GU Cancers Symposium

Long-term data from the phase 3 JAVELIN Bladder 100 trial continued to show an overall survival (OS) boost with frontline avelumab maintenance in patients with metastatic urothelial cancer.

The authors aimed to show that the positive safety/tolerability profile for darolutamide established in nonmetastatic patients also extended to the metastatic setting.

The phase 3 PROpel trial showed that adding the PARP inhibitor olaparib to abiraterone acetate in the frontline setting significantly improved radiographic progression-free survival versus placebo plus abiraterone in patients with metastatic castration-resistant prostate cancer.

“There’s excellent image quality,” said David M. Schuster, MD, “and also the potential for low urinary secretion, which, as we know, is important for imaging prostate cancer.”

“Darolutamide improved overall survival despite a high rate of subsequent life prolonging systemic therapies in the placebo group,” said Matthew R. Smith, MD, PhD, lead author of the phase 3 ARASENS trial.

The phase 3b PRESIDE trial showed that continuing enzalutamide in combination with docetaxel and prednisolone delayed disease progression in patients with metastatic castration-resistant prostate cancer who progressed on enzalutamide alone.

“Not only does a deep PSA response identify patients who will have improved survival and progression-free outcomes, but also it is also associated with maintenance of health-related quality of life, improved patient reported physical wellbeing, and a reduced risk of worsening pain and fatigue intensity,” said Eric Jay Small, MD.

Patients treated with apalutamide achieved a PSA90 response at a 70.4% rate compared with 62.5% of patients who received enzalutamide at the end of the 12-month follow-up.

Findings from the phase 3 MAGNITUDE trial showed that adding niraparib to abiraterone acetate significantly extended radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations.

“I think what we're showing here is that the overall survival benefit, as well as the safety analysis, regardless of the number of comorbidities, was rather significant,” said study coauthor Neal D. Shore, MD.

“[These favorable findings just speak] to the complexity of the health index for these patients,” says Neal D. Shore, MD, FACS.

“It's the first time that any gene expression test has been analyzed in a randomized trial, even if it's post-hoc, in intermediate-risk patients,” says Daniel E. Spratt, MD.

The PHS290 polygenic hazard score is based on 290 genetic variants linked with prostate cancer risk.

In the phase 2 SWOG 1500 study, cabozantinib (Cabometyx) significantly improved progression-free survival versus sunitinib (Sutent) in patients with metastatic papillary renal cell carcinoma.

Darolutamide is currently approved for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

The immunotherapy/TKI combination significantly improved overall survival versus sunitinib.

Papillary renal cell carcinoma (RCC) is a rare malignancy, accounting for 15% of all RCC cases.

“These findings support the importance of genomic testing to identify patients eligible to consider olaparib treatment,” said Johann de Bono, MB CHB, PhD, MSC.

The FDA is scheduled to decide on a new drug application for tivozanib by March 31, 2021, for use in relapsed/refractory renal cell carcinoma.

The multikinase inhibitor showed significant intracranial and extracranial responses in patients with metastatic renal cell carcinoma and brain metastases.

The combination of the anti–PD-1 immunotherapy and the multikinase inhibitor also extended progression-free survival in the phase 3 KEYNOTE-581/CLEAR trial (Study 307).

Safety findings from the final analysis of the phase 3 ARAMIS trial showed that the androgen receptor inhibitor remained well tolerated with longer treatment.

The ongoing trial is enrolling patients at 62 locations in the United States and worldwide.

The treatment was also shown to be safe and tolerable in this patient population.

“Among patients treated with apalutamide, molecular signatures indicative of increased immune activity, decreased vascularization, or decreased proliferative capacity at baseline were each independently associated with long-term response,” reported Felix Y. Feng, MD.

Based on findings from the phase 3 CheckMate 9ER trial, the FDA approved nivolumab/cabozantinib for use in the first-line setting for patients with advanced RCC.

The FDA is scheduled to make a decision on a new drug application for 18F-DCFPyL on or before May 28, 2021.

The FDA recently approved a less-frequent, fixed dose of durvalumab at 1500 mg every 4 weeks for use in patients with metastatic urothelial carcinoma.

After adjusting for crossover using a preplanned sensitivity analysis, investigators for the pivotal phase 3 TITAN trial found a 48% reduction in the risk of death in patients treated with apalutamide plus ADT versus ADT alone.

The antibody-drug conjugate was previously granted an accelerated approval by the FDA in this setting based on results from the phase 2 EV-201 trial.