Sunday, December 24, 2017

About DAMN time!!! Opdivo approved as adjuvant for resected melanoma with lymph node involvement or metastatic disease!!!!

Even before I wrote this little story, as I was getting my last dose of Nivolumab in June of 2013, Love Potion...or Patient...#9!!!!!  which includes this history of Opdivo's development ~

Once upon a time (2005), in a land far, far away...(Japan), ONO Pharmaceutical generated ONO4538, an anti-PD1 monoclonal antibody, in research collaboration with Medarex (who called the product, MDX1106).  In 2009, the big, getting ever bigger, (? benevolent) King of the World, Bristol-Myers Squibb (BMS) acquired the rights to develop ONO4538/MDX1106/BMS936558  in North America.   In an additional agreement in 2011, BMS attained the rights to the product in the rest of the world...except Japan, Korea, and Taiwan...where ONO retained exclusive development rights and is conducting Phase II studies with ONO4538 in non small cell lung cancer and melanoma and Phase III studies in renal cell carcinoma currently.  However, no results of either of those studies can be found.  Thus began the exploration of BMS 936558 in the Americas! 

~ to as recently as this past November when I put together this post (which covers the results of the CheckMate-238 trial):  Review of adjuvant treatment in Stage III melanoma and "death knell" for ipi and interferon in that role!!!!  I have NEVER stopped SCREAMING about the obvious need to approve anti-PD-1 for the adjuvant treatment of melanoma in Stage III AND IV patients!!

Thanks to all the ratties and researchers who kept of 4 days ago - it's finally done:  FDA Approves Adjuvant Nivolumab for Melanoma

The OncLive link above notes:  "The FDA has approved nivolumab (Opdivo) as an adjuvant treatment for patients with completely resected melanoma with lymph node involvement or metastatic disease, based on findings from the phase III CheckMate-238 trial."

Here's a synopsis of Opdivo's approvals by the FDA:  History of Opdivo from

Development History and FDA Approval Process for Opdivo

Sep 22, 2017Approval  Opdivo gets Approval for  Hepatocellular Carcinoma Previously Treated with Sorafenib
Aug  1, 2017Approval Opdivo approved in MSI-H or dMMR Metastatic Colorectal Cancer That Progressed after Treatment
Feb  2, 2017Approval Opdivo  approved in urothelial cancer Previously Treated then Locally Advanced or Metastatic 
Nov 10, 2016Approval Opdivo is the First Immuno therapy Approved in Head and Neck Cancer
May 17, 2016Approval Opdivo Approved for the Treatment of Hodgkin Lymphoma
Jan 23, 2016Approval Opdivo + Yervoy Approved in Unresectable or Metastatic Melanoma Across BRAF Status
Nov 23, 2015Approval Approves Opdivo to Treat Metastatic Renal Cell Carcinoma
Oct  9, 2015Approval Expands Approved Use of Opdivo (nivolumab) in Advanced Lung Cancer
Oct  1, 2015Approval Approval for Opdivo + Yervoy in BRAF V600 Wild-Type Melanoma
Mar  4, 2015Approval Expanded use of Opdivo to Treat Lung Cancer approved
Dec 22, 2014Approval Opdivo Approved for Advanced Melanoma
Dec  6, 2014Opdivo Demonstrates High Overall Response Rate of 87% for Treatment of Relapsed or Refractory Hodgkin Lymphoma
Nov 16, 2014Study Comparing Opdivo to Chemotherapy Demonstrates Survival Benefit
Oct 30, 2014Phase 2 Objective Response Rate and Survival Data for Opdivo in NSCLC to be Presented
Oct  6, 2014BMS Announces Collaboration to Evaluate Opdivo in Combination to Treat Non-Small Cell Lung Cancer
Sep 26, 2014Bristol-Myers Squibb Announces Multiple Regulatory Milestones for Opdivo 
Ratties are truly and for certain (along with at least one special mouse, my dear Edster!) amazing peeps.  And while one of us changes little alone.........together......The Rats of NIMH                                    (No Idiotic/Injurious/Insulting/Intensely awful Melanoma Here!!!)  HAVE CHANGED THE WORLD!!!!!Thanks and much love to each and every one of you.  Merry Christmas!!! - love, c 


  1. Celeste--You were kind enough to comment on my posts at MPIP, and you're my "go to" source for "entry points" into any of my melanoma research topics. I was the one who was surprised that my medical onc at MD Anderson initially recommended peginterferon for my Stage iIIB melanoma. HOWEVER, she then changed her mind after looking at the MD Anderson pathologists review of my sentinel node and wanted to get me into a "Nivo v. Nivo+Ipi" clinical trial. Unfortunately, that trial was not available to me at KU Med where I'm being treated, BUT THEN the news came out that the FDA approved Nivo for adjuvant treatment for folks like me (your post here is great). I feel like doing a course of treatment for Nivo is almost a no-brainer for me. So here's my question--do you have something that shows what the likely length of treatment will be for someone in my shoes? The Opdivo site basically says "stay on this until you see the effect you want on the tumor or it becomes too toxic" (my words), but in the adjuvant setting we don't have a tumor response to use to measure, so I'm wondering if we're talking 6 months, one year, etc. It wasn't clear to me how long the folks on the clinical trials were on it, or whether there's any "conventional wisdom" about the length of treatment in the adjuvant setting. If you have anything you can point me to, I would be most appreciative!! (I'm amazed and awed by the amount of great information you put out in digestible form for folks who want to research and be their own best advocate. Thank you so much for ALL that you do. You're a true hero in my book!!)

  2. Thanks for your kind words. The question you pose IS the zillion dollar question...though many melanoma ratties are helping find the answer. I was in the Stage IV, NED arm of this trial:

    The treatment duration was 2 1/2 years for all participants (with disease or without). I was treated with nivo from December of 2010 until June of 2013. My onc and lead researcher, Jeff Weber has often said that we were probably treated "too long" and that it is likely that a certain quantity of the med provides the needed positive effect and more only increases risk of side effects. Here is a link to a variety of posts that address your question indirectly (esp when you read those that note folks who have to stop immunotherapy due to side effects do as well as those who take it longer):

    Many melanoma peeps (with active disease and without) in the research and my personal friends...are living large after choosing to STOP immunotherapy. They (and I) are the canaries in the coal mine and we continue to sing. Currently, researchers are leaning to 1-2 years of therapy as the general duration of treatment.

    This is probably not the explicit, clearly defined answer you would like...but that's melanoma for you!!! Keep me posted. I wish you my best! - c