The unblinding of phase 3 trial data of SynCore Biotechnology Co Ltd’s (杏國新藥) newly developed pancreatic cancer drug SB05PC showed no statistical significance when compared with the control group, the drugmaker said yesterday.
SB05PC is designed to prolong patients’ lives, and the trial ended once all participants had passed away, the company said.
The trials tested whether people taking the drug would on average live significantly longer than those in the control group, it added.
Photo: CNA
The trials tested for overall survival time — the time the patient survives from the beginning of treatment — and progression-free survival time — the time the patient’s cancer does not worsen from the beginning of treatment, it said.
The median overall survival time for the 108 participants treated with SB05PC was 226 days, while their median progression-free survival time was 113 days.
Meanwhile, the median overall survival time of the 100 patients in the control group was 209 days, while their median progression-free survival time was 110 days, the drugmaker said.
“The difference between the two groups was not statistically significant,” Tim Lee (李志文), chairman of the drugmaker’s parent company Sinphar Pharmaceutical Co Ltd (杏輝醫藥), told a news conference in Taipei.
Other secondary gauges, such as disease control rate, objective response, rate and duration of response also did not show statistical significance, the company said.
The disease control rate averaged 59.38 percent in the treatment group, compared with 48.86 percent in the control group; the objective response rate was 11.46 percent in the treatment group, compared with 6.82 percent in the control group; and response to the drug averaged 4.1 months in the treatment group, compared with 5.6 months in the control group, it said.
SB05PC was developed as a second-line treatment to be combined with chemotherapy drug gemcitabine for patients who do not respond well to first-line drug Folfirinox, SynCore said.
Trail participants either received SB05PC in combination with gemcitabine, or only gemcitabine in the control group, it said.
Although no statistical significance, which would allow SynCore to seek approval for the treatment, was found, the trials were meaningful, as it would base the further development of SB05PC on the results, Lee said.
Phase 3 trials were conducted in seven countries — Taiwan, the US, France, Hungary, Israel, Russia and South Korea — and some populations seemed to react better to the drug, Lee said.
“It was a valuable experience, and we also learned how to be more exact in deciding the development direction of a new drug. This experience is an intangible asset,” Lee said.
SynCore has been developing SB05PC for six years, investing NT$2 billion (US$71.65 million) in the treatment, Lee said, adding that Sinphar funded the project with NT$1.77 billion.
After ending the project, Sinphar is expected to regain profitability, Lee said, aiming to post annual net profit of about NT$400 million.
SynCore reported a net loss of NT$159 million for the first six months of this year, while Sinphar reported net profit of NT$10.34 million, down 71 percent from a year earlier, Sinphar data showed.
Singapore-based ride-hailing and delivery giant Grab Holdings Ltd has applied for regulatory approval to acquire the Taiwan operations of Germany-based Delivery Hero SE's Foodpanda in a deal valued at about US$600 million. Grab submitted the filing to the Fair Trade Commission on Friday last week, with the transaction subject to regulatory review and approval, the company said in a statement yesterday. Its independent governance structure would help foster a healthy and competitive market in Taiwan if the deal is approved, Grab said. Grab, which is listed on the NASDAQ, said in the filing that US-based Uber Technologies Inc holds about 13 percent of
The domestic unit of the Chinese-owned, Dutch-headquartered chipmaker Nexperia BV will soon be able to produce semiconductors locally within China, according to two company sources. Nexperia is at the center of a global tug-of-war over critical semiconductor technology, with a Dutch court in February ordering a probe into alleged mismanagement at the company. The geopolitical tussle has disrupted supply chains, with some carmakers reportedly forced to cut production due to chip shortages. Local production would allow Nexperia’s domestic arm, Nexperia Semiconductors (China) Ltd (安世半導體中國), to bypass restrictions in place since October on the supply of silicon wafers — etched with tiny components to
Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) yesterday received government approval to deploy its advanced 3-nanometer (3nm) process at its second fab currently under construction in Japan, the Ministry of Economic Affairs said in a news release. The ministry green-lit the plan for the facility in Kumamoto, which is scheduled to start installing equipment and come online in 2028 with a monthly production capacity of 15,000 12-inch wafers, the ministry said. The Department of Investment Review in June 2024 authorized a US$5.26 billion investment for the facility, slated to manufacture 6- to 12nm chips, significantly less advanced than 3nm process. At a meeting with
Taiwan’s food delivery market could undergo a major shift if Singapore-based Grab Holdings Ltd completes its planned acquisition of Delivery Hero SE’s Foodpanda business in Taiwan, industry experts said. Grab on Monday last week announced it would acquire Foodpanda’s Taiwan operations for US$600 million. The deal is expected to be finalized in the second half of this year, with Grab aiming to complete user migration to its platform by the first half of next year. A duopoly between Uber Eats and Foodpanda dominates Taiwan’s delivery market, a structure that has remained intact since the Fair Trade Commission (FTC) blocked Uber Technologies Inc’s
RSS