Petros Grivas, MD, PhD, reviews data from recent subgroup analyses for the JAVELIN Bladder 100 study for advanced urothelial carcinoma from the 2021 ASCO GU Virtual Symposium.
Petros Grivas, MD, PhD: We are very excited to present data at the ASCO GU [American Society of Clinical Oncology Genitourinary Cancers Symposium] 2021 on the JAVELIN Bladder 100 trial. The questions that are being posed are: What are the updates? What are the main points of the subset analysis? Our colleagues from Japan did a very nice job presenting the data in the Japanese cohort of patients, and this is relevant because you have potential differences in ethnic groups, which is always important to look at when we are conducting research in the context of inclusion and equitable health care.
The main takeaway point from the Japanese subset analysis is that the benefit of avelumab appears to be consistent across the board, even in different subsets of patients. In the patients from Japan, there was a similar finding, that the benefit with avelumab as switch maintenance therapy in patients who have achieved response, or stable disease, after induction of the therapy, is significant and consistent across different subgroups. This was corroborated by the Japanese subset analysis. The take-home points for the practicing clinician are there; if you have a patient you are treating in the frontline setting with advanced urothelial cancer, whom you advise to do chemotherapy—whether it is gemcitabine-cisplatin or gemcitabine-carboplatin, depending on starting fitness—and the patient achieves response or stable disease, then there is level 1 evidence that maintenance immunotherapy with avelumab would be useful, based on the data from the JAVELIN Bladder 100 trial. This signal and evidence were consistent across different subsets of patients.
Another question was posed: Does the number of cycles, and the duration, of induction platinum-based chemotherapy matter in terms of the benefit of avelumab as switch maintenance therapy in advanced urothelial cancer? We performed a subset analysis, based on the JAVELIN Bladder 100 trial, and Dr Yohann Loriot presented the data at ASCO GU. The subset analysis tried to evaluate the overall survival and PFS [progression-free survival] benefit with avelumab, depending on the number of pretrial chemotherapy cycles. People underwent gemcitabine-cisplatin or gemcitabine-carboplatin before the trial, and if they had achieved a response, or stable disease, they went on to the JAVELIN Bladder 100 trial.
Based on the subset analysis, it appears that the benefit with avelumab as switch maintenance immunotherapy was significant, regardless of the number of cycles that patients had received before they start avelumab. Patients may have received 4, 5, or 6 cycles. Regardless of this number, the benefit with avelumab appears to be consistent across the different subsets of patients. If you ask me, in clinical practice, if I would give 4, 5, or 6 cycles, my answer is simple. This decision is being made before maintenance starts, and it depends on the risk-to-benefit ratio for each patient. For example, if a patient is deriving significant benefit from induction chemotherapy, does not have any major toxicity, and can get through chemotherapy OK, then I try to push for to 6 cycles. On the other hand, if a patient is having significant toxicity and is not benefiting much on chemotherapy, maybe this counts as stable disease. For this patient I may stop at 4 cycles. It is an individually based decision, and I tend to restage a certain percentage of patients after 3 cycles. Then I decide, based on beneficial risks, how many cycles I give.
Transcript edited for clarity.