Dr Grünwald on Tumor Burden Outcomes From the CLEAR Trial in Advanced RCC 

Viktor Grünwald, MD, PhD, professor of interdisciplinary genitourinary oncology at the University Hospital Essen, discusses 

findings from the phase 3 CLEAR trial (NCT02811861)

, highlighting the differences in tumor burden between patients with advanced renal cell carcinoma (RCC) treated with lenvatinib (Lenvima) plus pembrolizumab (Keytruda) vs those treated with sunitinib (Sutent).

The analysis sought to observe changes in tumor burden between treatment arms. Results presented at the 

 indicated that at the time of overall disease progression, the tumor burden of target lesions was lower in patients treated with lenvatinib plus pembrolizumab vs those treated with sunitinib, Grünwald states. Patients treated with lenvatinib plus pembrolizumab exhibited a –48.1% median change in sums of targeted lesions from baseline vs –17.4% in patients treated with sunitinib.

As part of the analysis, during survival follow-up, investigators also evaluated subsequent anticancer therapy. The results showed that more patients in the sunitinib arm (n = 246) received subsequent anticancer therapy compared with those in the lenvatinib plus pembrolizumab arm (n = 181), Grünwald notes. Seventy patients in the combination arm received cabozantinib (Cabometyx) as their first subsequent therapy and experienced a median time to discontinuation of 13.2 months compared with 7.1 months among the 25 patients who received cabozantinib as first subsequent therapy in the sunitinib arm. Axitinib (Inlyta) was administered to 20 patients as first subsequent therapy in the combination arm; these patients had a median discontinuation time of 23.7 months vs 12.6 months among the 14 patients who received axitinib as first subsequent therapy in the sunitinib arm.

These findings suggest that the lower tumor burden observed at progression with lenvatinib plus pembrolizumab could enhance the effectiveness of subsequent therapies, such as cabozantinib and axitinib, Grünwald explains. Although these findings are observational, they highlight the importance of exploring how initial tumor burden reduction with frontline therapy could affect the efficacy of subsequent treatments, which could help inform future therapeutic strategies in advanced RCC, Grünwald concludes.

Videos

Viktor Grünwald, MD, PhD, discusses differences in tumor burden between patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab vs sunitinib.

Viktor Grünwald, MD, PhD, an attending physician at the Hannover Medical School, discusses tumor remission in patients with renal cell carcinoma (RCC).

At the European Cancer Congress 2013, Grünwald presented data from a large study that looked at tumor response as a prognostic factor in patents with metastatic RCC. The analysis aimed to determine how the quality of tumor remission and the depth of remission will influence the prognostic outcome of patients. In the trial, data on 2,749 patients were prospectively gathered from Pfizer trials from 2003 to 2011.

The analysis revealed that patients who had superb tumor shrinkage (at least 60%) had excellent outcome in terms of overall survival (OS). However, Grünwald says, this applied to only 10% of the patients studied, so there remains a need to expand the prospect of tumor shrinkage and OS benefit to more patients.

Viktor GrÃ¼nwald, MD, PhD, an attending physician at the Hannover Medical School, discusses tumor remission in patients with renal cell carcinoma (RCC).

Dr. GrÃ¼nwald on Tumor Remission in RCC

Viktor Grünwald, MD, PhD, an attending physician at the Hannover Medical School, discusses a phase III trial that compared dovitinib (FGFR inhibitor) to sorafenib (VEGF inhibitor) for patients with metastatic renal cell carcinoma (mRCC) following prior treatment with one VEGF inhibitor and one mTOR inhibitor.

The primary endpoint of the trial was progression-free survival (PFS) with a total enrollment of 570 patients. Given the large size of the trial, an analysis of overall survival was also plausible, Grünwald states. In the trial, the median PFS was found to be 3.7 months with dovitinib compared to 3.6 months with sorafenib (HR = 0.86; 

 = .063). The median OS was 11.1 and 11.0 months in the dovitinib and sorafenib, respectively (HR = 0.96; 

Overall, these results indicate a negative trial, states Grünwald. However, since this is the first phase III trial specifically in the third-line setting, Grünwald believes the results support the use of sorafenib in this space.

View more from the 2013 European Cancer Congress

Viktor GrÃ¼nwald, MD, PhD, from the Hannover Medical School, discusses a phase III trial that compared dovitinib to sorafenib for patients with mRCC following prior treatment with one VEGF inhibitor and one mTOR inhibitor.

Viktor Grunwald, MD, PhD

Articles

Dr Grünwald on Tumor Burden Outcomes From the CLEAR Trial in Advanced RCC

Dr. GrÃ¼nwald on Tumor Remission in RCC

Dr. GrÃ¼nwald on Dovitinib Versus Sorafenib in mRCC