We attended the ESGO conference in Copenhagen and saw the presentation of the study results, which had already received FDA approval back in February!<\/p>\n
On February 10, 2026<\/strong>, the U.S. Food and Drug Administration (FDA<\/strong> ) approved a new combination of the immunotherapy drug pembrolizumab (Keytruda)<\/strong> and the chemotherapy drug paclitaxel<\/strong> (regardless of concurrent treatment with bevacizumab) for adult female patients with platinum-resistant epithelial ovarian cancer<\/strong>, fallopian tube cancer, or primary peritoneal cancer, whose tumors are PD-L1-positive<\/strong> and who have already received one or two systemic therapies<\/strong>.<\/p>\n The approval was granted based on the final results of the international Phase 3 ENGOT-ov65 \/ KEYNOTE-B96 trial<\/strong>.<\/p>\n 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. <\/p>\n Key findings in female patients with PD-L1-positive tumors<\/strong>:<\/p>\n Progression-free survival (PFS)\u2014<\/strong> that is ,<\/strong> the time until the next recurrence of the disease\u2014was 8.3 months<\/strong> with pembrolizumab versus 7.2 months<\/strong> without pembrolizumab. This means that the combination therapy was able to delay the progression of the disease for a longer period. <\/p>\n<\/li>\n Overall survival (OS)<\/strong> was also better: an average of 18.2 months<\/strong> with pembrolizumab versus 14.0 months<\/strong> without, indicating a significant survival benefit.<\/p>\n<\/li>\n<\/ul>\n These differences were statistically significant\u2014meaning they could not be attributed to random fluctuations\u2014and show that immunotherapy, when used in addition to chemotherapy, can both delay disease progression and prolong life.<\/p>\n The approval applies only to patients whose tumors are PD-L1-positive<\/strong>, meaning they express certain immune markers. To this end, the FDA has additionally approved a companion PD-L1 test<\/strong> (the PD-L1 IHC 22C3 pharmDx)<\/em> as a basis for selecting patients who may benefit from this therapy. <\/p>\n 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. <\/p>\n \u2714\ufe0f New Treatment Option<\/strong> \u2714\ufe0f PD-L1 test is important<\/strong> \u2714\ufe0f Not<\/strong> yet approved in Europe<\/strong> \u2714\ufe0f Clinical Implications<\/strong>\ud83e\uddea What was the study about?<\/strong><\/h3>\n
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\ud83e\uddec PD-L1 test as a prerequisite<\/strong><\/h3>\n
! Safety & Side Effects<\/strong><\/h3>\n
\n\ud83d\udccd What does this mean for female patients in Germany?<\/strong><\/h3>\n
This FDA approval marks an important milestone: For the first time, a combination immunotherapy has been officially approved<\/strong> for PD-L1-positive, platinum-resistant ovarian cancer, based on robust data demonstrating longer survival and better disease control<\/strong>.<\/p>\n
A prerequisite for use is a positive PD-L1 status<\/strong>, which must be determined before starting therapy, similar to other immunotherapies.<\/p>\n
In Europe<\/strong>\u2014including Germany\u2014this treatment is not yet officially approved,<\/strong> 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<\/strong>. <\/p>\n
This combination could represent a significant additional treatment option<\/strong> in the future, particularly for patients with PD-L1-positive, platinum-resistant tumors\u2014especially when standard therapies are no longer effective.<\/p>\n