Overall survival and progression-free survival of subgroups with avelumab first-line maintenance for advanced urothelial carcinoma

A recent study suggests that avelumab maintenance treatment was found to help advanced urothelial carcinoma (UC) patients who did not show disease progression after having at least four cycles of prior chemotherapy and were on maintenance treatment at least 4 weeks after the chemotherapy, to live longer. This study was published in the journal, European Urology.

The JAVELIN Bladder 100 was a phase 3 trial in which 700 patients with advanced UC were included who did not show disease progression after 4-6 cycles of chemotherapy. They were randomized to receive either avelumab + Best Supportive Care (BSC) or BSC alone. Subgroups were defined according to quartile duration (Q), estimated chemotherapy cycles, and the interval between maintenance and chemotherapy. The duration of median follow-up in both arms was >19 mo. The primary endpoint of the study was overall survival (OS); additionally, progression-free survival (PFS) and safety were also assessed.

After the study was over, it was observed that the hazard ratio for OS with avelumab + BSC versus BSC alone were by chemotherapy duration- <Q1: 0.65, Q1-Q2: 0.79, Q2-Q3: 0.74, and >Q3: 0.63. By number of cycles-4 cycles: 0.69, 5 cycles: 0.98, and 6 cycles: 0.66 while by interval -4-<6 wk: 0.75, 6-<8 wk: 0.67, and 8-10 wk: 0.69. Similarly, PFS and safety showed similar results across subgroups.

It can be concluded that OS and PFS in subgroups may be generally consistent in the overall population and with similar safety findings. Thus, avelumab maintenance treatment helped patients with advanced UC to live longer.

High-dose vitamin D supplementation well-tolerated and effective in managing overactive bladder dry in children

According to a recent study, high-dose vitamin D supplementation (VDS) plus standard urotherapy (SU) is safe and efficacious in managing overactive bladder dry in children. This study’s findings were published in The Journal of Urology.

This 3-arm, randomized clinical trial included 303 pediatric patients. Out of these, 100 children were randomized to receive 8 weeks of high-dose VDS, which consisted of vitamin D3 drops encapsulated as soft capsules, 2400 IU/d, plus SU (VDS + SU group). The other groups were administered 5-10 mg/d of solifenacin plus SU (SOL + SU group; n=102), or SU alone (SU group; n=101). The primary outcome of the study was reduction in voiding frequency. Secondary outcomes included nocturia, quality of life score, improvement in urgency, participant satisfaction, and pediatric lower urinary tract symptom score. Also, the treatment-related adverse events were recorded for each group.

It was observed that the VDS + SU group showed greater improvements in voids/d than the SOL + SU group and the SU group post intervention. The greatest improvement in quality of life and pediatric lower urinary tract symptom scores was also seen in the VDS + SU group. Both the SOL + SU and SU groups showed similar patient satisfaction. The VDS + SU group did not exhibit an increased risk of treatment-emergent adverse events as found in the other groups.

Based on the above results, it can be concluded that high-dose of VDS plus SU, when given to children for managing overactive bladder dry, may be effective and well-tolerated and hence, may be used as a novel therapeutic option.

Lenvatinib plus pembrolizumab shows improved efficacy and overall survival in patients with advanced renal cell carcinoma

A recent study suggests that lenvatinib plus pembrolizumab shows improved efficacy and overall survival (OS) in specific subgroups of patients with advanced renal cell carcinoma(RCC). This study was published in the journal, European Urology Oncology.

The CLEAR trial was a phase 3, open-label, multicenter, randomized study that included 1069 patients who were randomized in a 1:1:1 ratio. The participants received either 20mg orally once a day of lenvatinib plus 200mg pembrolizumab intravenously once every 3 weeks, lenvatinib plus everolimus, or 50 mg sunitinib taken orally once daily for a period of 4 weeks and subsequently no treatment for 2 weeks. The International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk subgroup analyzed progression-free survival, duration of response and objective response rate (ORR).

It was found that the patients administered with lenvatinib plus pembrolizumab with a confirmed complete response or >75% target-lesion reduction by 6 months showed an OS of ≥91.7% at 24 months. Compared to sunitinib, lenvatinib plus pembrolizumab showed longer median progression-free survival and a higher ORR. Based on the above results, it can be concluded that lenvatinib plus pembrolizumab may provide improved efficacy and better survival than sunitinib in patients with advanced RCC.

Patients with metastatic castration-resistant prostate cancer benefit from niraparib plus abiraterone acetate and prednisone

A recent study suggests that patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA alterations showed clinically relevant outcomes when treated with niraparib plus abiraterone acetate and prednisone (AAP). This study’s results were published in the Annals of Oncology.

The phase 3, MAGNITUDE trial included 212 HRR+ patients with/without BRCA1/2 alterations. They were randomized in a 1:1 ratio to receive 200mg of niraparib orally plus AAP (1000 mg/10 mg orally) or placebo plus AAP. At the second prespecified interim analysis (IA2), the secondary endpoints assessed were time to symptomatic progression, time to initiation of cytotoxic chemotherapy and overall survival (OS).

It was found that at IA2 with 24.8 months of median follow-up, niraparib plus AAP showed significantly prolonged radiographic progression-free survival (rPFS) (19.5 versus 10.9 months; hazard ratio (HR) = 0.55 [95% confidence interval (CI) 0.39-0.78] consistent with the first prespecified interim analysis. Similarly, in the total HRR+ population, rPFS was also prolonged. In the niraparib plus AAP group, time to symptomatic progression and time to initiation of cytotoxic chemotherapy showed improvements. Even the analysis of OS with niraparib plus AAP in the BRCA1/2 subgroup demonstrated a lower hazard ratio.

From the above results, it is clear that niraparib plus AAP in patients with BRCA1/2-altered mCRPC, may demonstrate an improved rPFS and other clinically relevant outcomes.