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)

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)