Bladder Cancer Highlights from the ESMO 2022
Dr. Charlene Mantia, a medical oncologist at Dana-Farber Cancer Institute specialized in cancers of the genitourinary tract, presented and discussed bladder cancer clinical updates from the ESMO 2022.
“There is not a lot of practice-changing in bladder cancer, but there are the important updates from the EV-103 Cohort K”, dr. Mantia started.
The EV-103 Cohort K trial showed that the first-line enfortumab vedotin and pembrolizumab resulted in high ORR with rapid responses in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer (la/mUC).[1]
A critical need for effective and tolerable first-line treatment options for la/mUC patients is still present because the majority of those patients are ineligible for first-line cisplatin-based chemotherapy and most of them will eventually progress.[1]
Updates from the EV-103 Cohort K trial
The EV-103 Cohort K trial evaluated the efficacy of enfortumab vedotin monotherapy or in combination with pembrolizumab in previously untreated cisplatin-ineligible patients with la/mUC.[1]
A total of 149 patients were randomly assigned to receive either enfortumab vedotin (1.25 mg/kg) alone on days 1 and 8 or in combination with pembrolizumab (200 mg) on day 1 of 3-week cycles.[1]
The confirmed objective response rate (ORR) for patients treated with the combination of enfortumab vedotin and pembrolizumab was 64.5% (95% CI 52.7 to 75.1) compared to 45.2% (95% CI 33.5 to 57.3) for those treated with enfortumab vedotin monotherapy.[1]
“The responses that we saw were really rapid, 85.7% of patients’ responses were observed at first assessment. Confirmed ORRs were consistent across all subgroups, and even in patients with liver metastases, difficult to treat patient population, the ORR was 54%”, she added.
Furthermore, the results showed that 97.1% of patients treated with enfortumab vedotin plus pembrolizumab had a reduction in tumour volume. The safety profile for this treatment combination was tolerable and generally consistent with the known data.[1]
“Overall, these confirm encouraging data of the combination of enfortumab vedotin and pembrolizumab”, she concluded.
RACE IT trial
The RACE IT phase II trial assessed the safety and efficacy of preoperative radiation therapy before radical cystectomy combined with immunotherapy in patients with locally advanced bladder urothelial carcinoma (cT3/4 cN0/N+ cM0).[2]
Eligible patients received 240mg nivolumab intravenously every 2 weeks for 4 cycles, beginning 1 week before 50.4 Gy bladder/pelvis radiotherapy. Patients underwent radical cystectomy with standardized pelvic lymphadenectomy after completing neoadjuvant radio-immunotherapy (RIT).[2]
At the end of week 15, the primary endpoint of completed treatment (RIT and radical cystectomy) was obtained in 27 of 31 patients (87.1%). The radiological objective response rate was 70.9% (CR 16.1%, PR 54.8%, SD 25.8%, and PD 3.2%). The pathological response rate was ypT0 in 38.7% of patients and ≤ ypT1 in 58.1% of patients. The disease-free survival rate at 12 months was 90.6%.[2]
“I think this is a small study, a small number of patients, that shows this approach is feasible and safe. But we really need more data to show how efficacies this is in this patient population”, dr. Mantia concluded.
Dr. Mantia’s full presentation can be found here:
Speaker’s conclusions:
- According to the EV-103 Cohort K trial, the combination of enfortumab vedotin and pembrolizumab continues to show encouraging efficacy, and it’s likely to become a first-line treatment option for cisplatin-ineligible patients with la/mUC.[1]
- Based on the RACE IT phase II trial’s findings, preoperative radiation therapy plus immunotherapy is feasible and safe for patients with locally advanced bladder urothelial carcinoma.[2]
REFERENCE:
- https://www.urotoday.com/conference-highlights/esmo-2022/esmo-2022-bladder-cancer/139496-esmo-2022-lba73-study-ev-103-cohort-k-antitumor-activity-of-enfortumab-vedotin-monotherapy-or-in-combination-with-pembrolizumab-in-previously-untreated-cisplatin-ineligible-patients-with-locally-advanced-or-metastatic-urothelial-cancer-la-muc.html (access:28.01.2023)
- https://www.urotoday.com/conference-highlights/esmo-2022/esmo-2022-bladder-cancer/139454-esmo-2022-race-it-a-prospective-single-arm-multicenter-phase-ii-trial-to-assess-safety-and-efficacy-of-preoperative-radiation-therapy-before-radical-cystectomy-combined-with-immunotherapy-in-locally-advanced-urothelial-carcinoma-of-the-bladder.html (access:28.01.2023.)