ESMO Annual Congress

Combining the antibody-drug conjugates sacituzumab govitecan and enfortumab vedotin was safe, feasible, and produced high and early response rates in patients with treatment-resistant metastatic urothelial cancer.

The combination of oral masofaniten (formerly EPI-7386) and enzalutamide was well tolerated and elicited durable reductions in PSA levels in patients with metastatic castration-resistant prostate cancer.

"The main highlight of this trial was the complete response rate, which was around 22%," says , Guru P. Sonpavde, MD.

"The surprise to me was the grade 3/4 adverse events [were] better with 177Lu-PSMA-617, SAEs [were] better with 177Lu-PSMA-617, and dose adjustments [were] better with 177Lu-PSMA-617," says Oliver Sartor, MD.

At the time of data cutoff, 16 patients in cohort 1 and 27 patients in cohort 3 had been treated with TAR-210, an intravesical delivery system for erdafitinib.

"With this specific study, what we wanted to do is find out whether there was more information that we could leverage from preexisting material within the STRATOSPHere Biomarker Development Study; namely, the diagnostic H&E sample," says Charles Parker, MD.

ARX517, a PSMA­-targeting antibody-drug conjugate, demonstrated favorable efficacy and safety in a phase 1/2 trial in patients with metastatic castration-resistant prostate cancer.

Toni K. Choueiri, MD, highlights data from the phase 2 LITESPARK-003 trial, which were presented at the 2023 ESMO Congress.

Data showed a 20% reduced risk of recurrence or death among patients who received everolimus compared with placebo.

"TAR-210 is set to become a potentially new option for this patient population after failure of BCG treatment," says Andrea Necchi, MD.

“There’s a 72% less chance of recurrence with oral erdafitinib than with standard of care. The problem is tolerability,” says James W.F. Catto, PhD, FRCS.

“In other words, there's a 72% less chance of recurrence with oral erdafitinib than with standard of care. The problem is tolerability,” says James W.F. Catto, PhD, FRCS.

“The recommended phase 2 dose was dose level 2, so 8 mg/kg of SG with EV 1.25mg/kg,” says Bradley McGregor, MD.

Treatment with the intravesical chemotherapy delivery system TAR-200 led to complete responses in over three-fourths of patients with BCG-unresponsive, high-risk non–muscle-invasive bladder cancer.

“We have not previously managed to beat first-line chemotherapy in any trial in unselected first-line urothelial cancer, so this is a big step in that direction,” says Thomas B. Powles, MBBS, MRCP, MD.

“These data from the MAGNITUDE study demonstrate the risk-benefit profile for the combination of niraparib plus abiraterone acetate for patients with metastatic CRPC and BRCA mutations and establishes a new standard of care for these patients,” says Kim Nguyen N. Chi, MD, FRCPC.

“No doubt about it, this is unequivocally a positive trial by the rPFS criteria. Quite positive,” says A. Oliver Sartor, MD.

A post hoc analysis from the phase 3 CLEAR trial showed that frontline lenvatinib plus pembrolizumab elicited improved tumor response vs sunitinib across subgroups of patients with clear cell renal cell carcinoma.

“This is the first time [in urothelial carcinoma] we've managed to beat chemotherapy in the first-line setting for overall survival,” said Thomas B. Powles, MBBS, MRCP, MD.

Frontline therapy with nivolumab plus gemcitabine-cisplatin, followed by nivolumab maintenance, led to improved overall and progress-free survival in patients with unresectable or metastatic urothelial carcinoma.

Adding niraparib to abiraterone acetate and prednisone (AAP) was associated with an overall survival benefit compared with AAP alone in patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer.

“Belzutifan demonstrated a significant improvement in PFS with a hazard ratio of .75, and a significant P value. Similar findings were noted at the second interim analysis with a hazard ratio of .74,” says Laurence Albiges, MD, PhD.

“Future studies should focus on patient selection and the identification of positive predictive markers of response, more so than treating all comers, which several studies have shown has not really worked here or they acknowledge it,” says Julie N. Graff, MD.

“Belzutifan plus cabozantinib continue to show durable anti-tumor activity in patients with clear cell RCC who are treatment naïve or previously treated,” said Toni K. Choueiri, MD.

Data from the study showed a median PSA-PFS of 13 months with the combination therapy compared with 7.8 months with enzalutamide alone.

The phase 3 PRESTO trial had 3 arms: ADT alone; ADT plus apalutamide; and ADT plus apalutamide plus abiraterone/prednisone.

“These data do suggest that [enfortumab vedotin-ejfv (Padcev) and pembrolizumab (Keytruda)] is a viable treatment option for cisplatin-ineligible patients,” says Jonathan E. Rosenberg, MD.

“There were no serious skin events that occurred on this study, which I think is a credit to the study team that worked with the investigators to manage the manage the toxicity and prevent serious skin reactions,” says Jonathan E. Rosenberg, MD.

"When the blood tests were positive, workups were typically completed in less than 3 months. I think this is really a new concept. It shows it is feasible to detect cancers using blood tests," said Deb Schrag, MD, MPH.

“Responses occurred across all International mRCC Database Consortium risk groups—both in the favorable and intermediate/poor risk groups,” said Jamie R. Merchan, MD.