This is week #9 on clinical study, as I received my infusion of M7824 yesterday as planned. All of my pre-therapy vitals and bloodwork came back fine, which meant the treatment was a go. As with previous infusions, there were no issues during or after. Everything went just fine.
It was unfortunately a later night than expected, as Lorie and I just missed our 7:30pm train and had to catch one leaving the next hour. So, we ended up walking in the door at home around midnight. Could always be worse!
Following the discussion in my past few blog posts, I’ve been learning more about the concept of “pseudoprogression,” or the apparent growth of a tumor followed by sustained regression, which is common following treatment with checkpoint inhibitors. For example, I came across the video clip below by OncLiveTV that contains a discussion of “Pseudoprogression With Checkpoint Inhibitors in Non-Small Cell Lung Cancer,” where panelists explore the implications of this phenomenon for patients with NSCLC. While I do not have NSCLC, the overall concept of pseudoprogression with checkpoint inhibitors is relevant to my treatment and latest scan results – whereby the tumor growth exhibited could be from inflammation due to an ongoing positive immune response, or from an actual increase in the tumor that continues until the body’s immune system overpowers the cancer. It could also be a combination of the aforementioned. In any event, I think that pseudoprogression is an important concept for patients receiving some immunotherapies to better understand – especially when getting imaging results following treatment.
PS – anyone who knows me, knows that I’m a big Chicago Cubs baseball fan (having grown up in Chicago)…so I’d be remiss if I didn’t ask you to keep voting for retired catcher David Ross on this season’s ‘Dancing with the Stars’. In case you missed his debut performance, here’s a clip where he danced to Steve Goodman’s “Go Cubs Go” – while wearing Cubs gear.
Standing on the train platform this morning on my way to NYC, the late British rocker Joe Cocker’s version of Feelin’ Alright was playing over the sound system. Not only a good song to start the daily commute, it seemed an appropriate theme for this blog post.
It was exactly one week ago today that I received my first infusion of an experimental cancer immunotherapy agent, called M7824, as part of a Phase 1 clinical trial at the National Institutes of Health (NIH). Recall from my prior post that M7824 is a completely novel, first-in-class, bispecific fusion protein of an avelumab-like antibody linked to two molecules of TGF-beta trap. While very early in the process, I’m happy to report that so far I’m feelin’ alright.
As someone who has received three cycles of chemotherapy and a total radiation dose of 70 Gray over seven weeks, I can say with conviction that, so far, being treated with an immunotherapy agent has been a proverbial walk in the park. In fact, if it weren’t for the fact that this clinical study is not placebo controlled, I would seriously question whether or not I was in the active arm of the study.
For example, in contrast to chemotherapy and radiation, I haven’t experienced any of the hallmarks of traditional cancer therapy, such as nausea or fatigue, with the experimental immunotherapy agent. Important to note, however, every drug has side effects and checkpoint inhibitors like M7824 are associated with their own unique spectrum of immune-related adverse events. These include dermatologic, gastrointestinal, hepatic, endocrine, and other less common inflammatory events. In some cases, these side effects can be managed with corticosteroids or diphenhydramine. Less frequently, clearly defined autoimmune systemic diseases, such as lupus, have been reported.
In fact, approximately 30-40% of patients treated with approved PD-1/PD-L1 checkpoint inhibitors (nivolumab/pembrolizumab) will have dermatologic complications. For most patients, dermatologic toxicity is the earliest immune-related adverse event experienced, with onset an average of 3.6 weeks after treatment initiation¹. Accordingly, it may be too early for me to be experiencing any such side effects.
Of course, having a “safe” drug is important – but for me, the real hope is that M7824 is effective in treating my recurrent disease. In this regard, in an interview with EP Vantage earlier this month, Luciano Rossetti, Merck KGaA’s head of R&D, told EP Vantage that M7824 is “the most exciting clinical asset in our pipeline right now” adding that it has yielded “spectacular” early data. You can read the full interview by clicking here.
I remain hopeful and strongly believe that my generation could be among the last to experience toxic upfront treatments like chemotherapy and radiation thanks to the many advances being made with immunotherapy.
It’s that time of year again; where we get together with family and friends to celebrate the Thanksgiving holiday. It is also a time for reflection and appreciation, which has even greater meaning for me this year.
It was the day before the Thanksgiving holiday in 2015 when I first discovered a suspicious lump protruding from the right side of my neck. The formal diagnosis of Stage IV oropharyngeal cancer would occur several weeks later, but I knew at the time that the palpable growth just below my jaw line was anything but benign.
As a senior executive working in the field of biotechnology, and in particular the area of oncology, being diagnosed with cancer was difficult – but hearing “Stage 4” was especially disheartening. While staging systems are specific for each type of cancer, in general the cancer stage refers to the size and extent of the disease and is assigned a number from 1 to 4. If my cancer was confined to the right tonsil (where it started…) and hadn’t spread elsewhere, I would have been diagnosed with Stage 1 disease. Localized spreading would have been Stage 2 and depending on the extent of involvement of nearby lymph nodes – progress to Stage 3. When cancer has metastasized, or spread to other organs or throughout the body, it can be classified as Stage 4 and may also be called advanced or metastatic cancer. Stage 4 usually carries a grim prognosis compared to earlier stages of the disease.
Accordingly, when one is diagnosed with Stage 4 cancer, the immediate concern is whether or not the individual will be able to survive the disease. For me, however, the bigger concern was surviving the treatments and their side effects. In particular, my experience licensing and launching a product to treat oral mucositis made me very familiar with this debilitating side effect from both radiation and chemotherapy.
When reviewing treatment options with Dr. David Pfister, my medical oncologist at Memorial Sloan-Kettering Cancer Center (MSKCC), I was really hoping that I would be a candidate for recent advances, such as biologic agents and immunotherapies. This was due to my familiarity with their targeted and less toxic profiles, especially when compared with chemotherapy and radiation. In fact, back in early April 2010 I published a 150-page industry report titled “Cancer Vaccine Therapies: Failures and Future Opportunities” and later that year held the inaugural “Cancer Immunotherapy: A Long-Awaited Reality” conference that took place at the New York Academy of Medicine in New York. For more information and background on immunotherapy, read “Insight: Training immune system to fight cancer comes of age” by Bill Berkrot of Reuters.
Unfortunately, approved targeted agents like Erbitux® (cetuximab) still require combination with radiation therapy and its associated side effects. Immunotherapies, such as Opdivo® (nivolumab) and Keytruda® (pembrolizumab) were only recently approved by the FDA to treat head and neck cancer, but their initial indications are limited to patients with disease progression during or after chemotherapy. I remain hopeful that use of these and other new agents will expand to newly-diagnosed patients going forward and that ultimately we no longer rely upon chemotherapy or radiation to treat this disease.
Nonetheless, it is encouraging to see two new drugs approved to treat head and neck cancer this year and know that there are options for me in the unfortunate event that my disease returns. In this regard, I was glad to help ring the Nasdaq Stock Market Opening Bell last month to celebrate cancer immunotherapy advances and the one-year listing anniversary of the Loncar Cancer Immunotherapy ETF (Ticker: CNCR). I first met Brad Loncar (@bradloncar on Twitter), Chief Executive Officer of Loncar Investments, at my inaugural cancer immunotherapy conference and he was kind enough to extend me an invitation to the Nasdaq event.
Ultimately, I went through seven weeks of daily radiation and three cycles of chemotherapy at the start of this year, which as actor Michael Douglas was quoted “somehow seemed very accurately mapped to the seven circles of hell.” In 2010, Michael Douglas was also diagnosed with Stage 4 oropharyngeal cancer and went through the same treatment regimen at MSKCC in New York.
So, while this year started off rough (understatement), I am extremely lucky and thankful to have no evidence of cancer following treatment and to finally be free of “most” of the debilitating side effects from therapy. For example, in recent months I have noticed a dramatic improvement in both energy level and saliva output and have started to reverse a 40-pound decline in weight I experienced during and after treatment.
Aside from eternal gratitude for my wife and daughters’ love and support throughout the process, I would like to extend a special thanks to all of the healthcare providers at MSKCC for their superb care. From my “dream team” consisting of medical oncologist Dr. David Pfister, radiation oncologist Dr. Nancy Lee, and surgeon Dr. Benjamin Roman to amazing nurse practitioner Nicole Leonhart and all of the others who cared for me. I wouldn’t be here today without you!
For my family, friends, and colleagues – too numerous to name – thank you again to EVERYONE that helped in some way…the thoughts, emails, prayer chains, food deliveries, financial support, hospital visits, etc. were all greatly appreciated.
My next PET scan is scheduled for early February 2017 and I hope to report that all remains clear around that time.
PS – as a native of Chicago and loyal fan, I am also thankful to have witnessed the Cubs baseball team winning the World Series for the first time in 108 years in 2016! Go Cubs Go!