Positive results from Hutchmed and Takeda trial for CRC drug published in Lancet

By Liza Laws

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Takeda Japan Fda Food and drug administration Hutchmed Colorectal cancer

Positive phase 3 results from a trial studying fruquintinib, in patients with previously treated colorectal cancer (CRC) were announced by Hutchmed and Takeda on Friday (June 16).

The small molecule inhibitor of vascular endothelial growth factor receptors (VEGFRs) with potential anti-angiogenic and antineoplastic activities is orally available. Once taken, the drug inhibits VEGF-induced phosphorylation of VEGFRs 1,2, and 3 that may result in the inhibition of migration, proliferation, and survival of endothelial cells, micro-vessel formation, the inhibition of tumor cell proliferation, and tumor cell death. Expression of VEGFRs may be upregulated in a variety of tumor cell types.

The results from FRESCO-2 study have been published in medical journal, The Lancet. A summary of the results from between 24 June 2022 and 12 September 2022 were presented at the European Society for Medical Oncology Congress 2022.

FRESCO-2 is a global phase 3 multi-regional clinical trial (MRCT) conducted in the US, Europe, Japan and Australia investigating fruquintinib plus best supportive care (BSC) vs placebo plus BSC in patients with previously treated metastatic CRC.

The study met its primary and key secondary endpoints, demonstrating that treatment with fruquintinib resulted in a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS), respectively. The safety profile of fruquintinib in was consistent with previously reported fruquintinib studies.

FRESCO-2 was a key study supporting regulatory submissions to the US Food and Drug Administration (FDA) for fruquintinib for the treatment of previously treated metastatic CRC, which was accepted for review and granted Priority Review​ in May 2023. Filing of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and an NDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) are planned in 2023.

Exlusive license agreement closed

In March 2023, Hutchmed and Takeda closed an exclusive license agreement to further the global development, commercialization, and manufacture of fruquintinib outside of China.

CRC is a cancer that starts in either the colon or rectum. The companies found during their research that according to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with more than 935,000 deaths in 2020. In the US and that it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2023.

They also found out that in Europe, CRC was the second most common cancer in 2020, with approximately 520,000 new cases and 245,000 deaths. In Japan, CRC was the most common cancer, with an estimated 148,000 new cases and 60,000 deaths in 2020. Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options.  Some patients with metastatic CRC may benefit from personalized therapeutic strategies based on molecular characteristics; however, most patients have tumors that do not harbor actionable mutations.

Fruquintinib and approval in CRC in China

Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE. 

It has been included in the China National Reimbursement Drug List (NRDL) since January 2020.  ELUNATE​ is indicated for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). 

Hutchmed markets fruquintinib in China in partnership with Eli Lilly and Company.

The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated.

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