Interim data from a Phase 1/2 clinical trial evaluating Leap Therapeutics' (NASDAQ:LPTX) TRX518, combined with chemo agent gemcitabine and Merck's (NYSE:MRK) Keytruda (pembrolizumab) or Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab), in patients with advanced solid tumors showed a positive effect. The results were presented at the ESMO I-O Congress in Geneva.
Patients receiving TRX518 + gemcitabine showed a disease control rate (DCR) of 52% (n=13/25), all with stable cancer with no responders.
14 patients have been enrolled in the TRX518 + Keytruda or Opdivo arm. A patient with esophageal squamous cell carcinoma who received TRX518 + Keytruda experienced a complete response, sustained for seven months and counting. A patient with ocular melanoma experienced a 23% reduction in tumor volume with six months of stable cancer. A patient with urothelial carcinoma who received TRX518 + Opdivo who failed to respond to Keytruda experienced a partial response and remained on therapy for six months.
TRX518 is a humanized monoclonal antibody that binds to the glucocorticoid-inducible TNF-superfamily receptor (GITR). It is believed to enhance the immune system's anti-tumor response.
Patients with gastric or gastroesophageal junction cancer who received DKN-01 + Keytruda showed an overall response rate (ORR) of 23.5% and a DCR of 59%. The company reported an ORR of 46.7% last month in esophageal cancer patients receiving DKN-01 + Celgene's Abraxane (paclitaxel).
Management will host a conference call on Monday, December 17, at 8:30 am ET to discuss the results.
Previously: Leap's lead candidate shows positive action in esophageal cancer study (Nov. 9)
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