On September 13, 2024 Ascendis Pharma A/S reported initial data showing signs of clinical activity in heavily pre-treated patients with platinum-resistant ovarian cancer (PROC) treated with TransCon IL-2 β/γ in combination with chemotherapy in its ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ (Press release, Ascendis Pharma, SEP 13, 2024, View Source [SID1234646562]). First results will be shared in Poster 762P at ESMO (Free ESMO Whitepaper) 2024, the annual meeting of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) being held in Barcelona from September 13-17, 2024.
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Of the 18 patients (median age 64 years) included in the initial data, 14 were efficacy evaluable patients who had 1 or more post-baseline tumor assessment(s), plus an additional 4 who discontinued treatment before the first post-baseline tumor assessment due to disease progression or death. Anti-tumor clinical responses were observed in 29% (4/14) of the efficacy evaluable patients (2 confirmed and 2 unconfirmed partial responses in patients who had received three to seven prior lines of treatment – including patients whose disease had previously progressed on Elahere, also called mirvetuximab soravtansine-gynx), suggesting clinical activity in heavily pre-treated patients. The data suggest that TransCon IL-2 β/γ was generally well-tolerated: the most common treatment-emergent adverse events related to combination therapy with TransCon IL-2 β/γ plus chemotherapy were fatigue, thrombocytopenia, neutropenia, and anemia. Most TransCon IL-2 β/γ-related TEAEs were grade 1 or 2.
"Building on results announced at ASCO (Free ASCO Whitepaper) 2024 in melanoma, we are excited now to see meaningful signs of anti-tumor activity in combination with chemotherapy in our second indication-specific cohort of heavily pretreated patients who have exhausted standard-of-care options," said Stina Singel, M.D., Ph.D., Executive Vice President, Head of Clinical Development, Oncology, at Ascendis Pharma. "We look forward to providing further updates as patients continue on study treatment."
About TransCon IL-2 β/γ & IL-Believe
TransCon IL-2 β/γ is a novel prodrug with sustained release of an IL-2Rβ/γ-selective IL-2 analogue (IL-2 β/γ). IL-2 β/γ is transiently attached to an inert carrier by a TransCon linker, which under physiological conditions releases active IL-2 β/γ in a predictable, sustained manner. This results in lower Cmax and longer half-life, which is expected to widen the therapeutic index.
TransCon IL-2 β/γ is being investigated in IL Believe, a multicenter Phase 1/2, multi-cohort study in adult patients with locally advanced or metastatic solid tumors. As of the July 29, 2024, data cut off, 42 patients whose disease had progressed within six months after completing platinum-based chemotherapy were enrolled in the PROC dose expansion cohort (Cohort 3 in the trial). Treatment for patients in Cohort 3 included intravenous TransCon IL-2 β/γ at the recommended Phase 2 dose of 120 μg/kg every 3 weeks in combination with the physician’s choice of paclitaxel, docetaxel, or pemetrexed. Disease response was assessed every 9 weeks using RECIST v1.1. and safety, efficacy, and biomarkers were evaluated.