Abstract 1469P
Background
Pembrolizumab/Axitinib (PAXI) combination is approved as first-line therapy in mRCC. The aim of this study is to evaluate outcomes of PAXI combo in the real-world in Italy.
Methods
This is a prospective study including patients (pts) diagnosed with mRCC who received PAXI as first-line therapy in recruiting Italian Centers. Data about patient characteristics, safety and outcome were collected.
Results
96 pts have been treated from January 2021 to April 2022. The majority had clear-cell histology (81%). Sarcomatoid features was present in 22.9% (48 pts unknown). Grade 3-4 histology was the most represented accounting for 72%. About one half of pts (44%) had synchronous metastasis. In 68% of cases nephrectomy was performed. The most common metastatic sites were: lung (61%), lymph nodes (47%), bone (39%). Liver and brain were involved in 20% and 9% of cases respectively. IMDC was assessed in 87 pts: 19% were good-risk, 60% intermediate-risk, 21% poor-risk. At time of analysis, treatment was ongoing in 70% of pts, both pembrolizumab and axitinib were still ongoing in 65% of cases. Progression occurred in 25% of pts. Landmark 6-mos and 12-mos progression-free survival were 77% (95%CI 66-84) and 60% (95%CI 46-72) respectively. With a median follow-up of 8 mos and 16% of deaths, landmark 6-mos and 12-mos overall survival were 90% (95%CI 81-95) and 74% (95%CI 59-84) respectively. Among 76 evaluable pts, 79% reached disease control rate, with 4% complete response, 49% partial response and 26% stable disease. About half of pts (57%) presented clinically significant adverse event (AE), defined as AE requiring corticosteroids (29%), hormone replacement (11%), drug delay (71%), discontinuation (16%) or dose reduction (36%). The most frequent AE were hepatic (18%), endocrine (14%) and gastro-intestinal (16%). Grade ≥3 was reported in 28% of cases. In 19 pts (21%) a second clinically significant AE also occurred. Among the 29 pts that discontinued treatment, 59% received a subsequent line of therapy.
Conclusions
Our findings support the effectiveness and safety of first-line PAXI combination in mRCC pts also in routine clinical practice.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Azienda Ospedaliera Santa Maria, Terni.
Funding
Has not received any funding.
Disclosure
F. Calabrò: Other, Institutional, Advisory Role: BMS, MSD, AstraZeneca, Ipsen, Merck, Pfizer; Other, Institutional, Sponsor/Funding: Parexel, Syneos, PRA, IQVIA, J&J, Janssen, Icon, Roche, Eisai, Bayer. All other authors have declared no conflicts of interest.