On September 6, 2022] SciClone Pharmaceuticals (Holdings) Limited (the "Company", together with its subsidiaries, the "Group", stock code: 6600. HK) reported that the first patient has been successfully dosed in China in the Phase III clinical study (the "REPLATINUM") of its pipeline product RRx-001 for the third line and beyond small cell lung cancer ("SCLC") (Press release, SciClone Pharmaceuticals, SEP 6, 2022, View Source [SID1234621813]).
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The REPLATINUM, a controlled, open-label, randomized Phase III study, is conducted simultaneously in China and the United States, and is designed to enroll 292 patients in total. The REPLATINUM will evaluate the efficacy and safety of RRx-001 administered sequentially with platinum doublet for the third line and beyond SCLC by comparing to platinum doublet alone.
RRx-001 is a potential first-in-class ("FIC") small molecule with multiple mechanisms of action including CD47-SIRP α targeting, RONS generation, and epigenetic modulations. It can regulate a variety of tumor microenvironment abnormalities: downregulating CD47-SIRP α, repolarizing tumor-associated macrophages from protumor M2 to antitumor M1, activating tumor suppressor genes through epigenetic modulation to reverse chemoresistance, normalizing tumor blood vessels to enhance chemotherapeutic drugs penetration, and inducing the generation of RONs to cause tumor cell necrosis. The data from a Phase II clinical trial showed that RRx-001 has promising efficacy and safety profile in treating patients with various solid tumors such as SCLC. RRx-001 shows potential benefits of improve patients’ survivals in comparison with current standard cares.
In REPLATINUM, eligible patients of third line and beyond SCLC will be randomized 1:1 into 1 of 2 parallel arms. Patients in Arm 1 will receive RRx-001 followed by platinum doublet (platinum plus etoposide) chemotherapy for 4 cycles, and then alternating cycles of RRx-001 and single agent platinum (the "Platinum Stacking Phase") until progression. Patients in Arm 2 will receive the standard of care platinum doublet chemotherapy for 4 cycles. At radiologic progression in Arm 2, patients may "cross-over" to the Platinum Stacking Phase of Arm 1. The primary objectives of the REPLATINUM are progression free survival ("PFS") and overall survival ("OS") in Arm 1 comparing with Arm 2. The secondary objectives include the overall response rate ("ORR") and the duration of response ("DOR") between the two arms.
"There is a significant unmet medical need for the treatment of SCLC worldwide, and more effective treatment options are urgently needed in clinical practice. The current research data shows that RRx-001 can reverse chemoresistance and resensitize tumors to platinum-based therapy with a favorable safety profile. We look forward to positive results from the REPLATINUM, thereby offering SCLC patients with the opportunity to benefit from new treatment options,"said Professor Zhang Li, the global principal investigator of the REPLATINUM and Director of the Department of Medical Oncology, Sun Yat-sen University Cancer Center.
Dr. Mao Li, Vice President, General Manager of Research and Development and Chief Medical Officer of the Companysaid, "The completion of dosing in the first patient in China is a significant material progress of the REPLATINUM. The Company expects RRx-001, an innovative FIC small molecule with differentiated mechanisms of action, will be able to advance the clinical treatment of SCLC worldwide and offer new options to patients."