KEY TAKEAWAYS
- This phase 3 Keynote-826 study assessed pembro + chemo vs. placebo + chemo in patients with persistent, recurrent, or metastatic cervical cancer.
- The study’s dual primary endpoints were OS and PFS.
- Pembro + chemo extended OS and PFS vs. placebo + chemo irrespective of bev use and showed a manageable safety profile.
In the KEYNOTE-826 study, a combination of pembrolizumab (pembro) and chemotherapy (chemo), with or without bevacizumab (bev), showed statistically significant and clinically relevant enhancements in overall survival (OS) and progression-free survival (PFS) for patients (pts) with persistent, recurrent, or metastatic cervical cancer. This exploratory analysis examined the outcomes for different patient subgroups characterized by the inclusion or exclusion of bev in their treatment regimen.
The study included adult pts with persistent, recurrent, or metastatic forms of various cervical cancers who hadn’t undergone previous chemotherapy and were not candidates for curative treatment. Disease measurability followed RECIST v1.1 guidelines, and pts were expected to have an ECOG PS score between 0–1. A tumor sample was also required for PD-L1 status determination. Patients were randomized to receive either 200 mg of pembro every three weeks or a placebo for up to 35 cycles, alongside chemotherapy (either paclitaxel and cisplatin or carboplatin), optionally with bev. The dual primary endpoints were OS and PFS, gauged through investigator assessment according to RECIST v1.1 in specific patient populations. The impact of bev use was examined using hazard ratios and 95% confidence intervals based on a stratified Cox regression model.
Of 617 pts, 308 were in the pembro + chemo group (63.6% with bev) and 309 in the placebo + chemo group (62.5% with bev). The main reason for excluding bev was medical contraindication (75.9%). The combination of pembro + chemo improved OS and PFS compared to placebo + chemo in patient subgroups, regardless of bev usage. Treatment-related adverse events of grade ≥3 were more frequent in the pembro + chemo group compared to the placebo + chemo group, both for subgroups with and without bev.
The addition of pembro to chemotherapy extended both OS and PFS when compared to chemotherapy alone, irrespective of the addition of bev. The safety profile of this regimen was considered manageable.
Source: https://www.emma.events/site/programme/?sessiondetail=4534540&trackid=0&a=esgo2023#!
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03635567
Lorusso, D., Colombo, N., Monk, B.J., Dubot, C., Cáceres, V., Hasegawa, K., Shapira-Frommer, R., Salman, P., Yañez, E., Gümüs, M., De Mendoza, M.O.H., Samouëlian, V., Castonguay, V., Arkhipov, A., Li, K., Toker, S., Tekin, C., Tewari, K.S. Pembrolizumab + Chemotherapy For First-Line Treatment Of Patients With Persistent, Recurrent, Or Metastatic Cervical Cancer: Bevacizumab Subgroup Analysis Based On Protocol-Specified Final Overall Survival Results Of KEYNOTE-826.
