We attended the ESGO conference in Copenhagen and saw the presentation of the study results, which had already received FDA approval in February!

Keytruda + Paclitaxel as a new option for platinum-resistant ovarian cancer

On February 10th, 2026, the US Food and Drug Administration (FDA) approved a new combination of the immunotherapy drug pembrolizumab (Keytruda) and the chemotherapy drug paclitaxel (regardless of parallel treatment with bevacizumab) for adult 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.

Approval was granted based on the final results of the international Phase 3 ENGOT-ov65 / KEYNOTE-B96 study.

🧪 What was the study about?

The KEYNOTE-B96 study enrolled 643 patients whose tumors continued to grow after previous platinum-based chemotherapy. All patients were randomised to receive paclitaxel and optional bevacizumab; in addition, half received pembrolizumab and the other half received a placebo.

Important results in patients with PD-L1-positive tumors:

• Progression-free survival (PFS), i.e., the time until the next spread of the disease, was 8.3 months with pembrolizumab vs. 7.2 months without pembrolizumab. This means that the combination therapy was able to halt the disease for longer.

• Overall survival (OS) was also better: an average of 18.2 months with pembrolizumab vs. 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 in addition to chemotherapy can both delay progression and prolong life.

🧬 PD-L1 test as a prerequisite

The approval applies only to patients whose tumors are PD-L1 positive, i.e., who have certain immune markers. For this purpose, an accompanying PD-L1 test (the PD-L1 IHC 22C3 pharmDx) has also been recognized by the FDA as a basis for selecting patients who could benefit from this therapy.

! Safety & Side Effects

The frequency of side effects associated with the combination was comparable to previous experience with these drugs and did not reveal any unexpected safety issues. However, immune-related reactions, infusion reactions, and other typical effects may occur, which is why careful medical supervision is important.

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📍 What does this mean for patients in Germany?

✔️ New treatment option
This FDA approval marks an important step: for the first time, a combination immunotherapy has been officially approved for PD-L1-positive, platinum-resistant ovarian cancer because solid data is available demonstrating longer survival and better disease control.

✔️ PD-L1 test important
A prerequisite for use is a positive PD-L1 status, which must be determined before the start of therapy, similar to other immunotherapies.

✔️ Not yet approved in Europe
This treatment is not yet officially approved in Europe, including Germany, but the data has been presented there and the approval process at 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.

✔️ Relevance for treatment
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 announcement