1741P - Atezolizumab (ATZ) with split-doses of cisplatin plus gemcitabine in patients with locally advanced or metastatic urothelial carcinoma (SOGUG-AUREA): A multicentre, single-arm phase II trial

Background

Split-dose cisplatin plus gemcitabine is an alternative for combinations with immunotherapy in unfit patients for full doses of cisplatin. The combination of split-dose cisplatin with ATZ might be a feasible treatment that could provide better outcomes than single-agent monotherapy or carboplatin combinations.

Methods

SOGUG-AUREA recruited treatment-naive pts in advanced or metastatic settings considered unfit for full dose of platinum-based CT according to protocol. Pts received a split dose of cisplatin (35 mg/m2 ) and gemcitabine (1000 mg/m2) day ⅛ (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 pts characteristics, treatment compliance and preliminary survival.

Results

Between Jan 2021 and Feb 2022, 82 pts were screened, 66 pts were enrolled and 65 received at least one dose of study treatment. Baseline characteristics are outlined in the table. The median number of CT cycles administered was 5 (range: 1-6). ATZ median treatment duration was 5.7 m (range: 0.7-13.2). Therapy was discontinued in 27 (40%) pts. Most common ATZ discontinuation reasons were PD (24.6%), death (4.6%), adverse events (AEs) (4.6%) and toxicity (1.5%). Most common CT discontinuation reasons were PD (13.8%), end as scheduled (7.7%), AEs (6,2%), toxicity (4.6%), or death (4.6%). With a median follow-up of 5.9 m (range: 0.6-12.9), the median PFS was 6.7 m (95%CI: 5.9-7.3), with a 6-months PFS rate of 60.3% (95% CI: 47.3-76.9). The 6-months OS rate was 78.9% (95%CI: 68.8-90.4). Most frequent grade 3-4 toxicities were anemia (21.5%), neutrophil count decreased (20%) and platelet count decreased (12.3%). Table: 1741P

Conclusions

ATZ with split doses of CT was safely administered, with good adherence in a population of frail pts with mUC who were unfit for CT showing promising preliminary survival outcomes.

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).

Funding

Spanish Oncology GenitoUrinary Group (SOGUG) as Sponsor. Collaborator: Roche.

Disclosure

G.A. De Velasco Oria: Financial Interests, Personal, Advisory Board: Pfizer, Astellas, BMS, MSD, Ipsen, Bayer, Eusa P., Merck; Financial Interests, Personal, Invited Speaker: Pfizer, astellas, BMS, MSD, Roche, Ipsen, Merck; Financial Interests, Institutional, Research Grant: Roche. A. Pinto: Financial Interests, Personal, Invited Speaker: BMS, Pfizer, Ipsen, Roche, Janssen, Bayer; Financial Interests, Personal, Advisory Board: BMS, Pfizer, Ipsen, Roche, Merck, Janssen, Astellas, Bayer, Sanofi, Clovis; Financial Interests, Personal, Research Grant: BMS, Pfizer; Financial Interests, Other, Clinical trial payments: Janssen, Roche, Exelixis, Clovis, Aveo, Bayer. D. Lorente: Financial Interests, Personal, Invited Speaker: Astellas, AstraZeneca, Bayer, Bristol Myers, Janssen, MSD, Sanofi; Financial Interests, Personal, Advisory Board: AstraZeneca, Janssen, Pfizer, Sanofi. A. Gómez de Liaño: Financial Interests, Personal, Invited Speaker: Astellas, AstraZeneca, Ipsen, Janssen, MSD, Pfizer; Financial Interests, Personal, Advisory Board: Astellas, BMS, Ipsen, Janssen, Merck, Pfizer, Roche; Financial Interests, Other, Staff training: MSD; Financial Interests, Personal, Expert Testimony: Roche; Financial Interests, Institutional, Principal Investigator, Local PI: AstraZeneca, MedSIR. E. Martínez Ortega: Financial Interests, Personal, Other, Honoraria you have directly received for any speaker, consultancy or advisory role or similar activity: Ipsen Pharma, Roche, Sanofi. L. Jimenez Colomo: Financial Interests, Personal, Advisory Role: BMS, MSD, Astellas, Novartis, Roche, Merck, Eusa Pharma, Ipsen; Financial Interests, Personal, Invited Speaker: BMS, MSD, Astellas, Novartis, Roche, PharmaMar, Merck, Eusa Pharma, Ipsen. J. Puente: Financial Interests, Personal, Other, Speaker, consultancy & advisory role: Astellas, Janssen, MSD, Ipsen, Roche; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Other, Speaker & advisory role: AstraZeneca; Financial Interests, Personal, Other, Consultancy & advisory role: Eisai; Financial Interests, Personal, Invited Speaker, Speaker & advisory role: BMS, Merck, Pfizer; Financial Interests, Personal, Research Grant: Roche, MSD, Eisai, Ipsen, AstraZeneca, Novartis. O. Fernández: Financial Interests, Personal, Other, Honoraria you have directly received for any speaker, consultancy or advisory role or similar activity: Astellas, Janssen, AstraZeneca, Ipsen, Merck, Novartis, Eisai, BMS; Non-Financial Interests, Personal, Leadership Role, Member of SOGUG (Spanish Oncology Genitourinary Group) board: SOGUG. G. Anguera: Financial Interests, Personal, Speaker’s Bureau: Ipsen, Janssen, Astellas, Roche, Bristol Myers Squibb. All other authors have declared no conflicts of interest.