2380P - Real-world effectiveness of single agent enfortumab vedotin (EV) in patients (pts) with locally advanced or metastatic urothelial carcinoma (mUC) based on line of therapy and impact of prior platinum (plat) chemotherapy (chemo) and PD-1/PD-L1 inhibitors (PD-1/PD-L1i)

Background

EV is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated for the treatment (trt) of pts with mUC who have previously received a PD-1/L1i and plat chemo, or are ineligible for cisplatin-containing chemo and have received ≥ 1 prior lines of therapy. However real-world effectiveness of EV based on line of therapy and impact of prior trt is currently not well established.

Methods

This study used the nationwide (US-based) Flatiron Health EHR-derived de-identified database. Inclusion: diagnosis of advanced, recurrent or mUC of upper or lower urinary tract and trt with single agent EV in 2^nd line or beyond after 12/18/2019 (FDA accelerated approval date). Exclusion: Pts with no documentation of 1^st-line therapy or pts with no evidence of contact for 90 days from diagnosis of mUC at treating institution to ensure pts were actively engaged in care at the institution providing data. Time to next therapy (TTNT) and overall survival (OS) were summarized based on line of therapy and prior plat chemo and PD-1/L1i using Kaplan Meier survival estimates and its 95% confidence interval (CI).

Results

Overall 6,566 pts with mUC received trt of which 431 received EV from 1/17/2020 to 9/30/2022. Baseline pt characteristics for each line of therapy will be presented at the meeting. The table summarizes real world TTNT and OS of pts.

Table: 2380P

Median TTNT and OS in months and their 95% CI for EV based on line of trt and receipt of prior plat chemo or PD-1/L1i or not

Y, yes; N, No

Conclusions

EV retains activity in pts with mUC, regardless of prior receipt of plat chemo and PD-1/L1i, and line of systemic therapy. These data may further aid with patient counseling, prognostication, and selection of therapy in the clinics.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

B.L. Maughan: Financial Interests, Personal, Other, consultant: AbbVie, Pfizer, AVEO Oncology, Janssen, Astellas, Bristol Myers Squibb, Clovis, Tempus, Merck, Exelixis, Bayer Oncology and Peloton Therapeutics; Financial Interests, Institutional, Funding: Exelixis (Inst), Bavarian-Nordic (Inst), Clovis (Inst), Genentech (Inst) and Bristol Myers Squibb (Inst) . S. Gupta: Financial Interests, Personal, Other, presenter, honoraria, travel grant: SITC advances in Cancer Immunotherapy as the Salt Lake City Program Organizer and presenter, travel support from QED Biopharmaceutical; Financial Interests, Institutional, Funding: Bristol Myers Squibb, Rexahn, Incyte, Novartis, LSK, Five Prime, Mirati, QED, Debiopharm, Merck, Pfizer, AstraZeneca, MedImmune, Clovis, Immunocore, and Seattle Genetics. N. Agarwal: Financial Interests, Personal, Advisory Board, In the last two calendar years, I participated in the scientific advisory board of these pharma companies between February 2021 to April 2021. None after that: Merck, Aveo, Gilead, Lilly, Exelixis, Foundation Medicine; Financial Interests, Trial Chair, involved in the following phase 3 trials as the trial co-chair: TALAPRO-2, TALAPRO-3 (both Pfizer), and CONTACT-2 (Exelxis): Pfizer, Exelixis; Financial Interests, Institutional, Other, I serve in the leadership of my cancer center (Huntsman Cancer Institute, University of Utah. Salt Lake City, UT, USA). There are multiple research projects sponsored by these companies which pay money to my institution: Arnivas, Astellas, AstraZeneca, Bavarian Nordic, Bayer, Bristol Myers Squibb, Calithera, Celldex, Crispr, Eisai, Eli Lilly, EMD Serono, Exelixis, Genentech, Gilead, Glaxo Smith Kline, Immunomedics, Janssen, Lava, Medivation, Merck, Nektar, Neoleukin, New Link Genetics, Novartis, Oric, Pfizer, Prometheus, Rexahn, Roche, Sanofi, Seattle Genetics, Takeda, and Tracon; Financial Interests, Steering Committee Member, I am involved in the steering committee of the trials sponsored by these pharmas with no personal honorarium: AstraZeneca, Calithera, Clovis, Crispr, Eisai, Eli Lilly, Exelixis, Immunomedics, Janssen; Financial Interests, Steering Committee Member, I am involved in the steering committee of the trials sponsored by these pharma companies with no personal honorarium: Merck, Nektar, New Link Genetics, Oric, Pfizer, Prometheus, Rexahn, Takeda, and Tracon. U. Swami: Financial Interests, Personal, Advisory Board: Astellas, Exelixis, Seattle Genetics, Imvax, AstraZeneca, and Sanofi ; Financial Interests, Institutional, Funding: Janssen, Exelixis, and Astellas/Seattle Genetics. All other authors have declared no conflicts of interest.