Thomas E. Hutson, DO, PharmD, on RCC: Overall Survival Analysis of Lenvatinib, Pembrolizumab, and Sunitinib
2023 ASCO Annual Meeting
Thomas E. Hutson, DO, PharmD, of Texas Oncology, discusses the 4-year follow-up results from the CLEAR study for patients with advanced renal cell carcinoma (RCC). The data showed that lenvatinib plus pembrolizumab continues to demonstrate clinically meaningful benefit vs sunitinib in overall and progression-free survival, as well as in overall and complete response rates, in first-line treatment (Abstract 4502).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
Thomas E. Hutson :
On behalf of my co-investigators, I presented the final pre-specified overall survival from the Phase 3 CLEAR study with nearly four years follow up. The Phase 3 CLEAR study was an international randomized trial comparing Lenvatinib pembrolizumab, Lenvatinib everolimus versus Sunitinib as first-line therapy for patients with advanced renal cell carcinoma.
This data had previously been reported when it met its primary efficacy endpoint, which was improvement in progression-free survival. At that time of that presentation, the secondary endpoints of overall survival and objective response rates were also statistically significant. This resulted in regulatory approval of this regimen and rapid incorporation of this regimen as a major frontline therapy option for patients with advanced RCC throughout the world. This information was also previously published in the New England Journal of Medicine.
Now, with additional 23 months follow up, pleased to report that our overall survival is maintained with a hazard ratio of 0.79, and our other efficacy signals such as progression-free survival and response rate remain robust with this longer follow-up. There were also no new additional safety signals.
So in conclusion, we're pleased to report with additional nearly four years of follow-up the overall survival progression-free survival and objective response rates remain significant and robust when compared with Sunitinib with no new safety signals of the regimen. And Pembrolizumab and Lenvatinib remain a primary therapy for patients with advanced RCC.
The ASCO Post Staff
Paula Aristizabal, MD, MAS, of the University of California, San Diego, and Rady Children’s Hospital, talks about using a health systems strengthening approach to improve leukemia care and survival in a public Mexican hospital in the region of the border between the United States and Mexico. The demonstrated increase in overall survival across a decade after implementation of the program seems to validate the use of such models, not only to improve clinical outcomes, but also to build sustainable hospital capacity, financially and organizationally (Abstract 1502).
The ASCO Post Staff
Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, discusses the combination of erdafitinib and cetrelimab, which demonstrated clinically meaningful activity and was well tolerated in cisplatin-ineligible patients with metastatic urothelial carcinoma and fibroblast growth factor receptor alterations (Abstract 4504).
The ASCO Post Staff
Muhit Özcan, MD, of Turkey’s Ankara University School of Medicine, discusses waveLINE-007, a two-part study now recruiting in more than 20 locations, to determine the safety and recommended phase II dose of the antibody-drug conjugate zilovertamab vedotin in combination with R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone) in previously untreated patients with diffuse large B-cell lymphoma (DLBCL). Efficacy of this regimen will be investigated in the second half of the study (Abstract TPS7589).
The ASCO Post Staff
Lisa A. Carey, MD, of the University of North Carolina at Chapel Hill, and Javier Cortes, MD, PhD, of the International Breast Cancer Center and Universidad Europea de Madrid, discuss phase II findings showing that one in three patients with HER2-positive early breast cancer may safely omit chemotherapy. Among the chemotherapy-free patients treated with trastuzumab and pertuzumab, the 3-year invasive disease–free survival was 98.8%, with no distant metastases (Abstract LBA506).
The ASCO Post Staff
Funda Meric-Bernstam, MD, of The University of Texas MD Anderson Cancer Center, discusses interim results from the DESTINY-PanTumor02 trial, the first tumor-agnostic global study of fam-trastuzumab deruxtecan-nxki (T-DXd) in a broad range of HER2-expressing solid tumors. This agent showed an encouraging overall response rate, particularly in patients with IHC 3+ expression; durable clinical benefit; and a manageable safety profile in these heavily pretreated patients. T-DXd may be a potential new treatment option for this population (Abstract LBA3000).
