On April 9, 2021 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported the initiation of patient dosing in UPLIFT, a single-arm registration strategy to evaluate the safety and efficacy of upifitamab rilsodotin (UpRi, XMT-1536) in patients with platinum-resistant ovarian cancer who have received up to four lines of therapy (Press release, Mersana Therapeutics, APR 9, 2021, View Source [SID1234577790]).
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"UpRi has demonstrated clinically meaningful activity, a biomarker-response relationship and a differentiated tolerability profile without severe neutropenia, peripheral neuropathy or ocular toxicity in heavily pretreated ovarian cancer patients who have limited options and poor prognosis. The UPLIFT strategy is critical to bringing this promising agent to patients waiting for new therapies," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics.
UPLIFT will evaluate the safety and efficacy of UpRi in patients with platinum-resistant ovarian cancer who have received up to four lines of therapy. Consistent with the bevacizumab label, patients previously treated with three or four lines of therapy may enroll without regard to prior bevacizumab treatment. There is no exclusion for patients with baseline peripheral neuropathy. Patients may enroll without regard to NaPi2b expression; however, the role of the biomarker will be evaluated. The primary endpoint will be the objective response rate (ORR) in the high NaPi2b population and the secondary endpoints will be the ORR regardless of NaPi2b expression, as well as duration of response and safety.
"We believe this study design, which is an amendment to the ongoing Phase 1 expansion study, allows for significant operational efficiencies and leverages our current momentum in patient enrollment. The study design also allows us the opportunity to fully evaluate the role of the biomarker with endpoints in both the high NaPi2b and overall populations. We are excited to open this cohort to this heavily pretreated patient population with few options," said Arvin Yang, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Mersana Therapeutics.
The single-arm registration strategy is an amendment to the ongoing multinational, multi-center, open label study protocol, and the Company expects to enroll approximately 100 patients with high NaPi2b expression and up to 180 patients overall.