Nivolumab for Adenocarcinoma - 1270225

Hi Phillydaughter,

I hope all is going well. Some have suggested that people with adeno nsclc may be able to access nivo through insurance already since the reports are super promising. Tom is my go to for info on the subject if there is no news from him there hasn't been any. Of course I'd look at our blog posts from faculty on the subject as well. There's a link to the latest info during ASCO. http://cancergrace.org/topic/information-on-projected-release-dates-fwi…

Merck has applied for Keytruda label expansion to treat adeno, and the FDA accepted the application early in June. I don't recall any action yet from BMS on Opdivo for adeno.

Both Keytruda and Opdivo are approved for melanoma, and Opdivo for squamous NSCLC. Since they are approved, they can legally be prescribed, it's payment that is at issue. Your insurance may approve it, there may be possibilities under compassionate use that I am unfamiliar with.

Intriguing to me is that NCCN recently updated their guidelines to include Opdivo as second line for adeno without PD1 expression testing. I have been unable to confirm this, since the NCCN guidelines are behind a paywall. I also THINK (but could sure be wrong) that that means Medicare will start to pay. Again, I have no conformation of this, despite reaching out to a few sources that I thought might be able to help.

That being said, in Merck's case, the deadline for FDA response is rapidly approaching. It took the FDA less than a week for approval of Opdivo in squamous, I suspect the hold-up now is what to do with the PD1 expression information. Require testing? Not? Determine a level? Using who's test, since there are a number of competing tests out there, and it's just not clear.

http://cancergrace.org/lung/2015/06/24/asco_2015_immunotherapy_nsclc_bi…

There are doctors here who have much better insight, since they haven't weighed in on the NCCN issue I guess they don't know. I'm probably much more willing to be wrong in my opinions, since I'm so used to it. :)

But, in any event, it has to be soon. It's hard to be patient, I know, since my wife and I are waiting, although the Alimta treatments are keeping Lucy stable. I know that's a matter of time.

Sorry there's no definitive answer, unless your able to afford $150k out of pocket on a 1 out of 4 or 5 chance it will have an effect.

And atezolizumab (MPDL3280a, Roche's PD-L1 entrance) is probably a year away yet for adeno.

I'll also add that there is a meeting July 9 of the FDA's: Oncologic Drugs Advisory Committee, the announced agenda is for necitumumab in combination with gemcitabine and cisplatin for first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer.

I keep hoping to see that they've modified the agenda to include Keytruda, but I have NO idea how likely or even possible that is. I just know that the Opdivo approval in squamous NSCLC was unexpectedly fast, so I hope for anything.

I am a little mystified by the lack of better info on a BMS application for adeno, I've seen it mentioned in an article, but have missed any press release from BMS on an sBLA application, or of an FDA acceptance of an application. These are usually trumpeted loudly.

My mom is suffering from stage 4 non small lung cancer (adenocarcinoma). The EGFR result is as follows: EXON 19: MUTATION DETECTED. EXON 18,20,21: Negative (Wild type).
She took TARCEVA for 11 months. Good results in first three months, then stable condition but now tumour has increased. Yesterday, she started chemo with alimta+carboplatin. I hope the results of that are good.
I wanted to ask about this new drug nivolumab. Recent studies have indicated a positive result for non squamous cancer patients with nivolumab. Is it available to be bought or only for trials? My mom is in Pakistan. Can the drug be shipped or brought in person to Pakistan? Or will she have to come to the US if we want to use Nivolumab. Also, since its so expensive, can a non US citizen be eligible for trials in the US?. Do reply, Thanks.

Much of what you ask involves questions best asked of your local doctors, they know the laws governing medical care in Pakistan.

If money is no object, Nivolumab (marketed as Opdivo) is certainly available here in the US. But it's not like a bottle of pills you can have prescribed, buy and transport.

Patients need not be citizens to participate in clinical trials if they meet the trial’s specific medical eligibility requirements.

Thanks Tom for the reply. Wish ur wife, u and ur family the best of luck with this. May ur wife have a long healthy life!
I think Nivolumab comes in a vile. And one vile is around $2500? Maybe one treatment would need more than one vile according to the weight of the patient. (My mom weighs around 170 pounds) That may be a bit too much. But will try my best. Right now, I am hoping the chemo will have good results. May I know if Nivolumab can be shipped by air without damaging its contents, are there any special precautions needed for it? And if you don't know, what is the best place to contact for getting this info.

Wow. I don't know how things are in Pakistan, but here in the US you can't just buy most medicines.

A google search gave me the following, but I'm afraid you are at the limit of anything I know. I can't be of any further assistance.

https://bmsdm.secure.force.com/opdivohcp/servlet/servlet.FileDownload?f…

Good luck.

My mother:
79 y/o never smoker, EGFR-, Alk -, ros-, braf-, KRAS+ (only discovered 3/15)
dx 12/08 with IIIB adenoca with malignant effusion.
4 cycle carbo/taxol- no change
18 months tarceva/avastin ( SWOG trail), 25% progression)
18 months alimta ( no change), stopped due to renal insufficiency
1/15- liver metastases and new activity in rt lung
randomized to docetaxel rather than nivolumab- chose to drop out of trial to receive docetaxel close to home
2 cycles docetaxel- severe fatigue
4 cycles alimta- worsening pleural effusion rt lung
now 1 cycle Gemzar

weaker, losing weight, dyspneic

Kaiser patient- Kaiser will not offer PD-1 inhibitor unless fully FDA approved- will not allow out-of pocket payment either

My questions:
1)The pharmaceutical company did test her for PD-1 when she entered the trial, but the will not release her PD-1 status.
Any strategies to obtain compassionate release of the PD-1 status knowing that FDA approval may hinge on PD-1 status

2) any updates on status of FDA approval? next few weeks? months?

I've been out of town for a while, thanks Philly.

I can't address question 1.

Question 2, our oncologist has gotten approval for Nivolumab. She has Medicare through BCBS of Minnesota.

NCCN guidelines for nivolumab is regardless of PD1 expression.

I am still confused about Nivolumab's FDA approval for adeno, I have seen nothing. I'm sure that BMS is happy with the NCCN guidelines, though, since it's a strong argument for off label coverage.

Merck's PD-1 drug pembrolizumab (keytruda) has an action date of October 2, and it appears they're dancing with the FDA on the subject of PD-1 status requirement or no, so that's an unkown at this point.

Hi, Philly.

I am going to answer this on our status thread, I'll try to get back here with a link soon.

Here's the link -

http://cancergrace.org/topic/new-forum-member-from-the-twin-cities-in-m…