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LP166: VOLGA: Results from the phase 3 safety run-in with durvalumab (D) + tremelimumab (T) + enfortumab vedotin (EV) for cisplatin-ineligible muscle-invasive bladder cancer (MIBC)

Speaker
Prof. Dr. T. (Thomas) Powles
Authors
Powles T.1, Bupathi M2, Joshi M.3, Fleming M.4, Gomez De Liano A.5, Morales-Barrera R.6, Vuky J.7, Pili R.8, Hois S.9, Boulos S.10, Drakaki A.11
Institutions
1Barts Cancer Institute, Queen Mary University of London, Genitourinary Oncology, London, United Kingdom, 2Rocky Mountain Cancer Centers, Medical Oncology, Littleton, United States of America, 3Penn State Cancer Institute, Department of Medicine / Division of Hematology and Oncology, Hershey, United States of America, 4Virginia Oncology Associates, Medical Oncology / Hematology / Radiation Oncology, Norfolk, United States of America, 5Complejo Hospitalario Universitario Insular Materno Infantil, Genitourinary Oncology, Las Palmas, Spain, 6Vall d´Hebron Institute of Oncology, Vall d´hebron University Hospital, Universitat Autònoma de Barcelona, Medical Oncology, Barcelona, Spain, 7OHSU Knight Cancer Institute, Medicine, Portland, United States of America, 8Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Medicine, Buffalo, United States of America, 9AstraZeneca, Immuno-Oncology, Cambridge, United Kingdom, 10AstraZeneca, Clinical Development, Cambridge, United Kingdom, 11David Geffen School of Medicine, University of California, Division of Hematology/Oncology, Los Angeles, United States of America
Event
14th European Multidisciplinary Congress on Urological Cancers
Date
10 November 2022
Topic
Urothelial Cancer - Treatment

Introduction & Objectives

Approximately 40% of patients with MIBC are cisplatin-ineligible, and in this patient population, radical cystectomy (RC) alone remains the standard of care. VOLGA is the first international Phase 3 study examining the novel triplet combination of D (anti-PD-L1) + T (anti-CTLA-4) + EV (antibody–drug conjugate directed against nectin-4) for cisplatin-ineligible MIBC. Here, we present the safety run-in (SRI) results from VOLGA (NCT04960709).

Materials & Methods

Eligible patients were ≥18 yrs, cisplatin-ineligible (Galsky criteria), with histologically documented MIBC (urothelial and/or mixed) and clinical stage of T2-4aN0-N1M0 including T1N1M0. Treatment for the SRI population comprised 3 cycles of neoadjuvant therapy Q3W: D (1500 mg; Day 1 each cycle) + T (75 mg; Day 1, Cycle 1 and Day 8 Cycle 2) + EV (1.25 mg/kg; Days 1 & 8 each cycle), followed by radical cystectomy. In the adjuvant phase, patients receive 9 cycles of therapy Q4W: D (Day 1 each cycle) + T (Day 1, 1st cycle only). Primary SRI endpoints were safety and tolerability. Data cutoff was August 2022.

Results

A total of 17 patients participated in the SRI (see Table). All 3 neoadjuvant cycles were completed by 13 patients. Radical cystectomy was performed in 14 patients, with no delays in time to surgery. Overall, 16 patients experienced ≥1 treatment-related AE (TRAE): 8 patients had Grade 3 or 4 TRAEs, and no Grade 5 TRAEs occurred. Disease progression occurred in 1 patient prior to cystectomy and in 1 patient post-surgery. Further safety and efficacy for the SRI population will be presented.

Baseline Characteristics (N=17) n (%)
Age Median: 75 years; Range: 50-83
Male 16 (94)

ECOG Performance Status
    0
    1
    2


8 (47)
8 (47)
1 (6)
Tumor Stage
    T2
    T2a
    T2b
    T3
    T4a
Regional Lymph Nodes
    N0
    N1
Metastases
    M0

7 (41)
3 (18)
3 (18)
2 (12)
2 (12)

15 (88)
2 (12)

17 (100)

Conclusions

Preliminary safety results from the SRI portion of the VOLGA trial support continued evaluation of the triplet regimen of D+T+EV in patients with cisplatin-ineligible MIBC. The randomized phase 3 portion of VOLGA has opened for enrollment, with a recent protocol amendment to also include patients who refuse cisplatin.

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