Saturday, April 16, 2022 4:23:29 PM
Efficacy and safety of the anti-PD-L1 monoclonal antibody
Socazolimab in combination with carboplatin and etoposide
for extensive-stage small cell lung cancer: Results from the
phase Ib clinical trial
Background: The study (ClinicalTrials.gov, NCT04346914) is an open, single-arm phase 1b clinical trial investigating the safety, tolerability, and efficacy of the recombinant human anti-programmed death-ligand 1 (PD-L1) monoclonal antibody Socazolimab in combination with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer. Excellent safety and efficacy had been demonstrated in
previous phase I clinical trials.
Methods: Patients received Socazolimab (5mg/kg) every three weeks until disease
progression or physician decision. Carboplatin injections were administered every
three weeks under the same dosing schedule, and continuous etoposide injections (100mg/m2 ) on days 1, 2, and 3 of the 3-week treatment cycle. The primary endpoint of the study was safety. Secondary endpoints included the objective response rate
(ORR), progression-free survival (PFS), disease control rate (DCR), duration of
response (DOR), and overall survival (OS).
Results: From 15th April 2020 (enrollment date) to 30th December 2021 (data cutoff),
20 patients with extensive-stage small lung cell cancer were administered with
Socazolimab, carboplatin and etoposide. ORR was 70.0% (95% CI: 45.72%, 88.11%).
Median PFS was 5.65 months (95% CI: 4.14, 6.54), and the median DOR was 4.29
months (95% CI: 2.76, 5.85). Median OS was 14.88 months (95% CI: 10.09, NE). 95%
of patients experienced grade 3 and above treatment-related adverse events. No
treatment-related deaths had occurred.
Conclusions: Results revealed that the combination therapy of Socazolimab, carboplatin and etoposide demonstrated good safety and anti-tumor activity for the firstline treatment of extensive-stage small cell lung cancer, with an OS higher than those
of previous clinical trials, notably IMPOWER133 (12.3 months) and CASPIAN (12.9
months). A phase III, randomized, placebo-controlled clinical trial (ClinicalTrials.gov,
NCT04878016) is currently being conducted with 498 patients.
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