ASCO 2023:Kelun Pharma’s SKB264 shows early signs of potential in NSCLC patients

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ASCO 2023:Kelun Pharma’s SKB264 shows early signs of potential in NSCLC patients


SKB264 is an innovative anti-TROP2 ADC that specifically targets a poor prognosis marker found in 70% of non-small cell lung cancer (NSCLC) cases. It employs a sulfonyl pyrimidine-CL2A-carbonate linker, which enables a delicate balance between stability in circulation and effective release of the payload within tumor cells. This ADC boasts an impressive drug-to-antibody ratio (DAR) of 7.4. According to data presented at the ASCO 2023 conference, as of February 9, 2023, a total of 43 patients had been enrolled in the study, with 39 of them being evaluated for their response to treatment. The median follow-up period was 11.5 months, and the median treatment period was 5.7 months. An objective response rate (ORR) of 44% was observed among the estimated patients, with a median response time (DoR) of 9.3 months.

In the subgroup analysis of patients with wild-type EGFR who had previously received a median of two lines of therapy, including anti-PD-1/L1, the ORR was 26% (5 out of 19 patients), the disease control rate (DCR) was 89% (17 out of 19 patients), the median progression-free survival (PFS) was 5.3 months, and the 9-month overall survival (OS) rate was 80.4%. Additionally, for the subgroup of patients with EGFR mutant NSCLC resistant to TKIs, the ORR was 60% (12 out of 20 patients), the DCR was 100% (20 out of 20 patients), the median PFS was 11.1 months, and the 9-month PFS rate was 66.7%.

Regarding safety, approximately 67.4% (29 out of 43) of patients experienced grade ≥ 3 treatment-related adverse events (TRAEs). The most commonly reported grade ≥ 3 TRAEs were decreased neutrophil count (32.6%), anemia (30.2%), decreased white blood cell count (23.3%), stomatitis (9.3%), rash (7.0%), and decreased lymphocyte count (7.0%). Grade 4 TRAEs were limited to neutropenia and reduction in white blood cell count. Notably, there were no TRAEs that led to treatment discontinuation or death.

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