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关心肿瘤领域的各位客官一定对PD-1 / PD-L1这个靶点不陌生。本周灵麦将与您分享EvaluatePharma对该靶点结合疗法的独家分析。
早在2015年时，EvaluatePharma就注意到不少生物公司将研究方向投向PD-1 / PD-L1抗体与其他疗法，如化疗，癌症疫苗，基因疗法等结合疗法的开发。如今，该领域的研究热度有增无减， 从2015年的215项研究实验激增到不少于765项研究实验。从数据上看（图1），Merck的Keytruda和Bristol-Myers的Opdivo无疑是聚光灯的焦点。Merck的Keytruda更是以268项研究实验位居第一，其中包含90项与化疗结合疗法的研究，88项与小分子化和物结合疗法的研究（图2）。
图1 PD-1 / PD-L1抗体结合疗法研究2015 vs 2017
图2 PD-1 / PD-L1抗体结合疗法汇总
从治疗领域的角度去看（图3），我们可以不意外的发现，大部分研究的重点放在了黑色素瘤和非小细胞肺癌。黑色素瘤是免疫肿瘤学第一也是迄今为止最令人印象深刻的一个治疗领域。绝大多数的研究都是为了扩大新药能治疗范围，治疗高发人群。而非小细胞肺癌可能是目前最有潜力的肿瘤市场。由于Opdivo Checkmate-026 trial的失败，使得Merck 的Keytruda一家独大。根据灵麦医药独家推广的Evaluatepharma数据库分析，该药品于2014年9月上市，2016年全球销售额达到USD 1.402 billion， 而2022年将达到USD 9.448 billion， CAGR 达到37% (2016-22)。也难怪其他竞争者纷纷想在这个领域分一杯羹。这也不难得出为什么Keytruda结合疗法的研究热度居高不下。
图3 PD-1 / PD-L1抗体结合疗法在各治疗领域研究占比
而根据灵麦医药独家推广的Biotechgate博谷数据库显示，有11个Keytruda结合疗法相关的项目正在全球寻找合作伙伴， 其中以临床Ⅰ期和Ⅱ期为主。（详见Biotechgate博谷数据库）
正在愁没有好项目的客官，可别错过Biotechgate博谷数据库这么强大有力的工具，赶快联系我们。
When in November 2015 EP Vantage published its first immunooncology analysis we identified 215 studies of anti-PD-1/PD-L1 projects combined with other approaches, and called this an important industry theme. It is a measure of how central combos have become that today, barely 18 months on, that total has been blown out of the water.
The surge in combo studies over the past 18 months has come across the board, but the biggest increase has been seen with Keytruda. Combinations involving Merck & Co’s anti-PD-1 MAb have spiralled from 70 to 268, and the drug has overtaken Bristol-Myers Squibb’s Opdivo to stand today as the most extensively combined PD-1/PD-L1 agent.
Within the Keytruda total, a remarkable 90 trials involve chemo combinations – an important emerging theme – while 88 study the drug with a small molecule. Both totals outstrip the 75 trials of straight combinations of Bristol’s Opdivo plus Yervoy, which at one point looked like making CTLA4 inhibition the most important combo consideration.
Indication-wise, it is perhaps not surprising to see major combination efforts in melanoma and NSCLC. Melanoma is the first and to date most impressive setting for immuno-oncology, and major efforts are under way to expand the reach of novel drugs beyond a subgroup of strongly responding patients. NSCLC, meanwhile, is perhaps the biggest potential oncology market. Although with Opdivo failing in the Checkmate-026 trial, and Keytruda securing first-line US approval on the basis of Keynote-021 data, is fast becoming Merck & Co’s private space (Event – Merck’s daring bid for lung cancer domination, April 28, 2017). Again, however, the dominance of one player is not stopping others from fighting for a piece of the pie.
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灵麦医药是以下两家情报数据库在中国的独家合作伙伴：
Biotechgate/博谷 - 全球创新药和器械产品收购和引进数据库
EvaluatePharma/预估医药 - 全球医药研发、销售、市场预估等竞争情报数据库
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