KEY TAKEAWAYS
- The study IMvigor130 trial Phase 3, registered under NCT02807636, aimed to assess PFS in patients with mUC treated with atezo combined with platinum and gemcitabine.
- Patients were randomly assigned to receive atezo with platinum and gemcitabine (Arm A), atezo alone (Arm B), or placebo plus platinum and gemcitabine (Arm C).
- The study demonstrated that atezo with platinum and gemcitabine is a viable treatment option for mUC.
Patients with metastatic urothelial carcinoma (mUC) who received first-line (1L) of atezo with platinum and gemcitabine (Arm A) had a significantly longer progression-free survival (PFS) than those who received a placebo plus platinum and gemcitabine (Arm C) (Galsky Lancet 2020). The preliminary results indicated that Arm A patients fared better than Arm C for overall survival (OS), although the difference was not statistically significant (Galsky Lancet 2020; Galsky AACR 2021). Despite programmed cell death ligand 1 (PD-L1) status, in exploratory analyses, atezo enhanced OS when coupled with cisplatin (cis) versus carboplatin (carbo). The final Arms A and C OS data are presented here. Subjects were randomly given a 1:1:1 ratio to Arms A, Arm B (atezo alone), or Arm C. Patients in Arms A and C were given cisplatin and carboplatin, respectively. Hierarchically assessed PFS according to INV RECIST 1.1, OS(Arm A vs. C), and OS (Arm B vs. C) were co-primary outcomes. In addition, data on adverse events, overall response rate (ORR), duration of response (DOR), disease control rate (DCR; confirmed CR, PR or [SD 6≥ mo]), and exploratory data on OS are also included.
As of the data cutoff date of August 31, 2022 (49 months from the last randomly assigned patient), the HR for the cis subgroup was 0.76 (95% CI 0.57, 1.01; Table), while the OS advantage for ITT pts was not statistically significant. Arm A had a DCR of 65% (290/447) in ITT points, while Arm C’s DCR was 60% (239/397). In Arm A, 81% (370/454) of patients evaluable for safety experienced a Grade 3/4 tx-related adverse event (TRAE), whereas, in Arm C, 80% (312/389) did so. A total of 2% of patients in Arm A and 1% in Arm C experienced Grade 5 TRAEs; 9% in Arm A and 4% in Arm C experienced Grade 3/4 AEs of interest.
The superior OS seen in the ITT population with mUC when treated with atezo + plt/gem compared to placebo + plt/gem did not reach statistical significance in this final analysis. Patients who received cis rather than carbo with atezo + plt/gem fared better on OS, as was found in earlier exploratory data. Researchers saw no new warning signs that could be considered safe.
Source:https://meetings.asco.org/abstracts-presentations/217831
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT02807636
Matt D. Galsky, Jose Angel Arranz Arija, Maria De Santis, Ian D. Davis, Aristotelis Bamias, Eiji Kikuchi, Xavier Garcia del Muro, Se Hoon Park, Ugo De Giorgi, Boris Alekseev, Marina Mencinger, Kouji Izumi, Javier Puente, Jian-Ri Li, Peter H. O’Donnell, Sandrine Bernhard, Chooi Peng Lee, Fabiola Bene-Tchaleu, Sanjeev Mariathasan, Enrique Grande/Atezolizumab (atezo) + platinum/gemcitabine (plt/gem) vs placebo + plt/gem for first-line (1L) treatment (tx) of locally advanced or metastatic urothelial carcinoma (mUC): Final OS from the randomized Phase 3 IMvigor130 study./J Clin Oncol 41, 2023 (suppl 6; abstr LBA440) DOI10.1200/JCO.2023.41.6_suppl.LBA440
