Mersana Therapeutics Reports Updated Interim Data from the Ovarian Cancer Cohort of the XMT-1536 Phase 1 Expansion Study
- Maintained 34% objective response rate and 79% disease control rate, including two complete responses
- XMT-1536 continues to be generally well-tolerated with no new safety signals
- Data to be presented and discussed during a conference call today at
“These data further support the continued development of XMT-1536, our first-in-class Dolaflexin ADC targeting NaPi2b, which has recently been granted FDA Fast Track Designation. We are eager to advance XMT-1536 into registration-enabling studies based on its observed antitumor activity and favorable safety profile in an ovarian cancer population with a very poor prognosis and limited treatment options,” said
This interim analysis focused on the ovarian cancer cohort of the Phase 1 expansion study, including heavily pre-treated patients with platinum-resistant or refractory ovarian cancer, fallopian tube or primary peritoneal cancer who have received up to three lines of prior therapy, and in some cases four lines of prior therapy regardless of platinum status. With a data cutoff of
Key findings include:
| • |
Safety profile consistent with previously reported expansion data and no new safety signals observed | ||
| o | The most frequently reported treatment-related adverse events (TRAEs) were generally Grade 1-2 fatigue, nausea, decreased appetite, vomiting and transient AST elevation without associated changes in bilirubin or cases of Hy’s law. | ||
| o | There were no reported cases of severe neutropenia, peripheral neuropathy or ocular toxicity. | ||
| • | Continued, significant anti-tumor activity in platinum-resistant and platinum-refractory ovarian cancer and in ovarian cancer previously treated with bevacizumab, PARP inhibitors, or both | ||
| o | Of the 29 patients that were evaluable for response, 2/29 (7%) achieved confirmed complete responses (CRs) and 8/29 (28%) achieved confirmed partial responses (PRs) for an objective response rate (ORR) of 34%. Additionally, 13/29 (45%) patients achieved stable disease (SD); the disease control rate (DCR) was 23/29 (79%). | ||
| • | 70% of responses were observed within two cycles and 100% of responses were observed within four cycles. Responses appeared to deepen over time, including responses in patients receiving reduced dose levels. | ||
| • | The majority of responders had prior treatment with bevacizumab, PARP inhibitors, or both. Both patients with confirmed CRs had prior treatment with bevacizumab and PARP inhibitors. | ||
| • | Reduction in tumor volume was observed in the majority of patients achieving a best response of stable disease. | ||
| • | Data continue to support a NaPi2b biomarker-based patient selection strategy based on depth, time on study and quality of response | ||
| o | 50% of patients with higher NaPi2b expression are ongoing in the study while only 33% of patients with lower Napi2b expression are ongoing in study. Median duration of response was not yet reached in the 7 patients with ovarian cancer with higher NaPi2b expression. | ||
| o | The Company expects to define the patient selection strategy based on the total data set from patients treated with XMT-1536. | ||
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Source: Mersana Therapeutics, Inc.