Delving into the Latest Updates on Onamelatucel-L with Synapse

Overview

Basic Info

Drug Type

Immune cell therapy

Synonyms

CANVAXIN

Target-

Mechanism-

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Melanoma

Inactive Indication-

Originator Organization

CancerVAX, Inc.

Active Organization

CancerVAX, Inc.

Inactive Organization

CancerVax Corp.

Drug Highest PhaseDiscovery

First Approval Date-

Regulation-

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The efficacy of cytoreductive surgery for metastatic melanoma depends in part on the patient's immune response, which can be modulated by post-operative active immunotherapy with Canvaxin therapeutic polyvalent cancer vaccine (CancerVax Corp., Carlsbad, CA). Canvaxin vaccine induces polyvalent humoral and cell-mediated immune responses to a wide variety of protein and ganglioside melanoma antigens; these responses correlate with subsequent prognosis in immunized patients. Matched-pair analyses of data from extensive phase II trials have demonstrated a consistent overall survival (OS) benefit for Canvaxin therapy in stage IV melanoma (five-year OS of 39% for 107 vaccine patients versus 20% for 107 non-vaccine patients; P = .0009) and stage III melanoma (five-year OS of 49% for 739 vaccine patients versus 37% for 739 non-vaccine patients; P = .0001). Vaccine-induced immune responses have been correlated with survival after resection of local, regional, and distant melanoma. In 77 patients who received Canvaxin vaccine after resection of stage IV melanoma, five-year OS rate was 75% for patients with an elevated level of IgM antibodies against a 90-kD glycoprotein antigen (TA90) expressed by the vaccine, and a strong delayed-type hypersensitivity (DTH) response to the vaccine; by contrast, survival was 36% for patients who had either an elevated IgM response or a strong DTH response, and only 8% if neither response was strong (P < .001). In 59 patients with resected stage III melanoma, both cellular (DTH) and humoral (anti-TA90 IgG and IgM antibodies) immune responses impacted survival (P = 0.046, 0.0005, and 0.0053, respectively). In stage II melanoma, five-year OS and disease-free survival rates were 94% and 89%, respectively, when maximal anti-TA90 IgM titre was at least 1:800, compared to only 52% and 17%, respectively, for lower titres (P = .0001). Cumulatively, these data represent the largest phase II experience for any cancer vaccine and indicate the clinical efficacy of stimulating a patient's endogenous immune response to melanoma.

01 Dec 2003·Seminars in cancer biologyQ1 · MEDICINE

Antigen-based immunotherapy of melanoma: Canvaxin therapeutic polyvalent cancer vaccine

Q1 · MEDICINE

Review

Author: Eddy C Hsueh ; Donald L Morton

As yet there are no FDA-approved cancer vaccines for malignant melanoma, but encouraging response rates and low toxicities reported in phase I/II trials suggest that antigen-based active immunotherapy may complement current treatment modalities. The cumulative data for Canvaxin therapeutic polyvalent cancer vaccine represent the largest phase II clinical trial of any cancer vaccine. Univariate and multivariate analyses of these data have demonstrated the prognostic significance of this allogeneic whole-cell preparation as a postoperative adjuvant treatment for patients with stage III and IV melanoma. The vaccine has also been shown promising results after resection of stage II melanoma and in patients with regional in-transit disease. The consistent correlation between immune and clinical responses to the vaccine suggests that immune parameters may be used to monitor a patient's response to vaccine therapy.

15 Jan 2003·JOURNAL OF CLINICAL ONCOLOGY

Humoral immune response to a therapeutic polyvalent cancer vaccine after complete resection of thick primary melanoma and sentinel lymphadenectomy.

Article

Author: Ye, Wei ; Essner, Richard ; Hsueh, Eddy ; Gupta, Rishab K ; Yee, Reynold ; Chung, Mathew H ; Morton, Donald L

PURPOSE:

A therapeutic polyvalent cancer vaccine (Canvaxin vaccine; CancerVax Corp, Carlsbad, CA) induces antibodies to a glycoprotein tumor-associated antigen (TA90). However, endogenous immune responses to TA90 have also been reported. This study examined anti-TA90 antibody responses with respect to the survival of patients who received adjuvant vaccine immunotherapy after resection of thick (> or = 4 mm) primary cutaneous melanoma.

PATIENTS AND METHODS:

Serum specimens were obtained from 54 patients immediately before and then 1, 2, 4, and 6 months after wide local excision of thick primary cutaneous melanoma and sentinel lymphadenectomy. All patients were offered adjuvant therapies with the vaccine, high-dose interferon, or other agents. An enzyme-linked immunosorbent assay was used to determine serial serum titers of immunoglobulin G (IgG) and IgM antibodies against TA90. These titers were correlated with clinical course.

RESULTS:

Forty-three patients chose vaccine therapy, and 11 patients chose postoperative observation. Preoperative anti-TA90 IgG and IgM titers were similar for vaccine and observation groups (P =.184). At a median follow-up of 26 months, univariate analysis of Cox regression showed that disease-free survival and overall survival of vaccine patients were significantly correlated with maximal IgM response (P =.0006 and.006, respectively) but not with maximal IgG response (P =.73 and.95, respectively). Neither response predicted survival in the observation group.

CONCLUSION:

Postoperative vaccine therapy may enhance IgG and IgM immune responses to TA90 after surgical resection, but only the IgM response is correlated with improved survival. These findings may become useful to guide selection of patients for postoperative adjuvant therapy of high-risk melanoma.

100 Deals associated with Onamelatucel-L

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Melanoma	Phase 3	US	CancerVax Corp.	24 Jan 2003
Melanoma	Phase 3	AU	CancerVax Corp.	24 Jan 2003
Melanoma	Phase 3	BR	CancerVax Corp.	24 Jan 2003
Melanoma	Phase 3	CA	CancerVax Corp.	24 Jan 2003
Melanoma	Phase 3	FR	CancerVax Corp.	24 Jan 2003
Melanoma	Phase 3	DE	CancerVax Corp.	24 Jan 2003
Melanoma	Phase 3	IE	CancerVax Corp.	24 Jan 2003
Melanoma	Phase 3	IL	CancerVax Corp.	24 Jan 2003
Melanoma	Phase 3	IT	CancerVax Corp.	24 Jan 2003
Melanoma	Phase 3	NL	CancerVax Corp.	24 Jan 2003