At 80 years old, former U.S. Senator Harry M. Reid’s struggle with pancreatic cancer was close to the end. But the ex-boxer and hard-scrabble fighter that he is propelled him to survive despite the extremely low odds: he is now spending time with his adult children and grandchildren. This appreciation for life itself brought him to an eccentric physician, billionaire businessman, and biotech entrepreneur named Dr. Patrick Soon-Shiong. Reid—with his high powered Washington connections—sought out a second opinion consulting Francis Collins, the Director of the National Institute of Health (NIH). Collins cautioned the Ex-Senator that Dr. Soon-Shiong was “unconventional.” Well, perhaps, but so is Reid. The Ex-Senator moved forward with Dr. Soon-Shiong’s novel IV therapy to treat the late-stage pancreatic cancer. What a decision. The pancreatic cancer is now in remission! Upon seeing the results, his oncologist declared, “it must be witchcraft.” Now Mr. Reid spends his time with family—grown children and grandchildren while he frets more about protecting himself against COVID-19 than dying of cancer. Dr. Soon-Shiong pulled off a near miracle, and now his biotech ventures—NantKwest and ImmunityBio—sponsor the same treatment in a Phase II clinical trial addressing pancreatic cancer.
An amazing story, to say the least, reported by several media, including the Washington Post. An exceptional guy, Harry M. Reid, accomplished a lot as an attorney and politician who served as the United States Senator from Nevada from 1987 to 2017. He led the Senate’s Democratic Conference from 2005 to 2017 and was the Senate Majority Leader for nearly a decade from 2007 to 2015.
Hard Scrabble Nevada Life
He didn’t have it easy as a child—no silver spoon here growing up hard-scrabble in Nevada’s outback mining town of Searchlight. Born to a rock miner as a young boy, he lived in a shack with no indoor toilet, hot water, or telephone. Playing football and boxing in Henderson, Nevada toughened Harry up for what would be much later in life, the nasty politics of Washington, DC. Although he went on to earn his J.D. and eventually operate at an apex of power, he didn’t lose his hard-scrabble survival skills when pancreatic cancer struck—and he would need them. According to the Washington Post, by 2018, Reid told the New York times his pancreatic cancer diagnosis was “Your dead.”
Reid was sort of an unorthodox kind of politician himself and was in the middle of plenty of Washingtonian-battles in his day… Although a member of the staunch Republican-leaning LDS community, he often diverged politically at times, bringing tension between himself and some of the LDS faithful. But it was that unconventional and unorthodox point of view that also led him to another unconventional doctor that saved his life with an investigational therapy for pancreatic cancer.
With the results tagged “witchcraft,” Dr. Soon-Shiong’s unconventional IV therapy consists of combination immunotherapy, including aldoxorubicin HCI along with NantKwest’s PD-L1 tumor-targeted natural killer cells and ImmunityBio’s IL-15 superagonist N-803 with the general standard of care.
The Compassionate Use Program
The U.S. Food and Drug Administration approved of Dr. Soon-Shiong’s compassionate-use program, which ultimately included four patients suffering from certain forms of pancreatic, breast, and brain cancers. Or put another way, patients whose time had expired. The patients were treated with PD-L1 t-haNK and N-803 under single patient INDs, with two patients on treatment for an evaluable period. One patient reported ongoing, durable, complete response six months after treatment, and one observed response of stable disease. With some compelling results, the FDA approved the Investigational New Drug (IND) application to proceed with a larger clinical trial. Highlighting that reality, Soon-Shiong noted, “The prognosis for these patients, sadly, is months,” but there was at least a glimmer of hope now.
The Phase 2 Clinical Trial
Now Dr. Soon-Shiong’s ImmunityBio is sponsoring a Phase 2 clinical trial that initiated this month. Perhaps more pancreatic cancer patients can be helped—we hope so here at TrialSite News. Targeting up to 268 patients, the randomized, two-cohort, open-label study evaluates the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with aldoxorubicin HCI, N-803, and PD-L1 t haNK in subjects with locally advanced or metastatic pancreatic cancer. Each treatment (i.e., first-line maintenance, or second or later line) will be evaluated independently as a separate cohort. The study director is Dr. Lenny Sender.
Of course, the hope is that there will be many more comparable stories to the one of Harry Reid. Although the odds are against 100% success, each and every life saved is a victory for the patient and their loved ones; the families and friends that get to spend at least a little more time with someone special. Hence why TrialSite News was formed in the first place. To educate the public and professionals about the importance of clinical trials, the research sites, the processes, and the advances or setbacks—with an emphasis on the clinical investigational site or center. Advanced investigational cancer therapies can and do extend lives. Miracles, or “witchcraft” can happen.
Leonard S. Sender, MD, Senior Vice President of Medical Affairs for Pediatric, Adolescent, and Young Adult Oncology.
Call to Action: Do you have a loved one with pancreatic cancer? Consider consulting with your oncologist about Dr. Soon-Shiong’s approach. The contact for the study is here.