The first post in this series described how real world evidence (RWE) has gained traction in recent years, especially in human oncology, and how RWE holds promise in the veterinary space. This follow-up dives deeper into the ways that RWE is being used in human oncology and where there are parallel opportunities in the veterinary space.
In general, RWE is most useful when researchers define a set of questions and then conduct analyses to answer those questions using real world data. The resulting insights can guide clinical decisions at the point of care or support drug development efforts. Insights from RWE can also be used for discovery and publication in academic journals or for submissions to regulators like the FDA.
RWE and Specific Cohorts
Many of the important uses of RWE come from research questions aimed at characterizing the experience of a specific patient population that receives a treatment of interest.
- For example, this recent study looked at outcomes in melanoma patients who were re-treated with a PD-1 inhibitor drug and showed that patients who benefited from the first round of therapy also benefited from retreatment.
- Another prominent example was the use of RWE to help expand treatment options for male breast cancer. Pfizer had previously received approval for its drug palbociclib (Ibrance) in female breast cancer, but male breast cancer patients had not been included in the supporting clinical trials. Pfizer assembled RWE on male patients who had received palbociclib off-label and submitted that data to the FDA. This submission resulted in an April 2019 FDA approval for label expansion for palbociclib to include male patients.
- In the veterinary space, there may be insufficient data available on outcomes associated with some treatments, and RWE can help to address those gaps. For example, RWE could be used to study cohorts of dogs with transitional cell carcinoma treated with targeted therapies such as trametinib and/or lapatinib to better characterize duration of treatment, tolerability and survival. This is one type of research the FidoCure® team is working on.
RWE and Genomics
When real world datasets contain information about tumor genomic profiles, RWE becomes a powerful tool for understanding genomically-defined subpopulations.
- One such example is an abstract from the recent ASCO (American Society of Clinical Oncology) conference that looked at outcomes for lung cancer patients with a specific type of alteration in the EGFR gene. The data showed that the length of the x19 deletion does not affect outcomes secondary to first-line EGFR TKIs.
- In veterinary oncology, genomic testing data is increasingly available and more targeted therapies are entering use. The most obvious current example is the use of toceranib for the treatment of mast cell tumors, where c-kit mutation status is frequently characterized. In the future, As FidoCure® collects more clinico-genomic data, RWE can be used, for example, to understand outcomes for dogs with HER2 (ERBB2) mutated tumors who receive lapatinib.
RWE and Therapy
In both human and veterinary oncology, real world data captures choices made between different options for treatment doses, combinations, and sequences. RWE studies comparing different real world treatment options can provide valuable information to clinicians.
- This recent study investigated a cohort of prostate cancer patients in which two types of therapies were given either concurrently or sequentially and described their outcomes. Similar approaches can also be used to study different dosing options available for a treatment of interest.
- In cases where dogs receive a nonstandard combination of cancer drugs, real world veterinary data can be used to study tolerability and outcomes for a specific combination.
- RWE becomes exceedingly important in veterinary oncology, where funded clinical trials evaluating the different combinations or sequences of therapy is often not feasible
RWE and Veterinary Medicine
One of the largest and most ambitious canine health studies ever designed is the Golden Retriever Lifetime Study, which follows over 3,000 dogs throughout their lives, in collaboration with their veterinarians and with families. This project is a shining example of the power of RWE to both answer and generate questions about the nutritional, environmental, lifestyle and genetic risk factors for cancer and other diseases in dogs.
To learn more about the power of RWE in veterinary medicine, please listen to the outstanding webinar by Drs. Rod Page and Kelly Diehl where they discuss the Golden Retriever Lifetime Study and what they have learned and what they hope to learn about canine cancer.
Overall, the current uses of RWE in the human oncology space highlight the potential for RWE to impact veterinary oncology. FidoCure®’s science and research team is hard at work to help realize this potential. We are confident that our data, spanning over 800 dogs with cancer, can lead to exciting discoveries that will advance care and improve outcomes for canine cancer.