Ociperlimab/Tislelizumab Plus cCRT Bolsters PFS/Responses in LS-SCLC

Treatment with tislelizumab (Tevimbra) in combination with concurrent chemoradiotherapy (cCRT) with or without ociperlimab, may improve progression-free survival (PFS) and response rates among patients with first-line limited-stage small cell lung cancer (LS-SCLC), according to results from the phase 2 AdvanTIG-204 trial (NCT04952597) published in Journal of Thoracic Oncology Clinical and Research Reports.

Patients were divided among 3 arms in the trial: arm A, where patients received ociperlimab and tislelizumab plus cCRT (n = 41); arm B, where patients received tislelizumab plus cCRT (n = 42); and arm C, where patients received cCRT alone (n = 43).

The median PFS was 12.6 months (95% CI, 8.7-not estimable [NE]) in arm A, 13.2 months (95% CI, 8.5-NE) in arm B, and 9.5 months (95% CI, 8.3-14.4) in arm C; the HR for arm A vs arm C was 0.84 (95% CI, 0.46-1.52; P = .2793), and the HR for arm B vs arm C was 0.80 (95% CI, 0.45-1.44; P = .2414).

Additionally, a subgroup analysis by baseline characteristics and demographics demonstrated that the treatments in arm A and arm B were more favorable than the treatment in arm C. The investigators did note that this result did come with exceptions and should be treated with caution due to small sample sizes. A comparable PFS benefit between arm A and arm B was observed in an exploratory comparison (HR, 1.05; 95% CI, 0.59-1.87).

The overall response rate (ORR) per investigator was 85.4% (95% CI, 70.8%-94.4%) in arm A, 88.1% (95% CI, 74.4%-96.0%) in arm B, and 76.7% (95% CI, 61.4%-88.2%) in arm C; the respective complete response (CR) rates were 7.3% (95% CI, 1.5%-19.9%), 9.5% (95% CI, 2.7%-22.6%), and 2.3% (95% CI, 0.1%-12.3%). The median duration of response (DOR) in arm A, arm B, and arm C was 10.1 months (95% CI, 6.0-NE), 11.5 months (95% CI, 6.9-NE), and 8.2 months (95% CI, 5.6-NE), respectively.

Across all 3 treatment arms, the median overall survival (OS) was not reached, and a similar trend for survival was observed.

The median distant metastasis-free survival (DMFS) was 17.9 months (95% CI, 9.7-NE), 15.3 months (95% CI, 9.8-NE), and 20.0 months (95% CI, 8.6-NE) in arms A, B, and C, respectively.

“In the phase 2 AdvanTIG-204 trial, ociperlimab and tislelizumab plus cCRT and tislelizumab plus cCRT yielded a trend of improvement in PFS and numerically higher ORR vs cCRT alone, with no new safety signals identified beyond the known profiles of immune checkpoint inhibitors and cCRT, whereas the contribution of ociperlimab has not yet been proven,” said lead study author Youling Gong, MD, of the Thoracic Oncology Ward, Cancer Center, West People’s Republic of China Hospital, Sichuan University, Chengdu, People’s Republic of China, with study coninvestigators.

AdvanTIG-204 randomly assigned 1:1:1 a total of 126 patients with limited-stage SCLC to one of the 3 treatment arms. Treatment in arm A consisted of intravenous ociperlimab at 900 mg every 3 weeks and IV tislelizumab at 200 mg every 3 weeks plus cCRT for 4 cycles, then IV ociperlimab at 900 mg every 3 weeks and tislelizumab at 200 mg every 3 weeks. In arm B, treatment was IV tislelizumab at 200 mg every 3 weeks and cCRT for 4 cycles, then tislelizumab at 200 mg every 3 weeks. In arm C, treatment was cCRT for 4 cycles.

Eligible patients were 18 years or older with histologically or cytologically proven disease that could not be safely treated with definitive radiation, and who had not received prior treatment for LS-SCLC, measurable disease per RECIST v1.1, an ECOG performance of 2 or less, and a life expectancy of at least 12 weeks.

The primary end point of the trial was to compare PFS for arm A vs arm C and arm B vs arm C. Secondary end points included CR rate, ORR, DOR, and DMFS.

At least 1 treatment-emergent adverse event (TEAE) was experienced by all patients in the trial; the most common treatment-related TEAEs were anemia, nausea, and alopecia. Notably, grade 3 or higher treatment-related TEAEs occurred in arms A, B, and C, at rates of73.2%, 78.6%, and 65.1%, respectively.

Treatment-related TEAEs led to treatment discontinuation in 26.8%, 21.4%, and 4.7% of arms A, B, and C, respectively; the most common treatment-related TEAEs that led to discontinuation were radiation pneumonitis, decreased neutrophil count, pneumonitis, and decreased platelet count.

Reference

Gong Y, Pang Q, Yu R, et al. AdvanTIG-204: a phase 2, randomized, open-label study of ociperlimab plus tislelizumab and concurrent chemoradiotherapy versus tislelizumab and concurrent chemotherapy versus concurrent chemoradiotherapy in first-line limited-stage SCLC. JTO Clin Res Rep. 2025;6(11):100911. doi:10.1016/j.jtocrr.2025.100911