Moleculin Biotech has announced encouraging topline efficacy outcomes from its US Phase IB/II trial, MB-107, of Annamycin for soft tissue sarcoma lung metastases (STS lung mets) treatment.
The Phase IB in this open-label, multi-centre trial aims to determine the maximum tolerable dose and recommended Phase II dose, as well as assess the safety. Phase II focused on the efficacy of Annamycin as a monotherapy.
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The clinical benefit rate was 59.4%, with one participant achieving a partial response and 18 showing stable disease.
Dose and regimen-optimised participants showed progression-free survival (PFS) and an overall survival (OS) of around four and 20 months, respectively.
The median PFS was 63 days, and the median OS was 411 days for all participants.
In Phase II, at a dose of 330 mg/m², the median PFS was 105 days, with an OS of 13.5 months for those who had undergone a median of six previous therapies, exceeding typical outcomes for second-line monotherapies.
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By GlobalDataParticipants with fewer previous therapies and receiving the recommended Phase II dose showed even better outcomes, with an OS and PFS of 19.9 months and 127 days, respectively.
The study also highlighted that those who achieved a clinical benefit from Annamycin with two cycles experienced higher OS and PFS, indicating that the clinical benefit rate achievement led to better outcomes.
Overall disease control was found to be better at the 330 mg/m² dose. No cardiotoxicity was observed.
Annamycin holds fast track status and orphan drug status from the Food and Drug Administration for relapsed or refractory acute myeloid leukaemia (AML), as well as orphan drug status for soft tissue sarcoma.
The European Medicines Agency (EMA) has also granted orphan drug status for Annamycin in the treatment of relapsed or refractory AML.
Moleculin Biotech CEO and chairman Walter Klemp said: “These positive topline results from MB-107 are incredibly encouraging. The impact Annamycin demonstrated on median OS, particularly with patients who received multiple prior chemotherapy regimens, exceeded expectations. Additionally, the improvement seen with PFS after two doses represents a real potential for Annamycin to provide a meaningful treatment option for the treatment of STS lung mets.”
Soft tissue sarcomas are said to be a cancer originating in the body’s soft tissues, which often leads to lung mets, impacting OS.
Recently, the EMA approved the company’s application for the pivotal Phase IIB/III trial of Annamycin in combination with cytarabine for adults with AML.
