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
Reid Merryman, MD, of Dana-Farber Cancer Institute, discusses his findings on the regimen of epcoritamab plus rituximab and lenalidomide for patients with high-risk follicular lymphoma. Regardless of whether their disease progressed within 24 months of first-line chemoimmunotherapy, this regimen showed antitumor activity and a manageable safety profile in patients with relapsed or refractory disease. Epcoritamab, a subcutaneous T-cell–engaging bispecific antibody, may abrogate the negative effects of high-risk features (Abstract 7506).
The ASCO Post Staff
Nirav N. Shah, MD, of the Medical College of Wisconsin, discusses the efficacy and safety of pirtobrutinib, a highly selective, noncovalent BTK inhibitor, studied for more than 3 years in the BRUIN trial. The results showed that the use of pirtobrutinib continues to have durable efficacy and a favorable safety profile in heavily pretreated patients with relapsed or refractory mantle cell lymphoma and prior BTK inhibitor therapy. Responses were observed in patients with high-risk disease features, including blastoid/pleomorphic variants, elevated Ki67 index, and TP53 mutations (Abstract 7514).
The ASCO Post Staff
Alicia K. Morgans, MD, MPH, of Dana-Farber Cancer Institute, and Karim Fizazi, MD, of Institut Gustave Roussy, University of Paris-Saclay, discuss findings from the TALAPRO-2 study, which showed that talazoparib plus enzalutamide improved radiographic progression–free survival over standard-of-care enzalutamide as first-line treatment for patients with metastatic castration-resistant prostate cancer and HRR gene alterations. This regimen also delayed the time to deterioration in global health status and quality of life (Abstract 5004).
The ASCO Post Staff
Jonathan W. Riess, MD, of the University of California, Davis Comprehensive Cancer Center, explores the findings of three important clinical trials in lung cancer treatment: whether to incorporate immune checkpoint inhibitors into the treatment of EGFR-mutated lung cancer, the importance of central nervous system activity in EGFR-mutant lung cancer, and new therapies for disease with EGFR exon 20 insertion.
The ASCO Post Staff
Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center, and Gregory Roloff, MD, of the University of Chicago, discuss data that are the first to demonstrate post–FDA approval efficacy and toxicity rates of brexucabtagene autoleucel in adults with relapsed or refractory B-cell acute lymphoblastic leukemia. Although the data may confirm high response rates associated with this agent, they also highlight the need for interventions to reduce associated toxicities (Abstract 7001).
