We attended the ESGO conference in Copenhagen and saw the presentation of the study results, which had already received FDA approval back in February!
Keytruda + Paclitaxel as a New Treatment Option for Platinum-Resistant Ovarian Cancer
On February 10, 2026, the U.S. Food and Drug Administration (FDA ) approved a new combination of the immunotherapy drug pembrolizumab (Keytruda) and the chemotherapy drug paclitaxel (regardless of concurrent treatment with bevacizumab) for adult female patients with platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, whose tumors are PD-L1-positive and who have already received one or two systemic therapies.
The approval was granted based on the final results of the international Phase 3 ENGOT-ov65 / KEYNOTE-B96 trial.
🧪 What was the study about?
The KEYNOTE-B96 study randomly assigned 643 female patients whose tumors continued to grow after prior platinum-based chemotherapy. All patients received paclitaxel and, optionally, bevacizumab; in addition, half received pembrolizumab, while the other half received a placebo.
Key findings in female patients with PD-L1-positive tumors:
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Progression-free survival (PFS)— that is , the time until the next recurrence of the disease—was 8.3 months with pembrolizumab versus 7.2 months without pembrolizumab. This means that the combination therapy was able to delay the progression of the disease for a longer period.
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Overall survival (OS) was also better: an average of 18.2 months with pembrolizumab versus 14.0 months without, indicating a significant survival benefit.
These differences were statistically significant—meaning they could not be attributed to random fluctuations—and show that immunotherapy, when used in addition to chemotherapy, can both delay disease progression and prolong life.
🧬 PD-L1 test as a prerequisite
The approval applies only to patients whose tumors are PD-L1-positive, meaning they express certain immune markers. To this end, the FDA has additionally approved a companion PD-L1 test (the PD-L1 IHC 22C3 pharmDx) as a basis for selecting patients who may benefit from this therapy.
! Safety & Side Effects
The incidence of side effects with this combination was comparable to previous experience with these medications and did not reveal any unexpected safety issues. However, immune-mediated reactions, infusion reactions, and other typical effects may occur, which is why careful medical monitoring is important.
📍 What does this mean for female patients in Germany?
✔️ New Treatment Option
This FDA approval marks an important milestone: For the first time, a combination immunotherapy has been officially approved for PD-L1-positive, platinum-resistant ovarian cancer, based on robust data demonstrating longer survival and better disease control.
✔️ PD-L1 test is important
A prerequisite for use is a positive PD-L1 status, which must be determined before starting therapy, similar to other immunotherapies.
✔️ Not yet approved in Europe
In Europe—including Germany—this treatment is not yet officially approved, but the data have been presented there as well, and the approval process with the EMA is underway. This means that patients cannot yet routinely receive this option, but it is very likely that it will become available in Europe in the foreseeable future.
✔️ Clinical Implications
This combination could represent a significant additional treatment option in the future, particularly for patients with PD-L1-positive, platinum-resistant tumors—especially when standard therapies are no longer effective.
Source: FDA press release (the article is in English)
