Author Archives: Jessica Nguyen

First results of the NAPISTAR 1-01 study

New targeted therapy investigated for platinum-resistant ovarian cancer

At ESGO 2026, the first results of an early clinical trial of a new drug called TUB-040 in patients with platinum-resistant ovarian cancer were examined. This is an antibody-drug conjugate (ADC) – a targeted therapy that specifically recognizes cancer cells and transports a powerful cytotoxin 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 lung and intestine and is more abundant at the cell surface 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 that is primarily testing

  • how well a new medication is tolerated and

  • which dosage is suitable.

A total of 67 patients with platinum-resistant high-grade serous ovarian cancer were treated. Many of them had already received several therapies, on average four previous treatments, often including bevacizumab or PARP inhibitors.

What results were observed?

The results are very promising for an early study:

  • A confirmed tumor reduction was found in 50% of the patients.

  • Overall, the disease was at least stabilized in 96% of 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

The treatment was generally well tolerated. The most common side effects included nausea, fatigue and changes in blood values. Severe 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 patients?

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

However, this is still an early phase 1/2 study. The drug therefore still needs to be investigated in larger studies before a decision can be made as to whether it will be used regularly in the future.

Source: Publication (the article is in English)

Highlights from ESGO 2026 and new approval!

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.

📍 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

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

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 in 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 recurrence, 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)

Study objective achieved! – Results of the ROSELLA study

New findings on the treatment of platinum-resistant ovarian cancer - results of the ROSELLA study

At the end of January, the pharmaceutical company Corcept Therapeutics published a press release on the positive results of the ROSELLA study!

This study investigated whether the combination of the drug Relacorilant and the chemotherapy nab-paclitaxel can improve the survival of patients with platinum-resistant ovarian cancer.

What was the study about?

Platinum-resistant ovarian cancer means that the tumor has continued to grow despite platinum-based chemotherapy and only responds to a limited extent to standard therapies. Such patients often have a poor prognosis and only limited treatment options.

In the ROSELLA study, 381 patients worldwide were randomly divided into two groups:

  • One group received nab-paclitaxel alone (standard chemotherapy),

  • the other nab-Paclitaxel plus Relacorilant.

What did the study show?

📌 1. Lower risk of death
Patients who received Relacorilant in addition to chemotherapy had a 35% lower risk of death than those who received chemotherapy alone. This means that the new combination significantly prolonged overall survival.

📌 2. Longer survival time
On average, patients with Relacorilant lived for 16.0 months compared to 11.9 months with chemotherapy alone – i.e. around 4 months longer.

📌 3. better progression-free survival
It has previously been shown that the combination also improves the time until the disease progresses – i.e. the period in which tumors do not grow any further.

📌 4. well tolerated
Important: The combination was well tolerated and severe side effects did not occur more frequently than with chemotherapy alone. This means that Relacorilant brings its benefits without noticeably worsening safety for patients.

📌 5. no biomarker restriction
Unlike with some other therapies, it was not necessary to select patients according to a specific tumor biomarker in this study – the benefits of the therapy were independent of certain tumor characteristics.

What does this mean for patients in Germany?

Promising new treatment option in sight
The results are particularly important because they show for the first time that an additional substance not only delays progression but also prolongs overall survival – without additional safety issues.

Regulatory submissions currently underway
– In the US, the Food and Drug Administration (FDA) is currently reviewing Corcept’s application for approval of Relacorilant for platinum-resistant ovarian cancer; a result is expected by July 11, 2026.
– In Europe – including Germany – the application is also currently being evaluated by the European Medicines Agency (EMA).

➡️ Until approval, it will not remain a standard in Germany
Until Relacorilant is officially approved, this combination is not yet part of the regular treatment guidelines in Germany. But the current data are an important step in this direction.

Source: Press release from Corcept (the article is in English)