Author Archives: Rosa Kutz

Preliminary Results of the NAPISTAR 1-01 Study

New Targeted Therapy for Platinum-Resistant Ovarian Cancer Under Investigation

At ESGO 2026, the initial results of an early-phase clinical trial of a new drug called TUB-040 in patients with platinum-resistant ovarian cancer were presented. This is what is known as an antibody-drug conjugate (ADC) —a targeted therapy that specifically recognizes cancer cells and delivers a potent cytotoxic agent directly to them.

TUB-040 is an ADC that targets a protein called NaPi2b (sodium-dependent phosphate transport protein 2B). NaPi2b is a transporter that regulates phosphate in tissues such as the lungs and intestines and is found on the cell surface at a higher-than-average rate in high-grade serous ovarian cancer and non-small-cell lung cancer.

What was the study about?

The NAPISTAR 1-01 study is an early Phase 1/2a study primarily designed to evaluate,

how well a new drug is tolerated and
What is the appropriate dosage?

A total of 67 female patients with platinum-resistant high-grade serous ovarian cancer were treated. Many of them had already received multiple lines of therapy—an average of four prior treatments—which often included bevacizumab or PARP inhibitors.

What results were observed?

The results are very promising for an early-stage study:

A confirmed reduction in tumor size was observed in 50% of the patients.
Overall, the disease was at least stabilized in 96% of the patients.

In addition, many of the observed treatment responses were still ongoing at the time of the evaluation, so the final results are still pending.

Side Effects

Overall, the treatment was well tolerated. The most common side effects included nausea, fatigue, and changes in blood test results. Serious side effects were relatively rare. It is also important to note that no serious problems such as pneumonia, nerve damage, or eye problems were observed.

What does this mean for female patients?

The results show that TUB-040 could be a potential new treatment option for patients with platinum-resistant ovarian cancer, especially for those in whom multiple prior treatments have failed.

However, this is still an early Phase 1/2 trial. The drug must therefore be tested in larger studies before a decision can be made on whether it will be used routinely in the future.

Source: Publication (the article is in English)

Positive results from the DUO-O study!

New Combination Therapy for advanced ovarian cancer under investigation

The international Phase-Phase 3Study (DUO-O) has examined, whether a combination of immunotherapy, chemotherapy, targeted therapy and maintenance therapy that progress of newly diagnosed advanced ovarian cancer delay .

To the study measures more than 1,100 female patients took part, whose tumor no BRCAmutation showed. All received First of all the Standard Treatment with Carboplatin and Paclitaxel, frequently combined with the Antibodies Bevacizumab. Next, were various additional Combination Therapies Tested.

Key Findings finding of the study

The combination of durvalumab (immunotherapy) + chemotherapy + Bevacizumab, followed by a maintenance therapy with durvalumab, Bevacizumab and the PARPinhibitor olaparib, was able to the progression of disease significantly significantly.

In the case of all female patients without BRCAmutation remained the disease in on average 24.2 months stable, compared to 19.3 months under the previous standard treatment.
Especially clear was the effect in female patients with a so-called HRDpositive tumor biology: Here it lay the time until the progress in over three years.

The treatment with durvalumab alone in addition to standard therapy showed , however, no clear benefit .

Survival still unclear

Whether this combination also improve overall survival survival, is currently yet not Sure. In the previous Reports was able to yet none clear survival advantage displayed , but are longer longer are needed.

Side Effects

The Side Effects corresponded to in the Essential to which the individual Medications and were in total comparable to previous experiences.

What means that for patients?

The study shows that a combination of immunotherapy and PARPinhibitor in the Initial Treatment of the advanced Ovarian cancer that Progress the Illness possibly significantly longer delay can, especially in certain tumor biology.

Whether this treatment in the future become in the first-line will, depends , however, on further analyses and approval decisions .

Source: Publication (the article is in English)

Highlights from ESGO 2026 and a new approval!

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:

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.
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)

New final data: Immunotherapy with atezolizumab brings no additional benefit in recurrent ovarian cancer

The final results of the AGO-OVAR 2.29 (ENGOT-ov34) study were published in December 2025.

This large international phase III trial investigated whether the additional administration of the immunotherapy drug atezolizumab together with bevacizumab and non-platinum-based chemotherapy can prolong the survival of patients with recurrent ovarian cancer.
This form of cancer recurs even though platinum-based chemotherapy has already been given and is considered particularly difficult to treat.

A total of 574 patients were randomized in the study and received either the standard treatment (chemotherapy + bevacizumab + placebo) or atezolizumab in addition.

What did the study show?

➡️ No clear survival benefit was found with the addition of atezolizumab:

The median overall survival (OS) was around 14.2 months with atezolizumab and 13.0 months in the control group – this difference was not statistically significant, i.e. not clear enough to speak of a reliable advantage.
The median progression-free survival (PFS) – i.e. the time during which the tumor does not grow again – was practically the same with atezolizumab compared to 6.7 months in the control group and also without a statistically proven advantage.

💡 This means that immunotherapy with atezolizumab did not lead to a clear improvement in disease control or prolongation of life when given in addition to bevacizumab and chemotherapy in this study.

What about side effects?

Severe side effects (grade ≥ 3) occurred slightly more frequently in patients receiving atezolizumab (72% vs. 69%), but overall the safety profile was comparable to that already known for the individual drugs.

Was a difference observed depending on PD-L1 status?

The study also investigated whether patients with PD-L1-positive tumors (a possible indication of a better response to immunotherapy) benefit more from atezolizumab. This was not the case – the results were similar regardless of whether the tumor was PD-L1-positive or -negative.

Important contribution to research
Even if these particular results are negative, such large studies are important in order to understand exactly which therapies really help in which situations – and where we still need new approaches.

💡 Standards remain unchanged
For patients with platinum-resistant relapse, the established treatment options, such as chemotherapy with bevacizumab or other effective combinations, currently remain the recommended standard. Immunotherapy such as atezolizumab is currently not demonstrably more effective than standard treatment in this setting.

Source: Publication from ASCO (the article is in English)