Abstract 1895P
Background
Immunotherapy is associated with different response patterns compared with chemotherapy and targeted therapy, including delayed response and stabilization after disease progression. In clinical practice, immunotherapy can be continued after radiological progression when clinical benefit is observed. Therefore, progression-free survival (PFS), calculated with the first disease progression, may not express the real benefit derived from immunotherapy.
Methods
The Meet-URO 15 study was a multicentric retrospective analysis on 571 pretreated mRCC pts receiving nivolumab. TTF was defined as the time from start of therapy to the definitive disease progression which changed the therapeutic line or death. The comparison between TTF and PFS and the prognostic performance of the Meet-URO score versus (vs) the IMDC score according to TTF and PFS were assessed. Moreover, response and survival outcomes between TBP pts and non-TBP pts were evaluated.
Results
571 pts were included in the analyses (PMID: 34046089). Median TTF was 8.9 months (range: 7.2-10.2) and mPFS was 7.2 months (range: 5.8-8.6). The Meet-URO score performed better than the IMDC score in both TTF (c index: 0.63 vs 0.59) and PFS (0.62 vs 0.59). TBP pts were associated with higher overall response rate (34.4% vs 23.6%; p = 0.035) and disease control rate (61.3% vs 54.8%; p = 0.30). Moreover, TBP pts interestingly correlated with longer TTF (25.0 vs 10.7 months; p<0.001) and OS (42.5 vs 26.7 months; p<0.001), but had similar PFS compared with non-TBP pts. In TBP pts, a mean delay of 13.2 months (range: 6-20.4) from first to definitive disease progression was observed (25 vs 11.8 months), while non-TBP pts had overlapped TTF and PFS (10.8 months).
Conclusions
In pretreated mRCC pts receiving nivolumab, a small difference between mTTF and mPFS (∼2 months) was observed in the overall population. However, TBP pts were associated with significantly better ORR (+10%), TTF (+13 months) and OS (+ 15.8 months). Moreover, the Meet-URO score prognostically performed better with TTF than with PFS and compared with the IMDC score in both survival outcomes.
Clinical trial identification
Regional Ethical Committee of Liguria - registration number 068/2019.
Editorial acknowledgement
Legal entity responsible for the study
G. Fornarini.
Funding
Has not received any funding.
Disclosure
S.E. Rebuzzi: Financial Interests, Personal, Invited Speaker: GSK, BMS, Astellas; Financial Interests, Personal, Other, Travel accommodation: Janssen, MSD. S. Buti: Financial Interests, Personal, Advisory Board: BMS, Pfizer, MSD, MSD, Ipsen, AstraZeneca, Pierre-Fabre, Novartis; Financial Interests, Personal, Invited Speaker: BMS, MSD, Ipsen, AstraZeneca, Novartis; Financial Interests, Institutional, Local PI: BMS, Ipsen, AstraZeneca; Financial Interests, Institutional, Coordinating PI: BMS, MSD; Financial Interests, Institutional, Research Grant: Novartis; Non-Financial Interests, Other, Member of panel for kidney cancer guidelines: AIOM (Italian Association of Medical Oncology); Non-Financial Interests, Other, member and coordinator of the “Rare Tumors” group: Meet-URO group (Italian Network For Research In Urologic-Oncology). U.F.F. De Giorgi: Financial Interests, Personal, Advisory Board: Pfizer, BMS, MSD, PharmaMar, Astellas, Bayer, Ipsen, Novartis, Eisai, Janssen; Financial Interests, Personal, Invited Speaker: Roche, BMS, Clovis Oncology, AstraZeneca; Financial Interests, Institutional, Research Grant: AstraZeneca, Sanofi, Roche. P.A. Zucali: Financial Interests, Institutional, Local PI: Merck, Bayer, Pfizer, BMS Int. Corp. Belgium Branch. M. Soraru: Financial Interests, Personal, Advisory Role: Janssen; Financial Interests, Personal, Speaker, Consultant, Advisor: Janssen, Ipsen, BMS, Pfizer, Astellas, Sanofi, Roche, Novartis; Financial Interests, Institutional, Research Funding: Roche, Merck, Janssen. C. Masini: Financial Interests, Personal, Speaker, Consultant, Advisor: Ipsen, Astellas, BMS, MSD; Financial Interests, Personal, Advisory Role: BMS, Astellas, Ipsen, MSD, AstraZeneca, Janssen, Merck Serono. G. Fornarini: Financial Interests, Personal, Advisory Board: Amgen, Astellas, BMS, Janssen, Eisai, Ipsen, Pfizer, Bayer; Financial Interests, Personal, Other, ESMO meeting - travel accommodation: Ipsen. All other authors have declared no conflicts of interest.
Resources from the same session
1912TiP - STELLAR-304: A randomized phase III study of zanzalintinib (XL092) and nivolumab in non-clear cell renal cell carcinoma (nccRCC)
Presenter: Sumanta Pal
Session: Poster session 23
2366P - Phase I-II study of niraparib plus cabozantinib in patients with advanced urothelial/kidney cancer (NICARAGUA trial)
Presenter: Daniel Castellano Gauna
Session: Poster session 23
2367P - A randomized phase II study of atezolizumab (atezo) plus recombinant human IL-7 (CYT107) vs. atezo alone in patients with locally advanced or metastatic urothelial carcinoma (mUC)
Presenter: Russells Pachynski
Session: Poster session 23
2368P - Activity of cabozantinib (CABO) plus durvalumab (DURVA) in patients (pts) with advanced non-urothelial-carcinoma variant histologies (VHs) or urothelial carcinoma (UC) after platinum-based chemotherapy: Interim results from the phase II ARCADIA trial
Presenter: Patrizia Giannatempo
Session: Poster session 23
2369P - Phase II study of nivolumab (nivo) and ipilimumab (ipi) for advanced bladder cancer with variant histologies (BCVH)
Presenter: Bradley McGregor
Session: Poster session 23
2370P - Updated results of PEANUT trial: Pembrolizumab and nab-paclitaxel as salvage therapy for platinum-treated, locally advanced or metastatic urothelial carcinoma (mUC)
Presenter: Achille Bottiglieri
Session: Poster session 23
2371P - Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): Long-term outcomes from the JAVELIN Bladder 100 trial in older patients (pts)
Presenter: Shilpa Gupta
Session: Poster session 23
2372P - Efficacy of a tailored approach with nivolumab (N) and nivolumab+ipilimumab (N+I) as immuno-therapeutic boost in metastatic urothelial carcinoma (mUC): Final results of TITAN-TCC
Presenter: Marc-Oliver Grimm
Session: Poster session 23
2373P - Outcomes by retrospective eligibility for maintenance therapy of patients (pts) with advanced urothelial carcinoma (UC): Post hoc analysis of KEYNOTE-361
Presenter: Ronac Mamtani
Session: Poster session 23
2374P - A phase Ib single-arm trial of bintrafusp alfa (BA) for pretreated, locally advanced/unresectable or metastatic (advanced) urothelial cancer (aUC)
Presenter: Petros Grivas
Session: Poster session 23