Results in Fruquintinib Proof-of-Concept Phase II Clinical Trial for Non-Squamous NSCLC Show Promise

Results in Fruquintinib Proof-of-Concept Phase II Clinical Trial for Non-Squamous NSCLC Show Promise

Pharmaceutical company Hutchison China MediTech Limited (Chi-Med) recently announced that its R&D drug subsidiary Hutchison MediPharma Limited (HMP) will receive a $10 million dollar milestone payment from its partner Eli Lilly and Company (Lilly) due to positive results from a proof-of-concept Phase II clinical trial conducted in China for advanced non-squamous non-small cell lung cancer (NSCLC).

Statistics show that Chinese patients now account for approximately 36% of NSCLC cases in the world today. China’s high incidence of lung cancer is potentially linked to the country’s high level of cigarette smoking.

In the Phase II trial, researchers investigated the drug fruquintinib in the treatment of Chinese patients with advanced non-squamous NSCLC. Fruquintinib is an engineered, highly selective and potent oral inhibitor of vascular endothelial growth factor (VEGF) receptors, including VEGFR1, VEGFR2, and VEGFR3.

VEGF is a protein produced by cells that stimulates angiogenesis (i.e., the formation of new blood vessels). It is an established factor in several cancers, since a solid tumor cannot grow without an adequate blood supply transporting the required material, such as growth factors and other nutrients, to foster tumor growth. More recently, it was shown that VEGF’s role in cancer is not limited to angiogenesis and vascular permeability, contributing to the regulation of cancer stem cells and tumor initiation.

The results from the proof-of-concept Phase II trial showed fruquintinib met the primary endpoint of progression free survival in patients with advanced non-squamous NSCLC. Moreover, the adverse effects registered in the study are consistent with the drug’s safety profile, as patients experienced no new, unexpected adverse effects during the trial.

According to the licensing, co-development, and commercialization agreement with Eli Lilly for fruquintinib, Hutchison MediPharma Limited (HMP) is due to received reimbursements for additional clinical development for non-squamous NSCLC in China. The results from the proof-of-concept Phase II trial will be presented at an international medical conference next year.

The pharmaceutical company will initiate a Phase III study of fruquintinib in non-squamous NSCLC in China in the near future.

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