Hutchison China MediTech Ltd. is looking to gain regulatory approval for its experimental cancer drug savolitinib "as quickly as possible," having cleared a combination phase 2 trial with positive results.
Savolitinib has a real shot at becoming China's first home-grown oncology innovation to get global approval, CEO Christian Hogg told S&P Global Market Intelligence.
The Hong Kong-based drug developer, also known as Chi-Med, assessed the clinical effects of the drug when used in combination with AstraZeneca PLC's targeted therapies, Iressa and Tagrisso, in two phase 2 trials.
Patients taking part in the studies had a specific type of lung cancer called non-small cell lung cancer with mutations in the epidermal growth factor receptor, or EGFR, protein and MET-amplification.
Savolitinib is designed to inhibit a protein called mesenchymal epithelial transition factor receptor tyrosine kinase, otherwise known as c-MET. In cancer development, this protein can be mutated or overproduced in cells, leading to tumor formation.
The drug demonstrated positive results when used together with AstraZeneca's agents.
"Savolitinib's potential in combination with Tagrisso and Iressa is becoming more apparent in [the EGFR-mutated] lung cancer population [with MET-amplification]," said Susie Jana, a healthcare analyst at Edison Investment Research.
The targeted therapy is being studied for a number of cancer types at multiple research centers and is already in a phase 3 study as a monotherapy for kidney cancer. It was originally developed by Chi-Med's subsidiary, Hutchison MediPharma Ltd.
With the completion of the two phase 2 combination trials, the company will now focus on savolitinib's next studies.
"We'll be looking at the design of the phase 3 trial [in combination with Tagrisso and Iressa] very carefully to ensure that savolitinib has the best opportunity to get to an approval as quickly as possible," Hogg said.
"It depends on breakthrough therapy designation [from the U.S. Food and Drug Administration], and whether you're able to access the accelerated approval pathway, but I think 2020 is a fairly modest estimate [for market launch]," he added.
Hogg also hopes the drug's regulatory approval in China can run parallel with the U.S.
"The China market and bringing this therapy to patients is very important to us because there is a disproportionately large amount of MET-driven patients in China," he said.
The unmet medical need in China is high and savolitinib will provide patients with great benefit, he added.
Chi-Med's phase 2 combination trial for its other investigational cancer drug, fruquintinib, also yielded promising preliminary data when paired with Iressa.
"What's unique about fruquintinib is that it is very selective, it's very clean," said Hogg, adding that the drug has a good efficacy and safety profile because it will only bind to its targeted receptors and not other signaling proteins in a cell.
"As a result, the safety profile of fruquintinib is very, very unique and superior. What that allows you to do is to take this very clean drug and combine it with other therapies."
The phase 2 trial is the first time fruquintinib is being used in combination with another targeted therapy.
The drug is in phase 3 development as a monotherapy for lung cancer. The company is also planning to launch a phase 3 study for fruquintinib in combination with chemotherapy agent paclitaxel in China to treat gastric cancer.
In March, the drug met all primary and secondary endpoints in its phase 3 trial for treating colorectal cancer.
The company submitted a new drug application to the China Food and Drug Administration in June.
Expertise on board
Chi-Med has been bolstering its advisory support by adding experts to its board since January.
It appointed lung cancer expert Tony Mok to its board of directors in October.
"Tony Mok is a world leader in the field of clinical oncology, particularly in the area of non-small cell lung cancer and targeted therapy," said Hogg.
"I think it's extremely helpful to have people with that depth of expertise joining the board."
Before that, the company added Paul Carter, a former executive vice president of commercial operations at Gilead Sciences Inc. to the board in January.
In February, it tapped former chief medical officer of Takeda Pharmaceutical Co. Ltd. Karen Jean Ferrante as an independent director, and in March it added a former research and development executive with Pfizer Inc., Weiguo Su, as an executive director and a member of its technical committee.
"We've really been able to bring in some very high quality independent directors that can provide insights for the management team," said Hogg.