Keytruda Off Label

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meatie
Posts: 407
Joined: Wed Aug 20, 2014 8:13 am
Location: San Jose, CA

Keytruda Off Label

Postby meatie » Sun Aug 11, 2019 8:26 pm

Could anyone tell me the names of the oncologists that treating MSS patients using Keytruda off-label?

Also, how do I go about asking our oncologist to consult other oncologists that are using keytruda off-label, without appearing to give orders to our oncologist?

Meatie
Mother DX @59 8/14
cln+lvr res 9/14, stage 4
FOLOX+Avs 12-rd 10/14 to 4/15
Reoccurrence, KRAS mutant 11/15
Folfiri 18-rds 11/15-8/16
FOLFIRI with Ramicirumab 28-rds 8/17-9/18
Regorafenib 10/18-10/19
Lonsurf 10/19 onward

boxhill
Posts: 405
Joined: Fri Apr 06, 2018 11:40 am

Re: Keytruda Off Label

Postby boxhill » Mon Aug 12, 2019 11:10 am

To my knowledge, there are studies doing this.

https://clinicaltrials.gov/ct2/show/NCT03658772

ETA: sorry, I see that you have discussed trials on another thread.
F, 64 at DX CRC Stage IV
3/17/18 blockage, r hemi
11 of 25 nodes,5 mesentery nodes
5mm liver met out
pT3 pN2b pM1
BRAF wild, KRAS G12D
dMMR, MSI-H
5/4/18 FOLFOX
Neulasta 6/28
7/9/18 CT NED
11/20/18 CT NED. Enlarged spleen.
12/20/18 Liver MRI 5mm liver met? and 2 lymph nodes in porta hepatis
12/31/18 Keytruda
6/5/19 Triphasic CT LN and spleen normal, Liver node stable
6/28/19 Pause Keytruda, predisone for joint pain
7/31/19 Restart Keytruda
9/10/19 CT stable

WarriorSpouse
Posts: 206
Joined: Tue Aug 16, 2016 9:02 pm

Re: Keytruda Off Label

Postby WarriorSpouse » Mon Aug 12, 2019 4:00 pm

Boxhill,

Remember, Doctors have the ability to use off label based on their own training and experience. They can be the first one to off label use (FDA Approved Drugs) without others to follow.

If Botox can be used to fight migraines, initially off label; Keytruda should be allowed if traditional methods and means have failed. Also, the FDA has recently approved things such as Keytruda as part of the "Right to Try" rules. The FDA has approved the drug, but clinical trials have not yet determined how good it is and its use for certain circumstances.

These two things should help your doctor make the best decision for your treatments.

Good Luck!
WS
D/H 47 years old, 10/2014, Stage IV M/CRC, nodes 12/15, para-aortic, 5 cm sigmoid resection, positive Virchow. KRAS mut, MSS, Highly Differentiated, Lynch Neg, 5FU/LV and Avastin 1 YR (Oxi for 5 months), Zeloda/Bev since 01/2016. 02/2019 recurrence para-nodes, back to 5FU/LV Oxy/Bev. It is working again. "...Perseverance is not a long race; it is many short races one after the other."-Walter Elliot

Pyro70
Posts: 155
Joined: Mon Jan 21, 2019 4:25 pm

Re: Keytruda Off Label

Postby Pyro70 » Mon Aug 12, 2019 6:51 pm

Hi Meatie,

Any doctor can prescribe a drug off label. The main question is what is the medical rationale?

If you are MSS unless you have a high (or at least intermediate) TMB there is no reason to think that Keytruda monotherapy will work.

However, I’m currently tracking about 10 patients that are taking the combo of Regorafenib and a PD-1 inhibitor off label (I assume they all see different oncologists) Most of them just discussed the results of the Regonivo trial with their oncologists and their doctors were willing to give it a shot. I discussed it with my oncologist and she was very willing to try it off-label, when I reach that point. I notice you currently are on Regorafenib. You could add Keytruda since like Nivolumab is a PD-1 inhibitor so in theory they should be interchangeable. But I’d recommend going with Nivolumab, because that’s the drug used in the Regonivo trial and because it seems BMS has been quite willing to give the drug for free to patients trying it off-label. I’d suggest discussing the abstract and poster I shared in the regorafenib immunotherapy thread with your oncologist and ask him to try Regonivo.

Hope that helps

p.s. I hope in 2-3 months that we’ll see the first scan results from the people I’m tracking using this combo. If we see some real world successes, I think that will give us a lot more confidence in this combo.
Dx Jan 2017 stage IVB w/ PC age 35
FOLFOX
SEP 17 HIPEC 1, anastamosis leak
XELODA
MAR 18 HIPEC 2
JUN 18, ileo reversal and 2nd anastamosis leak

boxhill
Posts: 405
Joined: Fri Apr 06, 2018 11:40 am

Re: Keytruda Off Label

Postby boxhill » Tue Aug 13, 2019 2:02 pm

Something you are going to need to consider is whether your insurance will agree to pay for off-label use. It's great if they will, and certainly the recent studies make it more likely.

If they refuse, you can try to get it free or at reduced cost from the manufacturer.

I know that the projected cost of my roughly 2 year course of Keytruda is $240,000.
F, 64 at DX CRC Stage IV
3/17/18 blockage, r hemi
11 of 25 nodes,5 mesentery nodes
5mm liver met out
pT3 pN2b pM1
BRAF wild, KRAS G12D
dMMR, MSI-H
5/4/18 FOLFOX
Neulasta 6/28
7/9/18 CT NED
11/20/18 CT NED. Enlarged spleen.
12/20/18 Liver MRI 5mm liver met? and 2 lymph nodes in porta hepatis
12/31/18 Keytruda
6/5/19 Triphasic CT LN and spleen normal, Liver node stable
6/28/19 Pause Keytruda, predisone for joint pain
7/31/19 Restart Keytruda
9/10/19 CT stable


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