
Some interesting findings and interpretations:
Fixed dose of pegfilgrastim 6 mg/0.6mL or eflapegrastim 13.2 mg/0.6mL were used regardless of body weight in both studies. The median body weight for Korean was 57.4 kg and for Asian patients 56.3 kg in eflapegrastim group which was more than 20 kg lower than the median body weight for Non-Asian in eflapegrastim group (79 kg). This difference in the body weight might cause more frequent musculoskeletal symptoms for Asian patients. Moreover, these musculoskeletal pains did not cause serious morbidities because these could be managed with pain medicine including weak opioids and non-steroidal anti-inflammatory drugs.
AND
Although this study was designed to demonstrate non-inferiority as mentioned above, eflapegrastim had numerically better efficacy in the primary efficacy analysis, irrespectively of in Asians or non-Asians. Even though it is not considered statistically significant, we may suggest biologically plausible reasons for this. Eflapegrastim and pegfilgrastim had similar in vitro binding affinity but the FcRn fragment in eflapegrastim increased the uptake of the drug into bone marrow. In addition, eflapegrastim showed the greater bone marrow exposure and retention, resulting in increased potency in animal model [14]. These findings also support eflapegrastim same-day administration with chemotherapy, and a clinical trial is underway (NCT04187898).