Hutchmed (China) Ltd announced on Friday that it has voluntarily withdrawn its supplemental new drug application for fruquintinib in China.
The Hong Kong-based biopharmaceutical company, which is focused on the treatment of cancer and immunological disease, said the NDA was for fruquintinib in combination with paclitaxel to treat second-line advanced gastric or gastroesophageal junction adenocarcinoma, forms of stomach cancer.
Hutchmed said the application was based on data from the phase 3 Frutiga study, ‘which was declared positive due to a statistically significant improvements in many clinically meaningful endpoints, including progression-free survival’.
However, the improvement observed in the second primary endpoint of median overall survival was ‘not statistically significant’.
‘Extensive subsequent analyses conducted indicate that, although the high and imbalanced proportion of patients receiving subsequent antitumour therapies confounded the [overall survival] effect, fruquintinib plus paclitaxel demonstrated meaningful clinical benefit and favourable OS trends through a variety of models,’ Hutchmed nonetheless noted.
It added: ‘However, it became clear from dialogue with the Centre for Drug Evaluation of [China’s National Medical Products Administration] and its external committee members that the current understanding and interpretation of the OS results could not serve as the basis of the supplemental NDA approval, and that further work needs to be undertaken.’
In short, Hutchmed said, following a further internal review of the currently available data, and in light of recent discussions with the NMPA, the firm believes ‘that the submission is unlikely to support an approval in China at this time’.
Fruquintinib is approved in China, the US and Europe for previously-treated patients with metastatic colorectal cancer, Hutchmed noted.
‘Whilst disappointed by this outcome, we remain optimistic about the utility of fruquintinib in the treatment of gastric cancer,’ commented Chief Executive Officer & Chief Scientific Officer Weiguo Su. ‘The data set from Frutiga demonstrates that fruquintinib plus paclitaxel could offer a promising new treatment option to certain patients in future, and we are driven to investigate this possibility thoroughly.
‘We look forward to evaluating a path forward and would like to thank both the patients and principal investigators who took part in this study for contributing to a better understanding of this devastating disease.’
Shares in Hutchmed were trading 0.4% lower at 269.00 pence early on Friday afternoon in London.
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