IDM Pharma Presents Preliminary Results from Phase II UVIDEM(R) Melanoma Vaccine Clinical Trial
05 Jun 2007
Results show UVIDEM was well-tolerated with signs of durable disease control in advanced melanoma patients
IRVINE, CA, USA | June 5, 2007 | IDM Pharma, Inc. (Nasdaq: IDMI) today presented preliminary results from a Phase II UVIDEM
(IDD-3) melanoma vaccine clinical trial (DC-MEL-202). The results showed that UVIDEM was well tolerated with evidence of efficacy and induction of immune response in patients with progressive metastatic melanoma.
The data were presented by Merrick I. Ross, M.D., Professor of Surgery, Chief, Melanoma Section, Department of Surgical Oncology at The University of Texas M. D. Anderson Cancer Center in Houston as an oral presentation titled "Clinical and immunological responses in patients with malignant melanoma treated with a dendritic cell-based vaccine. Preliminary report from a multi- institutional phase II clinical trial" (# 3004) at the 2007 American Society of Clinical Oncology (ASCO) 43rd annual meeting in Chicago.
"We are in great need of new drugs to treat our patients with metastatic melanoma" said Dr. Ross. "The preliminary analysis of the phase II clinical trial with IDM Pharma's cancer vaccine, UVIDEM, suggests that several patients with advanced melanoma attained durable control of their disease after a treatment stimulating their own immune system cells. Additionally, the side effects experienced by our patients were minimal," he added.
Study design and findings
DC-MEL-202 is a single arm, two-stage Phase II trial designed to evaluate clinical and immunological activities and the safety of a multivalent dendritic cell-based vaccine in patients with in-transit or low volume metastatic melanoma. Thirty-three patients were treated in the study and the results to date are as follows:
-- Clinical response (RECIST): out of 30 patients evaluable for efficacy, 9 (30%) showed evidence of clinical benefit (1 complete response (CR), 2 partial responses (PR) and 6 stable disease (SD)) with duration of response ranging from 9.4 to 26.5 months.
-- Assessment of pathological response in target sites in 4 patients (2 PR, 2 SD) showed:
- complete pathological regression after resection of target sites in 2 patients; and
- two patients were rendered free of disease after clinical stable disease and surgery of lung metastases.
- Progression free survival (PFS) was 4.8 months with a median follow-up of 12 months.
- Overall survival (OS) has not yet been reached as 21 patients are still alive. The survival rate at 9 months was 70%.
- Immune response: 26 out of 29 evaluated patients (90%) showed detectable TAA-specific CD8+ T cells with 18 patients (62%) showing boosted or appearance of anti-TAA specific CD8+ T cells.
- UVIDEM was well tolerated with toxicity limited to mild events with only one possibly related serious adverse event (SAE) reported (age related macular degeneration).
About UVIDEM
UVIDEM is a therapeutic specific immunostimulant developed by IDM Pharma in partnership with sanofi-aventis. Sanofi-aventis has worldwide marketing rights to UVIDEM in melanoma. UVIDEM consists of mature dendritic cells loaded with lysates from melanoma tumor cell lines. UVIDEM is produced in IDM Pharma GMP manufacturing facilities in Irvine, California and in Paris, France. UVIDEM has been administered to 143 patients in clinical development. Completion of patient enrollment in two Phase II clinical trials was previously announced. Thirty-eight patients with malignant melanoma were included in the US Phase II study and 53 patients with resected stage II/III melanoma were included in the European randomized Phase II study. |
