An 'exceedingly low' percentage of patients with cancer enroll in clinical trials as the first course of therapy, according to results of a study conducted at Penn State College of Medicine and published in Journal of the National Comprehensive Cancer Network.
"There just aren't that many clinical trials available for patients when they're first diagnosed with cancer," Nicholas G. Zaorsky, MD, assistant professor of radiation oncology at Penn State College of Medicine, said in an interview.
The news comes at the same time as many new and potentially effective cancer treatments are emerging. One company leading the way is Oncolytics Biotech Inc., (a development stage biotech company developing an immuno-oncology virus (called pelareorep). Pelareorep is a safe and well-tolerated treatment that has the potential to kill cancer cells. It is being studied now for potential combination with Opdivo from Bristol-Myers Squibb Company, Roche's Tecentriq, Pfizer's and Merck's KGaA's Bavencio, as well as Keytruda from Merck & Co. Inc.
New Methods Emerging Quickly
Cancer grows in our bodies when our immune systems do not recognize tumors as foreign or a threat. The cancer tells the immune system and T cells to leave the tumor alone instead of directly attacking it. Immunotherapies – which includes checkpoint inhibitors – encourage our immune systems to recognize and kill cancer. But as low as 1 in 5 patients respond to checkpoint inhibitors.
That's where pelareorep comes in. Pelareorep has the potential ability to increase the percentage of patients who respond to immunotherapy. Pelareorep comes with compelling metastatic breast cancer survival data.
The primary objective of Oncolytics is to obtain regulatory approval for pelareorep as quickly as possible. The company's secondary objective is to expand pelareorep into commercially valuable new treatment areas with pharmaceutical partners.
Oncolytics has established a successful partnership with Adlai Nortye in China, Hong Kong, Macau, Singapore, South Korea, and Taiwan. As per the relationship, there is involved upfront and milestone payments of up to $86.6 million, with $65 million tied to potential development expansion.
Trials Are Needed to Make the Systems Work
In the meantime, the medical industry continues to pursue new trials of cancer treatments.
"There may be trials available for patients whose disease comes back, but not as many for patients just diagnosed. For the trials that do exist, there are some preferences for the patients who will be enrolled," said Dr. Nicholas G. Zaorsky (pictured above) from Penn State.
Overall, less than 5% of eligible adults participate in cancer clinical trials. In the retrospective cohort study, Zaorsky and colleagues gathered demographic and clinical information from the National Cancer Database on more than 12 million patients with 4 to 6 types of cancer between 2004 and 2015. They found that among these patients, only 11,577 (0.1%) participated in clinical trials as their first course of cancer therapy after diagnosis.
A greater proportion of trial participants vs. nonparticipants were white (88% vs. 84.8%), had metastatic disease (30.9% vs. 16.4%), had private/managed care insurance (56.4% vs. 41.8%) and had fewer comorbidities (Charlson-Deyo score 0, 81.9% vs. 75.7%). Univariate and stratified analyses showed patients with cancer who participated in clinical trials also had longer median OS (60 vs. 52.5 months; HR = 0.876; 95% CI, 0.845-0.907) than those not enrolled in a trial.
Zaorsky spoke about the need to make trials more inclusive, the importance of removing patient barriers and the lifesaving potential of clinical trial participation as a first intervention.
So, how does the United States compare with other countries in clinical trial accrual? According to the data, clinical trial accrual in the U.S. is very low among patients with cancer compared with other developed countries. There are some areas in Europe where, for certain cancers, accrual is in the teens, 20s or 30s. So overall, as a nation, the doctors thinks we could be doing better.
For biotech and pharma companies offering trials, the potential for new and potentially blockbuster treatments is significant. Major companies capable of playing a major role include:
Merck & Co. offers therapeutic and preventive agents to treat cardiovascular, type 2 diabetes, chronic hepatitis C virus, HIV-1 infection, intra-abdominal, fungal infection, insomnia, and inflammatory diseases; neuromuscular blocking agents; cholesterol modifying medicines; and anti-bacterial and vaginal contraceptive products. Merck recently disclosed an exclusive worldwide research collaboration and license agreement with Taiho Pharmaceutical Co, Ltd., and Astex Pharmaceuticals) focused on the development of small molecule inhibitors against several drug targets, including the KRAS oncogene, which are currently being investigated for the treatment of cancer.
Pfizer Inc. develops, manufactures, and sells healthcare products worldwide. It offers medicines and vaccines in various therapeutic areas, including internal medicine, vaccines, oncology, inflammation and immunology, and rare diseases. The company also provides over-the-counter medicines. Pfizer just announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for RUXIENCE™ (rituximab). RUXIENCE is a monoclonal antibody (mAb) for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).
Roche Holding AG engages in the diagnostics and prescription pharmaceuticals businesses in Switzerland, Germany, and internationally. Roche Holding AG made its second major gene therapy deal in a year recently, disclosing that it is spending $1.15 billion to obtain the rights to Sarepta Therapeutics Inc's investigational drug to treat duchenne muscular dystrophy (DMD) outside the United States.
For a more about biotech trends in diagnostics and the companies delivering new solutions, view the report at USA News Group: https://usanewsgroup.com/2020/02/24/why-biotechnology-companies-are-so-important/
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Study: Few cancer patients pursue trials. Appl Rad Oncol.