Multiple Study Results for Kelun-Biotech's TROP2 ADC (Sac-TMT) Were Presented at 2024 ESMO Congress

The 2024 European Society of Medical Oncology (ESMO) Annual Meeting was officially held in Barcelona, Spain from September 13-17, which brought together cutting-edge research progress in the global field of oncology. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) announced the results of multiple clinical studies on TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870 ), the core product of the company, at the conference.

Patients with R/M CC who had progressed on or after platinum-doublet chemotherapy and received no more than 2 systemic therapies (PD-(L)1 inhibitors allowed) for R/M disease were enrolled and evaluated with sac-TMT at a dose of 3 or 5 mg/kg every 2 weeks in combination with pembrolizumab (KEYTRUDA®) at a dose of 400 mg every 6 weeks during the safety-introduction phase. and explored to doses considered well tolerated during the dose expansion phase. 38 patients had a median follow-up of 6.2 months with an ORR of 57.9% , including 3 complete remissions. Remission was also observed in patients receiving anti-PD-1 therapy (ORR 68.8%, 11/16), with a 6-month PFS rate of 65.7% and a 6-month DoR rate of 82.1%.

Prof. Xiaohua Wu said, “Cervical cancer is the fourth leading cause of cancer deaths in women, and immunotherapy PD-1/PD-(L)1 has already been widely used as the standard of care for first- or second-line recurrent treatment, and when these patients relapse again, the exploration of immuno-targeting for TROP2 ADC sac-TMT that I am presenting today has the potential to fulfill the unmet clinical need and bring new therapeutic options to patients.”

On the same day, on behalf of the research team, Prof. Danbo Wang from Liaoning Cancer Hospital orally presented the results of the phase 2 clinical trial of TROP2 ADC sac-TMT monotherapy for the treatment of advanced endometrial cancer (EC) and ovarian cancer (OC) in the gynecologic oncology oral session of the congress. In the endometrial cancer cohort, 44 patients had a median follow-up of 7.2 months. 52.3% of patients had received prior second-line or higher therapy and had a relatively poor baseline. Sac-TMT still achieved an objective remission rate (ORR) of 34.1% and a disease control rate (DCR) of 75%, while median progression-free survival (PFS) was 5.7 months. In the ovarian cancer cohort, with a median follow-up of up to 28.2 months in 40 patients, all of whom had received second-line or higher therapy and 87.5% of whom were platinum-resistant, sac-TMT monotherapy achieved a 40% ORR and 75% DCR with a median PFS of 6 months.

Professor Danbo Wang said, “I am very honored to share the clinical study results of ADC for gynecological cancer at the ESMO Congress this year. The incidence rate of endometrial cancer in China's developed cities is rising year by year, and it may become the most common gynecological malignancy among Chinese women in the future. In contrast, ovarian cancer, most notably characterized by its insidious onset, high rate of late detection and high mortality rate, has long been a treatment difficulty for clinicians. There are still many challenges in late line treatment, and the current treatments options are limited where new therapeutic strategies is to be explored urgently. I am immensely proud of the domestically developed TROP2 ADC sac-TMT for its stunning efficacy data demonstrated as well as the controllable safety profile in the trial, which shows great therapeutic potential.”

The results of an exploratory analysis of patients with or without prior treatment with PD-(L)1 inhibitors in the Phase 3 study (OptiTROP-Breast01) of sac-TMT versus chemotherapy in patients with advanced triple-negative breast cancer (TNBC) who have received prior treatment were presented as a poster on September 16, local time, at the congress.

The OptiTROP-Breast01 study is a multicenter, randomized controlled, open-label, phase 3 clinical study co-led by academician Binghe Xu of the Cancer Hospital of the Chinese Academy of Medical Sciences and Professor Yongmei Yin of the Jiangsu Provincial People's Hospital. It aims to evaluate the efficacy and safety of sac-TMT versus TPC in patients with locally advanced or metastatic TNBC who have received or have not received prior treatment with PD-(L)1 inhibitors. Patients treated with sac-TMT had a higher ORR benefit compared to patients treated with TPC (eribulin, vincristine, capecitabine, or gemcitabine), regardless of whether the patients had been previously treated with a PD-(L)1 inhibitor. In the subgroup of patients previously treated with PD-(L)1 inhibitors, the median PFS was 5.6 months in the sac-TMT group and 2.7 months in the TPC group, and in the subgroup of patients who had not received prior PD-(L)1 inhibitor therapy, the median PFS was 7.2 months in the sac-TMT group and 2.3 months in the TPC group in terms of safety, the sac-TMT group was overall similar to the chemotherapy group, with controllable adverse effects. Analysis of interim data from the OptiTROP-Breast01 study showed statistically and clinically significant improvements in progression-free survival (PFS) and overall survival (OS) in patients treated with sac-TMT compared to chemotherapy.

Kelun-Biotech will continue to accelerate the R&D and clinical progress of its drug candidates, enhance its integrated drug development capabilities, and optimize its OptiDC R&D platform to support the R&D of innovative drugs, strengthen its commercialization capabilities, and remain committed to addressing the unmet medical needs in China and around the world, with the primary goal of providing patients around the world with significant clinical value, cost-effective, and innovative ADC drugs.

About Kelun-Biotech

Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.