Despite an FDA rejection earlier this year for one of its lead meds, Hutchmed is pressing ahead with oncology development efforts.
Monday, the company shared the news that fruquintinib succeeded in a phase 3 trial in second-line treatment of advanced gastric cancer or gastroesophageal junction adenocarcinoma. The trial tested fruquintinib in combo with the chemotherapy paclitaxel against solo paclitaxel, also known as Bristol Myers Squibb's Abraxane.
Investigators observed a statistically significant improvement in progression-free survival. Overall survival rates were not statistically significant despite some improvement in the median overall survival, the company said.
Hutchmed plans to share full results of the trial, plus findings from ongoing analyses, at an upcoming scientific meeting, the company said. The drugmaker also plans to share the findings with regulators in China.
Fruquintinib won approval in China back in 2018 to treat patients with metastatic colorectal cancer who have already been treated with specific drugs, including anti-VEGF therapy. The drug is marketed in China as Elunate, and Eli Lilly is helping with marketing in the country.
Outside of China, Hutchmed retains global rights to the drug.
In 2020, the FDA granted fruquintinib fast-track designation in metastatic colorectal cancer. Hutchmed plans to complete new drug application filings for that indication in the U.S., Europe, and Japan in 2023 based on a multi-regional clinical trial that tested the drug combined with best supportive care in patients with advanced, refractory metastatic colorectal cancer.
Hutchmed designed fruquintinib to improve kinase selectivity to minimize off-target toxicities, the company said in its statement. The “generally good” tolerability of the drug suggests that it may be suitable for combinations with other anti-cancer therapies, according to the drugmaker.
Gastric cancer is the fourth leading cause of cancer death worldwide. In 2020, more than one million new cases and approximately 769,000 deaths occurred, including an estimated 331,600 in China. The cancer is often diagnosed at an advanced stage due to late-onset symptoms, leading to limited treatment options for patients.
As for the rest of Hutchmed's prospects, one of its cancer drugs was rejected by the FDA in May because its trial was conducted solely in China. The company was issued a complete response letter in response to its application for surufatinib in pancreatic and extra-pancreatic neuroendocrine tumors.
Hutchmed is also testing AstraZeneca-partnered savolitinib paired with AZ’s Tagrisso. That Hutchmed drug is also already approved in China.