Atezolizumab in Combination With Bevacizumab and Chemotherapy Versus Bevacizumab and Chemotherapy in Recurrent Ovarian Cancer - a Randomized Phase III Trial

Trial ID # NCT03353831; AGO-OVAR2.29
Phase III
Drug Class Immunotherapy: Checkpoint Inhibitors/PD-L1
Drug Name Atezolizumab
Alternate Drug Names Tecentriq, Anti-PD-L1 Monoclonal Antibody MPDL3280A , MPDL3280A, RG7446
Drugs in Trial Atezolizumab, Bevacizumab, Liposomal doxorubicin, Paclitaxel
Eligible Participant

Platinum resistant ovarian cancer with 1-2 prior therapies or recurrent ovarian cancer with 3 prior therapies that is not considered for platinum-based chemotherapy

Patients Enrolled

550; 73% w/ prior bevacizumab

Therapy Setting

Recurrence

Study Design

Double Blind, Randomized

Endpoints

ORR, DoR, PFS, OS, evaluated per RECIST

Efficacy

Pac/PLD+Bev+Ate (n=285) vs Pac/PLD+Bev+Placebo (n=289):

ORR: 39.6 vs 43.5%
PFS: 6.4 vs 6.7 months, HR: 0.87 (0.73-1.04, p=0.12)
DoR: 8.6 vs 6.1 months
OS: 14.2 vs 13.0 months, HR: 0.83 (0.68-1.01, p=0.06)

Exploratory analysis; w/ prior bev, w/ paclitaxel chemotherapy:
w/ prior bev: OS: 14.9 vs 12.6 months, HR: 0.74 (0.59-0.93)
w/ paclitaxel chemotherapy: OS: 16.2 vs 14.3 months, HR: 0.75 (0.57-0.98) 

Clinically Significant Adverse Events

Pac/PLD+Bev+Ate vs Pac/PLD+Bev+Placebo:
Serious AE: overall (63.7 vs 51.4%)
Grade 3-4 AE: overall (71.5 vs 68.9%), neutropenia (16 vs 11.9%)

Conclusion

The addition of atezolizumab to single agent chemotherapy with bevacizumab does not significantly improve PFS or OS in platinum resistant recurrent ovarian cancer patients or recurrent ovarian cancer patients who are not candidates for platinum therapy

Reference

Marme F et al. Atezolizumab versus placebo in combination with bevacizumab and non-platinum-based chemotherapy in recurrent ovarian cancer: Final overall and progression-free survival results from the AGO-OVAR 2.29/ENGOT-ov34 study. J Clin Oncol 42, 2024 (suppl 17; abstr LBA5501)
https://ascopubs.org/doi/10.1200/JCO.2024.42.17_suppl.LBA5501

Marme F et al. Slide from presentation
https://www.clearityfoundation.org/wp-content/uploads/2024/06/AGO-OVAR2.29-ASCO-2024-slide-from-pres.pdf

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