Keytruda – what a 40% response rate has meant to me.

Keytruda – what a 40% response rate has meant to me.

By Bill Drake, TargetCancer Foundation Advocacy Council Member

On September 11, 2013 I was diagnosed with an adenocarcinoma malignant tumor on my esophagus at my GI junction, inside my GI specialist’s office on Cape Cod. I was there for my routine “over 50” colonoscopy.

While lying on the cold examination table, covered only by my humiliating hospital “Johnny”, patiently awaiting my intravenous anesthesia, I got to talking to the nice attendant nurse for a few moments. It occurred to me that I’d been hearing too much lately about a deadly disease of the top end of the digestive system that had recently taken two important people– first the quick death of my 56 year old neighbor, then the tragic exit of my hero writer, debater, and radical thinker, Christopher Hitchens.

Esophageal cancer — a “rare” cancer, was killing these people, and it turned out to be a cancer the nurse seemed aware of. Now I was hoping…wondering, no way I could have a problem? Why would I? I had no symptoms that caused me concern. No issues swallowing. But, I reasoned, never hurts to check.

That’s when I just had to ask if the fine doctor would be so kind as to take a quick peak down my esophagus when he was finished with the other end. I had no idea what that request entailed from a procedural perspective, but I did have this odd queasy feeling that I should be scoped, and hoped, of course, that it was going to be nothing.

You see, I had bad acid reflux since I was a kid. I over ate many meals. Members of my family joked that we would just sprinkle Tums on top of the pies during Thanksgiving. I spent too many years overweight, and remember nights waking from a deep sleep, aspirating acid up into my nose and sinuses. My primary doc never warned me of my risk, and never offered me any thoughts on the symptoms. What’s the worry?

But after describing these experiences to the kind young nurse, I noticed that she was listening to me with a concern that was not dismissive, and the next thing I knew, she had me signing a few papers and the fix was in — I was getting an unscheduled upper endoscopy on the spot. It took only an hour, and then it happened — I was ushered (as Christopher Hitchens so aptly named in his last work “Mortality”) into lovely downtown “Tumortown”. I was so angry, at myself, and my GP. How could I have not been scoped sooner? Moments before I lived comfortably in “Wellville”. With a quick look at the ugly color image held up by Dr. Segal — an ulcerated alien being lodged in my esophagus — I knew that Tumortown was now my town.

That nurse was the first person to save my life. And as I write this TargetCancer Foundation posting, more than three and a half years after I took up residence in Tumortown, my life has been saved by a small collection of brilliant clinicians, radiation oncologists, and chemical oncologists. Now, thanks to some fundamental breakthroughs in cancer treatment over the past three years, my rare cancer cells and lymph node tumors are being hammered into submission by my own revved up T-cells, stimulated by the latest immune check point inhibitor monoclonal antibody agent called Pembrolizumab, branded “Keytruda” and marketed worldwide by Merck.

I have had three infusions of the agent, spaced out over three week intervals. Just a small unassuming bag of clear fluid that takes only 15-20 minutes to infuse. During my past three years of EC survival, my cancer cells responded well to radiation and cisplatain, with no side effects to complain about, and no measurable node growth until this year. The new growth, as measured in centimeters on my cat scans, was enough to merit a stab at the leading edge of a new oncological paradigm shift; immunotherapy.

pembro

I’m here to report to you that this is a major shift, happening right now, rooted in measurable clinical trial results. A shift representing fundamental new insights into methods to “unmask” fast mutating cancer cells so that the immune system T-cells can identify and kill these weird cells that refuse to die on their own.

The check point inhibitor monoclonal antibody agent technology has proven over the past five years to be a life saving therapy for some cases of metastatic melanoma, and every month since, new clinical studies are showing its safety and efficacy in lung, colon, brain, other cancers.

The news went national during December 2015 when 91-year-old President Jimmy Carter reported his brain tumors were being suppressed and dissolved by his charged-up immune system, extending his life in Tumortown, the active agent: Keytruda.

Then clinical studies reported in 2015 were a breakthrough for esophageal cancer. Scientists conducted a phase II study of 37 PD-1 positive patients with metastatic esophageal cancer, infusing them each with Keytruda.

By histology, 40% of the patients with adenocarcinoma “had positive responses, and were continuing to respond at one year”. That result took the breath away from esophageal cancer oncologists across the world.

On October 24, 2016 Keytruda received FDA approval for first-line metastatic non-small cell lung cancer treatment. The therapy blew out of the melanoma and lung clinical trial morass quickly. Because it was working on cancer, it was fast tracked by the FDA. Very exciting news.

Now, we’re dreaming that immunotherapy is about to rock the world of esophageal cancer, and other rare cancers.

Since 2015, Merck has significantly increased its advertising and promotion of Keytruda. This past year I’ve seen full-page ads in the New York Times, plus TV spots on CNN, and many other national media channels.

Research into the effectiveness of pembrolizumb has exploded the past two years. A quick search for “pembro” clinical trials listed on ClinicalTrials.Gov currently lists over 400 trials in the recruitment phase, and for a vast array of cancer varieties and patient types.

When I reviewed all my potential options to access Keytruda, I decided to apply for Merck’s “compassionate care” program. I visited Merck’s site (see link below) completed the required short application, and had my oncologist do the same. We were informed in a few weeks that I was accepted into the program. I’m so grateful that Merck offered me access to a one year supply of pembrolizumb — an estimated value of $250,000 if the drug was purchased over-the-counter. So, while I’m not in a clinical trial, the cost of my infusions this year is being covered by Merck’s “compassionate care” program.

My most recent scans show that I’m among the lucky 40% of EC survivors that respond “beautifully” to the agent, as my oncologist Dr. Jeffery Azolli at Massachusetts General Hospital remarked. We both marveled at the two scans side by side – before and after only three infusions of Keytruda. All troubling lymph nodes were measurably smaller, and some were gone totally.

I’m now experiencing a “durable” immune response, no infusions, and still no growth. Side effects are where skill and art come into play for Dr. Azolli, as we’re treating a nagging autoimmune response in my lungs (coughing) with anti-inflammatory steroids. Needless to say, I’m thrilled that my immunotherapy is for real, and that I “continue to respond”. More infusions are planned. No problem.

The exciting aspect of this new line of research, is that in the coming decade, many other check-point inhibitor pathways will be discovered and explored, and will be exploited by new agents that may be both safe and will enable the human immune system to destroy cells from all cancers including rare cancers. A Stanford University research team discovered one such example several years ago, called CD-47, and their advanced agent is now in human trials, along with many more.

Most leading-edge immunotherapy researchers believe that a “cocktail” of monoclonal antibodies, using different pathways, will ultimately lead to the most powerful treatment, and some day soon, maybe in 5-10 years, all of us in Tumortown will have a safe path to Wellville.

Related Links: 

Merck Access Programs
https://www.merckaccessprogram-keytruda.com

FDA Approval in NSCLC
http://www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-keytruda-pembrolizumab-metastatic-nsclc-

NBC News: Jimmy Carter
http://www.nbcnews.com/health/cancer/heres-look-keytruda-drug-jimmy-carter-says-made-his-tumors-n475561

ASCO Post: Impact in GI Cancers
http://www.ascopost.com/issues/february-25-2016/anti-pd-1pd-l1-antibodies-make-strong-showing-in-gastrointestinal-cancers

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