Sensei Biotherapeutics experiences preliminary knowledge from a section 1/2 trial of solnerstotug in PD-L1-resistant tumors.
Sensei Biotherapeutics publicizes favorable preliminary outcomes from the dose enlargement portion of its section 1/2 trial which is evaluating solnerstotug (previously SNS-101) in PD-L1 resistant tumors, in line with a information launch from the corporate.
“Checkpoint inhibitor resistance stays a big problem for sufferers with superior most cancers, with restricted therapy choices past chemotherapy or medical trials,” Dr. Ron Weitzman, Chief Medical Officer of Sensei Biotherapeutics, stated within the information launch. “Traditionally, sufferers who progress on PD-L1 remedy are estimated to have a 5% or much less chance of response to PD-L1 rechallenge, making this a particularly difficult-to-treat inhabitants, and a big unmet medical want. The preliminary 14% response fee seen with solnerstotug is almost 3 times larger than what would usually be anticipated on this setting. We consider these early knowledge counsel solnerstotug could present a significant medical profit in choose tumor varieties, and we stay up for additional evaluating its potential in section 2.”
Key findings included a 14% total response fee in three sufferers and a 62% illness management fee in 13 sufferers amongst 21 evaluable PD-L1–resistant “sizzling” tumor sufferers.
One affected person with Merkel cell carcinoma (MCC) achieved a sturdy full response with 15 milligrams per kilogram (mg/kg) solnerstotug and Libtayo (cemiplimab) and stays on therapy at 42 or extra weeks after beforehand receiving PD-L1 remedy for 15 months within the adjuvant setting earlier than progressing.
Glossary:
Full response: disappearance of all indicators of most cancers.
Cytokine launch syndrome: immune response inflicting flu-like signs.
Illness management fee: share of sufferers with managed most cancers.
Monoclonal antibody: lab-made protein focusing on most cancers cells.
General response fee: share of sufferers with tumor shrinkage.
Partial response: tumor shrinkage with out full disappearance.
Steady illness: most cancers neither shrinking nor rising.
VISTA (V-domain Ig suppressor of T cell activation): immune checkpoint regulator suppressing T-cell exercise.
One other affected person with MCC achieved a partial response at Week 12 with the identical mixture and stays on therapy at 12 or extra weeks after prior checkpoint remedy, together with PD-1 and CTLA-4 inhibitors, with a greatest response of secure illness earlier than development.
A affected person with microsatellite instability-high colorectal most cancers (MSI-H CRC) achieved a partial response at week 36 following sturdy secure illness by way of therapy and stays on remedy at 36 or extra weeks. This affected person had beforehand obtained PD-L1 remedy for greater than 4 years, attaining an entire response earlier than progressing.
Moreover, six PD-L1–resistant sufferers with secure illness stay on therapy previous 12 or extra weeks, with tumor reductions starting from 0% to 17%, suggesting sturdy illness management in a subset of sufferers, as per the discharge. All PD-L1–resistant sufferers with tumor shrinkage stay on remedy, indicating potential for extended profit. No sufferers with microsatellite secure colorectal most cancers (CRC) skilled an entire or partial response, in line with prior checkpoint remedy outcomes on this “chilly” tumor kind.
Relating to security, solnerstotug stays properly tolerated, with no dose-limiting toxicities and most negative effects being grade 1 (delicate) or 2 (reasonable). Amongst 60 sufferers, 4 (7%) had grade 1 cytokine launch syndrome, all delicate and manageable. Two sufferers within the mixture cohort skilled immune-mediated results.
Solnerstotug is a conditionally lively monoclonal antibody focusing on VISTA (V-domain Ig suppressor of T cell activation).
A complete of 60 sufferers have been enrolled within the trial, of which 40 sufferers with “sizzling” tumors, resembling non-small cell lung most cancers, head and neck most cancers, melanoma, renal cell carcinoma, Merkel cell carcinoma, microsatellite instability-high colorectal most cancers and different tumor varieties have been included. All obtained solnerstotug (3 mg/kg or 15 mg/kg) with Libtayo. Eleven had not but reached the primary baseline scan, and eight discontinued the research earlier than any post-baseline scan.
The research additionally included 20 sufferers with PD-(L)1 non-responsive microsatellite secure colorectal most cancers to evaluate potential exercise in “chilly” tumors. Ten obtained monotherapy with solnerstotug (15 mg/kg), and 10 obtained solnerstotug (15 mg/kg) with Libtayo. Seventeen have been evaluable for efficacy, and three discontinued earlier than any post-baseline scan.
The corporate plans to provoke a section 2 research within the first quarter of 2026.
“Whereas we stay within the early phases of evaluating solnerstotug’s therapeutic potential, the noticed responses — notably in MCC and MSI-H CRC — are encouraging given the traditionally poor prognosis of those sufferers as soon as they’ve progressed on checkpoint remedy,” Dr. Shiraj Sen, medical oncologist and Director of Scientific Analysis at NEXT Oncology – Dallas, and a principal investigator for the solnerstotug research, stated within the information launch. “Continued medical analysis shall be key in figuring out which sufferers are most definitely to learn from this method.”
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