CLINICAL TRIALS PROFILE FOR MARQIBO KIT

All Clinical Trials for marqibo kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00025259 ↗	Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease	Completed	National Cancer Institute (NCI)	Phase 3	2002-09-01	This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00025259 ↗	Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease	Completed	Children's Oncology Group	Phase 3	2002-09-01	This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00072384 ↗	Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma	Completed	National Cancer Institute (NCI)	Phase 3	2007-04-16	Phase III trial to determine the effectiveness of combining systemic chemotherapy and subtenon carboplatin with ophthalmic therapy in treating children who have intraocular retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether systemic chemotherapy and subtenon (under the conjunctiva of the eye) carboplatin combined with ophthalmic therapy is effective in treating intraocular (within the eyeball) retinoblastoma.
NCT00072384 ↗	Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma	Completed	Children's Oncology Group	Phase 3	2007-04-16	Phase III trial to determine the effectiveness of combining systemic chemotherapy and subtenon carboplatin with ophthalmic therapy in treating children who have intraocular retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether systemic chemotherapy and subtenon (under the conjunctiva of the eye) carboplatin combined with ophthalmic therapy is effective in treating intraocular (within the eyeball) retinoblastoma.
NCT00098839 ↗	Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2005-02-01	This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them or by stopping them from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer cells more effectively.
NCT00098839 ↗	Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)	Completed	Children's Oncology Group	Phase 1/Phase 2	2005-02-01	This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them or by stopping them from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer cells more effectively.
NCT00144963 ↗	Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia	Completed	Acrotech Biopharma LLC	Phase 1/Phase 2	2002-07-01	The purpose of this study is to find the highest safe dose and to assess the anti-tumor effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

Clinical Trial Conditions for marqibo kit

Condition Name

Condition Name for marqibo kit
Intervention	Trials
Leukemia	3
Recurrent Childhood Acute Lymphoblastic Leukemia	3
Recurrent Childhood Lymphoblastic Lymphoma	3
Stage IV Childhood Hodgkin Lymphoma	2

Condition MeSH

Condition MeSH for marqibo kit
Intervention	Trials
Leukemia	14
Precursor Cell Lymphoblastic Leukemia-Lymphoma	13
Leukemia, Lymphoid	13
Lymphoma	9

Clinical Trial Locations for marqibo kit

Trials by Country

Trials by Country for marqibo kit
Location	Trials
United States	464
Canada	64
Australia	33
New Zealand	9
Puerto Rico	6

Trials by US State

Trials by US State for marqibo kit
Location	Trials
Texas	19
California	17
Illinois	14
New York	14
Maryland	13

Clinical Trial Progress for marqibo kit

Clinical Trial Phase

Clinical Trial Phase for marqibo kit
Clinical Trial Phase	Trials
Phase 3	8
Phase 2	9
Phase 1/Phase 2	4

Clinical Trial Status

Clinical Trial Status for marqibo kit
Clinical Trial Phase	Trials
Completed	14
Active, not recruiting	4
Terminated	4

Clinical Trial Sponsors for marqibo kit

Sponsor Name

Sponsor Name for marqibo kit
Sponsor	Trials
National Cancer Institute (NCI)	18
Spectrum Pharmaceuticals, Inc	11
Children's Oncology Group	8

Sponsor Type

Sponsor Type for marqibo kit
Sponsor	Trials
Other	23
Industry	21
NIH	18

Marqibo kit Market Analysis and Financial Projection

Marqibo Kit: Clinical Trials, Market Analysis, and Projections

Introduction

Marqibo, a liposomal formulation of the chemotherapy drug vincristine sulfate, has been a significant development in the treatment of acute lymphoblastic leukemia (ALL). Here, we will delve into the clinical trials, market analysis, and projections for Marqibo Kit.

Clinical Trials and Approval

Initial Approval

Marqibo was approved by the FDA on August 9, 2012, for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more lines of anti-leukemia therapy. The approval was based on a single-arm clinical trial that demonstrated a 15% complete response (CR) plus complete response with incomplete blood count recovery (CRi) rate, with a median CR+CRi duration of 28-56 days[1][3].

Post-Marketing Commitments

As part of the approval, the FDA required post-marketing commitments, including a randomized clinical trial to provide evidence of clinical benefit. This trial aims to evaluate the substitution of Marqibo for standard vincristine sulfate injection in the treatment of newly diagnosed ALL in patients aged 60 and older. If successful, this trial could lead to full approval[1].

Ongoing and Future Trials

In addition to the post-marketing commitments, other clinical trials are ongoing. For example, a Phase I dose-escalation study is investigating the combination of Marqibo with bendamustine and rituximab in patients with indolent non-Hodgkin lymphoma. This study aims to establish the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of the combination[4].

Market Analysis

Current Market Size

The global market for Marqibo was estimated to be worth US$ 211 million in 2023. This market is expected to grow, driven by the increasing incidence of ALL and the need for effective treatments in relapsed or refractory cases[2].

Market Projections

By 2030, the global market for Marqibo is forecasted to reach US$ 351.2 million, with a compound annual growth rate (CAGR) of 6.9% during the period from 2024 to 2030. This growth is attributed to the expanding patient population and the integration of Marqibo into existing oncology treatment protocols[2].

Key Players

Talon Therapeutics, now part of Spectrum Pharmaceuticals, is the primary player in the Marqibo market. Spectrum Pharmaceuticals has a strong focus on hematology and oncology, and Marqibo fits seamlessly into their existing infrastructure, contributing to their growing hematology franchise[5].

Market Segmentation

By Type

The Marqibo market is segmented by type, with formulations available in 25ml and 31ml vials. These different formulations cater to various patient needs and treatment regimens[2].

By Application

Marqibo is primarily used in hospitals and pharmacies. The drug's unique preparation and administration requirements make these settings crucial for its distribution and use[2].

Safety and Efficacy

Safety Profile

Marqibo has a reasonable safety profile, similar to that of standard vincristine sulfate. However, it is contraindicated in patients with demyelinating conditions, such as Charcot-Marie-Tooth syndrome, and in those with hypersensitivity to vincristine sulfate or its components. The most common adverse reactions include peripheral neuropathy, which can lead to treatment discontinuation[1][5].

Efficacy

The clinical trials have shown that Marqibo produces responses, including complete responses, with a minimum duration of 28-56 days. An 8% subsequent stem cell transplant rate after achieving CR or CRi with Marqibo has also been observed[1].

Preparation and Administration

Unique Preparation

Marqibo is notable for its preparation, which is conducted at the pharmacy level rather than at a commercial site. The kit includes vincristine sulfate, liposomes, and sodium phosphate injection, along with specific instructions for preparation. Post-marketing commitments include exploring simpler preparation options to eliminate the need for heating the drug in the pharmacy[1].

Administration

Marqibo is administered at a dose of 2.25 mg/m² IV every 7 days as a 60-minute infusion for a 28-day course of treatment. This regimen is designed to optimize the drug's efficacy while managing its toxicity profile[1].

Market Access and Support

Spectrum Therapy Access Resources (STAR)

To facilitate access to Marqibo, Spectrum Pharmaceuticals offers the STAR program, which includes reimbursement support, co-pay assistance, and patient assistance. This program helps patients and healthcare professionals navigate the complexities of accessing the drug[5].

Conclusion

Marqibo Kit has established itself as a valuable treatment option for adult patients with Ph- ALL in second or greater relapse or whose disease has progressed following two or more lines of anti-leukemia therapy. With ongoing clinical trials and post-marketing commitments, the drug is expected to continue contributing to the treatment landscape of ALL.

Key Takeaways

• Clinical Trials: Marqibo was approved based on a single-arm trial and is subject to post-marketing commitments for further clinical benefit evidence.
• Market Size and Growth: The global market for Marqibo is projected to reach US$ 351.2 million by 2030, with a CAGR of 6.9%.
• Safety and Efficacy: Marqibo has a reasonable safety profile and demonstrates efficacy in producing complete responses in ALL patients.
• Preparation and Administration: Unique pharmacy-level preparation and specific administration guidelines are critical for the drug's use.
• Market Access: Spectrum Pharmaceuticals' STAR program supports patient access to Marqibo.

FAQs

What is Marqibo used for?

Marqibo is used for the treatment of adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL) in second or greater relapse or whose disease has progressed following two or more lines of anti-leukemia therapy.

What is the unique aspect of Marqibo's preparation?

Marqibo is prepared at the pharmacy level, which is unusual compared to most commercial drug preparations.

What are the common adverse reactions associated with Marqibo?

The most common adverse reactions include peripheral neuropathy, which can lead to treatment discontinuation.

What is the projected market size for Marqibo by 2030?

The global market for Marqibo is forecasted to reach US$ 351.2 million by 2030.

Who are the key players in the Marqibo market?

Talon Therapeutics, now part of Spectrum Pharmaceuticals, is the primary player in the Marqibo market.

Sources

1. FDA Summary Review: "202497Orig1s000 Summary Review" - FDA.
2. Market Report: "Marqibo - Global Market Share and Ranking, Overall Sales and ..." - Valuates Reports.
3. Corporate Update: "Tekmira Provides Corporate Update and Announces 2011 Results" - Tekmira.
4. Clinical Trial Protocol: "A Phase I Dose-Escalation Study of Vincristine Sulfate Liposome Injection (Marqibo®)" - ClinicalTrials.gov.
5. Product Launch: "Spectrum Pharmaceuticals Launches Marqibo® (vinCRIStine sulfate LIPOSOME injection)" - Business Wire.