2365MO Study EV-103 cohort L: Perioperative treatment w/ enfortumab vedotin (EV) monotherapy in cisplatin (cis)-ineligible patients (pts) w/ muscle invasive bladder cancer (MIBC)
Recommended Citation
Sridhar S, O'Donnell PH, Flaig TW, Rosenberg JE, Hoimes CJ, Milowsky MI, Srinivas S, George S, McKay RR, Petrylak DP, Coelho Barata PM, Hwang C, Cruz-Correa M, Iafolla M, Mckean M, Dreicer R, Brancato S, Lukas JJ, Yu Y, Moon H. 2365MO Study EV-103 cohort L: Perioperative treatment w/ enfortumab vedotin (EV) monotherapy in cisplatin (cis)-ineligible patients (pts) w/ muscle invasive bladder cancer (MIBC). Ann Oncol 2023; 34:S1203.
Document Type
Conference Proceeding
Publication Date
10-1-2023
Publication Title
Ann Oncol
Abstract
Background: Current SOC for pts w/ MIBC is neoadjuvant cis-based chemotherapy followed by radical cystectomy and pelvic lymph node dissection (RC+PLND). For pts who are cis-ineligible, SOC is RC+PLND alone but adjuvant therapy may be recommended. Due to high rates of recurrence in cis-ineligible pts, an urgent unmet need remains. Neoadjuvant EV showed promising antitumor activity in MIBC (pathological CR [pCR] of 36%, pathological downstaging [pDS] of 50%) in EV-103 Cohort H ( Petrylak 2022 ). Cohort L examines a perioperative approach. Methods: Cohort L enrolled pts who are cis-ineligible w/ previously untreated MIBC (cT2-T4aN0M0 or cT1-T4aN1M0) who are medically fit for and agree to undergo curative intent RC+PLND within 12 wks. Pts received 3 cycles of neoadjuvant EV (1.25mg/kg) on Days 1 and 8 of each 3-week cycle followed by RC+PLND and then 6 cycles of adjuvant EV (1.25 mg/kg) on Days 1 and 8 of every 3 week cycle starting 8 weeks post-RC. Primary endpoint is pathological CR (pCR) per central pathology review; secondary endpoints include pathological downstaging (pDS) rate per central pathology review, safety and tolerability. Here we present initial results from the neoadjuvant/RC+PLND phase + 30 days post surgery. Results: 52 pts were enrolled. 51 pts were treated w/ EV in the neoadjuvant phase w/ a median of 3 cycles; 42 pts (82.4%) completed RC+PLND. One pt achieved clinical CR and elected not to undergo RC+PLND and was excluded from pCR and pDS analyses; 17/50 (34.0%) pts had a pCR. pDS was seen in 21/50 (42.0%) pts. In the neoadjuvant/RC+PLND phase, of 51 treated pts most common EV-related TEAEs were fatigue (52.9%), rash maculo-papular (31.4%), and nausea (29.4%). 39.2% of pts had an EV-related TEAE ≥ grade 3; 31.4% pf pts had a RC-related TEAE ≥ grade 3. No surgeries were delayed due to EV-related TEAEs. One pt (2.0%) experienced an EV-related death (Stevens-Johnson syndrome) before surgery. Conclusions: EV continues to show promising activity and was tolerable in cis-ineligible pts w/ MIBC in this ongoing trial. Both the efficacy and safety profiles were consistent with previously reported data from Cohort H. These data support the ongoing phase 3 trials evaluating EV + pembrolizumab in MIBC. Clinical trial identification: EudraCT 2018-001527-39; Release Date: Amendment 11, 15-Feb-2023.
Medical Subject Headings
Hematology
PubMed ID
Not assigned.
Volume
34
First Page
S1203
