On July 28, 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 UPGRADE, a Phase 1 combination dose escalation umbrella study to evaluate the safety and efficacy of upifitamab rilsodotin (UpRi, previously XMT-1536) in combination with other ovarian cancer therapies (Press release, Mersana Therapeutics, JUL 28, 2021, View Source [SID1234585258]). The initial arm of this umbrella study is evaluating carboplatin in combination with UpRi followed by continuation of UpRi monotherapy in patients with platinum-sensitive ovarian cancer.
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"The initiation of UPGRADE is another important milestone for Mersana as we work to build UpRi into a foundational medicine in the treatment of ovarian cancer," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "To date, UpRi data has demonstrated clinically meaningful activity and a differentiated tolerability profile without severe neutropenia, peripheral neuropathy or ocular toxicity in patients with heavily pretreated platinum-resistant ovarian cancer. The initiation of the UPGRADE umbrella study is a critical first step in evaluating the potential of UpRi in earlier lines of therapy."
The UPGRADE Phase 1, open-label, dose-escalation portion of the study will determine the maximum tolerated dose (MTD) and safety and tolerability of a once-every-four-week (Q4W) administration of UpRi in combination with carboplatin for six cycles followed by continuation of UpRi monotherapy in patients with platinum-sensitive high-grade serous ovarian cancer following 1-2 prior platinum-based regimens. Patients will not be preselected for NaPi2b expression; however, archival or fresh tissue will be required for retrospective assessment of expression. Upon completion of the dose-escalation portion of the study, the Company plans to initiate the expansion portion to assess both tolerability and efficacy and inform the further development of UpRi in a broader and earlier-line patient population.
"We are excited to initiate UPGRADE and are beginning with a platinum combination because platinum remains the mainstay therapy in earlier-line platinum-sensitive ovarian cancer. UPGRADE is intended to allow us to assess the advantages of combining with carboplatin for six cycles and replacing paclitaxel, an agent that carries significant toxicities. We will also evaluate the benefit of continuing treatment with UpRi as a single agent beyond the six cycles of combination therapy," said Arvin Yang, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Mersana Therapeutics. "In the future, we plan to evaluate non-platinum-based combinations in this umbrella study to assess the potential of bringing UpRi to patients who do not benefit from platinum. We believe UpRi’s differentiated tolerability profile without the overlapping toxicities commonly seen with other ADC platforms may provide a significant advantage as a combination therapy for people living with ovarian cancer."