REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug Deruxtecan Initiated in Patients with Platinum-Resistant Ovarian Cancer
Raludotatug deruxtecan is an investigational specifically engineered potential first-in-class CDH6 directed DXd antibody drug conjugate (ADC) discovered by
Between 70% and 80% of patients diagnosed with advanced ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens.1 The median overall survival for advanced ovarian cancer following recurrence is approximately two years, with a five-year survival rate of less than 30%.2,3 Up to 85% of advanced ovarian tumors have overexpression of CDH6, which is associated with poor prognosis.4,5
The initiation of REJOICE-Ovarian01 is based on results from an ongoing phase 1 trial of raludotatug deruxtecan presented at the
“Raludotatug deruxtecan has shown promising activity in a phase 1 trial of patients with advanced ovarian cancer,” said
“The prognosis for the majority of patients diagnosed with advanced ovarian cancer is bleak, with a low five-year survival rate, underscoring the critical need for the development of innovative and effective therapies,” said
About the REJOICE-Ovarian01 Trial
REJOICE-Ovarian01 is a global, multicenter, randomized, open-label phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant, high-grade ovarian cancer, including primary peritoneal or fallopian tube cancer, who received at least one and no more than three prior systemic lines of anticancer therapy, including prior treatment with mirvetuximab soravtansine for those with documented high-folate receptor alpha expression.
The phase 2 part of REJOICE-Ovarian01 will assess the safety and tolerability of three doses of raludotatug deruxtecan (4.8 mg/kg, 5.6 mg/kg, or 6.4 mg/kg) to identify the recommended dose for the phase 3 part of the trial. The primary endpoint of the phase 2 part of the trial is objective response rate (ORR) as assessed by blinded independent central review (BICR). Secondary endpoints include ORR as assessed by investigator, duration of response (DoR), progression free survival (PFS) and disease control rate (DCR) – all assessed by both BICR and investigator – and overall survival (OS).
The phase 3 part of REJOICE-Ovarian01 will assess the efficacy and safety of raludotatug deruxtecan at the selected dose compared to investigator’s choice of chemotherapy (paclitaxel, pegylated liposomal doxorubicin, gemcitabine, or topotecan). The dual primary endpoints of the phase 3 part of the trial are ORR and PFS as assessed by BICR. Secondary endpoints include PFS and ORR as assessed by investigator, DoR and DCR as assessed by both BICR and investigator, and OS. Pharmacokinetic and biomarker endpoints also will be assessed in both parts of the trial.
The trial is expected to enroll approximately 650 patients across
About Ovarian Cancer
More than 324,000 women were diagnosed with ovarian cancer worldwide in 2022.6,7 Between 70% and 80% of patients diagnosed with advanced ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens.1 The median overall survival for advanced ovarian cancer following recurrence is approximately two years, with a five-year survival rate of less than 30%.2,3 For patients that develop resistance to platinum-based chemotherapy, treatment options are limited.8
The introduction of targeted therapies has expanded treatment options and improved survival outcomes for some patients with ovarian cancer, but additional options are needed for patients with tumors that progress on available medicines.9
About CDH6
CDH6 (human cadherin-6) is a cadherin family protein overexpressed in several cancers, including ovarian tumors.4 An estimated 65% to 85% of patients with ovarian cancer have tumors that express CDH6, which is associated with poor prognosis.4,5 There is currently no CDH6 directed therapy approved for treatment of any cancer.
About Raludotatug Deruxtecan
Raludotatug deruxtecan (R-DXd) is an investigational, potential first-in-class CDH6 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, raludotatug deruxtecan is comprised of a humanized anti-CDH6 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
In addition to the REJOICE-Ovarian01 trial, raludotatug deruxtecan is being evaluated in a phase 1 trial in advanced ovarian cancer as part of a strategic collaboration with
About the
About the DXd ADC Portfolio of
The DXd ADC portfolio of
Designed using Daiichi Sankyo’s proprietary DXd ADC Technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan and DS-3939 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.
About
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At
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At
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Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in
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References:
1 Pignata S, et al. Ann Oncol. 2017
2 Shimokawa M, et al. J Cancer. 2018; 9(5):872.
3 Colombo N, et al. Int J Gynecol Cancer. 2017
4 Bartolome RA, et al. Mol Oncol. 2021 Jul; 15(7): 1849-18865.
5 Shintani D, et al. Gynecol Oncol. 2022;166(Suppl 1): S116.
6
7 SEER Cancer Stat Facts: Ovarian Cancer. Data from SEER 18 2011-2017.
8 Mor G, et al. Cancer biology & therapy. 2011;11(8), 708–713.
9 Kurnit K, et al. Obstetrics and Gynecology. 2021; 137(1): 108-121.
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