Axel Merseburger, MD, PhD, is a professor of urology and chairman of the Department of Urology at University Hospital Schleswig Holstein, Campus Lübeck.

Dr Merseburger on Real-World Outcomes With First-Line Axitinib Plus Avelumab in RCC

“The main goal… [was] to compare data from the JAVELIN Renal 101 trial, which led to the approval of axitinib and avelumab in a lot of countries, [with real-world data.] The results we saw in the clinical trial [vs] real-world data collection [were] consistent…with regard to OS and rPFS.”

Axel Merseburger, MD,PhD, professor, urology; chairman, Department of Urology, University Hospital Schleswig Holstein, Campus Lübeck, discusses the real-world efficacy and safety of first-line avelumab (Bavencio) plus axitinib (Inlyta) in patients with advanced renal cell carcinoma, according to data from the prospective noninterventional AVION study.

The phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly longer progression-free survival (PFS) and higher objective response rates (ORRs) with axitinib plus avelumab compared with sunitinib (Sutent) in patients with advanced renal cell carcinoma (RCC), Merseburger begins. These data led to regulatory approval of the combination in several countries, he adds.

Recent real-world data from the AVION study corroborated these findings, providing further evidence of the regimen's effectiveness and tolerability in clinical practice, Merseburger states.

At the data cutoff date of July 5, 2024, the median overall survival (OS) in the AVION study had not been reached. However, the 6- and 12-month OS rates were 89.1% (95% CI, 81.2%-93.8%) with axitinib plus avelumab and 82.7% (95% CI, 73.5%-88.9%), respectively, he reports. Patient demographics included individuals with poor prognostic features, reflecting a real-world patient population, Merseburger notes. The median PFS was 11.3 months (95% CI, 8.1-not evaluable); this was also consistent with the results from JAVELIN Renal 101.

The ORR in the AVION study was 46% (95% CI, 35.2%-57.0%), and the disease control rate (DCR) was 79.3% (95% CI, 69.3%-87.3%). Furthermore, the regimen's safety profile was manageable, with grade 3 or higher toxicities occurring at a low frequency, reinforcing the favorable tolerability observed in the pivotal trial, Merseburger says.

The consistency between the AVION real-world data and the JAVELIN Renal 101 trial supports the clinical utility of this combination across diverse patient populations, including those with poor prognostic factors, and confirm its place as a standard-of-care option, Merseburger concludes.

Videos

Axel Merseburger, MD, PhD, discusses the real-world efficacy and safety of first-line avelumab plus axitinib in advanced renal cell carcinoma.


The expert panel concludes its discussion by providing key takeaways on the evolving bladder cancer treatment landscape following ESMO 2023.

Key Takeaways on Evolving Bladder Cancer Treatment Landscape

The panel discusses the Large Urology Group Practice Association and provides insights on collaborative care approaches in bladder cancer.

Approach to Collaborative Care in Bladder Cancer

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Enfortumab Vedotin and the Role of ADCs in Bladder Cancer

The expert panel reviews highlights from ESMO 2023 and discusses ongoing developments in the treatment landscape for bladder cancer.

Bladder Cancer: Highlights from ESMO 2023 and Ongoing Developments

Comprehensive insights on treatment considerations and managing immunotherapy-related adverse effects for patients with bladder cancer.

Bladder Cancer: Treatment Options and Managing Adverse Effects

The panel discusses strategies for monitoring patients with non–muscle invasive bladder cancer and the potential role of biomarkers.

Monitoring Patients With NMIBC

Expert perspectives on treatment options available for patients with bladder cancer and the role of trimodal therapy.

Treatment Considerations and Role of Trimodal Therapy in Bladder Cancer

A panel of experts on bladder cancer provide an overview of the stratification, natural history, and treatment of bladder cancer.

Overview of Non–Muscle Invasive Bladder Cancer (NMIBC)

Axel Merseburger, MD, PhD, chairman, Clinic of Urology, University Hospital Schleswig-Holstein in Lübeck, Germany, discusses results from the phase 3b PRESIDE trial (NCT02288247) in metastatic castration-resistant prostate cancer (mCRPC). 

The randomized study investigated the efficacy of continuing enzalutamide (Xtandi) plus androgen deprivation therapy (ADT) with docetaxel and prednisolone in chemotherapy-naïve patients with mCRPC who had progressed on enzalutamide plus ADT. All enrolled patients were administered 160 mg of enzalutamide plus ADT in period 1 of the trial. Patients who experienced a change in prostate-specific antigen response of at least 50% from baseline to week 13 and subsequent disease progression were then randomized to receive enzalutamide or placebo, plus 75 mg/m2 of docetaxel, 10 mg of prednisolone, and ADT.

The continuation of enzalutamide produced a statistically significant advantage in progression-free survival (PFS) compared with placebo, meeting the trial’s primary end point, Merseburger says. The hazard ratio for PFS was 0.72 in favor of the enzalutamide combination with a corresponding 

Axel Merseburger, MD, PhD, discusses results from the phase 3b PRESIDE trial in metastatic castration-resistant prostate cancer. 


Axel Merseburger, MD, PhD

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