Sensei Biotherapeutics Reports Favorable Initial Clinical Activity Data For Solnerstotug In Resistant Tumors

Sensei Biotherapeutics Inc. SNSE late Thursday released initial results from the dose expansion portion of its Phase 1/2 trial evaluating solnerstotug (formerly SNS-101) for cancer.

The Phase 1 dose expansion trial is evaluating solnerstotug as monotherapy and in combination with Regeneron Pharmaceuticals Inc.‘s REGN Libtayo (cemiplimab) in both a basket of “hot” tumors that typically respond to immunotherapy but have progressed on prior PD-(L)1 therapy and a single “cold” tumor histology (microsatellite stable (MSS) Colorectal Cancer (CRC) that is typically unresponsive to immunotherapy.

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As of March 17, the study has enrolled 60 patients. Key findings include:

Among 21 evaluable PD-(L)1 resistant “hot” tumor patients, the combination of solnerstotug + cemiplimab demonstrated a 14% ORR (overall response rate), which is almost 3x higher than historical PD-(L)1 rechallenge response rates (≤5%), and a 62% DCR (disease control rate), suggesting meaningful disease control in resistant tumors.
One durable complete response in a patient with Merkel Cell Carcinoma (MCC).
Two partial responses (PRs): one in a second MCC patient and one in a microsatellite instability-high (MSI-H) CRC patient.
All patients with tumor shrinkage remain on treatment, suggesting potential for prolonged clinical benefit.
An additional 11 patients have not yet reached the first baseline scan, and an additional eight patients discontinued the study before any post-baseline scan.
All patients in this cohort had progressed on prior PD-(L)1.

Six PD-(L)1 resistant patients with stable disease remain on treatment past 12+ weeks, with tumor reductions ranging from 0% to 17%, suggesting durable disease control in a subset of patients.

All PD-(L)1 resistant patients on the study with tumor shrinkage remain on treatment, suggesting the potential for prolonged benefit.

None of the MSS CRC patients experienced a CR or PR, consistent with prior checkpoint therapy in this “cold” tumor type.

Solnerstotug continues to be well tolerated, with no dose-limiting toxicities and the majority of AEs Grade 1 or 2 in severity.

Out of 60 patients, there have been four (7%) cases of Grade 1 cytokine release syndrome (CRS), all mild and manageable. Two patients in the combination cohort experienced immune-mediated events.

Price Action: SNSE stock is up 32.31% at $0.57 at the last check Friday.

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