Patient-centricity is the key to more successful research and adoption of new treatments.

ASCO’s 2023 Annual Meeting drew oncology professionals from around the world to learn about new clinical advances in cancer research, gain real-time insights from world-renowned experts and connect with one of the largest, most diverse audiences in global oncology. Peer-to-peer interaction is the most exciting aspect of these meetings for many attendees, and is extremely valuable in progressing research. The theme of this year’s meeting –“Partnering With Patients: The Cornerstone of Cancer Care and Research” was a reminder that interaction with patients who participate in clinical trials is just as important. They are actually the most important partners in research, and it is their participation that has made virtually all progress in cancer care or the last 50+ years possible.

Patient centricity has long been a buzz-word in the clinical trial community, but the concept is slowly beginning to take hold. It’s a re-setting of goals beyond collecting data from “subjects,” to the intentional inclusion of the real-world needs of patients and their caregivers. The pandemic actually helped to move the needle when it forced creative solutions that ultimately reduced patient burdens connected to clinical studies. Remote monitoring, allowing patients to get lab work at locations closer to home and even shipping drugs to patients homes are now finding their way into standard trial practice.

While these logistical improvements are beneficial, we still have a long way to go to making patients true partners in clinical research, and ASCO 2023 president Eric P. Winer, set a challenge to “,,, unequivocally recommit ourselves to patients . . . Better, more equitable and engaged cancer care hinges on forging deeper, more meaningful relationships between oncology clinicians and the people we care for.”

When everyone from trial designers to those who review and analyze data recognizes the value of this approach, both the efficiency and effectiveness of trials will be improved. Costs will be reduced and lessons learned will be more quickly translated into clinical practice. CROs who innovate and evolve in guiding studies to serve the greater healthcare community and patients in all parts of the world will play a large part in this transformation. At George Clinical it has always been our mission to improve the quality of life and the access to the best treatments for all people regardless of their demographic or economic background, and this mission drives the way we approach clinical trials. 

Along with the discussions about re-committing to patients that were woven throughout ASCO 2023 meetings, there were many exciting presentations on the latest cancer treatment research. Those that promise major shifts in cancer treatment were particularly noteworthy. 

 

mRNA moves beyond COVID-19 to personalized cancer vaccines.

Cancer vaccines are poised on a new era with the data from the Merck/Moderna study of the mRNA-4157 vaccine in conjunction with Merck’s Keytruda showing a reduced risk of distant metastasis or death by 65% in stage III & IV melanoma patients. It’s another positive by-product of the pandemic, which proved that the mRNA technology used to create COVID-19 vaccines was safe and effective. That opened the door for the greater possibility of personalized vaccines that train the immune system to attack a specific type of cancer cells in tumors. 

Cancer vaccines actually refers to vaccines that will help prevent cancer from returning after initial treatment. While the COVID-19 vaccine used a string of mRNA encoding to prevent the disease from occurring, cancer vaccines hold mRNA that encodes for proteins found on the vaccine recipient’s cancer cells. Specifically, they are neoantigens — proteins that are made because of mutations in the cancer cells’ DNA. The vaccine stimulates immune cells like T cells to attack the neoantigens and therefore the cancer.

Cancer vaccines can be personalized to each individual patient and produced in as little as eight weeks after a person’s cancer is biopsied. They promise a generation of cancer therapies that would be a new paradigm in treatment. The Merk/Moderna collaboration is one of many investigating this technology, and it is only a matter of time before these breakthroughs find their way into clinical practice. The hope is that soon there will be a cancer vaccine for almost any type of patient.

 

Research continues to reach for paradigm shifts in breast cancer.

Approximately one-third of those diagnosed with stage II, and more than half of those diagnosed with stage III HR+/HER2- EBC, experience cancer recurrence. Patients who have responded to treatment live with the constant underlying fear that their cancer will return. Researchers have been dedicated to finding treatments designed to keep that from happening, but there have been limited advancements in reducing that risk while maintaining quality of life for patients diagnosed with early breast cancer.

Data presented from the Novartis Phase III NATALEE trial at ASCO 2023 showed that Kisqali® (ribociclib) plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.2% in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (HR=0.748; 95% CI: 0.618, 0.906; p=0.0014), along with a consistent and clinically meaningful invasive disease-free survival benefit across key pre-specified subgroups.

These are extremely encouraging results that could fundamentally change the way we treat patients with stage II and III HR+/HER2- early breast cancer — giving them a well-tolerated option for a healthier future.  NATALEE creates the possibility to keep a broad population of patients cancer-free without the negative side effects that can disrupt the quality of so many cancer patients’ daily lives.

The NATALEE presentation was close to the heart of attending George Clinical team members, as we were partners in the study for the Chinese portion of the trial. We are proud to have been a part of this study and to have achieved a record-breaking recruitment rate for China and a lower screen fail rate compared to the rest of the sites in the world. We shared the same goal as our partners in the study of conducting clinical trials that could ultimately make a fundamental difference and improve the lives of patients.