- Updated data from a Phase 1 clinical trial assessing Daiichi Sankyo's (OTCPK:DSKYF)(OTCPK:DSNKY) lead antibody-drug conjugate (ADC) DS-8201 in patients with HER2-positive gastric cancer showed a treatment effect. The results were presented at the ASCO-GI Symposium in San Francisco.
- An analysis of a subgroup of 44 efficacy evaluable patients with HER2-expressing gastric cancer or gastroesophageal junction adenocarcinoma previously treated with Roche's Herceptin (trastuzumab) and chemo showed a 45.5% (n=20/44) response rate and a disease control rate (responders + those with stable disease) of 81.8% (n=36/44). Median duration of response was 7.0 months.
- On the safety front, the most common adverse events (AEs) were nausea (71.1%), decreased appetite (64.4%), decreased platelet count (33.3%), decreased white blood cell count (33.3%) and constipation (31.1%). The most common Grade 3 (serious) AEs were anemia (24.4%), decreased neutrophil count (15.6%), decreased platelet count (13.3%) and decrease white blood cell count (11.1%). The most common Grade 4 (life-threatening) AEs were decreased platelet count (4.4%), decrease white blood cell count (4.4%) and decreased neutrophil count (4.4%).
- Two potential cases of interstitial lung disease in the gastric cancer group were reported. There were three discontinuations.
- A Phase 2 study is currently recruiting patients.
- DS-8201 is an ADC consisting of a humanized HER2 antibody attached to a cytotoxic payload (topoisomerase I inhibitor) via a tetrapeptide linker designed to reduce systemic exposure to the chemo. Daiichi calls it "smart chemotherapy."
- Previously: Daiichi's novel antibody-drug conjugate DS-8201 shows treatment effect in early-stage breast cancer study (Dec. 7, 2017)
- Now read: Daiichi Sankyo (DSNKY) Investor Presentation - Slideshow
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