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Health See other Health Articles Title: New Lung Cancer Drug in China: Faster, Cheaper R&D Medscape... The Chinese targeted drug for non-small cell lung cancer (NSCLC), icotinib (Conmana, Zhejiang Beta Pharma Co., Ltd.), might herald a wave of new anticancer drugs, rapidly and cheaply developed in China before going on to penetrate other world markets. So writes D. Ross Camidge, MD, PhD, from the University of Colorado Comprehensive Cancer Center, in Aurora, in an editorial published online in the Lancet Oncology. The editorial accompanies publication of the ICOGEN trial of icotinib in patients with NSCLC, which was reported by Medscape Medical News when it was presented last year at the Chinese Society of Clinical Oncology meeting. Both drugs are epidermal growth factor receptor (EGFR) inhibitors, and benefit from these drugs is seen predominantly in NSCLC patients who harbor EGFR mutations. There is a huge interest in China and other Asian countries in these drugs because there is a much higher incidence of EGFR mutations among Asian patients with NSCLC (up to 60%) than among Western populations (where the EGFR mutations are found in about 10% to 20% of NSCLC patients). Icotinib Phase 3 Trial ICOGEN was a phase 3 trial that established the noninferiority of icotinib when compared with gefitinib (Iressa, AstraZeneca Pharmaceuticals LP), say the investigators, led by Yuankai Shi, MD, from the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing. The trial was conducted in 400 patients with advanced NSCLC (not selected by EGFR mutation status) and found that the median progression-free survival was not significantly different: 4.6 months on icotinib vs 3.4 months on gefitinib (P = .13). The most common adverse effects with both drugs were rash (41% of patients in the icotinib group vs 49% gefitinib) and diarrhea (22% icotinib vs 29% gefitinib). Icontinib is a valid therapeutic option for patients with NSCLC, the researchers concluded. They also noted that patients with EGFR mutations are more likely to benefit than patients without EGFR mutation. This conclusion was based on a retrospective analysis of 134 lung tissue samples that were tested for EGFR mutation status (51% of which were positive for EGFR mutations). Kick-Start to Chinese Industry Writing in the editorial, Dr. Camidge suggests that icotinib was a "perfect test case for kick-starting the Chinese anticancer drug industry." Developed by Zhejiang Beta Pharma, with support in part from the Chinese National Key Special Program for Innovative Drugs, the product reached the market in record time, taking only 8 years from early-stage development to launch, which is 2 years faster than is standard in high-income countries elsewhere in the world, he notes. In addition, the cost of development (rumored to be $20 to $30 million) was a fraction of what it would have been in the United States or Europe, where the development of a new anticancer drug runs to hundreds of millions of dollars, he adds. From a clinical point of view, icontinib is very much a "me-too" drug, Dr. Camidge writes. As an EGRF inhibitor for use in NSCLC, it has the same mechanism of action and no real difference in efficacy and safety than the other 2 agents in this class that are already on the market, gefitinib and erlotinib (Tarceva, Osi Pharmaceuticals, Inc.). (Another drug in this class has just been launched, afatinib [Gilotrif, Boehringer Ingelheim Pharmaceuticals, Inc.]) Icotinib has a disadvantage in dosing: because of its short half-life, icotinib needs to be taken 3 times daily, whereas the other drugs are taken only once daily. However, icotinib had a big advantage when it comes to price — it is available in China for about two thirds of the price of erlotinib and gefitinib, Dr. Camidge notes. "In a country where self-payment for drug is routine, local uptake has been enormous," he writes. The drug was approved in China in June 2011 and is estimated to be making more than $100 million in sales annually. Any new drug in this class, as well as clinical trials in this patient population, will now have to take "into account the rising use of icotinib in this population," Dr. Camidge said. Icotinib is likely to be used predominantly in China, and although licenses for other countries could be sought, the product "might be expected to have minimal importance worldwide," Dr. Camidge concludes. The ICOGEN study was supported by Zhejiang Beta Pharma and was partly supported by grants from the Chinese Government. Dr. Shi and several coauthors report no relevant financial relationships, but 3 coauthors are company employees, and another is an employee of a Chinese contract research organization. Dr. Camidge reports no relevant financial relationships. Lancet Oncol. Published online August 13, 2013. Abstract, Editorial Post Comment Private Reply Ignore Thread
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