Vincristine sulfate liposomes injection (Marqibo) in heavily pretreated patients with refractory aggressive non‐Hodgkin lymphoma

Abstract

BACKGROUND: Marqibo, a sphingosomal/cholesterol encapsulation of vincristine sulfate has targeted, increased, and sustained delivery of vincristine to tumor tissues. A phase 2, open‐label, single‐arm, and multinational study evaluated the efficacy and tolerability of Marqibo as a single agent in patients with multiply relapsed or refractory aggressive non‐Hodgkin lymphoma (NHL). METHODS: Eligible patients had relapsed or refractory de novo or transformed aggressive NHL and prior treatment with at least 2 multiagent chemotherapy regimens. Marqibo was administered at 2 mg/m2, every 2 weeks, for a maximum of 12 cycles or until toxicity or disease progression. RESULTS: One hundred and nineteen patients were enrolled and treated on trial. Ninety‐six had histological confirmed de novo (N = 89) or transformed (N = 7) aggressive NHL. Median number of cycles was 4 (median dose/cycle 4 mg). Overall response (CR and complete response unconfirmed and PR) was 25% (95% confidence interval [CI], 17, 35), CR and complete response unconfirmed confirmed by external reviewers was 5%. Median overall survival was 6.6 months (Kaplan‐Meier estimate, 95% CI, 4.7, 9.8). Grade 3 of 4 neurotoxicity occurred in 32% of patients. All patients had prior neurotoxic agents, and 85% had baseline residual neuropathy symptoms (grades 1‐2) from prior treatment. CONCLUSIONS: Marqibo is an active agent in patients with heavily pretreated aggressive NHL, and tolerated at approximately twice the dose intensity of standard vincristine. Its activity supports further investigation as a substitution for vincristine in combination treatment of lymphoid disorders. Cancer 2009. © 2009 American Cancer Society.

Pharmacokinetic characteristics of vincristine sulfate liposomes in patients with advanced solid tumors

“…Previous studies have demonstrated that the liposomal encapsulation of VCR increased its antitumor efficacy without increasing toxicity [8][9][10][11] . Marqibo ® (Vincristine sulfate liposomes injection, Hana Biosciences, Inc) has been extensively studied for its capability to prolong the pharmacokinetics and subsequent exposure of VCR to cancer cells [5,6,12] , thus increasing its antitumor activity [5,13,14] . However, Marqibo ® was developed as a 3-vial kit containing 100 mg/mL of injectable sphingomyelin/cholesterol liposomes, 14.2 mg/mL of injectable sodium phosphate and Oncovin (injectable vincristine sulfate).…”

Liposome and Their Applications in Cancer Therapy

“…The liposomal formulation of vincristine made by Talon was registered under trade name of Marqibo. Marqibo was approved in 2012 by the FDA for the treatment of acute lymphoblastic leukemia (Sarris et al 2000;Rodriguez et al 2009). Celator Pharmaceuticals Inc developed CPX-351, a liposomal formulation of cytarabine and daunorubicin.…”

Are PEGylated liposomes better than conventional liposomes? A special case for vincristine

“…The ORR was 14%. In the pivotal phase II study of SM/Chol liposomal vincristine, 119 patients with multiple relapsed or refractory aggressive NHL were treated intravenously at 2 mg/m 2 every two weeks to estimate the therapeutic effect and tolerability of this formulation (Rodriguez et al, 2009). The ORR was 25% and showed approximately twice the dose intensity tolerability compared to vincristine solution.…”