Chaired by Prof. Axel Merseburger (DE), Prof. Karim Fizazi (FR) and Prof. Valerie Fonteyne (BE), the game-changing session on day three of EMUC23 was a wrap-up of what has been an exciting year for genitourinary cancer treatment trials.
Urologist Ms. Maxine Tran (GB) delivered a presentation on ‘Nephron Sparing Treatment (NEST) for small renal masses’, a feasibility study of a cohort embedded randomised controlled trial comparing nephron sparing treatment for small renal masses.
Ms. Tran stated that feasibility of the trial was demonstrated, intervention was acceptable (85%), there were fewer complications, less reduction in renal function, reduced hospital stays, decrease in costs, and intervention showed equivalent cancer control.
In his presentation, ‘Update on PSMA targeting’, Dr. Andrea Farolfi (IT) shared results and comparisons of the PSMAfore (phase 3) and ENZA-p (phase 2) trials.
Dr. Farolfi: “PSMA-targeted radioligand therapy (RLT) is gaining momentum globally and there are new trials coming. Lutetium PSMA is quite active in this taxane-naïve metastatic castration-resistant prostate cancer (CRPC) space, and was extremely well tolerated. We have a new therapy that eventually, when regulators approve, will be available for patients in this space.”
“We do not need to sacrifice the quality of life (QoL) for oncological benefits. Enzalutamide combination and enzalutamide monotherapy do not negatively affect health-related quality of life (HRQoL),” stated Prof. Stephen Freedland (US) in his presentation on the EMBARK trial.
According to Prof. Freedland, in patients with high-risk biochemical recurrence (BCR) compared with leuprolide acetate, the enzalutamide combination demonstrated a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) (HR 0.42; 95% CI, 0.30-61; P<0.0001).
“Enzalutamide monotherapy also demonstrated statistically significant and clinically meaningful improvements in MFS (HR 0.63; 95%, CI 0.46-0.87; P=0.0049), time to PSA progression, and time to the first new antineoplastic therapy. No new safety signals observed to date with enzalutamide treatment”.
“Enzalutamide in combination with androgen deprivation therapy (ADT), if approved in this setting, has the potential to become a new standard of care for patients with high-risk BCR (biochemical recurrence).”
In her lecture, ‘Update on TALAPRO and PROpel’, medical oncologist Dr. Friederike Schlürmann (FR) shared a summary of game-changing improvements in overall survival (OS) over the years with the addition of PARPi to ADT+ARSI (androgen receptor signalling agent) in metastatic castration-resistant prostate cancer (mCRPC).
Dr. Schlürmann: “The TALAPRO and PROpel trials show clinical benefit beyond HRRm, and all trials support activity for PARPi + NHA in HRRm/BRCAm mCRPC. There must be caution with cross-trial comparison and differences in the study designs, populations and dosing schedules between trials may provide considerations for the differences seen between trials.”
On the topic of testing, Dr. Schlürmann stressed that somatic testing for BRCA1/2 has to become the standard of care in PCa.
Great news for BCa patients
Prof. Tom Powles (GB) was beamed in from America to deliver a presentation on the EVO-302/KEYNOTE-A39 trial. “This is the first time that platinum-based chemotherapy has been surpassed in OS in patients with previously untreated locally advanced/metastatic urothelial carcinoma (la/mUC). The overall results support enfortumab vedotin plus pembrolizumab (EV+P) as a potential new standard of care for 1L la/mUC.”
According to Prof. Powles, EV+P showed statistically significant and clinically meaningful improvement in efficacy over chemotherapy with a progression-free survival (PFS) of HR 0.45 and OS was 0.47%. Median PFS (mPFS) and median OS (mOS) were nearly doubled in the EV+P arm compared with chemotherapy. The benefit in prespecified subgroups and stratification factors were consistent with the overall population. The safety profile aligned with expectations and no new safety signals observed. EV treatment-related adverse events of note were skin reactions, peripheral neuropathy and sensory events.
Dr. Yohann Loriot (FR) presented on the THOR trial, stating that in the trial that erdafitnib significantly extended the OS in patients with advanced/mUC with FGFRalt after prior treatment with anti-PD-(1), with a mOS of 1 year.
According to Dr. Loriot, erdafitnib provided a 36% reduction in risk of death compared to chemotherapy, the OS benefit of erdafitnib was consistent across the relevant subgroups, and it offered significantly longer PFS and greater objective response rate (ORR) compared to chemotherapy.
Dr. Loriot: “This phase 3 THOR study supports the clinical efficacy of erdafitnib as the standard of care option for patients with mUC with FGFRalt after anti-PD-(L) 1 treatment, and the OS benefit of erdafitnib in patients with mUC with FGFRalt supports molecular testing for FGFRalt in all patients with mUC”.
You can watch a webcast recording of the full presentations on the EMUC23 Resource Centre.