Abstract 1474P
Background
The current treatment landscape in mRCC is based on antiangiogenic and immune-based therapies demonstrating a significant improvement in survival. However, there is a paucity of well-validated prognostic and predictive biomarkers. The main objective was to evaluate the role of PD-L1 as an independent prognostic factor in a cohort of mRCC patients treated only with antiangiogenic agents.
Methods
Retrospective, multicentre (25 centres) study on patients (pts) that had received antiangiogenic drugs, but no immune based therapies, during treatment sequence. Demographic and tumor-related data were obtained from medical records. PD-L1 expression (22C3 pharmDx) from primary tumor tissues were centrally obtained. Univariable and multivariable log-rank test and Cox regressive models were used.
Results
242 out of 340 pts (71.2%) were assessable, mean age was 64.0 (SD 11.5) years and 185 (76.4%) were men. According to the IMDC score; 13 pts (7.8%) had favourable, 92 (55.4%) intermediate and 61 (36.7%) poor prognosis. 113 pts (46.7%) received a single line of antiangiogenics. Sunitinib was chosen as first line in 70.7% and pazopanib in 26%. PD-L1 tumor expression was <1% in 205 (84.7%) and >1% in 37 (15.3%) of the samples. Overall survival (OS) showed statistically differences according to PD-L1 expression (median of 14.5 months (m) for PD-L1 <1% vs 9.7m for PD-L1 ≥1%) (p=0.0023). OS based on the IMDC score was [median (m;95%CI)]: for the favourable [37.8m;3.7-49.1)], intermediate [15.1m (12.3-20.8)] and poor 4.2m (2.1-7.3) prognosis groups (p<0.05). The multivariable analysis identified the worst survival for PD-L1 expression ≥1 % (HR 0.62 (0.41-0.93), p=0.0216), poor IMDC prognosis criteria (HR 0.40 (0.28-0.57), p<0.05) and more than one metastatic location (HR 0.66 (0.48-0.91), p=0.0106).
Conclusions
To our knowledge, this is the first study analyzing the value of PD-L1 expression in a population of mRCC pts who had died and treated exclusively with antiangiogenics. The results of our analyses show that PD-L1 expression has a prognostic role in mRCC pts, suggesting its value as an indication of using check-point inhibitors from the first line and not only antiangiogenic drugs.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
SOGUG.
Funding
Pfizer S.L.U.
Disclosure
E. Feliciangeli: Financial Interests, Personal, Invited Speaker: GP Pharma, Servier, Astellas. S. Galvan Ruiz: Financial Interests, Personal, Invited Speaker: Astellas, Ipsen, Ipsen, Pfizer, Servier, Merck, Roche; Financial Interests, Personal, Advisory Board: Ipsen, BMS, BMS, Lilly, Ipsen. A. Gómez de Liaño: Financial Interests, Personal, Invited Speaker: Astellas, AstraZeneca, Ipsen, Janssen, MSD, Pfizer; Financial Interests, Personal, Advisory Board: Astellas, BMS, Ipsen, Merck, Janssen, Pfizer, Roche; Financial Interests, Personal, Training: MSD; Financial Interests, Personal, Expert Testimony: Roche; Financial Interests, Institutional, Principal Investigator: AstraZeneca, MedSIR. B. Perez Valderrama: Financial Interests, Personal, Advisory Board: Pfizer, Astellas Pharma, Bristol Myers Squibb, Ipsen, EUSA Pharma, Sanofi-Aventis, Merck, MSD, AstraZeneca; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb, Roche, Bayer, EUSA Pharma, MSD, Merck, Pfizer, Janssen, Astellas Pharma. A. Rodriguez Sanchez: Financial Interests, Personal, Advisory Board: Roche, Janssen, Sanofi, Merck, Ipsen, Eisai, Bristol. C. Suarez Rodriguez: Financial Interests, Personal, Advisory Board: Astellas Pharma, Bayer, Bristol Myers Squibb (Inst), Ipsen, Pfizer S.L.U, Sanofi- Aventis, Hoffmann-La Roche Ltd., Merck Sharp and Dohme; Financial Interests, Personal, Invited Speaker: Astellas Pharma, Bristol Myers Sqquib (Inst), Ipsen, Pfizer S.L.U, Hoffmann-La Roche Ltd.; Financial Interests, Institutional, Funding: Ipsen. M. Lázaro Quintela: Financial Interests, Personal, Other: Pfizer, Lilly, MSD, BMS, Astellas, Janssen, Ipsen, Bayer, Roche, AstraZeneca, Boheringer, Takeda; Financial Interests, Personal and Institutional, Principal Investigator: Mirati, Roche, AstraZeneca, Janssen. E. Gallardo Diaz: Financial Interests, Personal, Advisory Board: Sanofi, Janssen, Astellas, Pfizer, Bayer, Roche, Ipsen, Eisai, EUSA Pharma, BMS, AstraZeneca, Merck, Daiichi Sankyo, Techdow, Lilly; Financial Interests, Personal, Invited Speaker: Sanofi, Janssen, Astellas, Pfizer, Bayer, Roche, Ipsen, Eisai, EUSA Pharma, BMS, Merck, Daiichi Sankyo, MSD, Menarini, Rovi, Leo Pharma, Boehringer Ingelheim; Financial Interests, Personal, Expert Testimony: Merck, Novartis, Pfizer; Financial Interests, Institutional, Invited Speaker: Astellas, Medivation, Ipsen, Janssen, Pfizer, Lilly, Pfizer-Merck, MSD, BMS, Bayer, Daiichi Sankyo, Roche, AstraZeneca, Novartis, Seattle Genetics, Incyte, Aveo, Exelixis, Immunicum, Mediolanum, Clovis, QED Therapeutics; Non-Financial Interests, Leadership Role, Member of the Board: SOGUG; Non-Financial Interests, Leadership Role, Member of the Board of Thrombosis and Cancer Section: SEOM. J. Guma I Padro: Financial Interests, Personal, Advisory Board: Sanofi/aventis, Kite/Gilead; Financial Interests, Personal, Other: Sanofi/aventis. J. Puente: Financial Interests, Personal, Invited Speaker: Astellas, Janssen, Bayer, AstraZeneca, Ipsen, Roche, BMS, Merck, Pfizer; Financial Interests, Personal, Advisory Board: Eisai. M. Martinez Kareaga: Other, Personal, Invited Speaker: Roche, Bristol Myers Squibb; Other, Personal, Advisory Board: Merck. M.D.C. Beato Zambrano: Financial Interests, Personal, Other: Roche, Pfizer, BMS. All other authors have declared no conflicts of interest.