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GU Cancers 2021 | JAVELIN Bladder 100: avelumab shows OS benefit for bladder cancer

Petros Grivas, MD, PhD, Seattle Cancer Care Alliance, Seattle, WA, shares an update on the Phase III randomized JAVELIN Bladder 100 trial (NCT02603432) investigating avelumab plus best supportive care in patients with locally advanced or metastatic urothelial cancer. Dr Grivas reports that the trial showed an overall survival (OS) benefit in all participants, with an even greater benefit in participants with high PD-L1 expression, and a manageable toxicity profile. Subset analysis found that the benefits from avelumab therapy were independent of the duration of prior chemotherapy and the number of prior chemotherapy cycles. This interview took place during the 2021 Genitourinary Cancers Symposium.

Transcript (edited for clarity)

We are all super excited for the JAVELIN Bladder 100 trial. Just to remind the audience, this was a practice-changing trial that Professor Powles presented at the ASCO 2020 virtual meeting as a plenary session; and subsequently, the paper was published in the New England Journal of Medicine on September 18, 2020, resulting in the change in guidelines in NCCN and US, and European guidelines, and subsequent approval by European Medicine Agency a few weeks ago, and the FDA had approved this approach on the end of June 2020...

We are all super excited for the JAVELIN Bladder 100 trial. Just to remind the audience, this was a practice-changing trial that Professor Powles presented at the ASCO 2020 virtual meeting as a plenary session; and subsequently, the paper was published in the New England Journal of Medicine on September 18, 2020, resulting in the change in guidelines in NCCN and US, and European guidelines, and subsequent approval by European Medicine Agency a few weeks ago, and the FDA had approved this approach on the end of June 2020. This was a Phase III randomized clinical trial with switch maintenance avelumab plus best supportive care versus best supportive care alone, in patients who had achieved a response or stable disease to induction platinum-based chemotherapy in the frontline setting.

So, there was a frontline switch maintenance therapy trial evaluating again, avelumab as a single agent plus best supportive care, or best supportive care alone, in those with no progression on prior induction chemotherapy. The trial have shown overall survival benefit, hazard ratio 0.69, in all comers regardless of PD-L1 expression. The degree of benefit was even higher in patients with PD-L1 high expression; but because of the robust and significant, statistical and clinical significant benefit with avelumab in all comers, and across different subsets of patients, this agent was approved in everybody who had the response of stable disease in induction chemotherapy.

Many colleagues were asking, is there any difference in the margin to the degree of benefit with avelumab, based on the number of chemotherapy cycles that patients had received before, four or five or six cycles of gem/cis or gem/carbo. So, we evaluated this question and we did a subset analysis, and we showed that the benefit of avelumab was independent and was consistent regardless of the duration of prior chemo and the number of prior chemo cycles. So, four or five or six cycles in all those subgroups of patients. Avelumab appeared to be very significant in terms of overall survival benefit, and the benefit appeared to be consistent.

So, my take on it is the decision about the number of cycles depends on the individual patient level discussion between benefits and risks, having a patient with significant response and benefit with manageable toxicity. This patient I may go up to six cycles. If the patient is struggling with toxicity, neuropathy, fatigue, cytopenias, and has a stable disease, I may stop at four cycles. I think the decision about how many cycles to give of chemo depends on this individual benefit-risk ratio profile for each patient, but our report at ASCO GU 2021 showed that the benefit of avelumab appears to be regardless of the number of prior chemotherapy cycles.

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Disclosures

Petros Grivas, MD, PhD, has received institutional research funding from Bavarian Nordic, Bristol-Myers Squibb, Clovis Oncology, Debiopharm, Immunomedics, Pfizer, Merck, QED Therapeutics, GlaxoSmithKline, Mirati Therapeutics and Kure It Cancer Research; and has participated in consultancy work with AstraZeneca, Dyania Health, EMD Serono, Immunomedics, Infinity Pharmaceuticals, Janssen, Merck, Mirati Therapeutics, Genentech, Pfizer and Seattle Genetics.