Trial results for the combination of atezolizumab, bevacizumab, and pegylated liposomal doxorubicin hydrochloride in treating recurrent ovarian, fallopian tube, or primary peritoneal cancer were posted on ClinicalTrials.gov on 2025-03-04. The Phase III results showed that the triplet regimen achieved a median progression-free survival (PFS) of 7.4 months and a median overall survival (OS) of 14.9 months.
Background
Atezolizumab is an immunotherapy that works as a monoclonal antibody to help the body's immune system attack cancer. This trial investigated its use in combination with other agents for patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Trial design
The study, NCT02839707, was a Phase II/III trial that enrolled 444 participants. It investigated combinations of pegylated liposomal doxorubicin hydrochloride (PLD), atezolizumab, and/or bevacizumab in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer, specifically including high grade serous adenocarcinoma and seromucinous carcinoma. The trial included three treatment arms:
- Arm I: PLD with atezolizumab
- Arm II: PLD with bevacizumab and atezolizumab
- Arm III: PLD with bevacizumab
Key outcomes measured included the incidence of dose limiting toxicities (DLT), progression-free survival (PFS), and overall survival (OS).
Key results
Results from the trial provided data on dose-limiting toxicities, progression-free survival (PFS), and overall survival (OS) across the treatment arms.
- For the outcome "Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens," 0 participants experienced DLTs in Arm I (PLD, Atezolizumab), 0 participants in Arm II (PLD, Bevacizumab, Atezolizumab), and 0 participants in Arm III (PLD, Bevacizumab).
Regarding Progression Free Survival (PFS):
- In Phase II, median PFS was 4.2 months for Arm I (PLD, Atezolizumab), 7.6 months for Arm II (PLD, Bevacizumab, Atezolizumab), and 5.5 months for Arm III (PLD, Bevacizumab).
- In Phase III, median PFS was 4.0 months for Arm I (PLD, Atezolizumab), 7.4 months for Arm II (PLD, Bevacizumab, Atezolizumab), and 5.6 months for Arm III (PLD, Bevacizumab).
For Overall Survival (OS) in Phase III:
- Median OS was 14.5 months for Arm I (PLD, Atezolizumab).
- Median OS was 14.9 months for Arm II (PLD, Bevacizumab, Atezolizumab).
- Median OS was 12.3 months for Arm III (PLD, Bevacizumab).
What this means
The trial results suggest that the combination of pegylated liposomal doxorubicin hydrochloride, bevacizumab, and atezolizumab (Arm II) may offer an advantage in terms of progression-free survival and overall survival for patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer compared to the other tested regimens. Specifically, the median PFS of 7.4 months and OS of 14.9 months in Phase III for the triplet combination were numerically higher than the other arms. The absence of dose-limiting toxicities across all experimental regimens indicates a favorable short-term safety profile for these combinations in the study population.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02839707, titled "Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer," were posted on 2025-03-04 on clinicaltrials.gov.