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Visugromab shows initial efficacy and safety in urothelial carcinoma
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“The impressive duration of response, still expanding with 6/8 responses ongoing, is indicative of restoration of a lasting immunologic tumor control in advanced solid tumor patients,” says Eugen Leo, MD, PhD, MBA
The GDF-15 neutralizing antibody visugromab (CTL-002) in combination with nivolumab (Opdivo) demonstrated promising anti-tumor activity and a manageable safety profile in patients with urothelial carcinoma (UC), according to findings from the phase 2a GDFATHER-2 trial (NCT04725474) exploring the therapy combination in advanced solid tumors.
The study remains ongoing with plans to enroll over 200 patients in up to 7 cohorts.
Data from the UC and non-small cell lung cancer (NSCLC) cohorts of the study were presented at the European Society for Medical Oncology Immuno-Oncology Congress 2023 in Geneva, Switzerland.1
The trial enrolled patients with advanced solid tumors, including those with urothelial carcinoma, who were relapsed or refractory to checkpoint inhibitor (CPI) therapy and had exhausted standard-of-care options. Patients in the study received intravenous visugromab 10 mg/kg once every 2 weeks plus nivolumab 240 mg once every 2 weeks. The primary end point was objective response rate (ORR).
The ORR among patients in the UC cohort (n = 27) was 14.8%. The mean duration of response has surpassed 11 months in the NSCLC cohort and 10 months among patients in the UC cohort and is further expanding, with 6/8 subjects in response continuing on with study treatment.
“The impressive duration of response, still expanding with 6/8 responses ongoing, is indicative of restoration of a lasting immunologic tumor control in advanced solid tumor patients that had previously exhausted available standard of care and are relapsed/refractory to prior anti-PD-1/PD-1 treatment as defined by strict criteria,” added Eugen Leo, MD, PhD, MBA, Chief Medical Officer at CatalYm, in a news release on the findings.2
Responses were observed in both PD-L1 positive and negative tumors, with most seen in PD-L1 positive tumors. Notably, all 3 patients in the UC cohort with PD-L1 levels of Tumor Proportion Score greater than 5 achieved a partial or complete response. Partial responses were observed in 2 patients, and a complete response was observed in 1 patient. All remain ongoing.
Overall, the treatment was well-tolerated and the majority of treatment-emergent adverse events (TEAEs) were mild to moderate. Greater than grade 3 TEAEs were reported in 3.7% of patients included in the study.
The study remains ongoing with plans to enroll over 200 patients in up to 7 cohorts. According to the news release, CatalYm plans to launch randomized, controlled studies on combination therapies with visugromab in several major cancer indications in the first half of 2024.
“We continue to make important progress in our phase 2 evaluation of visugromab, further demonstrating the potential of GDF-15 neutralizing approaches as a critical component for treatment success in a broad range of anti-cancer regimens,” said Phil L’Huillier, Managing Director and Chief Executing Officer at CatalYm, in the news release.2 “The next stage is to expand our clinical evaluation in 2024 to further maximize the value of GDF-15-targeting therapies for patients both in advanced and earlier stages of their disease. There is a huge unmet medical need not only in CPI-relapsed/refractory solid tumors but also in newly diagnosed metastatic solid tumor disease, where despite all encouraging recent advances, a cure or at least true long-term-remission/-disease control are still far out of reach for the vast majority of patients, who ultimately will die from their disease. We want to improve patient’s lives and outcome with a well tolerable immunotherapy concept that we see emerge here.”
References
1. Definitive results for NSCLC and Bladder cancer cohorts in the phase 2a trial of visugromab (CTL-002) in advanced/metastatic anti-PD/PD-L1 relapsed/refractory solid tumors (GDFATHER-trial). Presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2023. December 6-8, 2023. Geneva, Switzerland. Abstract 118O
2. CatalYm presents positive phase 2a outcome for visugromab in advanced NSCLC and urothelial cancer at the ESMO Immuno-Oncology Congress 2023. News release. CatalYm. December 6, 2023. Accessed December 8, 2023. https://www.businesswire.com/news/home/20231206416372/en/CatalYm-Presents-Positive-Phase-2a-Outcome-for-Visugromab-in-Advanced-NSCLC-and-Urothelial-Cancer-at-the-ESMO-Immuno-Oncology-Congress-2023
