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
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
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
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
Jennifer A. Woyach, MD, of The Ohio State University Comprehensive Cancer Center, discusses results of a phase III study showing that progression-free survival with ibrutinib plus obinutuzumab plus venetoclax is not superior to ibrutinib plus obinutuzumab for treatment-naive older patients with chronic lymphocytic leukemia (CLL) in the setting of the COVID-19 pandemic. Long-term follow-up will determine whether there are advantages to obinutuzumab plus venetoclax, with special attention to measurable residual disease and therapy discontinuation (Abstract 7500).
The ASCO Post Staff
Muhit Özcan, MD, of Turkey’s Ankara University School of Medicine, discusses phase II findings from the waveLINE-004 study. It showed that the antibody-drug conjugate zilovertamab vedotin had clinically meaningful antitumor activity in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who experienced disease progression after, or have been ineligible for, autologous stem cell transplantation and/or chimeric antigen receptor T-cell therapy (Abstract 7531).
