CHENGDU, China, September 28, 2024 /PRNewswire/ — From September 25Th for 29Ththe 27th time China Congress of Clinical Oncology and the CSCO 2024 Annual Meeting was held at Xiamen. Experts and scholars in the field of oncology from all over China gather to discuss hot spots at the forefront of clinical practice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) presented several clinical research results and the progress of its TROP2 ADC sacituzumab tirumotecan (sac-™T, formerly SKB264/MK-2870) at the conference.
TNBC
In the evening from September 27Academics Binghe Xu from the Cancer Hospital of Chinese Academy of Medical Sciences gave an oral presentation and paper discussion on the results of the OptiTROP-Breast01 Phase III study of sacituzumab tirumotecan (sac-™T) in patients (pts) with metastatic or previously treated metastatic triple-negative breast cancer at Innovative. Drug Clinical Data Session.
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). Ing subset saka pts karo TROP2 H-skor> 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 was not reached (95% CI, 11.2 to NE) with SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The sac-™T group had a 47% reduced risk of death compared with the chemotherapy group (HR 0.53; 95% CI, 0.36 to 0.78; P = 0.00005). Compared with investigational chemotherapy options, sac-™T for metastatic TNBC patients showed a statistically and clinically significant improvement in PFS and OS, with an adjustable safety profile, and could be a new and effective therapeutic option for this group of patients.
Binghe Xu said, “Breast cancer is a very common malignant tumor in the world, threatening the life and health of women, among them, triple-negative breast cancer is also known as the ‘most toxic’ breast cancer because of its low therapeutic effect. advanced triple-negative breast cancer treatment that is, the proper and stratified treatment of Sac-™T can help meet the treatment needs of patients, and it may become the new treatment standard for triple-negative breast cancer. For the research and development of ADC, the domestic company has passed the stage of catching up and running in parallel, and now has become an important force in global ADC innovation, and we believe that one day, advanced triple-negative breast cancer patients can receive more effective treatment through ADC innovative drugs.
NSCLC
In the evening from September 28Prof. Wenfeng Fang from the Affiliated Cancer Hospital of Sun Yat-sen University verbally reported the results of the OptiTROP-Lung01study Phase II, first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with sac-™T in combination with KL-A167, an anti-PD-L1 monoclonal. antibodies, in the Innovative Medicines Clinical Data session, with paper discussion.
Pts with advanced treatment naïve NSCLC without actionable genomic alterations were enrolled to receive SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W (cohort 1A，130 Pts) or SKB264 5 mg/kg Q2W + KL-A027 90 mg/kg Q2W + KL-A167 90 133 Pts) in a non-random way. After a median follow-up of 14.0 mo and 6.9 mo for cohorts 1A and 1B, ORR was 48.6% (18/37, 2 awaiting confirmation), DCR was 94.6% and median PFS was 15.4 mo (95% CI: 6.7, NE) with 6-mo PFS rate 69.2% for cohort 1A; ORR was 77.6% (45/58, 5 pending confirmation), DCR 100% and median PFS was not reached with a 6-mo PFS rate of 84.6% for group 1B.
Prof. Wenfeng Fang said, “The emergence of ADC drugs created an era. The dual-drug regimen of sac-™T combined with immunotherapy led a new direction in the exploration of first-line treatment for advanced NSCLC, with very impressive efficacy observed in the data of preliminary studies. In the future, the potential for application sac-™T in the treatment of NSCLC is worth looking forward to, and sac-™T is expected to provide multiple treatment options and better patient survival, both in the driver-negative and EGFR-mutated patient population.”
CC
In the morning of September 28Professor Jing Wang of Hunan Cancer Hospital orally reported the results of sac-™T Plus Pembrolizumab Efficacy and Safety in patients with recurrent or metastatic cervical cancer. Pts with R/M CC who had progressed on or after platinum-double chemotherapy and received no more than 2 systemic therapies for R/M disease were enrolled. 38 pts were treated and followed for at least 17 weeks or 2 tumor assessments. Median follow-up was 6.2 mo, ORR was 57.9% (22/38, 3 unconfirmed), with 3 complete responses. Response was also observed in pts already treated with anti-PD-1 based therapy. Median PFS was not reached and the 6-mo PFS rate was 65.7%.
Professor Jing Wang said, “Cervical cancer highly expresses TROP2, and previous studies have suggested that the overexpression ratio is more than 90%. High TROP2 expression is closely related to the poor prognosis of tumor patients, and may be related to the sensitivity of some drugs. therapy, which makes it a target which is good to explore It is believed that with these promising results, more studies will appear in the field of gynecological oncology in the future to further validate the findings and bring hope to more cancer patients.
EC/OC
In the morning of September 28Dr. Zhu Yang of Liaoning Provincial Cancer Hospital shows the safety and efficacy results of sac-™T in pts with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a Phase 2 Study. In the endometrial cancer cohort, 44 EC pts were enrolled and the mean follow-up time was 7.2 mo. 52.3% of pts have received ‰¥ 2 lines before therapy. ORR was 34.1% (15/44, 12 confirmed) and DCR was 75%. Median PFS was 5.7 mo (95% CI: 3.7, 9.4) with a 6-mo PFS rate of 47.5%.
40 OC pts were enrolled and mean follow-up time was 28.2 mo. All pts had received ‰¥ 2 previous lines of therapy (80% of pts ‰¥ 3 previous lines). 87.5% of pts were platinum-resistant. ORR was 40% (16/40, 14 confirmed) and DCR was 75%. mPFS was 6.0 mo (95% CI: 3.9, 7.3); mo was 16.5 mo (95% CI: 10.7, NE). In pts 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 platinum-resistant pts (n = 35), mPFS was 6.0 mo (95% CI: 5.3, 7.3) and mOS was 16.1 mo (95% CI: 10.5, NE).
Prof. Danbo Wang said, “Ovarian cancer and endometrial cancer have their own epidemiological characteristics, and the incidence rate of endometrial cancer in developed cities in China increase year by year, and may become the top gynecological malignant tumor in Chinese women in the future. In contrast, ovarian cancer is characterized by insidious onset, high late detection rate and 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 cancer. It not only achieves outstanding results in terms of efficacy, but also well-controlled safety. I believe that in future research and applications, it will be a leader in the field of ADC innovative drug development and bring new hope to gynecological oncology patients.
With a caring heart, Kelun-Biotech is committed to solving unmet clinical needs China and around the world. By focusing on the strength of its own technology, Kelun-Biotech can provide patients China with novel ADC drugs with significant clinical value and good cost-effectiveness, and increasing benefits for clinical patients. In the future, we will continue to accelerate the R&D and clinical progress of drug candidates, improve our integrated drug development capabilities, and contribute to the realization of Healthy China 2030.
