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GU Cancers 2021 | Trial updates from ASCO GU 2021: SPIRE, NEO-BLADE, P3BEP and SAPROCAN

Alison Birtle, MRCP, FRCR, MD, Lancashire Teaching Hospitals, Preston, UK, shares updates on key clinical trials presented at ASCO GU 2021, including the Phase IIa SPIRE trial (EudraCT: 2015-004062-29), the Phase II NEO-BLADE trial, the Phase III P3BEP trial (NCT02582697) and the Phase II SAPROCAN trial (ISRCTN22566729). The SPIRE trial is investigating the DNA methyltransferase inhibitor, guadecitabine, plus gemcitabine and cisplatin (GC) as a neoadjuvant therapy for patients with bladder cancer. Results of the expansion cohort were presented, which concluded that guadecitabine plus GC and G-CSF has a manageable safety profile and did not compromise radical surgery, radiotherapy or cisplatin dose intensity. The NEO-BADE trial is investigating neoadjuvant nintedanib versus placebo with GC for the treatment of locally advanced muscle invasive bladder cancer (MIBC). The P3BEP trial is investigating accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumors. Finally, the SAPROCAN trial is investigating the Src kinase inhibitor, saracatinib, with docetaxel for the treatment of metastatic castration-resistant prostate cancer. This interview took place during the 2021 Genitourinary Cancers Symposium.

Transcript (edited for clarity)

So, there were two studies that I was involved with that were presented as trials in progress at ASCO GU21 and one of these was in prostate cancer and one of these was in testicular cancer. So, the SPIRE trial is finished its earlier phase, it’s Phase II. And this looks like it’s a positive study, I’m pleased to say. And one of the reasons I’m particularly pleased about this is we’ve done multiple studies adding in another agent to gemcitabine and cisplatin standard chemotherapy...

So, there were two studies that I was involved with that were presented as trials in progress at ASCO GU21 and one of these was in prostate cancer and one of these was in testicular cancer. So, the SPIRE trial is finished its earlier phase, it’s Phase II. And this looks like it’s a positive study, I’m pleased to say. And one of the reasons I’m particularly pleased about this is we’ve done multiple studies adding in another agent to gemcitabine and cisplatin standard chemotherapy. And the concern is always that you might actually compromise your chemotherapy by this triplet. And what we saw actually with SPIRE is that the investigation medical product added in, which is given by a subcutaneous injection, actually seems to both improve efficacy and there were no real issues with additional toxicity, which was fantastic.

So, we’re looking to take this forward into a larger phase study. You remember this time last year at GU 20, my colleague Syed Hussain presented the NEO-BLADE study, which looked at adding nintedanib into gemcitabine-cisplatin chemotherapy neoadjuvantly, which showed a survival advantage. So, we have now got some trials for the first time that are showing an improvement with triplet therapy for standard chemotherapy, which I think is really exciting because, until fairly recent times we’ve never improved survival for patients with bladder cancer over the last 20 years. And obviously in the last year, we’ve had numerous studies looking at immunotherapy, chemotherapy combinations in first-line metastatic disease that have been resoundingly disappointing. So, the standard of care in first-line metastatic disease has remained giving chemotherapy. So, anything we can do in sort of the neoadjuvant setting to improve survival earlier and upfront is fantastic. A bit like giving upfront chemotherapy for high-risk locally advanced prostate cancer from the STAMPEDE data.

The second study that’s a trial in progress is the study from the amazing ANZUP Trial Group. The trials group in Australia, New Zealand goes from strength to strength. If you look at what they’ve presented with leading the world in the PSMA lutetium therapy and the PSMA theranostics studies, it’s outstanding. But my particular interest this time around was in the accelerated BEP study for patients with intermediate and poor prognosis, germ cell tumors. And this is just really looking about how we give BEP and can we give it over a shorter time period safely and with potentially better efficacy? Cause obviously it’s about the doubling time of any of these, the poor prognosis as tumor types in particular. So, this is, I think, is a study that I’m very pleased that we’re involved with and is recruiting very well globally at the moment.

My downside of ASCO GU, very sadly, was the SAPROCAN study. This is looking at adding in another agent, a Src inhibitor, into standard docetaxel chemotherapy. And we’re all looking at combinations with docetaxel. And unfortunately, this study was not positive. And in fact, it looked as though some patients were doing actually better in the group that had placebo in docetaxel. But nevertheless, I’m so proud that we have a variety of trial options to offer our patients because all studies are about improving options, whether that’s improving outcomes or toxicity or health economics for our patients and the default position for any patient should be that we can try and offer them a clinical trial.

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Disclosures

Alison Birtle, MRCP, FRCR, MD, has received research support from Sanofi Aventis, and has participated in advisory boards or provided educational support to Janssen, Astellas, Bayer, Roche, BMS, Pfizer, Sanofi Aventis and MSD.