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
Tycel J. Phillips, MD, and Alex F. Herrera, MD, both of the City of Hope National Medical Center, discuss findings from the POLARIX study, which provided the largest prospectively collected circulating tumor DNA (ctDNA) data set on patients with previously untreated diffuse large B-cell lymphoma. Achieving ctDNA-negative status was associated with improved outcomes when patients were treated with polatuzumab vedotin-piiq plus combination chemotherapy vs combination chemotherapy alone (Abstract 7523).
The ASCO Post Staff
Alicia K. Morgans, MD, MPH, and Praful Ravi, MRCP, MBBChir, both of Dana-Farber Cancer Institute, discuss an individual patient-data analysis of randomized trials from the ICECAP collaborative. A PSA nadir of ≥ 0.1 ng/mL within 6 months after radiotherapy completion was prognostic for prostate cancer–specific, metastasis-free, and overall survival in patients receiving radiotherapy plus androgen-deprivation therapy for localized prostate cancer. These findings may help identify patients for therapy de-escalation trials (Abstract 5002).
The ASCO Post Staff
Penelope Bradbury, MBChB, of Canada’s Princess Margaret Cancer Centre, discusses phase III findings showing that, in patients with treatment-naive unresectable pleural mesothelioma, cisplatin and pemetrexed with pembrolizumab improved median overall survival with acceptable tolerability (Abstract LBA8505).
The ASCO Post Staff
Shailender Bhatia, MD, of the University of Washington and Fred Hutchinson Cancer Center, discusses phase I/II results on the efficacy of nivolumab with or without ipilimumab in patients with recurrent or metastatic Merkel cell carcinoma. The study found that, for this rare and aggressive skin cancer, nivolumab showed clinical activity in advanced disease. However, these results from CheckMate 358 do not suggest an additional benefit with ipilimumab added to nivolumab (Abstract 9506).
The ASCO Post Staff
Alberto Bossi, MD, of Institut Gustave Roussy, discusses phase III findings showing that combining prostate radiotherapy with systemic treatment did not improve overall survival in men with de novo metastatic castration-sensitive prostate cancer and low metastatic burden. However, best outcomes (radiographic progression–free-survival and overall survival) were observed in men receiving the standard of care plus abiraterone acetate plus prednisone with radiotherapy (Abstract LBA5000).
