Oncological treatment of further patients with Lartruvo (Olaratumab) should not be performed after a new study has now shown that the medicinal product will not bring about an extension of a patient's life expectancy

Preliminary results of the ANNOUNCE study have shown that Olaratumab (Lartruvo) in combination with Doxorubicin is not more effective than Doxorubicin alone when life expectancy results in the combination therapy group were compared with those from the total number of patients suffering from soft tissue sarcoma. Lartruvo is a monoclonal antibody authorised for the treatment of soft tissue sarcoma.

While the complete analysis of the study results is still outstanding, the European Medicines Agency (EMA) recommends refraining from treatment of new patients.

For patients currently treated with Lartruva, the treating doctor can consider further treatment with Lartruva if the respective patient benefits from this. Based on the previously available information, there are no up to now unknown safety risks. Comparable adverse effects occurred, no matter whether a patient was treated with the combination therapy or Doxorubicin alone.

Lartruvo was authorised for the treatment of advanced soft tissue sarcoma in November 2016. At the time of the authorisation, fewer data on Lartruvo were available due to the lower number of patients in the master study. For this reason, the medicinal product was authorised by the European Commission only on condition that the marketing authorisation holder submits additional supportive data from the ANNOUNCE study for the benefit and safety of the product.

Health care professional will be informed on the preliminary results of the above mentioned clinical study and current treatment recommendations shortly by the marketing authorisation holder. The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicnes and the EMA may also provide further statements.

Information for patients

• A new study shows that the combination of Lartruvo with Doxorubicin compared with Doxorubicin alone does not lead to a further extension of life expectancy.
• New treatments of patients with Lartruvo should not be performed.
• Patients currently treated with Lartruvo should talk to their doctor to discuss whether treatment with Lartruvo should be continued.
• No safety risks of Lartruvo have so for been identified.

Information for health care professionals

• In the Phase 3 "ANNOUNCE" study, treatment with Lartruvo was studied in combination with Doxorubicin in patients with advanced or metastasizing soft tissue sarcoma. A clinical benefit of Lartruvo in combination with Doxorubicin compared to Doxorubicin alone could not be shown after analysing the study data.
• The primary target criterion of the ANNOUNCE study, i.e. extension of the survival period, was reached neither in patients with soft tissue sarcoma (Hazard Ratio (HR): 1.05; Median 20.4 vs. 19.7 months for Lartruvo plus Doxorubicin vs. Doxorubicin), nor in a sub-population of patients with leiomyosarcoma (HR: 0.95; median 21.6 months for Lartruvo plus Doxorubicin vs. 21.9 months for Doxorubicin).
• Furthermore, no benefit was shown with regard to the extension of progression-free survival in patients with soft tissue sarcoma (HR: 1.23; median 5.4 months for Lartruvo plus Doxorubicin compared with 6.8 months for Doxorubicin). The latter was a secondary target criterion of the study.
• For these reasons, Lartruvo should not be prescribed to new patients.
• Until the final analysis of the study results has been completed, Lartruvo therapy of patients who have an individual benefit from the treatment can be continued.
• No new safety risks were identified during the study and safety profiles were comparable in both the above mentioned study arms.
• Health care professional will be informed on the preliminary results of the study and the current treatment recommendations in a letter.
• The Paul-Ehrlich-Institut is in contact with the sponsors of the clinical studies affected so that the necessary steps can be taken as soon as possible.

Additional information on Lartruvo

Lartruvo is a biomedical product for the treatment of cancer. It is authorised for antibody treatment of adults with advanced soft tissue sarcoma, a type of cancer which affects the soft, supportive tissues of the body such as the muscles, blood vessels, and fatty tissues.

Lartruvo is used in combination with Doxorubicin (another cancer medicine) in patients whose cancer is not amenable to surgery or radiotherapy.

On 9 November 2016, Lartruvo was granted a conditional approval by the European Commission. For further information on the medicinal product, please visit the website of the EMA:

Lartruvo European Public Assessment Report .

Additional information on the conditional approval

A conditional approval permits an early marketing authorisation of a medicinal product in the EU based on less extensive clinical data than normally required for a marketing authorisation. A conditional approval can be given to medicinal products for the treatment of a disease which is life-threatening or presents a severe impairment for a patient or a rare disease as well as products designed for the use in emergency situations as a reaction to a threat to public health.

The data available need not be comprehensive but should still show that the benefit of the product out-weighs its risks. The applicant is obliged to make available extensive data in a timely manner after the marketing authorisation has been granted. Special obligations apply for such medicinal products, which aim at obtaining complete data on the product.

Conditional approvals are always valid for one year. The EMA committees review the data available on the product and perform a renewed assessment of its risk/benefit ratio.