nivolumab or keytruda - 1267221

wnderwo
Posts:9

My dad does not qualify for the nivolumab trial but would like to try it. He has stage 4 adenocarcinoma NSCLC. When do you think it will be available for the general public? He is considering paying for keytruda (approved for melanoma) but he doesn't know if he has the PD 1 gene (3 biopsies never gave him the answer). He was pretty OK on abraxane for awhile..can't tolerate other chemos..allergic to carboplatin. Do you suggest he go back to abraxane and wait til nivolumab is available rather than try keytruda which he thought might only have a 20% chance of working? Dad is 79 and has diabetes. Also what is the form of marijuana that may shrink a brain tumor metastasis? Dad has mets to bone and brain and is currently fairly week after radiation to low back mets. He also recently had a 2nd targeted radiation to the brain for those mets.

Thank you,

Forums

catdander
Posts:

Hello wnderwo and welcome to Grace. I'm sorry your dad is suffering this disease, it’s truly horrible.

I'm sorry too but as Grace faculty it's not possible for our doctors to say what someone should do. The other day Dr. West said, "but we’re not allowed to give individual patient recommendations, which would include things like interpreting the significance of progression. That’s really what a patient’s oncologist/medical team is for. GRACE wants to be able to provide the thought process and the tools, but we should leave the very subjective judgments to the patient and their doctor." http://cancergrace.org/topic/progression-on-iressa-after-15-months#post…

It's also important to understand that drugs/treatments without significant data as to benefit or harm or neutral effect aren't a topic of discussion for which Grace is set up to handle. No one knows for sure how canabis or nivolumab for that matter might effect your dad.

You mentioned your dad is or was taking Abraxane but couldn’t take a platinum based chemo. Just an fyi, there are other chemo drugs that are used such as, alimta (for nonsquamous), gemzar and navelbine.

I hope you dad does well,
Janine

JimC
Posts: 2753

Hi wnderwo,

In answer to a question about the availability of nivolumab and keytruda, Dr. West recently stated:

"I don’t think any of these options will have any meaningful chance of being compendia listed before the data on nivolumab’s large phase III trials in the second line setting are presented. After that, if positive (and everyone is hopeful that will be the case), I suspect it will only be a matter of months before the FDA approves it. Between the presentation of any positive data and an official FDA approval, there may well be a short interval of availability on a compassionate use basis, and I don’t know if there will be any real interval between compendia listing and FDA approval. Meanwhile, the other immune checkpoint inhibitors as well as nivolumab will also be the subject of a wide array of clinical trials that will serve as another way to have patients receive one of these agents." - http://cancergrace.org/topic/immunotherapy-patient-forum#post-1266550

I don't know of any evidence that marijuana can shrink brain mets. As Dr. West has stated:

"there’s an enormous gulf between lab-based work and actual findings that improve outcomes in human patients. There are probably around 1000 things reported to slow or shrink cancer in test tubes or animal models for every treatment that actually helps human patients with cancer.

I’m not saying it’s impossible that cannibis is significantly beneficial in fighting cancer. I’m just saying that the evidence offered is so weak that it would need to be far stronger to graduate to becoming “speculative”. I don’t consider the kind of evidence available on this hypothesis to be in the same ballpark, and probably not in the same atmosphere, as clinically meaningful, credible evidence of a significant beneficial effect in human cancer patients." - http://cancergrace.org/topic/cannabis-oil-anyone-know-anything#post-126…

JimC
Forum moderator

Dr West
Posts: 4735

Given our legal limitations, we really can't make recommendations about treatments that aren't FDA approved, especially since these questions don't have any evidence-based answer, but rather require a medical judgment.

As my answer above betrays, I'm not confident that marijuana is likely to lead to a clinically significant improvement in cancer. It may make people feel better in terms of several symptoms, but there's no compelling evidence that it's an effective anti-cancer treatment in actual human patients.

Good luck.

-Dr. West

biggerten
Posts: 83

In my role as frantic googler and spouse of a cancer patient, last year I came across the following, for what it's worth - http://cancergrace.org/topic/information-on-projected-release-dates-fwiw

If that bears out, second line Nivolumab may be available for nsclc the second half of next year, although I don't know how fast medicare reimbursement follows FDA approval. I have no window on how the private insurance reimbursement process works.

If I recall correctly, Bristol Myers is on track to complete a rolling submission for third line Nivolumab in squamous nsclc by the end of this year, and I think FDA then has ninety days.

Keytruda would be off label, as I'm sure you know, so that becomes a real financial hurdle for most of us, but it may be available second half of 2015 as well.

I'll include your dad and family in my prayers.