Results from the phase 1b/2 EV-103 trial showed promising anti-tumour activity of neoadjuvant enfortumab vedotin in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin therapy.
Up to 1 in 4 patients diagnosed with urothelial cancer present with muscle-invasive disease, which has a substantial risk of progression or metastasis. Neoadjuvant chemotherapy has been shown to prolong overall survival for patients who are cisplatin-eligible . The standard of care for cisplatin-ineligible patients undergoing surgery does not include neoadjuvant therapy. Enfortumab vedotin is an antibody-drug conjugate directed to Nectin-4, which is highly expressed in urothelial cancer and has been shown to benefit locally advanced or metastatic urothelial pre-treated cancer patients, including cisplatin-ineligible patients .
Cohort H of the EV-103 phase 1b/2 trial (NCT03288545) evaluated the anti-tumour activity of neoadjuvant enfortumab vedotin in patients with MIBC who are cisplatin-ineligible. Participants received 3 cycles of neoadjuvant enfortumab vedotin prior to radical cystectomy plus pelvis lymph node dissection. A total of 22 patients were treated, of which 19 patients completed all 3 cycles of enfortumab vedotin, 21 patients underwent a radical cystectomy, and 1 had a partial cystectomy. The primary endpoint was pathological complete response rate. Prof. Daniel Petrylak (Yale School of Medicine, CT, USA) presented the results .
Pathological complete response was observed in 36.4% (n=8) of patients; the pathological downstaging rate was 50% (n=11). The most common treatment-related adverse events were fatigue, alopecia, and dysgeusia. No surgeries were delayed due to enfortumab vedotin administration.
“The observed pathological complete response after neoadjuvant enfortumab vedotin showed promising activity in cisplatin-ineligible patients with MIBC. This justifies the ongoing phase 2 and phase 3 programmes which are evaluating enfortumab vedotin either alone or in combination with pembrolizumab in patients with MIBC,” concluded Prof. Petrylak.
- Pfister C, et al. Eur Urol. 2021;79:214–221.
- Powles T, et al. N Engl J Med 2021;384:1125–1135.
- Petrylak, DP, et al. Study EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients (pts) with muscle invasive bladder cancer (MIBC) who are cisplatin-ineligible. Abstract 435, ASCO GU 2022, 17–19 February.
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Table of Contents: ASCO GU 2022
Letter from the Editor
ASCO GU 2022 Highlights Podcast
First-line treatment with olaparib significantly improves PFS in mCRPC
First-line treatment with niraparib significantly improves PFS in HRR-mutated mCRPC
Darolutamide improves OS in mHSPC
Continued enzalutamide plus docetaxel offers clinical benefit for mCRPC patients who progress on enzalutamide
Radiohybrid PSMA PET imaging has favourable detection rate for prostate cancer recurrence
PSMA PET is a predictive biomarker in mCRPC progressing after docetaxel
Artificial intelligence improves prediction of long-term outcomes
Significant tumour response to neoadjuvant therapy in high-risk non-metastatic prostate cancer
Addition of abiraterone to ADT/docetaxel does not increase bone loss
Bavdegalutamide, a novel androgen receptor degrader, demonstrates clinical activity
No benefit of olaparib in previously untreated, platinum-ineligible, metastatic urothelial carcinoma
Rucaparib maintenance therapy extends PFS in platinum-responsive metastatic urothelial carcinoma
Positive efficacy and safety of N-803 plus BCG infusion in BCG-unresponsive NMIBC
Adding lenvatinib to pembrolizumab does not improve survival in advanced urothelial carcinoma
Maintenance niraparib fails to improve PFS in advanced urothelial cancer
First-line avelumab shows clinical activity in advanced urothelial carcinoma
Favourable pathologic response rate with neoadjuvant chemotherapy in high-risk upper tract urothelial carcinoma
Second-line nivolumab/ipilimumab boost improves ORR in metastatic urothelial carcinoma
Sacituzumab govitecan effective in platinum-refractory metastatic urothelial cancer
Neoadjuvant enfortumab vedotin promising in MIBC ineligible for cisplatin
Renal Cell Carcinoma
High-risk early RCC may benefit from neoadjuvant avelumab plus axitinib
DFS benefits with adjuvant pembrolizumab in RCC persist with longer follow-up
Biomarkers predict response to immune nivolumab (± ipilimumab) in advanced RCC
Combined nivolumab/axitinib treatment elicits good response in metastatic RCC
Folliculin mutations not associated with sporadic chromophobe RCC
Differential patterns of molecular alterations among sites of metastasis in RCC
Nivolumab monotherapy represents an alternative first-line treatment option for treatment-naïve mRCC
Penile & Testicular Cancer
HPV-positive and HPV-negative penile squamous cell carcinoma are molecularly distinct tumours
Atezolizumab does not improve survival in advanced penile cancer
Biomarkers to distinguish necrosis from teratoma before pcRPLND in testicular cancer
HPV and penile cancer
Bayer’s Nubeqa drug improves survival in prostate cancer trial