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▎The content team editor of WuXi AppTec today, Leap Therapeutics announced its new target DKK1 inhibitor DKN-01 as a single drug or in combination with paclitaxel, in the treatment of advanced gynecological cancer phase 2 "basket" clinical trial (Basket trial) to obtain positive results.
The test results showed that DKN-01 as a single agent showed clinical activity in the treatment of endometrial cancer patients, and the tumor's DKK1 expression level as a biomarker can predict the response level to therapy.
DKN-01 is a humanized monoclonal antibody that can block its activity by binding to the DKK1 protein.
DKK1 can regulate Wnt/β-catenin signaling pathway and PI3K/AKT signaling pathway, and has important reuse in tumor cell signal transduction and maintenance of tumor suppression microenvironment.
The US FDA has granted DKN-01 orphan drug designation for the treatment of gastric cancer.
BeiGene reached a cooperation with Leap Therapeutics last year and obtained the exclusive license for clinical development of DKN-01 in Asia (except Japan), Australia and New Zealand.
The combination therapy consisting of DKN-01 and the PD-1 inhibitor tislelizumab developed by BeiGene has also obtained fast-track qualification granted by the US FDA for the treatment of patients with high-expression of DKK1 in treated gastric cancer.
It has been used in combination with the PD-1 inhibitor Keytruda and has also obtained positive results in clinical trials for the treatment of patients with gastric cancer.
▲DKK1 can promote tumor growth by maintaining the tumor microenvironment (picture source: Leap's official website).
In this basket trial involving 111 patients with different types of advanced gynecological cancer, epithelial endometrial cancer (EEC) and epithelial ovarian cancer (EOC) ) And carcinosarcoma (MMMT) patients received DKN-01 monotherapy or DKN-01/paclitaxel combination therapy.
The test results showed that DKN-01 showed stronger anti-cancer activity in patients whose tumors highly expressed DKK1.
Among the 22 EEC patients who received DKN-01 monotherapy, the objective response rate of patients with high tumor expression of DKK1 (14%) was better than that of patients with low DKK1 expression (0%).
The disease control rate (57%) and progression-free survival (3.
0 months) of the patient group with high DKK1 expression were also better than those of the low expression group (7% and 1.
8 months, respectively).
Among 24 patients receiving DKN-01/paclitaxel combination therapy, the PFS of patients with high DKK1 expression was 5.
4 months, which was better than 1.
8 months in the low expression group (HR=0.
34, 95% CI: 0.
12, 0.
97).
"In this study, DKN-01 resulted in objective remission, including a patient who received monotherapy and had sustained complete remission for up to two and a half years.
Whether used as a single agent or in combination with paclitaxel, it was found in patients with advanced gynecological cancer.
“Dr.
Rebecca Arend of the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham,” said Dr.
Rebecca Arend of the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham .
.
real-world evidence suggests a poor prognosis in this patient population when other therapies.
this result supports highly endometrial cancer DKK1 in further exploration DKN-01 as a monotherapy or anti-PD-1 therapy in combination with Effect.
"Reference: [1] Leap Therapeutics Presents DKN-01 Clinical Data at the Society of Gynecologic Oncology 2021 Annual Meeting on Women's Cancer.
Retrieved March 22, 2021, from https://investors.
leaptx.
com/news-releases/news- release-details/leap-therapeutics-presents-dkn-01-clinical-data-society Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital.
The test results showed that DKN-01 as a single agent showed clinical activity in the treatment of endometrial cancer patients, and the tumor's DKK1 expression level as a biomarker can predict the response level to therapy.
DKN-01 is a humanized monoclonal antibody that can block its activity by binding to the DKK1 protein.
DKK1 can regulate Wnt/β-catenin signaling pathway and PI3K/AKT signaling pathway, and has important reuse in tumor cell signal transduction and maintenance of tumor suppression microenvironment.
The US FDA has granted DKN-01 orphan drug designation for the treatment of gastric cancer.
BeiGene reached a cooperation with Leap Therapeutics last year and obtained the exclusive license for clinical development of DKN-01 in Asia (except Japan), Australia and New Zealand.
The combination therapy consisting of DKN-01 and the PD-1 inhibitor tislelizumab developed by BeiGene has also obtained fast-track qualification granted by the US FDA for the treatment of patients with high-expression of DKK1 in treated gastric cancer.
It has been used in combination with the PD-1 inhibitor Keytruda and has also obtained positive results in clinical trials for the treatment of patients with gastric cancer.
▲DKK1 can promote tumor growth by maintaining the tumor microenvironment (picture source: Leap's official website).
In this basket trial involving 111 patients with different types of advanced gynecological cancer, epithelial endometrial cancer (EEC) and epithelial ovarian cancer (EOC) ) And carcinosarcoma (MMMT) patients received DKN-01 monotherapy or DKN-01/paclitaxel combination therapy.
The test results showed that DKN-01 showed stronger anti-cancer activity in patients whose tumors highly expressed DKK1.
Among the 22 EEC patients who received DKN-01 monotherapy, the objective response rate of patients with high tumor expression of DKK1 (14%) was better than that of patients with low DKK1 expression (0%).
The disease control rate (57%) and progression-free survival (3.
0 months) of the patient group with high DKK1 expression were also better than those of the low expression group (7% and 1.
8 months, respectively).
Among 24 patients receiving DKN-01/paclitaxel combination therapy, the PFS of patients with high DKK1 expression was 5.
4 months, which was better than 1.
8 months in the low expression group (HR=0.
34, 95% CI: 0.
12, 0.
97).
"In this study, DKN-01 resulted in objective remission, including a patient who received monotherapy and had sustained complete remission for up to two and a half years.
Whether used as a single agent or in combination with paclitaxel, it was found in patients with advanced gynecological cancer.
“Dr.
Rebecca Arend of the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham,” said Dr.
Rebecca Arend of the O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham .
.
real-world evidence suggests a poor prognosis in this patient population when other therapies.
this result supports highly endometrial cancer DKK1 in further exploration DKN-01 as a monotherapy or anti-PD-1 therapy in combination with Effect.
"Reference: [1] Leap Therapeutics Presents DKN-01 Clinical Data at the Society of Gynecologic Oncology 2021 Annual Meeting on Women's Cancer.
Retrieved March 22, 2021, from https://investors.
leaptx.
com/news-releases/news- release-details/leap-therapeutics-presents-dkn-01-clinical-data-society Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital.
