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
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
Sarah K. Tasian, MD, of Children’s Hospital of Philadelphia, summarizes three studies presented at ASCO: genomic determinants of outcome in acute lymphoblastic leukemia (ALL), a phase III trial of inotuzumab ozogamicin for high-risk B-cell ALL, and preliminary results from the first-in-child phase II trial of bosutinib in pediatric patients with newly diagnosed chronic myeloid leukemia (Abstracts 10015, 10016, and 10017).
The ASCO Post Staff
Omid Hamid, MD, of The Angeles Clinic & Research Institute, discusses study findings on fianlimab plus cemiplimab-rwlc, which showed clinical activity in patients with advanced melanoma, comparing favorably with other approved combinations of immune checkpoint inhibitors in the same clinical setting. This is the first indication that dual LAG-3 blockade may produce a high level of activity with significant overall response rate after adjuvant anti–PD-1 treatment. A phase III trial of this regimen in treatment-naive patients with advanced melanoma is ongoing (Abstract 9501).
The ASCO Post Staff
Narjust Florez, MD, of Dana-Farber Cancer Institute, and Ferdinandos Skoulidis, MD, PhD, of The University of Texas MD Anderson Cancer Center, discuss results of a biomarker subgroup analysis, showing that sotorasib demonstrated consistent clinical benefit vs docetaxel in all molecularly defined subgroups of patients with pretreated KRAS G12C–mutated advanced non–small cell lung cancer (NSCLC). Although no predictive biomarkers were confirmed, novel hypothesis-generating signals were observed (Abstract 9008).
The ASCO Post Staff
Lisa M. DeAngelis, MD, and Ingo K. Mellinghoff, MD, both of Memorial Sloan Kettering Cancer Center, discuss findings from the INDIGO trial showing that the IDH1/2 inhibitor vorasidenib improves progression-free survival for patients with residual or recurrent grade 2 glioma with an IDH1/2 mutation. These data demonstrate the clinical benefit of vorasidenib in this patient population for whom chemotherapy and radiotherapy are being delayed.
