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