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Association details:
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

DKK1 is a predictive biomarker for response to DKN-01: Results of a phase 2 basket study in women with recurrent endometrial carcinoma

Published date:
03/29/2023
Excerpt:
We conducted an open-label, Phase 2 basket study with 2-stage design in patients with endometrial carcinoma (EC) and platinum-resistant/refractory epithelial ovarian cancer....DKN-01 monotherapy and in combination with paclitaxel was more effective in patients with high DKK1-expressing tumors compared to low-expressing tumors. DKN-01 monotherapy demonstrated an objective response rate [ORR] of 25.0% vs. 0%; disease control rate [DCR] of 62.5% vs. 6.7%; median progression-free survival [PFS] was 4.3 vs. 1.8 months, and overall survival [OS] was 11.0 vs. 8.2 months in DKK1-high vs DKK1-low patients. Similarly, DKN-01 in combination with paclitaxel demonstrated greater clinical activity in patients with DKK1-high tumors compared to DKK1-low tumors
Secondary therapy:
paclitaxel
DOI:
10.1016/j.ygyno.2023.03.013
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Leap Therapeutics Presents DKN-01 Clinical Data at the Society of Gynecologic Oncology 2021 Annual Meeting on Women's Cancer

Published date:
03/22/2021
Excerpt:
Leap Therapeutics, Inc...announced....DKN-01 demonstrated objective responses, including a monotherapy complete response continuing now for over 2 and a half years, and durable tumor reductions as a single agent and in combination with paclitaxel in the advanced gynecologic cancer patients....The disease control rate and progression-free survival were strongest in patients whose tumors express high levels of DKK1 (DKK1-high)...
Secondary therapy:
paclitaxel
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Leap Therapeutics Presents DKN-01 Monotherapy Data at AACR Virtual Special Endometrial Cancer Conference

Published date:
11/09/2020
Excerpt:
DKN-01 demonstrated single agent activity in the EEC patients treated in the study, particularly in biomarker-selected subgroups relating to DKK1 biology...DKK1-high patients treated with DKN-01 monotherapy experienced a higher ORR and ODCR and longer PFS compared to DKK1-low patients.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Leap Therapeutics to Present Updated Data for DKN-01 Monotherapy and Paclitaxel Combination In Gynecologic Cancers

Published date:
04/23/2020
Excerpt:
The P204 study is a Phase 2 basket study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with relapsed/refractory epithelial endometrial cancer (EEC),...Patients with EEC and carcinosarcoma had higher tumor DKK1 expression and a higher percentage of Wnt activating mutations than the ovarian cancer patients....In the 20 patients with a Wnt signaling alteration, one patient (5%) has an ongoing complete response, one patient (5%) had a partial response, eight patients (40%) had a best response of stable disease, and 10 patients (50%) had progressive disease, representing an overall response rate (ORR) of 10% and a disease control rate (DCR) of 50%. In the group of six patients without any Wnt signaling alterations, one patient (16.6%) had a best response of stable disease and five patients (83.3%) had progressive disease.