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US genomic cancer profiling firm FMI heads to China, where access to new therapies lags
China lags the U.S., Europe and regional hubs such as Singapore and Hong Kong on access to cutting-edge cancer drugs, but the mainland will soon get a glimpse of potential next-generation targeted therapies as U.S.-listed genomic-sequencing firm Foundation Medicine Inc. (FMI) is aiming to launch there in the third quarter of this year.
The Boston-based and U.S-listed firm is one of a handful that perform detailed biopsies of tumors, seeking a range of cancer-causing genes, then creates a report on drugs approved, or in clinical trials that can be targeted at the tumors' profile, even if the treatment might be off-label.
That goes a bit beyond standard oncology practices of looking at the type or location of tumors, such as lung or gastric cancers, and prescribing drugs already approved for those diagnoses.
The gene-sequencing process draws on a library that grows with each biopsy and patient treatment, according to Colin Albert, commercial head Asia Pacific for Roche, which bought a majority interest in FMI in January 2015 in a partnership which includes R&D and new product development initiatives under Roche FMI
China's rules forbid taking biopsy material out of the country for examination, so to operate in the country, Roche FMI formed a local tie-up with Wuxi AppTec in October 2014, Albert said
Wuxi AppTec is a unit of WuXi Biologics, which last week priced Hong Kong IPO shares at HK$20.60 each, at the top of its range, to raise HK$3.98 billion ($511 million). The shares will make their debut on the Hong Kong stock exchange on June 13.
The tie-up with WuXi comes as many oncologists in Asia and elsewhere are radically re-thinking therapy approaches as gene sequencing has become faster and prices drop.
"Currently physicians in APAC (Asia-Pacific) are gaining experience with the Roche FMI Next Generation Sequencing (NGS) and are exposed to a wealth of information available from the comprehensive report produced through the Roche FMI platform, which supports physicians' decision-making process through small clinical trials," Albert said.
In many respects, that may fit with China's plans to bring in newer therapies at lower cost by promising access to a vast market.
In June, China's National Health and Family Planning Commission said AstraZeneca's cancer therapy Iressa, and Conmana for lung cancer from Hangzhou-based Betta Pharmaceuticals as well as hepatitis B therapy Viread marketed in China by GlaxoSmithKline and developed by Gilead Sciences would see price cuts of more than half as part of a pilot program.
Also included in the pilot, but not part of the price cuts, were Roche's lung cancer drug Tarceva and Celgene's blood cancer treatment Revlimid.
China would like to see some example of cost and benefit not only from lower cost therapies, but also via efforts to gather data on outcomes.
So would other countries and to that end, Roche FMI said it will be in seven markets in Asia Pacific by the end of the second quarter of this year: Hong Kong, Singapore, India, Taiwan, South Korea, Australia and Malaysia.
It's targeting 4,000 to 5,000 profiles completed by the end of 2018.
That figure would be a small slice of Roche FMI's global database of the genomic profiles of 125,000 patients, but it would add more data on Asia, which has a more than a third of all new cancer cases, with rates of lung and gastric cancer the highest worldwide.
Overall, World Health Organization figures show China was set to become the country with the most cancer cases.
But getting insurance companies, or national reimbursement programs to pay for sequencing profiles, with prices ranging from $1,000 to $5,000, has been a slow road, not only in Asia, but also in the United States.
At the same time, many oncologists are looking to "tumor-agnostic" drugs, such as Merck's immunotherapy, Keytruda, which came into prominence as the therapy that helped former President Jimmy Carter get remission from melanoma cancer. It has been indicated in other oncology uses as well.
But gathering proof that genomic-sequencing may aid in therapy decisions and can be cost effective means reaching out to doctors in the field. That process must start from scratch in China, because many front-line therapies are not available domestically, with the country's regulatory approvals lagging those in the U.S. or Europe by years.
However, with targeted therapies, there may be a chance to leap-frog the traditional approval cycle. China introduced fast-track approval channels for drugs that seek to bring in therapies to treat disease areas with high unmet need such as HIV/AIDs and cancer by easing clinical trial rules for drugs with global data on safe and effective use.
The Roche FMI effort in China will focus on driving the advancement of personalized cancer care, especially in the areas of lung, breast, colorectal and rare cancers, Albert said.
"In China, we will be investigating gastric and oesophageal cancer, both of which have one of the highest prevalence rates (globally). We will be testing 1,000 tissue samples, scanning for the full spectrum of genomic alterations present within the genome sample," he said.
"In some cases, we believe we will discover potentially actionable mutations that could have been missed in previous profiles. This will help us collect data on the epidemiology or disease landscape in China, and allow us to extrapolate that data for Asia."
