checkpoint trials for lung cancer 现行肺癌"检查点"免疫治疗药试

jaydad

目前有四大药厂在竞争,之外好象 还有小公司也在努力.
信息来自 https://clinicaltrials.gov/ 网页, 时间截止 2014-12-27. 有错请指正, 有漏请补充

MERCK 公司 抗PD-1 药 MK-3475 (通用名pembrolizumab, 商品名KEYTRUDA)
1) KEYNOTE-021 / NCT02039674

MK-3475  联合以下药物
a) Paclitaxel+Carboplatin
b) Paclitaxel+Carboplatin+Avastin
c) Permetrexate+Carboplatin
d) Ipilimumab (anti-CTLA4, 另一'检查点'免疫治疗药, BMS公司产品)
e) Erlotinib
f) Gefitinib
g) Carboplatin

2) NCT02085070
MK-3475 治疗肺癌脑转. 必须有0.5-2cm 大小的脑转, 必须有阳性PD-L1 结果 (5% 以上)

3) MK-3475 联合 放疗 NCT02318771

4) KEYNOTE-037 / 02178722
MK-3475 + INCB024360 (这个是IDO1 抑制剂)

5) KEYNOTE-010 / NCT01905657
分三组:
a) MK3475 低
b) MK3475 高
c) 化疗对照组

罗氏公司 抗PD-L1 MPDL3280A 通用名____, 商品名____
1) NCT02174172 / MPDL3280A 联合
a) Ipilimumab (anti-CTLA4, 另一'检查点'免疫治疗药, BMS公司产品)
b) Interferonn alpha-2beta

不收EGFR 或 ALK 阳性病人

2) NCT02013219 / MPDL3280A 联合 erlotinib
只收EGFR 阳性

3) NCT02298153/ MPDL3280A 联合INCB024360 (IDO1 抑制剂), 还未开始招收

4) NCT01988896/ MPDL3280A 联合 Cobimetinib (MEK 抑制剂)
因为 Cobimetinib也是新药, 需要过剂量试验关. Cobimetinib 是MEK 抑制剂, 对 KRAS 突变肺腺癌比较有用.

5) NCT02323191 / MPDL3280A 联合 抗CSF1R (RO5509554)

6) NCT02008227 / MPDL3280A 对比 DOCETAXEL
无须PD-L1阳性

7) NCT02031458
必须PD-L1阳性

8) NCT01375842 Phase 1 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors


AZD/ MedImmune 公司 抗PD-L1 Medi4736 通用名____, 商品名____
1) NCT02143466 / Medi4736 联合 AZD9291
EGFR 阳性

2) NCT02179671 / Medi4736 联合
a) gefitinib
b) AZD9291
c) selumetinib + Docetaxel
d) Tremelimumab (辉瑞的抗CTLA-4)

3) NCT02087423 / GLOBAL MEDI4736 STUDY
无须PD-L1 阳性

4) NCT02000947 /  MEDI4736 + Tremelimumab

5) NCT02273375 / 术后 用MEDI4736

6) NCT02088112 / MEDI4736 + GEFITINIB
EGFR 阳性

BMS 施贵宝 公司 抗PD-1 通用名 nivolumab, 商品名 OPDIVO

1) NCT02041533 / CHECKMATE-026 NIVOLUMAB 对照 化疗

2) NCT02066636 / CHECKMATE-153 全国范围安全试验

3) NCT01454102 / CHECKMATE-012 NIVOLUMAB 联合 化疗及 IPILIMUMAB

4) NCT02323126 / NIVOLUMAB 联合 EGF816 (EGFR T790M) 或 INC280 (c MET 抑制剂)

5) NCT02259621 / NIVOLUMAB 术后辅助治疗

B70520022019

真棒，希望国内早日同步

cnvicky

谢谢！！！！

jaydad

好消息: 今天, 2015 - 03- 05, BMS (施贵宝) 的 OPDIVO (nivolumab) 获批在美国上市用于 肺鳞癌 第二线后 治疗. 此前已获批治疗黑色素瘤.

Bristol-Myers Squibb (BMY) received FDA approval for treatment of lung cancer. Evercore ISI’s Mark Schoenebaum calls it the fastest approval he’s ever seen:

Bloomberg News

The Biologic License Application for Bristol-Myers’ PD-1 in squamous cancer was accepted LAST WEEK. The PDUFA was set in June. It was approved today. This is the fastest approval I’ve seen in my 15 year career. Congratulations to the Bristol-Myers regulatory and clinical development teams!

We don’t have label yet, but FDA press says that the OS benefit was “3 months.” We really need to see the curves (is there a tail? How big? What was the hazard ratio?).

I would expect the label, of course, to include both PD-1 expressers and non-expressers.

As a reminder, there are 100k 2nd line lung cancer drug treated patients in US and Western EU. Opdivo costs around $12,500 per month. WE DO NOT YET KNOW what the duration of therapy will be in this setting. If we assume 6 months, the “TAM” in 2nd line lung cancer is around $7.5B (TAM = 100% penetration and share).

HOWEVER – today’s approval is only for “sqaumous” lung, which is around 30% of patients. Thus the 2nd line squamous “TAM” is around $2.25B.

Shares of Bristol-Myers Squibb have gained 4.8% to $64.92 at 2:43 p.m. today.

UPDATE: Leerink’s Seamus Fernandez and Aneesh Kapur call the Bristol-Myers approval ‘blisteringly fast,’ and believes it will give the pharmaceutical company a head start over rivals Merck (MRK) and Roche (RHHBY):


Blisteringly fast approval (just 2 months after CHECKMATE-017 was stopped) and 3 months ahead of June 22 PDUFA provides Bristol-Myers a nice marketing window vs. Merck and Roche but is also positive for timing of approvals across indications for the class. We currently model Bristol-Myers as gaining 60% of the squamous non-small cell lung cancer (NSCLC) market. Given acceptance of the filing last week and submission in late December, the turnaround of ~2.5 months bodes well for timing of all future potential label expansions for the PD1/PDL1 class, which appears to have a mandate for resources and rapid action.

Shares of Bristol-Myers Squibb have gained 5.7% to $65.46 at 3:45 p.m., while Merck has dropped 1% to $57.74, and Roche has fallen 0.9% to $33.15.

brookzhan

真是好消息！关注！
已经有国内的病人去参加美国的临床试验了，希望有好的结果。
又是一条新的路线。
谢谢戴先生。

求我且

希望有好的结果，到国内不知什么时候了。多谢发消息的朋友。

lgx2232

多谢戴先生 您就像救世主一样 自己病魔缠身 还不辞辛劳在一次次给大家 发送着光明 我虽然看不懂但看到大家给您的回复 是好消息 我们大家一定加油努力等到医疗科研工作者攻克难关 拯救癌症患者出苦海