Yousef Zakharia, MD

Yousef Zakharia, MD, clinical associate professor of internal medicine at the University of Iowa, Holden Comprehensive Cancer Center, discusses the results of a phase 2 trial (NCT02891161) investigating concurrent durvalumab (Imfinzi) and radiation therapy followed by adjuvant durvalumab in patients with localized urothelial cancer of bladder.

This study enrolled 26 patients and the investigators had efficacy data for 24 patients. This regimen was deemed safe for use in patients and the safety has been presented prior to the efficacy. There were no major dose-limiting toxicities with this combination, according to Zakharia.

In the 24 evaluable patients, there was a disease control rate of 72% at the end of 1 year. After the completion of adjuvant daratumumab, there were 10 complete response, 3 partial responses, 1 patient with stable disease, and 6 patients with progressive disease. Zakharia says the progression-free survival rate was about 70%. The 1-year overall survival probability was 83.8% and the 2-year probability was 76.8%. The median overall survival had not been reached.

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Yousef Zakharia, MD, discusses the results of a phase 2 trial investigating concurrent durvalumab and radiation therapy followed by adjuvant durvalumab in patients with localized urothelial cancer of bladder.

Durvalumab Plus Radiation Therapy Demonstrates Efficacy in Bladder Cancer

Yousef Zakharia, MD, clinical associate professor of internal medicine at the University of Iowa, Holden Comprehensive Cancer Center, discusses the next steps after the phase 1 trial (NCT02535533) of seleno-L-methionine (SLM) in combination with axitinib (Inlyta) as treatment of adult patients with previously treated or relapsed clear cell renal cell carcinoma (ccRCC).

Zakharia says that 1 of the observations they had while investigating this clinical trial was that the higher the blood concentration was with SLM, the better response patients had. Although this was a small cohort of patients, the investigators amended the protocol in the study to allow patients with ccRCC to be treated based on their body surface area, and this topic is still ongoing among the authors.

If they continue to see efficacy in the phase 1 data, the next step will be to start a randomized clinical trial of axitinib as the standard of care and the combination of axitinib and SLM in patients with advanced metastatic ccRCC, according to Zakharia.

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Yousef Zakharia, MD, discusses the next steps after the phase 1 trial of seleno-L-methionine in combination with axitinib as treatment of adult patients with previously treated or relapsed clear cell renal cell carcinoma.

Evaluating Future Steps for Investigating Seleno-L-Methionine in RCC

Yousef Zakharia, MD, associate professor of medicine, University of Iowa, Holden Comprehensive Cancer Center, discussed recent phase I data from a study of seleno-L-methionine (SLM) in combination with axitinib (Inlyta) as treatment of patients with previously treated or relapsed clear cell renal cell carcinoma (ccRCC). Zakharia recently presented these data as part of the American Urological Association (AUA) Virtual Experience platform for the 2020 AUA Annual Meeting.

Out of 15 evaluable patients with ccRCC who progressed on one or more prior lines of treatment, responses were seen across all cohorts of patients who received SLM in combination with axitinib. Overall responses were seen in 53% of patients (n = 8). Complete responses (CRs) were observed in 2 patients. CRs for these patients were still ongoing at 31 and 29 months, respectively. Partial responses were observed in 6 patients, with a disease control rate of about 73%. Some responses lasted for more than 3 years.

There were no dose-limiting toxicities in the study. Most commonly, adverse events (AEs) were grades 1 and 2.The most common AEs that patients experienced were fatigue, diarrhea, hypertension, nausea, anorexia, cough, proteinuria, and weight loss. The most common grade 3 or 4 AE was hypertension. These AEs were consistent with the known toxicity of axitinib. No grade 4 and 5 toxicities were observed.

Yousef Zakharia, MD, discussed recent phase I data from a study of seleno-L-methionine in combination with axitinib as treatment of patients with previously treated or relapsed clear cell renal cell carcinoma. Zakharia recently presented these data as part of the American Urological Association Virtual Experience platform for the 2020 AUA Annual Meeting.

Promising Efficacy and Safety With Seleno-L-Methionine Plus Axitinib in ccRCC

Yousef Zakharia, MD, assistant professor, University of Iowa, Holden Comprehensive Cancer Center, discusses indoximod as an active IDO inhibitor in advanced melanoma.

Yousef Zakharia, MD | Authors

Articles

Durvalumab Plus Radiation Therapy Demonstrates Efficacy in Bladder Cancer

Evaluating Future Steps for Investigating Seleno-L-Methionine in RCC

Promising Efficacy and Safety With Seleno-L-Methionine Plus Axitinib in ccRCC

Indoximod as an Active IDO Pathway Inhibitor in Melanoma