Category Archives: News

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)

News for patients with platinum-resistant ovarian cancer

News for patients
with platinum-resistant ovarian cancer

The pharmaceutical company Eli Lilly recently received approval from the US Food and Drug Administration with a Breakthrough Therapy Designation for a new drug called sofetabart mipitecan was awarded. This designation is only awarded if an active substance shows initial indications that it could deliver significantly better results in a serious disease than previously available therapies.

What is Sofetabart mipitecan?

Sofetabart mipitecan is a so-called antibody-drug conjugate (ADC) that specifically targets the folic acid receptor alpha (FRα) on tumor cells and releases a chemotherapy substance there. This receptor is strongly present in many ovarian tumors, which should allow the drug to have a targeted effect.Previous results from early studies, which were presented at major cancer congresses such as ASCO 2025 and ESMO 2025, showed a tumor response in patients who had previously received standard therapies such as bevacizumab or mirvetuximab soravtansine. The data to date also indicate that side effects are manageable and that severe lung problems, nerve damage or severe eye damage rarely occurred.

What does the FDA designation mean?

The Breakthrough Therapy Designation is intended to accelerate the development process and enable earlier discussions with authorities. Although it is not a sure indication of approval, it does mean that the results to date are so promising that faster development and testing seems sensible.

Phase 3 study FRAmework-01 to start soon in Germany!

Based on these positive interim results, Lilly has initiated the phase 3 study called FRAmework-01 has been started. In this trial, sofetabart mipitecan is being investigated in patients with platinum-resistant ovarian cancer (PROC) as a single therapy patients with platinum-sensitive ovarian cancer (PSOC) in combination with bevacizumab.The start of the trial in Germany is planned for spring 2026. spring 2026 and offers patients the opportunity to participate in an ongoing Phase 3 trial, provided they meet the inclusion criteria (e.g. diagnosis of a platinum-sensitive or platinum-resistant tumor).

Sofetabart mipitecan is a promising drug that could be effective in difficult-to-treat, platinum-resistant ovarian cancer, especially in tumors that no longer respond to other treatments, and is therefore a potential new therapeutic option.

The new Phase 3 study FRAmework-01 offers the opportunity to participate in an international study in Germany before approval is granted at a later date. As soon as the study starts, you will find further information on our study portal!

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

New study data from ESMO 2025 – Immunotherapy brings survival benefit in platinum-resistant ovarian cancer for the first time

New study data from ESMO 2025
Immunotherapy provides first survival benefit in
platinum-resistant ovarian cancer

A press release on the initial results of the ENGOT-ov65/KEYNOTE-B96 trial was published in May 2025, and the latest promising results were presented at the ESMO Congress in Berlin at the weekend. This international phase III trial investigated whether the combination of pembrolizumab (an immune checkpoint inhibitor) and paclitaxel (a chemotherapeutic agent), with or without bevacizumab (an angiogenesis inhibitor), can prolong the survival of patients with platinum-resistant ovarian cancer .

The results show: Although the gain in progression-free survival (PFS), i.e. the time until the disease continues to grow, was rather small at around 2 months, this difference was clinically relevant. However, the significant advantage in overall survival (OS) is decisive: patients whose tumors were PD-L1-positive (a marker for response to immunotherapy) lived an average of 18.2 months compared to 14.0 months in the comparison group that only received chemotherapy.

This means that for the first time in this difficult disease, where previous therapies are often only effective in the short term, a real survival benefit has been shown with immunotherapy – and in a patient group that has not been pre-selected.

The safety profile of the combination therapy was also acceptable overall, although grade 3 or higher side effects occurred in around two thirds of patients. Particularly noteworthy: the survival benefit was independent of whether or not bevacizumab was also given.

Experts see these data as a potential turning point in the treatment of platinum-resistant ovarian cancer. Until now, the effectiveness of immunotherapies in this type of cancer has been limited. This could now change, especially for patients with PD-L1-positive tumors.

Nevertheless, experts such as Dr. Rebecca Kristeleit (London) emphasize that the results should be interpreted with caution. The clinical benefit must be weighed against possible side effects and costs. It also remains to be seen whether the combination will be approved in the future or can only be recommended for certain subgroups.

Finally, future combination therapies were also discussed in Berlin: so-called antibody-drug conjugates (ADCs) could be used together with immunotherapies in the future and thus offer further hope for patients with this difficult form of tumor.

Source: ESMO Congress Report (the article is in English)

The most important ASCO results for ovarian cancer

The most important ASCO results 2025
for ovarian cancer

Yesterday, the 26th NOGGO Update on Gynecologic Oncology took place, where important studies on ovarian cancer from ASCO 2025 were presented. We were there and would like to share the most important findings:

First-line therapy – surgery

The TRUST study clearly showed that the success of primary surgery (immediately after diagnosis) depends crucially on the location and quality of the surgical center. Patients who underwent surgery immediately had significantly longer progression-free survival compared to patients who underwent interval surgery (surgery after chemotherapy pre-treatment). There was also a numerical advantage in overall survival. The decisive factor for this was whether no tumor remnants (R0 result) remained at the end, regardless of the time of surgery. The choice of a good center for first-line treatment is therefore decisive for the further course of the disease!

First-line therapy – immunotherapy

The FIRST study investigated whether the addition of the immunotherapeutic agent dostarlimab to first-line chemotherapy provides an advantage. The results showed only a moderate effect: progression-free survival (the time without progression of the disease) was extended by a median of 1.5 months, while overall survival remained unchanged. In addition, no specific patient group could be identified that benefited particularly strongly.

Recurrence therapy – immunomodulation

The ROSELLA trial showed real progress for patients with platinum-resistant ovarian cancer: the combination of relacorilant and the chemotherapeutic agent nab-paclitaxel significantly prolonged progression-free survival – and an interim analysis showed a clinically meaningful benefit in overall survival of around 4.5 months. The combination was well tolerated; no new safety signals emerged.

Conclusion for clinics and patients

Despite positive signals from TRUST and ROSELLA, the current guidelines remain unchanged. The importance of high-quality surgery has been further strengthened by the TRUST trial, while the ROSELLA trial is the first to show concrete progress in recurrence setting with the combination of relacorilant and chemotherapy. The addition of immunotherapy in the first line has so far only shown limited benefit.

The results provide an exciting outlook, but current guidelines continue to recommend established therapies. Further analysis and confirmation will be crucial to set new standards.