Weill Cornell Medicine, New York, NY
Cora N. Sternberg , Axel Stuart Merseburger , Ernest Choy , Daniel E. Castellano , Fernando Lopez-Rios , Nicholas James , Giuseppe Luigi Banna , Ugo De Giorgi , Cristina Masini , Aristotelis Bamias , Xavier Garcia del Muro , Thomas Powles , Ignacio Duran , Craig Gedye , Marija Gamulin , Friedemann Zengerling , Lajos Geczi , Sabine de Ducla , Simon Fear , Yohann Loriot
Background: Atezo, a monoclonal antibody targeting PD-L1, is an approved therapy for locally advanced/metastatic UC based on IMvigor210 and IMvigor211 phase II and III trials. The single-arm SAUL study (NCT02928406) with a broader patient (pt) population demonstrated median overall survival (OS) of 8.7 months and a safety profile consistent with previous atezo trials. Methods: Pts with locally advanced/metastatic UC or non-UC of the urinary tract received atezo 1200 mg every 3 weeks until disease progression or unacceptable toxicity. Populations excluded from IMvigor211 (renal impairment, ECOG PS 2, treated asymptomatic CNS metastases, stable controlled autoimmune disease, concomitant steroids, HIV positive, non-UC) were eligible. The primary endpoint was safety; OS and overall response rate (ORR) were secondary endpoints. Predefined subgroup analyses included outcomes according to PD-L1 status (VENTANA SP142) and age in the overall population (and the IMvigor211-like subgroup for PD-L1). Results: Between Nov 2016 and Mar 2018, 1004 pts were enrolled; 997 received atezo. Efficacy is summarized below. Incidences of grade ≥3 treatment-related adverse events were similar irrespective of PD-L1 status (overall IC 0/1 vs 2/3: 11% vs 16%; IMvigor211-like IC 0/1 vs 2/3: 11% vs 15%) or age (≥65 y: 13%; ≥75 y: 12%; ≥80 y: 10%). Conclusions: OS and ORR appear more favorable in IC 2/3 vs IC 0/1 subgroups (overall and in the IMvigor211-like population). Atezo was effective and well tolerated across subgroups including elderly pts. Clinical trial information: NCT02928406
Endpoint | All pts, PD-L1 | IMvigor211-like, PD-L1 | All pts, age | ||||
---|---|---|---|---|---|---|---|
IC 0/1 (n=666) | IC 2/3 (n=268) | IC 0/1 (n=427) | IC 2/3 (n=176) | ≥65 y (n=624)a | ≥75 y (n=227)a | ≥80 y (n=78)a | |
Deaths, n (%) | 388 (58) | 132 (49) | 235 (55) | 82 (47) | 335 (54) | 128 (56) | 44 (56) |
Median OS, months (95% CI) | 7.9 (6.8–9.1) | 11.6 (8.8–18.8) | 9.0 (7.8–10.4) | 14.5 (9.5–18.8) | 8.5 (7.5–10.9) | 8.3 (7.3–10.9) | 8.3 (5.4–11.2) |
6-month OS rate, % (95% CI) | 57 (53–61) | 67 (61–72) | 61 (56–66) | 72 (65–78) | 60 (56–64) | 61 (54–67) | 59 (47–69) |
ORR, % (95% CI) | 10 (8–13) | 21 (16–26) | 10 (7–13) | 23 (17–30) | 14 (12–17) | 13 (9–18) | 8 (3–16) |
aSubgroups not mutually exclusive
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Abstract Disclosures
2023 ASCO Annual Meeting
First Author: Cora N. Sternberg
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