Results of past clinical trials
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Oncophage in metastatic kidney cancer
Protocol C-100-03
Phase 1/2
Summary of results presented at ASCO 1999 (abstract 1278)
Baylor University researchers presented data from a trial of Oncophage involving 34 patients with stage IV metastatic kidney cancer (protocol C-100-03). The response rate to vaccination with Oncophage was 12 percent, and eight additional patients showed stabilization of their disease. No significant toxicity related to Oncophage was observed. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, ASCO 1999
Summary of results presented at ASCO 2000 (abstract 1782)
Baylor University researchers reported findings from a study of Oncophage in metastatic kidney cancer (protocol C-100-03). In the trial, Oncophage treatment was associated with improvement in the course of disease in 35 percent of evaluable patients (19 out of 56). This includes responses seen in 10 percent of the patients, plus stabilization of disease in an additional 25 percent. The response rate observed with Oncophage is similar to what is observed with current treatments, but without the toxicities and side effects associated with those treatments. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, ASCO 2000
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Oncophage in metastatic kidney cancer
Protocol C-100-07
Phase 2
Summary of results presented at ASCO 2003 (abstract 1552)
Investigators from M. D. Anderson Cancer Center reported data from a trial of Oncophage in metastatic kidney cancer (protocol C-100-07). Of the 61 patients who received at least one dose of Oncophage vaccine, 21 patients responded clinically, including one patient who remained completely free of disease more than 2.5 years after treatment. Patients whose cancers progressed during Oncophage vaccination also received immunotherapy with interleukin 2 (IL-2); of the 16 patients with disease progression, seven achieved disease stability after addition of IL-2. Median progression-free survival was 18 weeks for all patients who received Oncophage, and 25 weeks for patients who also received IL-2. Two years after initiation of the vaccine, 30 percent of patients remained alive. No significant toxicity was observed to be associated with Oncophage treatment. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, ASCO 2003
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Oncophage in nonmetastatic kidney cancer
Protocol C-100-12
Phase 3
Summary of results presented at AUA 2007 (abstract 633)
Researchers from The Antigenics Renal Cell Carcinoma Study Group reported data from the Phase 3 trial of Oncophage in renal cell carcinoma. The end-of-study results showed that in a substantial subset of patients (n = 362) at intermediate risk for disease recurrence, Oncophage demonstrated an improvement in recurrence-free survival of approximately 45 percent. For intermediate-risk patients, there was also a trend towards improved overall survival, the study’s secondary endpoint. This is the largest, randomized Phase 3 kidney cancer trial ever completed in the adjuvant treatment setting.
Abstract, AUA 2007 |
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Oncophage in metastatic melanoma
Protocol C-100-02
Phase 1/2
Summary of results presented at AACR 2000 (abstract 3463)
M. D. Anderson Cancer Center researchers reported findings from a trial of Oncophage involving 36 patients with stage III and IV melanoma (protocol C-100-06). Twenty patients were rendered free of disease by surgery at the time of treatment with Oncophage, whereas 16 patients had residual disease at the time of treatment. With a median follow-up of 17 months, 19 out of 20 patients treated in the adjuvant setting were alive, and eight out of 16 patients treated in the residual disease setting were alive. No significant toxicity related to Oncophage was observed. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, AACR 2000
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Oncophage in metastatic melanoma
Protocol C-100-06
Phase 2
Summary of results presented at ASCO 2001 (abstract 1006)
Investigators from the Istituto Nazionale Tumori in Milan, Italy, announced data from a trial of Oncophage in melanoma (protocol C-100-06). Twenty-eight patients with stage IV metastatic melanoma were evaluated in the study. Five patients responded favorably to treatment with Oncophage, two in whom all evidence of melanoma disappeared (complete responses) for close to two years. The remaining three patients had stabilization of their disease for 153 to 272 days. In addition, three of the 11 patients who were rendered disease-free after surgery had long-term disease-free survival of 231 to 621+ days. Vaccination with Oncophage generated antimelanoma immunity in more than half of patients. No significant toxicity related to Oncophage was observed. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, ASCO 2001
Summary of results presented at AACR/NCI/EORTC 2001 (abstract 799)
Researchers from the Istituto Nazionale Tumori in Milan, Italy, reported findings from a trial of Oncophage in melanoma (protocol C-100-06). All 39 patients involved in the study underwent surgery, which rendered 11 patients disease-free, whereas 28 still had measurable disease. Of the patients who still had measurable disease, two patients had complete responses and three others experienced long-lasting disease stabilization. Of the 11 patients who were disease-free after surgery, three had long-term (>5 months) disease-free survival. No toxicity was observed with Oncophage treatment. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, AACR/NCI/EORTC 2001
Summary of results presented at AACR 2002 (abstract 719)
Investigators from the Istituto Nazionale Tumor in Milan, Italy, presented immunological findings from two trials of Oncophage in melanoma and colorectal cancer (protocols C-100-06 and C-100-05, respectively). The analysis demonstrated that antigen presentation by gp96, the heat shock protein used in Oncophage, could induce an immune response in this patient population. In the study, 10 out of 39 melanoma patients responded clinically to Oncophage treatment, including two patients whose cancer disappeared completely for more than two years. Of the 24 melanoma patients who were evaluated for immune response, 10 demonstrated increased antimelanoma T-cell activity. In colorectal cancer patients, a T-cell response was observed in 17 out of 29 patients, and seemed to be correlated with survival. The mechanism by which Oncophage induces immune response in melanoma and colorectal cancer was determined to be the same. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, AACR 2002
Summary of results presented at ASCO 2002 (abstract 49)
Investigators from the Istituto Nazionale Tumori in Milan, Italy, reported data from a trial of Oncophage in metastatic melanoma (protocol C-100-06). In the 39-patient trial, 14 patients reacted favorably to Oncophage treatment, including two with complete disease regression, three with disease stabilization of more than five months, and four who remained disease-free for up to 22 months. Almost half of the patients evaluated for immune response demonstrated a significant increase in melanoma-specific T cells. No toxicity was observed with Oncophage treatment. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, ASCO 2002
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Combination treatment with Oncophage, GM-CSF and IFN-alpha in metastatic melanoma
Protocol C-100-22
Phase 2
Summary of results presented at ASCO 2004 (abstract 7510)
Investigators from the Istituto Nazionale Tumori in Milan, Italy, presented findings from a Phase 2 trial of Oncophage as part of combination treatment for metastatic melanoma (protocol C-100-22). The study reported on 18 of the evaluable patients with stage IV melanoma, all of whom underwent surgery, then received Oncophage in combination with GM-CSF and IFN-alpha. The researchers reported that one of two patients rendered disease-free by surgery remained free of disease for 419 days. Of 16 patients with residual melanoma post-surgery, 10 experienced disease stabilization, lasting from 97 to 372 days. In addition, of 16 patients evaluated for immunological response, six of them — all exhibiting stabilized disease — had a demonstrable increase in antimelanoma immune response. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, ASCO 2004
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Oncophage in metastatic melanoma
Protocol C-100-21
Phase 3
Summary of results presented at ASCO 2006 (abstract 8002)
Updated findings from a Phase 3 clinical trial of Oncophage in metastatic melanoma (protocol C-100-21) showed that patients who received at least 10 doses of vaccine experienced an extension in median survival of 29 percent compared with those who received physician’s choice. In a subset analysis, Oncophage was associated with a potentially clinically relevant benefit compared with physician’s choice for patients with stages IV M1a and M1b melanoma, if at least 10 doses of vaccine were administered.
Abstract, ASCO 2006
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Oncophage in colorectal cancer
Protocol C-100-05
Phase 2
Summary of results presented at ASCO 2001 (abstract 1020)
Researchers from the Istituto Nazionale Tumori in Milan, Italy, presented data from a trial of Oncophage in colorectal cancer (protocol C-100-05). Twenty-nine patients with advanced-stage colon cancer that had spread to the liver were treated with Oncophage. The vaccination generated cancer-specific immunity in close to half of the patients. No significant toxicity related to Oncophage was observed. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, ASCO 2001
Summary of results presented at AACR 2002 (abstract 719)
Investigators from the Istituto Nazionale Tumor in Milan, Italy, presented immunological findings from two trials of Oncophage in melanoma and colorectal cancer (protocols C-100-06 and C-100-05, respectively). The analysis demonstrated that antigen presentation by gp96, the heat shock protein used in Oncophage, could induce an immune response in this patient population. In the study, 10 out of 39 melanoma patients responded clinically to Oncophage treatment, including two patients whose cancer disappeared completely for more than two years. Of the 24 melanoma patients who were evaluated for immune response, 10 demonstrated increased antimelanoma T-cell activity. In colorectal cancer patients, a T-cell response was observed in 17 out of 29 patients, and seemed to be correlated with survival. The mechanism by which Oncophage induces immune response in melanoma and colorectal cancer was determined to be the same. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, AACR 2002
Summary of results presented at ASCO 2002 (abstract 2290)
Researchers from the Istituto Nazionale Tumori in Milan, Italy, presented findings from a trial of Oncophage involving patients with colorectal cancer that had metastasized to the liver (protocol C-100-05). Two years after surgery, overall survival and disease-free survival rates for the 29 patients who received Oncophage were 79 percent and 32 percent, respectively. Almost 60 percent of patients in the study demonstrated a significant, tumor-specific, T-cell immune response, which was subsequently found to be an independent factor for prognosis. There was no toxicity observed with Oncophage treatment. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, ASCO 2002
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Oncophage in non-Hodgkin’s lymphoma
Protocol C-100-09
Phase 2
Summary of results presented at ASCO 2003 (abstract 2294)
M. D. Anderson Cancer Center researchers presented findings from a study of Oncophage as a treatment for non-Hodgkin’s lymphoma (protocol C-100-09). The study, which involved 10 patients with newly diagnosed or relapsed low-grade, indolent non-Hodgkin’s lymphoma, demonstrated that Oncophage vaccination was associated with clinical response in six patients: one partial response, two minor responses and three disease stabilizations. All responding patients were either previously untreated or received only one prior treatment regimen. Oncophage was well tolerated, with no adverse effects. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, ASCO 2003 |
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Oncophage in pancreatic cancer
Protocol C-100-01
Phase 1
Summary of results presented at ASCO 1999 (abstract 1687)
Investigators from Memorial Sloan-Kettering Cancer Center reported data from a trial of Oncophage in pancreatic cancer (protocol C-100-01). Five patients were treated with Oncophage after surgical removal of the pancreas. One patient treated with Oncophage was alive and disease-free 33 months after surgery. The remaining four patients died 8, 17, 30 and 36 months after surgery. Oncophage was shown to stimulate a tumor-specific immune response in two patients tested. No significant toxicity related to Oncophage was observed. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, ASCO 1999
Summary of results presented at ECCO 2003
Researchers from Memorial Sloan-Kettering Cancer Center presented data from a 10-patient Phase 1 pilot study of Oncophage in patients with nonmetastatic pancreatic cancer (protocol C-100-01). In the trial, manufacture of patient-specific Oncophage vaccines was feasible; no toxicity associated with vaccination was observed; and median overall survival was 2.5 years. One patient was still alive and disease-free after five years, and two other patients were alive and disease-free 2.1 years after treatment. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
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Oncophage in gastric cancer
Protocol C-100-04
Phase 1
Summary of results presented at ASCO 2000 (abstract 1825)
Investigators from Johannes Gutenberg University Hospital in Germany presented data from a trial of Oncophage in metastatic gastric cancer (protocol C-100-04). Sixteen patients were treated with Oncophage and, after an initial evaluation, approximately half of the patients appeared to be benefiting. No significant toxicity related to Oncophage was observed. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, ASCO 2000
Summary of results presented at ASCO 2002 (abstract 117)
Investigators from Johannes Gutenberg University Hospital in Germany reported data from a study of Oncophage in gastric cancer (protocol C-100-04). In the trial, 15 patients with gastric cancer (stage II to stage IV) underwent surgery, then Oncophage vaccination. At 32 months post-surgery, three were still disease-free, nine had survived, and the mean disease-free and overall survival rates were seven months and 16+ months, respectively. Cancer-specific immune response was observed in 73 percent of patients. No toxicity was observed to be associated with Oncophage treatment. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
Abstract, ASCO 2002 |
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Aroplatin in colorectal cancer
Protocol C-726-01
Phase 2
Summary of results presented at ECCO 2003
Investigators from the Arizona Cancer Center presented findings from a single-arm trial evaluating the effect of Aroplatin monotherapy in patients whose metastatic colorectal cancer is not responsive to standard cancer treatments (protocol C-726-01). One out of the 15 evaluable patients demonstrated a partial clinical response and two experienced disease stabilization. Aroplatin appeared well tolerated in the trial. Antigenics’ confirmation, data analysis and finalization of results reported by study investigators are ongoing.
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