Hi, Brian.

Recently, I have seen ads for the new immunotherapy drug, Opdiva, as being one to prolong the lives of those with advanced stage SCC in the lungs.

Since you are right on top of these things, I was wondering if you have heard if it would potentially benefit certain patients with lungs mets or OC/OPC in general.

Just curious .

Best,
Kerri

I am curious about this as well

If your lung cancer is a met from your oral/oropharyngeal cancer, the answer is yes you are a candidate. You need to have failed primary treatment with radiation and cisplatin to get into any on going trials. For the limited approval of the drug from FDA, you still need to have already had cisplatin. I watched this go through trials at the NCI oversight committee that I am on, and there are now 4 companies with variants of this idea in the market this was just the first. This got fast tracked from the FDA before the clinical trials were done because the results were so positive.

But not for everyone, and there are still many questions about the side effects and dosing levels to be answered in trials. So while immune checkpoint inhibitors (pd-1 pathway) are an amazing thing for turning your own immune system on, actually allowing it to see something that it was not recognizing as a threat before, there have been a few cases where the immune system attacked more than the tumor with a negative result to the patient.

This is an amazing breakthrough. My Xmas donation ask letter is partly written around this, this year that I will be sending out to thousands of OCF supporters in a week, as OCF was a financial funder along with the NCI and private sector in the idea. We also referred a bunch of patients into the trials. That portion of the patients that did respond have had long durable remissions. Remember that these were patients I was talking to had no hope, and the doctors had pretty much told them to go home and get their affairs in order.

People here on this board are probably the only ones who understand how this impacted me personally, as I talk to these kinds of patients every week, and it is one of the hardest parts of what I do for OCF. But today many of those patients are alive because of immune checkpoint inhibitors. It has completely changed the optimism that I can express to them, and where I can point them compared to just a year ago. The first out was from BMS, then Merck, then Astra Zeneca, and more companies are following as there are slightly different means to approach the idea.

I can see a point in the future where this will become part of the cocktail of things that are done in primary treatment. While we have epidermal grow factor monoclonal antibodies, which have been around for awhile; now we have one designed around the programed death immune checkpoint signaling pathway, and more mechanisms like this are being currently explored. The next step will be careful proteomic and genetic profiling of patients to determine which combination of these things will work for them, as we have seen with the EGFR attack, it does not work on every patient from every etiology.

Thanks for sharing all of your knowledge, Brian.

The future is looking brighter in cancer therapy.

Thanks for all that you do.

This is such great news as Brian has suggested this to me already. I am hopeful that I will soon be on one of these as my oncologist has told me it should be the next route I take. I don't want to get my hopes up too high, but the idea of possibly getting a few extra years is very encouraging.

This is indeed wonderful news.
To have Hope is a fantastic thing.
Having just read your email Brian, I want to take this opportunity to really express my appreciation for all that you do for OCF. Thankyou from the bottom of my heart.
Tammy and Kris.

So Friday afternoon had a meeting with Dr. Gillison, and she has let me know that early next year she will be the lead investigator on new trials using these drugs in primary treatment. The trials will essentially look at PDL-1 drug with radiation and cisplatin, PDL-1 with radiation and Erbitux ( in patients that have the marker for effectiveness of EGFR inhibitors), with PDL-1, radiation and no chemo. So those trials will allow these to get into the primary treatment realm likely as early as next fall if they have the same impact as they did in these failing patient trials. The future is brighter, and this is just the beginning of the types of therapies. They will also need to start genetic profiling of patients like they did for EGFR, so we can target just the patients in which this pathway or future ones is implicated in the original disease. A decade from now there will be an armamentarium of monoclonal antibody type drugs out there that will have efficacy in very specific patients that show a susceptibility to that particular one working in them.

While OCF has played a very small role in this as millions of dollars have been thrown at this idea from multiple sources, we have been players in small financial donations to research, and most importantly driving patients to the clinical trials that were so successful. We almost filled one trial by ourselves, and I am very grateful that those that we referred felt some comfort in following our recommendation, and that so many of the people that interact with OCF have come to donate what they can to not only keep OCF alive, but to allow us to contribute to things like this that we find promising. In the previous post I eluded to the Xmas ask letter that got mailed out to many people, If you would like to read it since it chronicles a little bit about how OCF came to be and what it has become you can follow this link. http://www.oralcancerfoundation.org/holiday/index.php

It's exciting to see things moving forward. Thanks, Brian!

Dear Brian,

Reading your Holiday Wish, I felt all kinds of emotions erupt within me: empowerment, inspiration, drive, joy, excitement, a sense of belonging to something greater than what I can ever do alone, belonging, tenacity, and hope...It brought tears to my eyes and passion to my voice as I read it aloud. It was nothing less than magnificent.

This news ignites new hope for patients who otherwise would be considered "terminal". And now, for patients as part of primary therapy!

I am so happy and proud that OCF is part of the future of these treatments!

I am so grateful to OCF this holiday season and every day. May your Holiday wish come true for you and for all of us.

I will be sharing this for sure!

Gratefully yours,
Kerri

For the Canadian members, this is an article and an explanatory talk from Dr. Pamela Ohashi, Senior Scientist, at the Princess Margaret Hospital on immunotherapy at the hospital.

http://thepmcf.ca/Our-Stories/Insid...most-comprehensive-immunotherapy-program

Even though my intimate involvement with cancer is less than three years, it really does seem what is happening now is proving to be a true shift in developing new therapies to cure cancers.

Like so many technologies, advancements become greater and more often. It seem very bright that in the next several years to a decade, there will be significant cancer curing therapies.

I'm so trilled to be so close to the head of these new advancements.

Thanks Brian and OCF!

Thanks for the updates in this fast moving field, and it seems we, at least myself, need to major in biology soon.

I've also been somewhat following INO-3112, (Inovio) Immunotherapy that generates Killer T-Cell response to destroy tumors with HPV (NCT02163057), which are in phase I and phase ll clinical trials for head and neck cancer, but don't see much mention of it.

https://clinicaltrials.gov/ct2/show/study/NCT02163057

In addition, CAR T-Cells also being injected directly into solid tumors such as head and neck cancer, which was posted in OCF News Feed.

http://www.pharmafile.com/news/5017...-cell-therapy-trial-head-and-neck-cancer

https://clinicaltrials.gov/ct2/show/NCT01818323

I am having trouble getting approved for Opdivo. It is in the appeal process. I have what I thought are all the qualifications. Head and Neck Cancer with original treatment on Cisplatin. Currently have lung mets. I was on Erbitux but it quit working. I really have no other viable options that have proof of working. I have very limited time. My tumors doubling rate is pretty quick, last 2 months it grew 3.5cm, which means that tumor will be 7cm two months from now. I have another tumor on the opposite side of lungs also. My whole feeling like I could beat this is going away quickly. After losing the other two guys on here that were ahead of me in treatment and diagnosis of lung mets, makes me chronologically the next one to go. Now it seems paperwork will be the death of me. I just don't understand how when there is a drug that has proven to put lung mets in remission, that it is so difficult to get approved. With only a 15% success rate, I need to get this drug and find out if it works on me quickly so I may have time to find a trial or start going down the panic of out of country physicians and/or the long list of unproven and sometimes odd treatments. Feel free to IM me to get my number if you have more info on any of this or message me or reply to post.

Dear Jeff,

After the phase 1 PDL1 trial (Opdivo), John was in a phase 2 Selinexor trial. It is a kind of targeted therapy. However, he was having major problems with pneumonia and postural hypotension that the doctors decided to take him off it. He was then placed on capcitabine, which has been around for years. He had to stop using that because he was hospitalized for 16 days with pneumonia brought on by silent aspiration. (It is for this reason that I feel very strongly that one should never underestimate swallowing problems.). I think in the interim the nodules grew and he had to be referred to palliative care.

Before he was in the Selinexor trial, he had six doses of Taxol and Carboplatin, which statistically, have a higher success rate than PDL1. The RO also managed to give him two rounds of radiation (20 grays each time) directed at the swollen nodes in his airway while he was having all that chemo.

Can you talk to your medical team about these other drugs? They may at least keep you in a stable condition.

That aside, I am sorry that you are having problems getting approved for Opdivo. I know how hard it is to keep on getting bad news and how scary it is. I do hope that your medical team, like John's, will take a positive approach and let you try whatever they have in their arsenal. I have you in my thoughts.

Jeff,
Have you called Bristol Meyers Squibb? I saw on another board one or two people got approved by BMS through some sort of compassionate care I think??
Not sure if BMS is who you are referring to when you say you were denied.
Have you looked at any trials with MEDI-4736? Or maybe try calling maker of Keytruda and see if they can help you. I feel your frustration and wish I knew how to help.
Nancy

Jeff, I sent you a private message please check it out. Brian

Jeff hasn't contacted me. Is anyone here emailing directly with him or in closer contact with him than this board? It is important that I get ahold of him ASAP

Brian, Ive sent Jeff an email to the address he has on file asking him to check his PM and contact you right away. Hopefully its the correct email address and he checks it frequently.


*** Update later 4/14 evening *** I was able to reach Jeff thru email and he did respond. He is aware of Brian's attempt to pass along info.

I first want to apologize for my overly emotional response. i am usually not like that at all and I like to keep myself on the straight forward talk.

After a long back and forth, my oncologist was able to get the approval for Opdivo. I should be starting soon, however I have this persistent infection in my jaw/neck that they would like to get rid of before starting. This may include taking out the titanium plate and screws from my mandiblectomy. I currently have had one screw work itself out and now have a few holes in my skin that show the titanium pieces through the holes.

I also want to thank everyone for their help and compassion. Gloria, it is comforting to hear from you as I have followed your husbands journey closely. You are beyond caring and supportive for still being around to help. Christine thank you so much for the email to let me know about the message from Brian, and Brian thank you so much for the message and offering your help. Nancy I also want to thank you for the support. I have not contacted BMS as I had never thought of it, but I will keep that in mind for the future. I should probably go back in the earlier posts of yours to read about your husbands journey of lung mets.

I don't know all the etiquette in what personal info I can give out as far as other ways to connect other than this board but if anyone would want more ways to connect, my main ways to talk to people and connect are through facebook, emails, and texts.

Jeff, no apologies necessary!!! We all are in this together and support each other. We all understand your situation and want to help as much as we can.

Here at OCF, we protect our members privacy. But its still best not to give out your personal contact info online. If you want to communicate with anyone besides thru this message board, they can send you their contact info thru a private message (PM).

Best wishes with everything!!!!

Jeff,
So happy you got approved! Best of luck with jaw infection It's never easy is it.

Jeff, there is no need to apologize or to thank me for throwing in my five cents' worth. I was so glad to hear you got approval for Opdivo and hope you will start soon. I stay on the forum because I personally learned so much from everyone and it is my way of paying it forward. I care because head and neck cancer is still fairly rare compared to the major cancers and there is not so much awareness of it. But the damage it does can be major as you and I have both found out.

Wishing you a speedy resolution for your jaw problems so that you can get started on Opdivo.