HCM - Hutchmed stock rises 15% as fruquintinib meets one main goal in gastric cancer trial
Hutchmed (China) ( NASDAQ: HCM ) said its medicine fruquintinib met one main goal but did not reach statistical significance in another in a phase 3 trial in Chinese patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The study dubbed FRUTIGA, evaluated fruquintinib combined with paclitaxel, against paclitaxel alone, as second-line therapy of advanced gastric cancer or GEJ adenocarcinoma in 703 Chinese patients.
The company said the trial met one main goal of statistically significant improvement in progression-free survival( ( PFS )), which was clinically meaningful.
PFS is the length of time during/after treatment a patient lives with the disease without it getting worse.
The other primary goal of overall survival (OS) was not statistically significant as per the pre-specified statistical plan, but there was an improvement in median OS, the company added.
Hutchmed noted that fruquintinib also showed a statistically significant improvement in secondary goals, which included objective response rate (ORR), disease control rate (DCR), and improved duration of response (DoR).
The safety profile of fruquintinib was consistent with previously reported studies, according to the company.
"The combination of fruquintinib and paclitaxel demonstrated significant clinical benefits for these patients in controlling this disease. Our team will continue to analyze the data and discuss these findings with the NMPA for possible NDA filing," said Weiguo Su, CEO and chief scientific officer, Hutchmed.
The company expects to report detailed results at an upcoming scientific meeting.
Hutchmed retains all commercial rights to fruquintinib outside of China. Fruquintinib is marketed as Elunate by Hutchmed with Eli Lilly ( NYSE: LLY ). The drug is not approved for use outside of China.
In August, fruquintinib met the main goal of a phase 3 trial in patients with a type of colorectal cancer.
HCM +15.35% to $11.42 premarket Nov. 14
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Hutchmed stock rises 15% as fruquintinib meets one main goal in gastric cancer trial