Approaching ICI Maintenance Therapy in Urothelial Carcinoma

EP: 1.Advanced Urothelial Carcinoma (UC): JAVELIN Bladder 100 Study

Now Viewing

EP: 2.Approaching ICI Maintenance Therapy in Urothelial Carcinoma

EP: 3.Urothelial Carcinoma: Role of ICI in Frontline Maintenance

EP: 4.Role of Chemoimmunotherapy in Frontline Treatment of mUC

EP: 5.Considering Second-Line ICI Therapy for mUC

EP: 6.KEYNOTE-361 Study for Advanced Urothelial Carcinoma

EP: 7.Emerging Data From ASCO GU 2021 in Urothelial Carcinoma

EP: 8.Future of Maintenance Therapy in Urothelial Carcinoma

Petros Grivas, MD, PhD: Are there different characteristics, baseline factors, or previous therapies, that can affect the decision of switch-maintenance avelumab in frontline maintenance therapy in advanced urothelial cancer? The short answer is we do not select the patients based on which chemotherapy regimen they received, response to prior chemotherapy, PD-L1 expression, or other clinical factors.

In my practice, we take all patients who come to us, in terms of patients who achieve response or stable disease to induction chemotherapy. They have no contraindication to immunotherapy; they get avelumab switch maintenance. We performed a different subset analysis, and treatment by subgroup interaction testing, and we saw benefits with avelumab across the board. Obviously, there are different degrees and magnitudes of that benefit, across different subsets of patients, but overall, I would say the benefit appears to be more or less consistent across the board, and I tend to use avelumab maintenance for all patients, as long as the patient received induction chemotherapy, and achieved response or stable disease.

Another big question is whether the practice-changing results of JAVELIN Bladder 100 trial translated to a tangible difference in clinical practice. Did these data change practice, and was this new standard of care adopted in different community oncology practices? We performed an analysis that is illustrated in abstract 407 at the ASCO GU 2021 [American Society of Clinical Oncology Genitourinary Cancers Symposium]. We interviewed oncology providers, physicians, and nurses who have experience in oncology, and asked them the following question: What is their adopted, or standard, clinical in the frontline setting for advanced urothelial cancer? Do they use concurrent chemoimmunotherapy that is not the standard practice, or do they use what I call the JAVELIN regimen, which is induction chemotherapy first—gemcitabine-cisplatin or gemcitabine-carboplatin, for example—followed by switch-maintenance immunotherapy with avelumab, in those who had stable response or stable disease in chemotherapy?

The vast majority of the responders—I think the numbers were between 67% and 70%—reported that they used the new standard of care, based on the JAVELIN Bladder 100 trial, which is chemotherapy alone, followed by switch-maintenance avelumab immunotherapy in those with response or stable disease. When we asked them which factors they took into account in making clinical decisions, the answers we got were overall survival, which is 1 of the most important factors, as well as responses, quality of life, and toxicity. These are important parameters, and we should do more studies like this, pragmatic studies looking at real-world populations. We should identify bias for the implementation of standards of care, and also what factors the providers are taking into account when they discuss decisions in clinical practice with the patient.

We are going to expand this. Obviously, we plan to publish this data, hopefully shedding some light on the adoption of the new standard of care in the frontline setting, based on the JAVELIN trial, in community oncology practices. We hope to understand better the different nuances and factors that providers and patients take into account when they make clinical decisions.

Transcript edited for clarity.