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<\/p>\n(UroToday.com) The 2026 ESMO annual meeting featured a germ cell tumor rapid oral session and a presentation by Dr. Darren Feldman discussing the safety and efficacy of ixotatug vedotin, a claudin-6-targeted antibody drug conjugate, as monotherapy in germ cell tumors. Claudin-6 is a cell surface protein and member of the claudin family of tight junction molecules expressed at high levels in multiple human cancers with little or no expression in normal adult tissues. Overexpression of Claudin-6 has been found to be highly prevalent in germ cell tumors:\u00a0<\/p>\n
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Germ cell tumors are the most common solid malignancy in adolescent and young adult men and are typically diagnosed in the third or fourth decades of life. Although most patients with newly diagnosed germ cell tumors are successfully treated with platinum-based chemotherapy, 20-30% relapse. Long-term survival for these patients is achieved in <10% of patients who progress post-high-dose chemotherapy + autologous stem cell transplantation, with chemotherapy regimens producing objective response rates of ~6-51%. Thus, clinically effective salvage therapies are limited.<\/p>\n
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Ixotatug vedotin is a first-in-class IgG1-vc-MMAE antibody drug conjugate that specifically targets Claudin-6-positive disease:![\"Ixotatug](\"https:\/\/www.newsbeep.com\/nz\/wp-content\/uploads\/2026\/10\/1792832290_669_image-1.jpg\")
Ixotatug vedotin monotherapy has previously demonstrated promising antitumor activity with a manageable safety profile in heavily pretreated Claudin-6-positive ovarian cancer. At the 2026 ESMO annual meeting, Dr. Feldman reported the safety and efficacy from an ongoing phase 1 study of ixotatug vedotin in patients with heavily pretreated germ cell tumor, including progression after high-dose chemotherapy with autologous stem cell transplantation.<\/p>\n
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Patients with previously treated advanced or metastatic germ cell tumor, not amenable to surgery, were enrolled across dose escalation and dose expansion cohorts. Patients received ixotatug vedotin (doses ranging from 0.4-3.4 mg\/kg) on Day 1 of a 21-day cycle. This analysis includes patients with germ cell tumor of the testicle (n = 9), ovary (n = 1), and extragonadal disease (n = 1). Responses were assessed by investigator per RECIST 1.1, and adverse events were graded by CTCAE v5.0:<\/p>\n
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Of 11 germ cell tumor patients treated to date, 10 were Claudin-6 positive (>30% expression), and the median age was 37 years (range 23-76). Patients received a median of 3 prior lines (range 1-5) of treatment, and 54.5% had prior stem cell transplantation:<\/p>\n
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Among the 11 evaluable patients, the objective response rate was 45.5% (95% CI 16.7-76.6), including 3 of 6 stem cell transplantation patients with confirmed responses. Disease control rate was 72.7% (95% CI 39.0-94.0), with a median progression-free survival of 5.8 months (95% CI 1.4-13.8). There was 1 patient with a maintained response of 47.4 months and treatment ongoing:<\/p>\n
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Ten (90.9%) patients experienced a treatment-emergent adverse event of any grade, and 7 (63.6%) patients experienced a grade 3+ treatment-emergent adverse event. Three patients experienced reversible grade 4 neutropenia (no febrile neutropenia), and two patients had grade 1 neuropathy at baseline and experienced grade 3 peripheral sensory neuropathy. There were no grade 5 adverse events observed:\u00a0<\/p>\n
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There were 7 of 11 patients who experienced a dose reduction, delay, or withdrawal due to any adverse event, with peripheral sensory neuropathy the most common adverse event leading to dose delay or reduction in 5 patients.\u00a0<\/p>\n
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Dr. Feldman concluded his presentation discussing the safety and efficacy of ixotatug vedotin as monotherapy in germ cell tumors with the following take-home messages:<\/p>\n
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\nIxotatug vedotin monotherapy demonstrated meaningful clinical activity in heavily pretreated patients with recurrent germ cell tumor, including patients with disease refractory to high-dose chemotherapy + autologous stem cell transplantation
\nIxotatug vedotin has a manageable safety profile, characterized by predominantly low-grade treatment-emergent adverse events
\nThis phase 1 data supports ongoing clinical investigation of ixotatug vedotin in germ cell tumors that have progressed on or after platinum-based chemotherapy
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Presented by: Darren Feldman, MD, Memorial Sloan Kettering Cancer Center, New York, NY<\/p>\n
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