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).
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.
Amer Methqal Zeidan, MBBS, MHS, of Yale University and Yale Cancer Center, discusses phase III findings on the first-in-class telomerase inhibitor imetelstat, which was given to patients with heavily transfusion-dependent non-del(5q) lower-risk myelodysplastic syndromes that are resistant to erythropoiesis-stimulating agents. Imetelstat resulted in a significant and sustained red blood cell (RBC) transfusion independence in 40% of these heavily transfused patients. The response was also durable and accompanied by an impressive median hemoglobin rise of 3.6 g/dL, and seen in patients with and without ring sideroblasts. Importantly, reduced variant allele frequency was observed in the most commonly mutated myeloid genes which correlated with duration of transfusion independence and hemoglobin rise, therefore suggesting a disease-modifying potential of this agent (Abstract 7004).
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).
Clifford A. Hudis, MD, ASCO Chief Executive Officer, talks about extending the reach and impact of ASCO by partnering with patients who play a key role in advancing science through clinical trial participation. With near-record numbers of registered attendees, the 2023 Annual Meeting fostered new connections and plans for collaborations.
Bobbie J. Rimel, MD, of Cedars-Sinai Medical Center, and Kathleen N. Moore, MD, of the Stephenson Oklahoma Cancer Center at the University of Oklahoma, discuss phase III results from the MIRASOL trial, which showed that mirvetuximab soravtansine-gynx prolonged overall survival vs investigator’s choice chemotherapy in patients with platinum-resistant ovarian cancer with high folate receptor-alpha expression. The findings suggest a new standard of care for this disease (Abstract LBA5507).
Tycel J. Phillips, MD, of City of Hope National Medical Center, and Emanuele Zucca, MD, of the Oncology Institute of Southern Switzerland and the International Extranodal Lymphoma Study Group, discuss findings from the largest prospective study of patients with primary mediastinal B-cell lymphoma. The trial data support omitting radiotherapy in patients who achieve complete metabolic response after immunochemotherapy (Abstract LBA7505).