KEY TAKEAWAYS
- The Phase III ATALANTE study was a double-blinded, randomized study into the efficacy of the drug Atezolizumab.
- The study evaluated the addition of Atezolizumab to standard treatment for PSROC patients who had received two previous lines of chemotherapy.
- The study’s primary outcome measure was PFS in the intent-to-treat (ITT) and PD-L1-positive patients, which was not met
- The study demonstrated the need for further investigation into tissue samples to understand the immunological environment of PSROC.
The Phase III ATALENTE study evaluated the benefits of adding Atezolizumab (Atz) with Chemotherapy and Bevacizumab for patients with PSROC (more than six months after the last platinum dose). The standard chemotherapy (Cx) consists of carboplatin + pegylated liposomal doxorubicin (CbD), gemcitabine (CbG), or paclitaxel (CbP), with or without bevacizumab (bev).
Patients were randomized 2:1 to Atz (n = 410) (1200 mg, d1, q3w or 800 mg, d1&15, q4w with CbD up to 24 months [m]) or placebo (Pbo) (n = 204) with Cx at investigator-choice (CbD/CbG/CbP, 6 cycles) plus bev (15 mg/kg, d1, q3w or 10 mg/kg, d1&15, q4w). The patients were stratified by platinum-free interval, PD-L1 status on biopsy at the beginning of the study, and by Cx cohort. Investigator-assessed progression-free survival (PFS) in the intent-to-treat (ITT) and PD-L1-positive (1% IC per tumor region) patients are the co-primary endpoints. The Type I error was specified at 0.025.
At a median follow-up of 36 months, in the ITT pts, the median PFS was 13.5 and 11.2 m for the Atz and Pbo groups, respectively (hazard ratio [HR], 0.83; 95% CI, 0.69-0.99; P =.041), and 15.2 vs. 13.1 m in the PD-L1-positive pts, respectively (HR, 0.86; 95% CI, 0.63 to 1.16; P =.30). The median overall survival (OS) in the Atz and Pbo groups was 35.4 vs. 30.6 m at 333/491 planned events in the ITT pts (HR, 0.81; 95% CI, 0.65 to 1.01). Grade 3 AEs and immune AEs were recorded in 88%, 86%, and 13%, 8%, respectively, of Atz and pbo patients.
Five treatment-related AEs led to mortality (Atz, n=3; pbo, n=2). However, the scores for the global health-related quality of life (HRQoL) did not significantly vary.
The PFS co-primary endpoints in the ITT and PD-L1-positive patients of the ATALANTE trial testing the addition of Atz to standard treatment were unmet. Additional analysis, an investigation into tissue samples, and an extended follow-up are required for a better understanding of the immunological environment of PSROC.
Source: https://www.annalsofoncology.org/article/S0923-7534(22)03904-7/pdf
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT02891824
Kurtz, J.E., Pujade-Lauraine, E., Oaknin, A., Cibula, D., Vergote, I.B., Rodrigues, M.J., Martinez-Garcia, J., Pautier, P., Lobbedez, F.J., Heudel, P. (2022) LBA30 – Phase III ATALANTE/ov29 trial: Atezolizumab (Atz) versus placebo with platinum-based chemotherapy (Cx) plus bevacizumab (bev) in patients (pts) with platinum-sensitive relapse (PSR) of epithelial ovarian cancer (OC). https://doi.org/10.1016/j.annonc.2022.08.026
