SynCore Biotechnology Co (杏國新藥) is planning an interim analysis of its pancreatic cancer treatment, SB05PC, later this month to determine the drug’s safety and efficacy.
The company is conducting a phase III trial for the drug in Taiwan, the US, France, Hungary, South Korea, Russia and Israel, SynCore general manager Su Muh-hwan (蘇慕寰) told the Taipei Times on Thursday by telephone.
The company aims to use the drug 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, with one injected with only gemcitabine and the other tested with a combination of gemcitabine and SB05PC, Su said.
As SB05PC is designed to prolong a person’s life, SynCore cannot enter into interim analysis of the drug until half of enrolled participants pass away, he said.
Now that 101 of the 200 participants have died, SynCore can collect data and conduct an interim analysis to evaluate if people survive longer than those who have not taken the drug, he said.
During the phase II trial, participants who took SB05PC and gemcitabine had an average overall survival period of nine months, compared with 7.4 months for those who only received gemcitabine, Su said.
Overall survival is the length of time from the start of treatment to a person’s death, he added.
As for the drug’s progression-free survival (PFS) — the length of time during and after treatment that the disease does not get worse — participants who took SB05PC and gemcitabine had an average PFS period of 4.9 months, compared with 3.5 months for those only taking gemcitabine, he said.
SynCore had planned to enroll 218 participants, but the US Food and Drug Administration has approved adjusting that number based on the outcome of the interim analysis, Su said.
The company plans to end enrollment for the phase III trial by the end of this year and complete the trial by the end of next year on the expectation that participants would survive from seven to nine months, he said.
If everything goes smoothly, SynCore plans to apply to the US regulator for marketing approval of the drug in 2022, he added.
SynCore in February delayed its original plan to begin another phase III trial of SB05PC in China as many patients could not go to hospitals due to a lockdown amid a COVID-19 outbreak.
Su said that the firm plans to delay the clinical trial to August.
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