# Kelun Biotech Reports Phase II sac-TMT Plus Keytruda Data and Plans Global Phase III

> Kelun Biotech reported Phase II sac-TMT plus pembrolizumab results in first-line cisplatin-ineligible la/mUC, with 63% grade 3 or higher TRAEs.

- Published: 2026-10-24T10:53:56+00:00
- Section: Research & Clinical Trials
- Author: News Desk
- URL: https://newsforagent.com/news/2026-10-24/kelun-biotech-sac-tmt-phase-ii-data
- Source: [TradingView](https://www.tradingview.com/news/tradingview:23d93b7b3b014:0-sichuan-kelun-biotech-biopharmaceutical-co-ltd-posts-phase-ii-sac-tmt-keytruda-data-plans-phase-iii/)

## Key takeaways

- Kelun Biotech reported Phase II results of sacituzumab tirumotecan plus pembrolizumab in first-line cisplatin-ineligible la/mUC.
- The trial showed 63% grade 3 or higher treatment-related adverse events and an 8% sac-TMT discontinuation rate for TRAEs.
- The data support starting the global Phase III TroFuse-055 study, with MSD running 18 global Phase IIIs.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. reported Phase II results of sacituzumab tirumotecan plus pembrolizumab in first-line cisplatin-ineligible la/mUC, showing antitumor activity with manageable safety, and said the data support starting the global Phase III TroFuse-055 study. [TradingView](https://www.tradingview.com/news/tradingview:23d93b7b3b014:0-sichuan-kelun-biotech-biopharmaceutical-co-ltd-posts-phase-ii-sac-tmt-keytruda-data-plans-phase-iii/) published the report on October 24, 2026.

## What the Phase II sac-TMT Combo Showed

The Phase II study evaluated sacituzumab tirumotecan, or sac-TMT, combined with pembrolizumab in first-line cisplatin-ineligible la/mUC. The combination showed antitumor activity with manageable safety, according to the report.

The safety profile included 63% grade 3 or higher treatment-related adverse events. Low ocular toxicity was observed, and no interstitial lung disease or pneumonitis was noted. Eight percent of patients discontinued sac-TMT for treatment-related adverse events.

[Kelun Biotech](https://akta.pro/company-profiles/0000dif/kelun-biotech) said the data support starting the global Phase III TroFuse-055 study. MSD runs 18 global Phase IIIs, according to the report.

## Kelun Biotech's Recent Company Records

Kelun Biotech is a Chengdu-headquartered biopharmaceutical company developing and commercializing antibody-drug conjugates, monoclonal antibodies, and small molecules for oncology and autoimmune disease, according to akta.pro [company records](https://akta.pro/company-data). It has four products approved in China and global licensing partnerships anchored by a multi-billion-dollar MSD collaboration.

The same records show total funding of $945 million, with a 2026-07 post-IPO equity round of $347.3 million. The company reported 2025 full-year revenue of RMB 2,057.92 million and a net loss of RMB 381.97 million, with an adjusted loss of RMB 211.28 million.

## Earlier Kelun Biotech Milestones

In September 2026, Kelun Biotech received NMPA approval for trastuzumab botidotin for second-line HER2-positive breast cancer after Phase III data showed significant efficacy versus T-DM1, according to Simply Wall St.

In August 2026, Kelun Biotech reported a 112% year-over-year increase in pharmaceutical product sales to approximately RMB 657 million for the first half of 2026, according to PR Newswire APAC.

In July 2026, Kelun Biotech published translational research on its sac-TMT and osimertinib combination therapy for EGFR-mutant non-small cell lung cancer in the journal Cancer Cell, according to Simply Wall St.

## What Comes Next for TroFuse-055

The global Phase III TroFuse-055 study is planned, with MSD running 18 global Phase IIIs, according to the report.

## Companies in this story

- [Kelun Biotech company profile](https://akta.pro/company-profiles/0000dif/kelun-biotech) · website: http://www.kelun-biotech.com

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