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- \nAn objective response rate of 50.5% was observed with raludotatug deruxtecan across all dose levels in these patients in the phase 2 part of REJOICE-Ovarian01<\/p>\n<\/li>\n
- \nPhase 3 part of REJOICE-Ovarian01 to evaluate 5.6 mg\/kg dose of raludotatug deruxtecan versus investigator\u2019s choice of chemotherapy<\/p>\n<\/li>\n<\/ul>\n
BASKING RIDGE, N.J. & RAHWAY, N.J.–(BUSINESS WIRE<\/a>)–
\nResults from the phase 2 (dose optimization) part of the REJOICE-Ovarian01<\/a> phase 2\/3 trial showed that raludotatug deruxtecan (R-DXd) demonstrated clinically meaningful response rates in patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer. These data were presented today during a late-breaking proffered paper session (LBA42<\/a>) at the 2025 European Society for Medical Oncology (#ESMO25) Congress.<\/p>\n\nRaludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada.<\/p>\n
\nThe median overall survival for advanced ovarian cancer following recurrence can be as little as two years, with a five-year survival rate of 31.8% for those with distant stage disease.1,2<\/sup> Between 70% and 80% of patients diagnosed with advanced ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens, highlighting the need for new treatment options.3<\/sup><\/p>\n
\nA confirmed objective response rate (ORR) of 50.5% (95% confidence interval [CI]: 40.6-60.3) was observed in patients (n=107)with platinum-resistant ovarian cancer receiving raludotatug deruxtecan across three doses (4.8 mg\/kg, 5.6 mg\/kg and 6.4 mg\/kg) as assessed by blinded independent central review (BICR). There were 3 complete responses (CRs) and 51 partial responses (PRs) seen, and a disease control rate (DCR) of 77.6% (95% CI: 68.5\u201385.1) was observed.<\/p>\n
\nIn patients receiving the 5.6 mg\/kg dose (n=36), a confirmed ORR of 50.0% (95% CI: 32.9\u201367.1) was observed as assessed by BICR with two CRs (5.6%), 16 PRs (44.4%) and a DCR of 80.6% (95% CI: 64.0\u201391.8). Clinically meaningful tumor responses were seen irrespective of dose and across a range of CDH6 expression levels.<\/p>\n
\nThe safety profile of raludotatug deruxtecan observed in REJOICE-Ovarian01 is consistent with safety findings from the phase 1 trial with no new safety signals identified. Nausea, anemia, asthenia and neutropenia were the most common treatment-emergent adverse events (TEAEs) across all doses. Treatment discontinuations due to treatment-related TEAEs occurred in 8.3% (n=3), 0.0% (n=0) and 8.6% (n=3) in the 4.8 mg\/kg, 5.6mg\/kg and 6.4 mg\/kg groups, respectively. Grade 3 or higher treatment-related TEAEs occurred in 27.8% (n=10), 30.6% (n=11), and 48.6% (n=17) of patients in the 4.8 mg\/kg (n=36), 5.6 mg\/kg (n=36), and 6.4 mg\/kg (n=35) groups, respectively.<\/p>\n
\nThe most common TEAEs (\u226510% of total population) in the 5.6 mg\/kg cohort included nausea (69.4%), anemia (58.3%), asthenia (50.0%), neutropenia (44.4%), vomiting (33.3%), constipation (27.8%), decreased appetite (25.0%), thrombocytopenia (19.4%), AST increase (16.7%), diarrhea (16.7%) and leukopenia (13.9%). Four (3.7%) interstitial lung disease (ILD)\/pneumonitis events were confirmed as treatment-related across all doses as determined by an independent adjudication committee. The majority of ILD events (one with 5.6 mg\/kg, two with 6.4 mg\/kg) were low grade (grade 1 or 2). One grade \u22653 (4.8 mg\/kg) ILD event was reported. Based on these efficacy and safety results, the 5.6 mg\/kg dose has been selected for the phase 3 part of the trial.<\/p>\n
\n\u201cWhen ovarian cancer becomes resistant to platinum-based chemotherapy, treatment options for patients become limited,\u201d said Isabelle Ray-Coquard, MD, PhD, President, ENGOT (European Network of Gynecological Oncology Trial) Group, Trial Leader, National Group of Investigators on the Studies of Ovarian and Breast Cancer (GINECO), and Medical Oncologist, Centre L\u00e9on B\u00e9rard, Lyon, France. \u201cThese promising results from the first part of REJOICE-Ovarian01 suggest that raludotatug deruxtecan may have an important role in treating patients with platinum-resistant ovarian cancer and support further evaluation in the phase 3 portion of this trial.\u201d<\/p>\n
\n\u201cIn this dose optimization analysis, rapid responses with impressive disease control have been observed with raludotatug deruxtecan across a range of CDH6 expression levels,\u201d said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. \u201cThese results, which contributed to the recent Breakthrough Therapy Designation in the U.S., reinforce the potential for raludotatug deruxtecan to become a new treatment option for certain types of patients with platinum-resistant ovarian cancer.\u201d<\/p>\n
\n\u201cWhile we have seen targeted treatment advancements and improved outcomes in ovarian cancer in recent years, there is still a high unmet need for additional options for patients,\u201d said Eliav Barr, MD, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. \u201cCDH6 is highly expressed in ovarian cancer, which underscores the potential of raludotatug deruxtecan to make an impact.\u201d<\/p>\n
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