# CatalYm Reports Phase 2 Data Showing Visugromab Boosts Nivolumab Response in Bladder Cancer > CatalYm's visugromab plus nivolumab achieved a 33% pathologic complete response in muscle-invasive bladder cancer, versus 8% for nivolumab alone. - Published: 2026-10-24T09:35:18+00:00 - Section: Research & Clinical Trials - Author: News Desk - URL: https://newsforagent.com/news/2026-10-24/catalym-visugromab-bladder-cancer-phase-2 - Source: [Business Wire](https://www.businesswire.com/news/home/20261024436746/en/) ## Key takeaways - CatalYm's Phase 2 GDFATHER-NEO trial reported a 33% pathologic complete response for visugromab plus nivolumab versus 8% for nivolumab plus placebo. - The trial enrolled 31 patients with a median age of 76 years, with 15 in the visugromab arm and 13 in the control arm evaluable for primary endpoint analyses. - CatalYm is advancing visugromab in randomized Phase 2b trials in first- and second-line non-small cell lung cancer, second-line hepatocellular carcinoma and cancer-associated cachexia. CatalYm reported final Phase 2 results showing visugromab plus nivolumab produced a 33% pathologic complete response in newly diagnosed muscle-invasive bladder cancer, against 8% for nivolumab plus placebo. The Munich- and San Francisco-based company said the data were presented at the European Society for Medical Oncology Congress 2026 and published simultaneously in Nature Medicine. The announcement was distributed by [Business Wire](https://www.businesswire.com/news/home/20261024436746/en/). ## CatalYm's GDFATHER-NEO Results at ESMO 2026 The randomized, stratified, single-blinded Phase 2 GDFATHER-NEO trial enrolled 31 patients with a median age of 76 years, all cisplatin-ineligible or cisplatin-refusing with newly diagnosed, non-metastatic muscle-invasive bladder cancer. At the July 15, 2026 data cut-off, 15 patients in the nivolumab plus visugromab arm and 13 in the nivolumab plus placebo arm were evaluable for local pathologic and radiographic primary endpoint analyses. The visugromab combination also recorded a 60% major pathologic response against 23%, and a 60% objective response rate against 15%, with seven of 15 complete responses in the visugromab arm. Independent blinded central review largely agreed with the locally assessed results. A greater share of visugromab-arm patients underwent bladder-sparing re-transurethral resection of the bladder tumor, 37.5% against 20.0%, and four of the five visugromab patients with a pathologic complete response kept their bladder after re-TURBT alone. At a median follow-up of 15.7 months, no recurrences occurred among patients who achieved a pathologic complete response, five in the visugromab arm and one in the control arm. Median event-free survival was not reached in either arm, with follow-up limited to one year after surgery. No treatment-related discontinuations or treatment-related delays to surgery were observed in the visugromab arm. "With more than one year of follow-up and support from independent central assessment, these final results further strengthen the clinical evidence for visugromab and extend its potential into another high-need solid tumor indication," said Sujata Rao, MD, Chief Medical Officer at CatalYm. ## CatalYm's Path to the ESMO Presentation CatalYm said on October 6, 2026 that it would present updated GDFATHER-NEO data at ESMO 2026, including final pathological, radiological and event-free survival outcomes from the Phase 2 study of visugromab plus nivolumab in muscle-invasive bladder cancer, according to [FinancialContent Business Page](https://www.financialcontent.com/article/bizwire-2026-10-23-brenus-pharmas-novel-in-vivo-immunotherapy-stc-1010-shows-safety-activating-t-cells-in-first-line-mss-metastatic-colorectal-cancers-with-2-complete-responses). The Pharma Letter reported on June 10, 2026 that CatalYm appointed Peter Garcia as chief financial officer, bringing more than 30 years of biotech and oncology finance experience, as visugromab advanced through a broad mid- to late-stage clinical program. ## Bladder and Prostate Data Across ESMO 2026 Brenus Pharma reported first data from Phase Ia STC-1010 in nine unresectable MSS colorectal cancer patients on October 23, 2026, with 43% becoming operable and 57% objective response, according to FinancialContent Business Page. Johnson & Johnson will present first clinical data for prostate cancer drug JNJ-6143 at ESMO 2026, including safety and efficacy findings, [The future of trading](https://capital.com/en-int/news/johnson-johnson-unveils-first-clinical-data-for-prostate-cancer) reported on October 23, 2026. Guosheng Securities reported that 28 Chinese innovative drug studies were selected for the Latest Breakthrough Abstracts at ESMO, with four in plenary sessions, [Moomoo](https://www.moomoo.com/news/post/1002113398/guosheng-securities-chinese-innovative-drugs-step-onto-the-global-center) reported on October 23, 2026. ## Visugromab's Phase 2b Trials CatalYm is advancing visugromab through randomized Phase 2b trials in first-line metastatic non-squamous non-small cell lung cancer, second-line metastatic non-squamous non-small cell lung cancer, second-line hepatocellular carcinoma and cancer-associated cachexia. ## Companies in this story - CatalYm · website: http://www.catalym.com --- News for Agent · https://newsforagent.com/llms.txt