TIGOS-LS, an open-label, randomized study of BMS-986489 vs durvalumab as consolidation therapy following chemoradiotherapy in limited-stage small-cell lung cancer.
Background: Standard treatment for limited-stage small-cell lung cancer (LS-SCLC) has recently changed to add durvalumab consolidation after concurrent chemoradiotherapy. Although durvalumab consolidation increases overall survival (OS; Cheng et al. 2024), other therapeutic agents may be able to provide further improvement. BMS-986489 is a potential first-in-class fixed-dose combination of atigotatug (BMS-986012) and nivolumab. Atigotatug binds to fucosyl-monosialoganglioside-1 (fuc-GM1), which is highly expressed on SCLC cells and is largely absent in normal tissues. This binding results in tumor cell death by antibody‑dependent cellular cytotoxicity, antibody-dependent cellular phagocytosis, or complement-dependent cytotoxicity. The immune effects initiated by atigotatug may further enhance T cell activation by nivolumab, thereby improving outcomes after chemoradiotherapy. In a randomized phase II study in extensive-stage SCLC, atigotatug improved median OS when added to carboplatin, etoposide, and nivolumab (CE/NIVO): 15.6 months (95% confidence interval [CI]: 11.3-NE) vs 11.4 months (95% CI: 9.3-16.5) with CE/NIVO alone (Kalinka et al. 2024). Methods: TIGOS-LS is an open-label, randomized study to evaluate the safety and efficacy of BMS‑986489 as consolidation therapy vs the new standard durvalumab following chemoradiotherapy in LS‑SCLC. Approximately 250 participants will be enrolled at 80 sites within the US. Eligible participants will be adults (≥18 years) with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and histologically or cytologically confirmed LS-SCLC. All participants must have completed concurrent chemoradiotherapy for LS-SCLC without progression; prophylactic cranial irradiation (PCI) will be permitted before initiation of study treatment. Confirmation of fuc-GM1 expression will not be required. Participants will be stratified based on disease stage (I/II vs III) and receipt of PCI and will be randomly allocated in a 1:1 ratio to either the BMS‑986489 or durvalumab arms. BMS-986489 or durvalumab will be administered intravenously at a fixed dose once every 4 weeks for up to 2 years or until other discontinuation criteria are met. Response will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Survival follow-up will occur every 12 weeks for up to 3 years. The primary endpoint is OS. Key secondary endpoints include progression-free survival, objective response rate, clinical benefit rate, disease control rate, duration of response, and safety parameters. Enrollment is projected to start in April 2025. Clinical trial information: NCT06773910.
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Author Details
Melissa Johnson
Sarah Cannon Research Institute, Nashville, TN
Abstract Details
Meeting
2025 ASCO Annual Meeting
Session Type
Poster Session
Session Title
Lung Cancer—Non–Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Track
Lung Cancer
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