1983P - Feasibility and efficacy of split-dose cisplatin with atezolizumab for cisplatin-ineligible urothelial carcinoma (SOGUG-AUREA): Final results

Background

Recent research suggests cisplatin offers immunomodulatory benefits with atezolizumab (ATZ) compared to carboplatin (Galsky et al. 2024). This aligns with nivolumab + gemcitabine/cisplatin emerging as the new frontline standard for urothelial carcinoma (UC) (Van der Heijden et al. 2023). In this phase 2 trial, we investigated the feasibility and efficacy of combining ATZ with a split-dose cisplatin regimen in UC patients (pts) ineligible for full cisplatin doses. Here, we present the final results of this study.

Methods

The phase II SOGUG-AUREA clinical trial recruited treatment-naive pts in advanced or metastatic settings considered unfit for full dose of platinum-based chemotherapy (CT). Pts received a split dose of cisplatin (35 mg/m2) and gemcitabine (1000 mg/m2) days 1 and 8 (up to 6 cycles) in combination with 3-weekly ATZ 1200 mg in D1 intravenously until progression, unacceptable toxicity, or absence of clinical benefit. Here we present the final results for confirmed objective response rate (ORR) according to RECIST 1.1 (primary endpoint).

Results

66 pts were included between Jan 2021 and Mar 2022. Baseline characteristics are outlined in the table. The confirmed ORR was 48.5% (95% CI: 36-61), with 7 (10.61%) pts having CR. The median duration of the response was 9.2 m (95%CI: 5.5-16.8). After a median follow-up of 11.6 m (range: 0.6-35.3), median PFS was 6.9 m (95%CI: 6.7-9.4), 12-m PFS rate of 31.0% (95% CI: 21.4-44.8). The median OS was 12.9 m (95% CI: 10.2-20.2), with a 24-m OS rate of 30.1% (95%CI: 20.6-44.1). Most frequent grade 3-4 toxicities were neutrophil count decreased (31.8%), anemia (25.8%) and platelet count decreased (19.7%). Table: 1983P

Conclusions

ATZ plus split doses of CT showed signs of activity in line with other chemo-ICI combinations surpassing the futility threshold in terms of ORR, in frail pts with UC. A third of pts were still alive after 2 years. Safety profile was consistent with previous experience.

Clinical trial identification

EudraCT 2020-001326-65; NCT04602078.

Editorial acknowledgement

We acknowledge MFAR Clinical Research staff for their assistance in the development of this abstract.

Legal entity responsible for the study

Spanish Oncology GenitoUrinary Group (SOGUG) as Sponsor.

Funding

Roche.

Disclosure

G.A. De Velasco Oria: Financial Interests, Personal, Advisory Board: Pfizer, Astellas, BMS, MSD, Ipsen, Bayer, AstraZeneca, Eisai; Financial Interests, Personal, Invited Speaker: Pfizer, Astellas, BMS, MSD, Roche, Ipsen, Merck, Novartis, Janssen, Bayer; Financial Interests, Institutional, Research Grant: Roche. A. Pinto: Financial Interests, Personal, Advisory Board: Pfizer, BMS, Janssen, Astellas, Ipsen, Clovis, Bayer, Sanofi, Roche, Merck, MSD, AstraZeneca; Financial Interests, Personal, Invited Speaker: Pfizer, Janssen, Astellas, Bayer, Pierre Fabre, Roche; Financial Interests, Personal, Research Grant: Pfizer, BMS; Financial Interests, Personal and Institutional, Local PI: Roche, Exelixis, Eisai, Bayer, Janssen, Novartis, BMS, Clovis, Aver, MSD; Financial Interests, Personal and Institutional, Coordinating PI: Pfizer, Bayer. D. Lorente: Financial Interests, Personal, Invited Speaker: Janssen, Astellas, Bayer, Sanofi, Bristol Myers, AstraZeneca, MSD; Financial Interests, Personal, Advisory Board: Janssen, Sanofi, Pfizer, AstraZeneca; Financial Interests, Personal, Other, Travel: Bayer, Pfizer. A. Gomez de Liano Lista: Financial Interests, Personal, Advisory Board: Astellas, BMS, Ipsen, Johnson & Johnson, Merck, Roche, MSD, Astellas, BMS, Ipsen, Johnson & Johnson, Merck, Roche, MSD; Financial Interests, Personal, Invited Speaker: Astellas, AstraZeneca, Ipsen, Johnson & Johnson, MSD, Bayer, Merck, Astellas, AstraZeneca, Johnson & Johnson, MSD, Bayer, Merck, Ipsen; Financial Interests, Institutional, Local PI: AstraZeneca, MedSIR, MSD, Merck, Johnson & Johnson, Gilead, AstraZeneca, MedSIR, MSD, Merck, Johnson & Johnson, Gilead; Non-Financial Interests, Member of Board of Directors: Grupo Germinal Oncológico, Grupo Germinal Oncológico. L. Jimenez Colomo: Financial Interests, Personal, Speaker, Consultant, Advisor: BMS, MSD, Pfizer, Astellas, Novartis, Roche, Merck, Eusa Pharma, Ipsen; Financial Interests, Personal, Other, Speak at sponsored meeting: PharmaMar. J. Puente: Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca, Janssen, MSD, Pfizer, Eisai, Ipsen, Roche, BMS, Merck, Novartis, Gilead; Financial Interests, Personal, Invited Speaker: Astellas, AstraZeneca, Janssen, MSD, Bayer, Pfizer, Eisai, Roche, BMS, Merck; Financial Interests, Institutional, Research Grant: Astellas, Roche, Merck. O. Fernandez Calvo: Financial Interests, Personal, Invited Speaker: Astellas, Astellas, Merck, Ipsen, MSD, AstraZeneca, Novartis; Financial Interests, Personal, Advisory Board: Ipsen, Eisai, AAA. G. Anguera: Financial Interests, Personal, Speaker’s Bureau: BMS, Merck. All other authors have declared no conflicts of interest.