CHENGDU, China, September 28, 2024 /PRNewswire/ — From September 25th at 29ththe 27th China Clinical Oncology Congress and the 2024 CSCO Annual Meeting were held in Xiamen. Experts and academics in the field of oncology from all over. Porcelain They met to discuss critical points at the forefront of clinical practice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) presented multiple clinical research results and progress of TROP2 ADC sacituzumab tirumotecan (sac-™T, formerly SKB264/MK-2870) at the conference.
TNBC
In the afternoon of September 27Academic Binghe Xu from cancer hospital of the Chinese Academy of Medical Sciences performed an oral presentation and paper discussion on the results of the Phase III OptiTROP-Breast01 study of sacituzumab tirumotecan (sac-™T) in patients (pts) with previously treated locally recurrent or metastatic triple negative breast cancer (TNBC) at the Innovative Drug Clinical Data Session.
The median PFS assessed by BICR was 6.7 months (95% CI: 5.5 to 8.0) with SKB264 and 2.5 months (95% CI: 1.7 to 2.7) with chemotherapy; The sac-™T group had a 68% reduction in the risk of disease progression or death compared with the chemotherapy group (HR, 0.32; 95% CI, 0.22 to 0.44; P <0,00001). En el subconjunto de pacientes con puntuación H de TROP2 > 200, median PFS was 8.3 months with SKB264 and 2.3 months with chemotherapy (HR, 0.29; 95% CI, 0.19 to 0.46). Median OS (95% CI, 11.2 to NE) was not reached with SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The sac-™T group had a 47% reduction in the risk of death compared with the chemotherapy group (HR, 0.53; 95% CI, 0.36 to 0.78; P = 0.00005). Compared with the investigator’s choice of chemotherapy, sac-™T for patients with metastatic TNBC showed statistically and clinically significant improvements in PFS and OS, with a manageable safety profile, and could be a new and effective therapeutic option for this patient group.
Binghe Xu said: “Breast cancer is a highly prevalent malignant tumor in the world, threatening the lives and health of women, among whom, triple negative breast cancer is also known as the ‘most toxic’ breast cancer.” due to its poor therapeutic effect. The future direction of advanced treatment of triple negative breast cancer is precise and stratified treatment that can help meet more treatment needs of patients and can be expected to become the new standard of treatment. second-line for advanced triple negative breast cancer. For ADC research and development, domestic companies have gone through stages of catching up and running in parallel, and have now become a major force in breast cancer technology. “ADC’s global innovation, and we believe that one day, patients with advanced triple negative breast cancer can get more effective treatment thanks to ADC’s innovative drugs.”
NSCLC
In the afternoon of September 28prof. Wenfeng Fang from Affiliated Cancer Hospital of Sun Yat Sen University orally reported the results of the phase II study OptiTROP-Lung01, a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) with sac-™T in combination with KL-A167, a monoclonal anti-PD- L1. antibody, in the Clinical Data of Innovative Medicines session, with a discussion of papers.
Patients with treatment-naïve advanced NSCLC without actionable genomic alterations were enrolled to receive SKB264 5 mg/kg every 3 weeks + KL-A167 1200 mg every 3 weeks (cohort 1A，130 patients) or SKB264 5 mg/kg every 2 weeks + KL -A167 900 mg every 2 weeks (cohort 1B, 133 Pts) in a non-randomized manner. After a median follow-up of 14.0 months and 6.9 months for cohorts 1A and 1B, ORR was 48.6% (18/37, 2 pending confirmation), DCR was 94.6% and median PFS was 15.4 months (95% CI: 6.7, NE) with a 6-month PFS rate of 69.2% for cohort 1A; ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100%, and median PFS was not reached with a 6-month PFS rate of 84.6% for the cohort 1B.
Teacher. Wenfeng Fang said: “The emergence of ADC drugs is epoch-making. The dual-drug regimen of sac-™T combined with immunotherapy is leading a new direction in exploring first-line treatment for advanced NSCLC, with striking efficacy observed in In the future, it is worth waiting for the preliminary study data on the potential of the application of sac-™T in the treatment of NSCLC, and it is expected that sac-™T will provide diversified treatment options and better survival benefits for more patients.
DC
On the morning of September 28Teacher Jing Wang of Hunan Cancer Hospital orally reported the efficacy and safety results of sac-™T Plus Pembrolizumab in patients with recurrent or metastatic cervical cancer. Patients with R/M CC who had progressed during or after platinum doublet chemotherapy and received no more than 2 systemic therapies for R/M disease were enrolled. 38 patients were treated and followed for at least 17 weeks or 2 tumor evaluations. Median follow-up was 6.2 months. The ORR was 57.9% (22/38, 3 unconfirmed), with 3 complete responses. Responses were also observed in patients who were previously treated with anti-PD-1-based therapy. Median PFS was not reached and the 6-month PFS rate was 65.7%.
Teacher Jing Wang said: “Cervical cancer highly expresses TROP2, and previous studies have suggested that the overexpression rate is more than 90%. High expression of TROP2 is closely related to the poor prognosis of tumor patients, and may also be related to the sensitivity of some drug therapies, making it a good target to explore. It is believed that with these promising results, more studies will emerge in the field of gynecologic oncology in the future to further validate these findings and provide hope. to a broader range of cancer patients.
CE/CO
On the morning of September 28Dr. Zhuo Yang of Liaoning Provincial Cancer Hospital shared safety and efficacy results of sac-™T in patients with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a phase 2 study. In the endometrial cancer cohort, 44 patients were enrolled CD and the median follow-up time was 7.2 months. 52.3% of patients had received ‰¥ 2 previous lines of therapy. The ORR was 34.1% (15/44, 12 confirmed) and the DCR was 75%. Median PFS was 5.7 months (95% CI: 3.7, 9.4) with a 6-month PFS rate of 47.5%.
40 OC patients were enrolled and the median follow-up time was 28.2 months. All patients had received ‰¥ 2 prior lines of therapy (80% of patients ‰¥ 3 prior lines). 87.5% of patients were resistant to platinum. The ORR was 40% (16/40, 14 confirmed) and the DCR was 75%. mPFS was 6.0 months (95% CI: 3.9, 7.3); month was 16.5 months (95% CI: 10.7, NE). In patients with TROP2 IHC H score > 200 (n = 13) or H score ‰¤ 200 (n = 22), the ORR was 61.5% (8/13, 7 confirmed) and 27.3% ( 6/22, 6 confirmed) respectively. In patients with platinum resistance (n = 35), mPFS was 6.0 months (95% CI: 5.3, 7.3) and mOS was 16.1 months (95% CI: 10.5, NE).
Professor Danbo Wang said: “Ovarian cancer and endometrial cancer have their own epidemiological characteristics, and the incidence rate of endometrial cancer in developed cities in Porcelain It is increasing year by year and may become the leading gynecological malignant tumor in Chinese women in the future. In contrast, ovarian cancer is characterized by an insidious onset, a high late detection rate, and a high mortality rate. Exploring new therapeutic strategies to overcome platinum resistance and improve the survival rate of ovarian cancer patients is a key direction for future research. Sac-™T shows great potential in the treatment of advanced endometrial and ovarian cancers. It has not only achieved remarkable results in terms of efficacy, but also well-controlled safety. “I believe that in future research and application, it will become a leader in the field of innovative ADC drug development and bring new hope to more gynecologic oncology patients.”
With a caring heart, Kelun-Biotech is committed to solving unmet clinical needs in Porcelain and all over the world. By focusing on its own technological strengths, Kelun-Biotech can provide patients in Porcelain with new ADC medicines with significant clinical value and excellent cost-effectiveness, and to improve benefits for clinical patients. In the future, we will continue to accelerate the R&D and clinical progress of our drug candidates, improve our integrated drug development capabilities, and contribute to the realization of a Healthy China 2030.
