In May, when the FDA rejected a cancer drug from Hutchmed of China, the U.S. regulator pinged the company for providing results from a trial conducted solely in its home country.
Three months later, on consecutive days, Hutchmed has revealed promising data from trials that can’t be questioned for their lack geographic diversity. The two studies of oncology treatments each spanned four continents.
One of the studies, a preliminary look at a phase 2 trial of Hutchmed and AstraZeneca’s savolitinib, shows that when it is paired with AZ’s blockbuster lung cancer treatment Tagrisso, the combo can help reduce tumors in a key subset of patients who had success with Tagrisso before developing resistance to it.
Not to be outdone, Hutchmed’s colon cancer drug fruquintinib posted phase 3 data that puts it in position to secure critical approvals outside of China.
First, in the lung cancer study, which enrolled 200 patients, the Tagrisso-savolitinib combo triggered tumor shrinkage in 32% of patients who had developed a resistance to Tagrisso as a solo agent.
When investigators narrowed the study population to 108 patients with high MET expression or amplification, the response rate jumped to 49%. And when that group was narrowed further, to include just those who have not had prior chemotherapy, the response rate ticked up another notch to 52%.
The results compare favorably to the 77 patients in the study determined to have low MET expression. In that group, the response rate was 9%.
MET is the most common biomarker in patients with epidermal growth factor receptor-mutated (EGFR-m) lung cancer who develop resistance to targeted therapy, AZ explained in a release.
The companies are studying the combo in the phase 3 Saffron trial, where it is pitted against platinum-based doublet chemotherapy in high MET patients.
Hutchmed and AZ’s collaboration on savolitinib began 11 years ago. The MET inhibitor has been approved in China, where it is known as Orpathys.
Tagrisso, which has been approved by the FDA to treat three types of NSCLC with EGFR-mutated tumors, generated $5 billion in 2021 in just its sixth full year on the market, making it AZ’s best-selling drug.
As for Hutchmed’s phase 3 trial of fruquintinib, the oral drug achieved its primary objective by keeping patients with advanced, refractory metastatic colorectal cancer alive longer than placebo. It also met its secondary goal of extending the period in which patients staved off disease progression.
In the study, investigators paired fruquintinib with best supportive care (BSC) and pitted the treatment against placebo plus BSC. They tested the combinations in patients who had progressed on standard chemo and relevant biologic agents and who had progressed on—or were intolerant to—the oral regimen of trifluridine plus tipiracil hydrochloride and/or Bayer's Stivarga.
The study took place in the United States, Europe, Australia and Japan, a key factor considering that three months ago, the FDA rejected the company’s promising kinase inhibitor surufatinib because trials for the neuroendocrine cancer treatment were limited to China.
The company said it will submit applications for marketing authorization “as soon as possible” in the U.S., Europe and Japan. Fruquintinib gained fast-track designation from the FDA in June 2020.