A Comparative Pharmacokinetic Study of 2 Pemetrexed Formulations in Indian Adult Chemonaive Patients With Adenocarcinoma Stage III/IV Non–Small Cell Lung Cancer. Issue 3 (29th March 2017) - Kavathiya, Krunal
Abstract: The study aimed to compare the pharmacokinetics of 2 pemetrexed formulations (Pemgem, Dr. Reddy's Laboratories w.r.t; Alimta, Eli Lilly) in adult chemonaive subjects with adenocarcinoma stage III/IV non–small cell lung cancer. All patients received 500 mg/m 2 pemetrexed (Alimta or Pemgem) as a 10‐minute infusion on day 1 of a 21‐day cycle. Plasma pemetrexed concentrations were determined on day 1 of cycle 1. Area under the concentration–time curve (AUC0–inf ) and the maximum plasma concentration (Cmax ) were estimated using noncompartment analysis and compared between the 2 arms. Forty‐eight patients were enrolled in the study, 24 in each arm. Patient demographics were comparable in both arms. Mean AUC0–inf for the generic and innovator formulations was 218.2 ± 19.18 and 223.6 ± 34.24 μg·h/mL, respectively, and mean Cmax was 119 ± 13.44 and 113 ± 7.26 μg/mL, respectively. Volume of distribution of pemetrexed was 17.5 and 27.6 L, clearance was 4.2 versus 4.72 L/h, and half‐life was 4.3 and 4.83 h in the 2 arms respectively. Both formulations showed comparable response rates (objective response of 45% versus 50% in the Pemgem and Alimta arms, respectively) and similar safety profiles. To conclude, Pemgem showed pharmacokinetic and safety profiles similar to Alimta. Substitution of Alimta with Pemgem will be cost‐effective and likely to yield comparable efficacy.