Debiopharm has enrolled first patient in SMARTPLUS-106, a Phase lb/II study in patients failing prior PD-1/PD-L1 treatment in selected solid tumors.
Debiopharm explained in an announcement Tuesday that SMARTPLUS-106, an exploratory study investigating the safety and efficacy of Debio 1143, a first-in-class oral IAP (Inhibitor of Apoptosis Proteins) inhibitor, in combination with the Immune Checkpoint Inhibitor (ICI), nivolumab, in patients with advanced solid tumors, such as small cell lung cancer (SCLC) or squamous cell carcinoma of the head & neck (SCCHN), who have progressed during or immediately after anti-PD-1/PD-L1 treatment.
According to Debiopharm, despite improved progression-free survival and overall survival rates observed with ICIs in some patients, most either do not respond to treatment or ultimately develop resistance to therapy, with only 10-30% of patients showing a durable treatment response. The combination of ICIs with Debio 1143 has strong therapeutic potential through its dual mode of action, fostering anti-tumor immunity and promoting programmed cell death in tumor cells.
Debio 1143 has demonstrated synergy with PD-1/PD-L1 ICIs, including nivolumab, promoting tumor immunity in pre-clinical models of cancer, Debiopharm said in the statement. Therefore the compound is expected to offer an immune-sensitizing effect and enhance patient response to ICIs. With SMARTPLUS-106, part of the broadest immune-oncology IAP clinical research program, Debiopharm said it hopes to extend the reach of current immunotherapy.