Upifitamab Rilsodotin (UpRi)

UpRi, a first-in-class ADC targeting the sodium-dependent phosphate transport protein NaPi2b, utilizes Mersana’s Dolaflexin platform to deliver approximately 10 DolaLock payload molecules per antibody. NaPi2b is an antigen that is broadly expressed in ovarian cancer and other cancers. We are investigating UpRi in UPLIFT, a single-arm registrational trial in patients with platinum-resistant ovarian cancer; UPGRADE, a Phase 1/2 umbrella trial evaluating UpRi in combination with other ovarian cancer therapies; and UP-NEXT, a Phase 3 clinical trial of UpRi as monotherapy maintenance following treatment with platinum doublets in recurrent platinum-sensitive ovarian cancer.

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for UpRi for the treatment of patients with platinum-resistant high-grade serous ovarian cancer who have received up to three prior lines of systemic therapy or patients who have received four prior lines of systemic therapy regardless of platinum status.

XMT-1536

For more information on the UPLIFT study in platinum-resistant ovarian cancer, visit clinicaltrials.gov (NCT03319628).

For more information on the UPGRADE combination study in platinum-sensitive ovarian cancer, visit clinicaltrials.gov (NCT04907968). 

For more information on the UP-NEXT study in recurrent platinum-sensitive ovarian cancer, visit clinicaltrials.gov (NCT05329545).

Expanded Access Policy Statement:

Patients with serious or life-threatening conditions occasionally request access to investigational agents outside of a clinical trial and prior to regulatory approval and commercial availability. These patients seek such access for any number of reasons, including failure of past treatments, intolerable side effects associated with their treatment, or because they do not meet the inclusion criteria for any ongoing clinical trial for their disease. 

Programs that allow for such access are known as Expanded Access Programs (EAPs) and are often also referred to as Early Access, Compassionate Use and Emergency Use. 

Currently, Mersana does not have an EAP for any of its investigational agents because we have not yet determined that there is sufficient clinical data to support granting expanded access. If Mersana ultimately adopts an EAP for one or more of its investigational agents, this Policy Statement will be updated accordingly.  In such event, Mersana will ensure that its EAP would comply with applicable legal and regulatory requirements. 

Questions regarding this Policy statement should be sent to medicalinformation@mersana.com. Information regarding Mersana’s clinical trials, as well as clinical trials and expanded access programs for other potential therapies, can be found on www.clinicaltrials.gov.