语言力求简洁。
这两天有两款PDAC的药消息说出来了，说是有breakthrough了？就详细的去看了看，话不多说，直接甩干货。
1.pelareorep
1.1 公司底色
公司：Oncolytics。机制上面大概是这个意思：意思是说有种溶瘤病毒，可以特异性的感染癌细胞，在正常细胞里面会被清理掉，引发免疫点位表达，让免疫细胞杀死，说是可以让冷肿瘤变成热肿瘤，对于不表达靶点的冷肿瘤细胞有效；
拉了一些伙伴做实验，主要做BC，GC，还有MM，不少伙伴对于这种新机制的东西，还是比较喜欢的，类似于加思科这种，新靶点，错过了那就损失严重，已经出数据的实验是BC，不过不要看到如此多的实验就感觉这个药会是个王炸级别，实际上大部分只签了供货协议，也就是说大家也是被溶瘤病毒的故事讲怕了，安全性没有落地前，没人出钱拿货，注意该公司所有的演示实验均未提及到副作用问题，以及病人基线问题，这也是其市值徘徊在1亿美元附近的原因，我们都知道那怎么说也是个病毒啊，安全性是必须提的：
这个实验，是对比加和不加这个药跟纯化疗的对比，有点想拍桌子，对于这种case应该跟8201比才算合理，只比较紫杉醇是否科学，值得探讨，不过可以看出这个用上去确实是有效的。当然这不仅仅是oncolytic热的开始，比如BMS2016年就在看相关方向，所以这个方向只是旧故事里面的一个新公司。
BMS is offering PsiOxus Therapeutics a massive deal to get exclusive rights of an oncolytic virus that could outperform the promising CAR-T therapies. PsiOxus Therapeutics, based in Oxford, develops immuno-oncolytic viruses to treat solid tumors. Its technology attracted a partnership with Bristol-Myers Squibb earlier this year, which is now offering the British biotech an impressive €850M ($886M) deal for the exclusive worldwide rights of NG-348, a next-generation oncolytic virus. BMS will pay PsiOxus €47.7M ($50M) upfront and funding for the preclinical development of NG-348.
1.2 PDAC实验情况
The study will be conducted at multiple centers in Germany and will be managed by AIO, an academic cooperative medical oncology group based in Germany.
数据来自于ROCHE签的供货协议实验：Enrollment in the GOBLET trial
About 55 patients are planned for enrollment across 4 separate cohorts.
Two cohorts will be with patients with colorectal cancer. In 1 cohort, 14 patients with third-line metastatic colorectal cancer will receive pelareorep in combination with atezolizumab and TAS-102 (trifluridine/tipiracil; Lonsurf). Another cohort will recruit 19 patients with first-line microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer to receive pelareorep in combination with atezolizumab.
A third cohort will recruit 12 patients with metastatic pancreatic cancer for first-line treatment with pelareorep in combination with atezolizumab, gemcitabine (Gemzar), and nab-paclitaxel (Abraxane). A fourth cohort will enroll 10 patients with advanced and unresectable anal cancer for second-line treatment with pelareorep in combination with atezolizumab.
As of the abstract's data cutoff date (July 28, 2022), seven of ten evaluable patients in GOBLET's PDAC cohort, which evaluates pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel, achieved a partial response (3 confirmed, 4 unconfirmed as of the cutoff date). An additional two patients achieved stable disease for an ORR and clinical benefit rate of 70% and 90%, respectively. No safety signals were observed with the studied combination.
总结一下：共实验了12个人，3个PR确认，其余没确认，就把ORR写成了70%，根本不可能，肺癌（要知道K药肺癌的ORR才50%～60%）？乳腺癌的ORR么当是？病人基线，安全性没有提及到，溶瘤病毒的数据是还需要观察，根据在乳腺癌上面的结果其实已经可以有些苗头了，JUST SO SO，当然具体问题具体分析，等待下一次实验数据。
2.Onivyde
这款药的分析药简单一些：是Ipsen买Merrimack的一款药，就是个化疗药，不过用了不同的送药抵达方式，已经在PDAC二线获批了的，这次的消息是一线阳性，具体数据没说，所以能够分析的就是二线数据，直接一点：
Study 1 demonstrated a statistically significant improvement in overall survival for the ONIVYDE/5-FU/LV arm over the 5-FU/LV arm as summarized in Table 5 and Figure 1. There was no improvement in overall survival for the ONIVYDE arm over the 5-FU/LV arm (hazard ratio=1.00, p-value=0.97 (two-sided log-rank test)).
总结一下：二线mOS 6.1m vs 4.2月
然后KN046的二线mOS是多少呢？
mOS是7.5m，是的人数9人，还需要多点数据才能看清，但是注意，这个实验是KN046的单药，上面的连用，简直是吊打级别，046连用化疗效果会再更好，具体看后续数据。而且从这款药的销量也可以看出问题，15年获批FDA二线，21年销量仅仅只有1.2亿英镑，所以这个药，实际效果如何是很好判断的，JUST SO SO。
$康宁杰瑞制药-B(09966)$ $溶瘤生物科技(ONCY)$ $Merrimack制药(MACK)$
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