Samsung Pharm & GemVax present pancreatic cancer immunotherapeutic drug, RIAVAX(TM), phase III results at ASCO 2021
PR89933
SEOUL, South Korea, June 5, 2021 /PRNewswire=KYODO JBN/ --
Samsung Pharm Co., Ltd. announced today that the company presented the results
of a phase III clinical trial of its pancreatic cancer immunotherapeutic drug
candidate called 'RIAVAX(TM) (GV1001)' conducted in Korea at the 2021 American
Society of Clinical Oncology (ASCO) Annual meeting.
ASCO 2021, which celebrates its 57th anniversary this year, runs from June 4th
to June 8th and will be held virtually due to COVID-19. Some 4500 experts in
the field gather every year to share and discuss the results of leading
clinical research and advance cancer research and development.
'RIAVAX(TM) ( GV1001)' is a peptide drug derived from human telomerase
consisting of 16 amino acids. It has been developed as an immunotherapeutic
drug for pancreatic cancer which works to activate immune cells to attack the
cancer cells. It is known to extend survival in pancreatic cancer patients with
high serum eotaxin levels when administered in combination with the current
chemotherapy, Gemcitabine/Capecitabine.
The RIAVAX Phase III clinical trial was conducted to investigate safety and
efficacy when given in combination with Gemcitabine/Capecitabine in 148
patients with locally advanced and metastatic pancreatic cancer at 16 hospitals
across Korea, including the Severance Hospital.
The results of the clinical trial showed median overall survival (OS) of 11.3
months in the treatment group compared to 7.5 months in the control group, with
statistically significant improvement (p=0.021). Another key endpoint which is
time to tumor progression (TTP) also showed a statistical significance with 7.3
months in the treatment group compared with 4.5 months in the control group
(p=0.021). No specific safety issues were reported. These results indicate that
RIAVAX(TM) should be considered as one of the treatment options for patients
with locally advanced and metastatic pancreatic cancer with high serum eotaxin
levels.
Samsung Pharm in-licensed domestic rights to RIAVAX(TM) from its affiliate,
GemVax & KAEL Co., Ltd. in 2014. GemVax & KAEL conducted a large-scale Phase
III clinical trial of RIAVAX(TM) ('TeloVac') in the United Kingdom from 2007 to
2011, with 1,062 locally advanced and metastatic pancreatic cancer patients.
The results of the TeloVac study were presented at 2013 ASCO followed by the
presentation an analysis of the correlation between the high eotaxin level and
improved survivals in pancreatic cancer patients administered with GV1001 at
2014 ASCO.
Source: GemVax
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