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
Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, discusses phase III findings showing that for patients with advanced or metastatic urothelial carcinoma and FGFR alteration who already had been treated with a PD-(L)1 inhibitor, erdafitinib significantly improved overall and progression-free survival, as well as overall response rate, compared with investigator’s choice of chemotherapy (LBA4619).
The ASCO Post Staff
Carmen E. Guerra, MD, MSCE, of the University of Pennsylvania Abramson Cancer Center, discusses three key abstracts presented at ASCO: strategies to increase accrual of underrepresented populations in Alliance NCTN trials, how patient-clinician education can strengthen partnerships and improve diversity in breast and lung cancer trials, and mediators of racial and ethnic inequities in clinical trial participation among U.S. patients with cancer from 2011 to 2022 (Abstracts 6509, 6510, 6511).
The ASCO Post Staff
Sebastian Stintzing, MD, of the Charité Universitätsmedizin Berlin, discusses results from the phase III FIRE-4 study, which showed that liquid biopsy is clinically relevant in verifying mutational status in patients with metastatic colorectal cancer and is efficacious in first-line treatment of FOLFIRI and cetuximab for patients with RAS wild-type disease (Abstract 3507).
The ASCO Post Staff
Smitha Krishnamurthi, MD, of the Cleveland Clinic, and Deb Schrag, MD, MPH, of Memorial Sloan Kettering Cancer Center, discuss phase III findings from the PROSPECT trial, which showed FOLFOX chemotherapy with selective use of radiation therapy and sensitizing fluoropyrimidine (5FUCRT) is noninferior to 5FUCRT for the neoadjuvant treatment of patients with locally advanced rectal cancer, prior to low anterior resection with total mesorectal excision (Abstract LBA2).
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).
