On September 20, 2021 PharmaMar (MSE:PHM) reported that new data on Yondelis (trabectedin) in patients with metastatic or inoperable leiomyosarcoma will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress, which is being held virtually from 16th to 21st September (Press release, PharmaMar, SEP 20, 2021, View Source [SID1234596669]).
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Under the title "LMS-04 study: a randomised, multicenter phase-III study comparing doxorubicin alone versus doxorubicin with trabectedin followed by trabectedin in nonprogressive patients as first-line therapy, in patients with metastatic or unresectable leiomyosarcoma. A French Sarcoma Group study," the French Sarcoma Group will present data from a phase III study comparing first-line treatment with trabectedin in combination with doxorubicin versus standard-o-care single-agent doxorubicin for the first-line treatment of patients with metastatic or unresectable leiomyosarcoma.
The study achieved its primary endpoint of Progression Free Survival (PFS), progression RECIST (Response Evaluation Criteria In Solid Tumors)1 , supplemented by central review. In the combination arm of trabectedin with doxorubicin, median PFS reached 12.2 months, compared to 6.2 months with single-agent doxorubicin (HR = 0.41; 95% CI 0.29-0.58; P<0.0001).
In addition, the Overall Response Rate (ORR) was 38% using the combination, compared to 13% in the comparator arm. Overall Survival (OS) was 30.5 months in patients who received trabectedin in combination with doxorubicin, compared to 24.1 months in patients who received doxorubicin alone.
Patricia Pautier, M.D., oncologist, head of the multidisciplinary committee of gynecologic oncology at Gustave-Roussy and lead author of the study, said: "Leiomyosarcoma has been classically reported as the most frequent soft tissue sarcoma subtype together with liposarcoma, a third of them have a uterine location. Patients have a poor prognosis when leiomyosarcomas are metastatic. In prospective clinical trials, a median PFS of about 6 months and overall survival of around 12–15 months are usually reported for patients treated with any first-line chemotherapy, representing a true unmet medical need. In general, Doxorubicin and Ifosfamide are the backbone of sarcoma treatment, but nor other association nor new therapies are superior to doxorubicin in terms of overall survival." She added: "Trabectedin is known to be active in second line treatment for leiomyosarcomas.
The previous phase II of the trabectedin-doxorubicin combination in metastatic or advanced LMS in first line therapy (LMS02) share very encouraging results in terms of ORR, PFS and OS. The results of the LMS04 study have confirmed that this combination is superior in terms of PFS to doxorubicin alone with a 6 months statistical benefit; the impact on PFS2 also is in favor of the use of the association in combination rather than in a sequential way. There is a clinical impact on overall survival and a longer follow-up will let us know if this therapy will impact overall survival and will be the new standard of treatment in this indication.