SynCore Biotechnology Co’s (杏國新藥) pancreatic cancer treatment, SB05PC, has passed an interim analysis showing that the drug is safe, the company said on Tuesday.
SynCore, which began the analysis in May, appointed four external experts and statisticians to serve on an independent data monitoring committee (DMC) to review the results from the phase III trial for SB05PC, which began on July 31.
“The committee concluded that SynCore can continue its phase III trial without any adjustments and that the drug is safe — the best conclusions the DMC could reach,” Tim Lee (李志文), chairman of parent company Sinphar Pharmaceutical Co Ltd (杏輝), told a news conference in Taipei.
The committee usually reaches one of three conclusions: to continue the phase III trial without adjustments, to halt the trial because the drug is not safe, or to make adjustments to the trial even though the drug is safe, Lee said.
“The DMC’s conclusion gave us more confidence in SB05PC, which should also delight our shareholders,” SynCore general manager Su Muh-hwan (蘇慕寰) said.
The phase III trial, which is expected to be completed next year, has 218 patients enrolled, Lee said.
SB05PC is designed as a second-line treatment in combination with gemcitabine, a chemotherapy medication, for people who do not respond to first-line medicine Folfirinox, a combination of leucovorin, fluorouracil, irinotecan and oxaliplatin.
Participants in the phase III trial are randomly separated into two groups: One is only injected with gemcitabine, while the other is given a combination of gemcitabine and SB05PC, Su said.
As SB05PC is designed to prolong a person’s life, SynCore cannot complete the trial until all of the patients pass away, Su said, adding that the firm would review whether patients on SB05PC survived longer than those without it.
During the phase II trial, participants who took SB05PC and gemcitabine had an average overall survival of nine months, compared with 7.4 months for those who only received gemcitabine, he said.
SynCore would determine whether a patient’s overall survival — the length of time from the start of treatment until their death — is longer in phase III or phase II, he added.
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