Arlene O. Siefker-Radtke, MD, on Metastatic Urothelial Carcinoma: New Data on Erdafitinib vs Chemotherapy From the THOR Study
2023 ASCO Annual Meeting
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).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
Arlene O. Siefker-Radtke:
We now have results from the THOR clinical trial studying erdafitinib in patients who have metastatic surgically unresectable urothelial carcinoma, who've received prior therapy for their tumor. This is the first clinical trial, showing proof of concept benefit from FGF targeted therapy, compared to what's been observed with chemotherapy.
The design of the trial takes patients who've had prior treatment, typically chemotherapy with platinum or carboplatinum, and patients may have had an immune checkpoint inhibitor. There are two cohorts to this trial. The cohort being presented is the group of patients who've had a prior immune checkpoint inhibitor. Patients were randomized between either erdafitinib alone or single agent taxane, or vinflunine, which is approved in Europe. And the results of the trial looked quite good indeed, with it hitting on all three endpoints.
The primary endpoint of the trial was median overall survival, and erdafitinib came in with a statistically significant improvement in overall survival with a median overall survival of 12 months compared to single agent chemotherapy, which was around 7.8 months. We also saw evidence of benefit in progression-free survival and overall survival. The progression-free survival with erdafitinib was around five and a half months. Single agent chemotherapy was half that amount, and the objective response rate for erdafitinib was around 45%, so that's 45% PRs and CRs, while single agent chemotherapy had a response rate of around 11%.
The toxicity reported is similar to what has been observed with other clinical trials of FGF targeted therapy, and as a result of this work, erdafitinib is here to stay as part of the standard armamentarium for the treatment of our urothelial cancer patients.
The ASCO Post Staff
Jennifer A. Ligibel, MD, of Dana-Farber Cancer Institute, discusses a telephone-based weight loss intervention that induced clinically meaningful weight loss in patients with breast cancer who had overweight and obesity, across demographic and tumor factors. Additional tailoring of the intervention may possibly enhance weight loss in Black and younger patients as well (Abstract 12001).
The ASCO Post Staff
Aaron T. Gerds, MD, of Cleveland Clinic Taussig Cancer Institute, talks about treating the anemia many patients with myelofibrosis experience because of JAK inhibitor therapy. The ACE-536-MF-001 study showed that luspatercept improved anemia and transfusion burden in this population, with a safety profile consistent with that in previous studies (Abstract 7016).
The ASCO Post Staff
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).
The ASCO Post Staff
Alicia K. Morgans, MD, MPH, of Dana-Farber Cancer Institute, and Karim Fizazi, MD, of Institut Gustave Roussy, University of Paris-Saclay, discuss findings from the TALAPRO-2 study, which showed that talazoparib plus enzalutamide improved radiographic progression–free survival over standard-of-care enzalutamide as first-line treatment for patients with metastatic castration-resistant prostate cancer and HRR gene alterations. This regimen also delayed the time to deterioration in global health status and quality of life (Abstract 5004).
The ASCO Post Staff
Lisa A. Carey, MD, of the University of North Carolina at Chapel Hill, and Dennis J. Slamon, MD, PhD, of the University of California, Los Angeles, discuss phase III study findings on ribociclib plus endocrine therapy as adjuvant treatment in patients with hormone receptor–positive, HER2-negative early breast cancer. When added to standard-of-care endocrine therapy, ribociclib improved invasive disease–free survival with a well-tolerated safety profile (Abstract LBA500).
