GOTHENBURG, Sweden I September 12, 2014 I Immunicum AB (publ) today announced that updated survival data from a completed Phase I/II study of INTUVAX will be presented on September 15 at the 3rd Annual Cancer Vaccines Conference in London. In this study, the therapeutic cancer vaccine INTUVAX is evaluated in patients with metastatic renal cell cancer.
The purpose of the study was to document the safety profile, the immunological response and to monitor the survival of patients with metastatic renal cell carcinoma after treatment with two INTUVAX injections.
The new survival data to be presented at the conference reveals that 7 out of 11 evaluable patients are still alive.
The median survival in a subgroup of five patients who were classified as high-risk patients is now exceeding 17 months. Two of these patients, one of whom is still alive, have achieved a survival of more than two years. This compares with an expected median survival of nine months following current standard treatment for this population – the tyrosine kinase inhibitor sunitinib. Notably, none of the high-risk patients in the INTUVAX study received tyrosine kinase inhibitors during the first nine months after vaccination.
Continued monitoring is necessary to clarify the survival rate among patients who have a slightly less aggressive disease (intermediate mRCC). The updated survival data show that five out of six patients in this subgroup are still alive. For three of these, survival is now exceeding 21 months.
In three out of four patients that received add-on treatment with tyrosine kinase inhibitors due to tumor growth, decreases of tumor size were noted. In two of these patients, this was particularly unexpected, as their tumor types (metastatic brain tumors and metastases in extensive sarcomatoid tumor transformation) rarely respond to treatment with sunitinib. Examinations with computed tomography (CT scan) indicate that all brain metastases have now disappeared.
“The study results indicate that the extended survival is a result of INTUVAX’ ability to achieve a tumor-specific immune response, that appears to inhibit the rate of growth in the tumor metastases. Preliminary data suggests that subsequent adjunctive treatment with tyrosine kinase inhibitors may enhance the anti-tumoral effect in a synergistic way,” says Dr. Alex Karlsson-Parra, Chief Scientific Officer at Immunicum.
“INTUVAX seems to prolong the survival of those renal cell cancer patients initially considered to have the worst prognosis. For patients with a less aggressive disease, longer follow-up is needed, but the current data is promising even in this group of patients. We look forward to soon start a Phase II trial, in order to progress INTUVAX towards a market registration as quickly as possible,” says Jamal El-Mosleh, CEO of Immunicum.
The above data will also be presented at the 22nd Annual International Cancer Immunotherapy Symposium in New York, which will be held on October 6 to 8.
About Immunicum AB (publ)
Immunicum AB (publ) develops vaccines for the treatment of tumor diseases. The company’s most advanced project is INTUVAX®, which is currently being evaluated in a Phase I/II study in patients with renal cancer. The project portfolio includes three further projects against various cancers, including liver cancer.
SOURCE: Immunicum
Post Views: 209
GOTHENBURG, Sweden I September 12, 2014 I Immunicum AB (publ) today announced that updated survival data from a completed Phase I/II study of INTUVAX will be presented on September 15 at the 3rd Annual Cancer Vaccines Conference in London. In this study, the therapeutic cancer vaccine INTUVAX is evaluated in patients with metastatic renal cell cancer.
The purpose of the study was to document the safety profile, the immunological response and to monitor the survival of patients with metastatic renal cell carcinoma after treatment with two INTUVAX injections.
The new survival data to be presented at the conference reveals that 7 out of 11 evaluable patients are still alive.
The median survival in a subgroup of five patients who were classified as high-risk patients is now exceeding 17 months. Two of these patients, one of whom is still alive, have achieved a survival of more than two years. This compares with an expected median survival of nine months following current standard treatment for this population – the tyrosine kinase inhibitor sunitinib. Notably, none of the high-risk patients in the INTUVAX study received tyrosine kinase inhibitors during the first nine months after vaccination.
Continued monitoring is necessary to clarify the survival rate among patients who have a slightly less aggressive disease (intermediate mRCC). The updated survival data show that five out of six patients in this subgroup are still alive. For three of these, survival is now exceeding 21 months.
In three out of four patients that received add-on treatment with tyrosine kinase inhibitors due to tumor growth, decreases of tumor size were noted. In two of these patients, this was particularly unexpected, as their tumor types (metastatic brain tumors and metastases in extensive sarcomatoid tumor transformation) rarely respond to treatment with sunitinib. Examinations with computed tomography (CT scan) indicate that all brain metastases have now disappeared.
“The study results indicate that the extended survival is a result of INTUVAX’ ability to achieve a tumor-specific immune response, that appears to inhibit the rate of growth in the tumor metastases. Preliminary data suggests that subsequent adjunctive treatment with tyrosine kinase inhibitors may enhance the anti-tumoral effect in a synergistic way,” says Dr. Alex Karlsson-Parra, Chief Scientific Officer at Immunicum.
“INTUVAX seems to prolong the survival of those renal cell cancer patients initially considered to have the worst prognosis. For patients with a less aggressive disease, longer follow-up is needed, but the current data is promising even in this group of patients. We look forward to soon start a Phase II trial, in order to progress INTUVAX towards a market registration as quickly as possible,” says Jamal El-Mosleh, CEO of Immunicum.
The above data will also be presented at the 22nd Annual International Cancer Immunotherapy Symposium in New York, which will be held on October 6 to 8.
About Immunicum AB (publ)
Immunicum AB (publ) develops vaccines for the treatment of tumor diseases. The company’s most advanced project is INTUVAX®, which is currently being evaluated in a Phase I/II study in patients with renal cancer. The project portfolio includes three further projects against various cancers, including liver cancer.
SOURCE: Immunicum
Post Views: 209
