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 too 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 th
ociperlimab, tislelizumab, and Chemoradiotherapy Show Promise in Limited-Stage Small Cell Lung Cancer
A phase 2 randomized trial (AdvanTIG-204) suggests that adding the immune checkpoint inhibitors ociperlimab and tislelizumab to concurrent chemoradiotherapy (cCRT) may improve outcomes for patients with limited-stage small cell lung cancer (LS-SCLC).However, the benefit of adding ociperlimab specifically remains to be proven.
The study, led by Youling Gong, MD, of the Cancer Center, West People’s Republic of China Hospital, Sichuan University, randomized 126 patients with LS-SCLC to one of three treatment arms:
* Arm A: Ociperlimab (900 mg every 3 weeks) + Tislelizumab (200 mg every 3 weeks) + cCRT (4 cycles), followed by ociperlimab and tislelizumab maintenance.
* Arm B: Tislelizumab (200 mg every 3 weeks) + cCRT (4 cycles), followed by tislelizumab maintenance.
* Arm C: cCRT (4 cycles) alone.
Patients were eligible if they were 18 years or older, had histologically or cytologically confirmed LS-SCLC unsuitable for definitive radiation, had not received prior treatment for LS-SCLC, had measurable disease (RECIST v1.1), an ECOG performance status of 2 or less, and a life expectancy of at least 12 weeks.
The primary endpoint was progression-free survival (PFS) comparing Arm A to Arm C and Arm B to Arm C. Secondary endpoints included complete response (CR) rate, objective response rate (ORR), duration of response (DOR), and disease-free survival (DMFS).
Results showed a trend toward improved PFS and numerically higher ORR with the addition of ociperlimab and tislelizumab plus cCRT (Arm A) and tislelizumab plus cCRT (Arm B) compared to cCRT alone (Arm C). However, Dr. Gong noted that the contribution of ociperlimab to this advancement has not yet been definitively established.
All patients experienced at least one treatment-emergent adverse event (TEAE).Common treatment-related TEAEs included anemia, nausea, and alopecia. Grade 3 or higher TEAEs occurred in 73.2% of patients in Arm A, 78.6% in Arm B, and 65.1% in Arm C. Treatment discontinuation due to TEAEs occurred in 26.8% of Arm A, 21.4% of Arm B, and 4.7% of Arm C, with radiation pneumonitis, decreased neutrophil count, pneumonitis, and decreased platelet count being the most common reasons. The safety profile was consistent with known risks associated with immune checkpoint inhibitors and cCRT, with no new safety signals identified.
The study was published in JTO Clinical and Research Reports in November 2025 (https://doi.org/10.1016/j.jtocrr.2025.100911).