Alice Donnelly, vice president, global project management, hematology/oncology, recaps discussions from ESMO 2019.
The leading global minds in oncology recently met in Barcelona, Spain, to focus on the development of better therapies for patients with cancer. The European Society for Medical Oncology (ESMO) 2019 conference provided an inspiring look into the future of oncology treatments and innovative therapies. Throughout the four-day conference, promising successes were shared including: new applications for T-cell therapy, the acceleration of rare disease trials, and innovations for NSCLC and ovarian cancer and breast cancer, among others.
During ESMO, we were engaged with the global oncology community to adapt scientific findings that lead to the creation of therapies for patients who need them most. Here are a few of the top takeaways from ESMO 2019 that are poised for impact.
Promise of Cellular Immunotherapy to Treat Solid Tumors
Adoptive T-cell therapies have been pursued to target liquid tumors for some time. This treatment modality holds real promise for patients and is being encouraged by both the US FDA and EMA, as most recently evidenced by the EMA giving priority designation to Carsgen’s CAR-T therapy.1
It was promising to hear that T-cell therapy is being explored further in the treatment of solid tumors. This may be a reality soon and is on the horizon for patients. Some early phase trials are showing promise in validating therapeutic targets and many in the oncology community are hopeful that we will see progress in these areas in the years to come.2
The Need for Cross-Departmental Communication
As this new area of immunotherapy advances, we as CROs have a key role to play in trial and protocol design and study execution. For example, at many large academic sites, solid and liquid tumors are often treated in different departments. While hematologists may be familiar with their apheresis departments, this is likely new territory for physicians treating patients with solid tumors. CROs can play a role in liaising across departments to ensure that sample collection and cellular handling and administration processes are well documented and clearly understood through extensive training, clear communication and precise tracking, all critical elements in the successful conduct of a cell therapy trial.
Beyond Randomization: Augmenting Trial Data to Match a Rare Disease Approach
As we better understand the genetic profiles of targeted cancers, the approach to several oncology studies look more like the pathway taken for a rare disease trial.
In a particularly interesting session “Is randomization of clinical trials still the gold standard?”,3 this clinical trial best practice was reassessed and compared to non-randomized controlled clinical trials to examine new opportunities beyond the limitations of the current randomization model. Limitations include focus on a single endpoint, cost, complexity, duration and the inability to easily detect rare treatment effects due to insufficient information.
Through our clinical trial work, we know the methods to generate the evidence needed to approve new treatments can lag behind the rapid scientific progress and innovation made to provide patients with fast access to new treatments. The ESMO session explored using a single-arm trial as a necessary and adequate first step for rare cancers. This new approach could create better alignment between scientific innovation and delivery of newly approved therapies for patients in a reasonable amount of time. However, it should be followed by efforts within a reasonable timeframe to demonstrate a level of evidence comparable to more common cancers, with the support of randomized clinical trials and real-world evidence.
All told, while a randomized study is still the most ideal approach to clinical trials, there are discussions about using more efficient ways to gather much needed data to help bring new therapies to market. In our clinical trial work with partners, we guide them toward a collaborative approach to help understand the validity of new methods and types of evidence to complement and augment randomized clinical trials.
Patient Reported Outcomes Improve Care
During clinical trials, the importance of sharing data between patients and clinicians is crucial. One of the ESMO presentations about patient reported outcomes (PRO), looked at the use of PRO reports to optimize care in real time both right before and between clinic visits. This is important because in a clinical trial context, symptom reports can be inaccurate when using traditional methods. To improve the critical role of feedback in the trial process, this new approach asked patients to report their own toxicity. It was shown that, when clinicians see patient’s symptom reports, there is in a high percentage of agreement (85% to 95% depending on the symptom). Results from a previous clinical trial (single center STAR study, stratified for tumor type) showed how PRO can improve cancer care and patient outcomes. Specifically, online reporting was shown to help cancer patients live longer. This is likely due to faster communication between patient and clinician and more efficient care team response time to those issues.
As an industry, we focus on helping our clients achieve improved patient outcomes. While the legitimacy of PROs is widely accepted and tracking improves outcomes, there are remaining challenges. It will be essential to integrate these processes into clinician workflow and avoid the proliferation of different systems and disjointed apps to decrease complexity.
ESMO 2019 engaged a global audience of oncology clinicians, scientists and journalists around one goal: improving patient outcomes. We left Barcelona inspired by innovations in science with a wide-range of new and adapted applications for oncology clinical trials. Moreover, we departed as a global force of innovation set out to help develop targeted therapies and help expand access for patients.
- Melão, Alive. “Carsgen’s CAR-T Cell Therapy Given Priority Designation in Europe for Multiple Myeloma.” Myeloma Research News, 25 Sept. 2019, https://myelomaresearchnews.com/2019/09/25/carsgen-car-t-cell-therapy-ct053-receives-ema-prime-status/.
- “’Living’” anticancer medicines: has a new era started?” Daily Reporter, ESMO Congress.
- Banerji, Udai et al. “Is randomisation of clinical trials still the gold standard?” Multidisciplinary session. ESMO 2019. https://cslide.ctimeetingtech.com/esmo2019/attendee/confcal/show/session/31