The 2024 American Society of Clinical Oncology Annual Meeting (ASCO) will be held in Chicago, USA, from May 31 to June 4. On April 24, ASCO's conference schedule and abstract title were officially launched, and the data of two clinical studies of SKB264, a new drug of Columbotai Trop2 ADC, will be presented orally at the meeting.
第一项研究为SKB264用于经治局部复发性或转移性三阴乳腺癌三期临床OptiTROP-Breast01的最新数据,将于美国当地时间2024年6月2日上午9:45-11:15在“Clinical Science Symposium- Next Generation Antibody-Drug Conjugates: The Revolution Continues” Session进行口头报告。 Session类型为clinical science symposium,为special session。
第二项研究为SKB264+KL-A167联合一线治疗晚期非小细胞肺癌二期临床OptiTROP-Lung01的最新数据,将于美国当地时间5月31日下午2:45-5:45在“Oral Abstract Session-Lung Cancer- Non-Small cell Metastatic” Session进行口头报告。
SKB264 is developed in-house by Columbus based on its OptiDC technology platform, and adopts a unique and differentiated design, from a high-affinity Trop2 antibody conjugated to a stable CL2A linker to a self-developed T030 toxin, with an average DAR of 7.4. The unique design allows SKB264 to achieve a better balance of efficacy and safety, and has been continuously verified in clinical trials.
summary
Columbotai has carried out 4 registrational clinical trials of SKB264 in China, covering the third-line and above for the treatment of advanced triple-negative breast cancer, EGFR-mutant non-small cell lung cancer, and the second-line and above for the treatment of HR+/HER2- breast cancer, and has obtained 4 breakthrough therapy designations. At the end of 2023, Columbotech has submitted a marketing application for SKB264, which is expected to be approved in the second half of 2024, and is expected to become the first domestic TROP2 ADC.
In terms of internationalization, our partner Merck has launched 7 global phase III clinical trials in just half a year, covering non-small cell lung cancer, endometrial cancer, breast cancer, gastric cancer and other tumor types, with a total of nearly 5,000 patients, truly becoming the bridgehead of Merck in the field of oncology and laying a solid foundation for Columbus SKB264 to achieve global market value.
- MK-2870-004: for EGFR mutation-positive non-small cell lung cancer that has progressed after immunotherapy and chemotherapy, 556 patients;
- MK-2870-005: advanced endometrial cancer, 710 cases;
- MK-2870-007: metastatic non-small cell lung cancer with high PD-L1 expression (TPS≥50%), 614 cases;
- MK-2870-009: for EGFR mutation-positive, immunotherapy-progressing non-small cell lung cancer (NSCLC), 520 patients;
- MK-2870-010: Monotherapy or in combination with Keytruda in the treatment of locally advanced or metastatic HR+/HER2- breast cancer, 1200 patients;
- MK-2870-015: Treatment of recurrent or metastatic gastric cancer, 450 cases;
- MK-2870-019: SKB264 (MK-2870) + Keytruda versus Keytruda for the adjuvant treatment of NSCLC patients (resectable stage II-IIIB (N2)) who received prior neoadjuvant Keytruda versus platinum-doublet chemotherapy and did not achieve a pathologically complete response after surgery, 780 patients.