Erbitux TAILOR-Made For China First-Line mCRC Market, But Brand Recognition Merck’s Real Goal?
This article was originally published in PharmAsia News
Executive Summary
Merck's plans to penetrate the Chinese market further with its anti-EGFR cancer therapy Erbitux have received a boost with the Phase III TAILOR trial showing significant benefits when used first-line in metastatic colorectal cancer in this population.
Merck KGAA says it will work to make Erbitux (cetuximab) available for patients in China as a first-line treatment for metastatic colorectal cancer (mCRC) as soon as possible. But it seems that the real benefit for the German company of any label expansion will be in helping build its brand presence in China rather than in absolute sales.
Erbitux was first approved in China for use in combination with irinotecan or as a single agent for mCRC refractory to irinotecan in 2006, but the standard first- and second-line regimens for colorectal cancer there are FOLFOX (leucovorin, 5-fluorouracil and oxaliplatin) and FOLFIRI (these first two drugs plus irinotecan).
An expanded approval in China would bring it into line with other major markets. First-line treatment of RAS wild-type metastatic colorectal cancer with Erbitux plus FOLFOX or FOLFIRI is already recommended in clinical guidelines by both the US National Comprehensive Cancer Network and the European Society for Medical Oncology clinical guidelines.
But such a label expansion to first-line use is unlikely to do much for the product's global sales, says Datamonitor Healthcare
analyst Dr. Dustin Phan. "Not only are both regimens effective and widely used for colorectal cancer globally, but Erbitux recently failed to receive a recommendation from NICE [in the UK] for first-line use due to its lack of cost-effectiveness. It’s hard to imagine that a cost-conservative national healthcare system like China’s would not make a similar assessment.
“This would then limit the drug’s first-line use in China to RAS wild-type mCRC patients with private insurance or self-funding. Merck has charity assistance schemes in place to promote the use of the Erbitux. Under these programs, patients will have a self-pay period of three months as opposed to six months. However, the relative high-cost of treatment for the majority of the Chinese population will still limit the drug’s peak patient share."
Looming Biosimilar Competition
Another problem for Merck is that Erbitux is also expected to experience loss of patent exclusivity in China in the second quarter of 2017, which will result in biosimilar competition and erosion of branded sales, with the first cetuximab biosimilars expected to reach the market in 2020.
"In addition, many branded drugs are extensively copied by domestic generics companies before their patents expire, and counterfeit drugs continue to be a significant problem in the Chinese market," said Phan.
"Merck is likely trying to break into the Chinese market where brand recognition is an important factor. Ultimately, I really see the results of this study (and the likely resulting label expansion) as an opportunity for Merck to establish a presence in the Chinese market. Roche is currently the biggest presence in the Chinese CRC market with Avastin, and Merck is likely trying to break into the Chinese market where brand recognition is an important factor," he added.
Positive Results
The top-line data from the 397-patient TAILOR study show that it met its primary endpoint of significantly increasing progression-free survival (PFS) in patients with RAS wild-type metastatic colorectal cancer (mCRC) treated with Erbitux plus FOLFOX chemotherapy, compared with FOLFOX alone.
Secondary endpoint results also support the superiority shown for PFS, Merck said, and the safety profile was similar to that seen in other pivotal trials. Secondary endpoints include overall survival, best overall response rate, time to treatment failure and rate of curative surgery for liver metastases.
The full study results will be submitted to upcoming international scientific meetings.
"This marks a significant step in the execution of our strategy in oncology, notably the expansion in growth markets like China," said Luciano Rossetti, head of global research and development of Merck’s biopharma business. They "reinforce the value and imperative of RAS biomarker testing in clinical practice, so as to provide patients with the right targeted therapy", he added.
Merck has a keen interest in China. As well as tapping into local innovation by nurturing Chinese start-ups, it has been strengthening its own presence in recent years in China. China has the world's second-largest single pharmaceutical market with an estimated annual growth rate of about 9% through to 2018.
(This story also appears in Scrip Intelligence. PharmAsia News brings selected complementary coverage from our sister publications to subscribers.)