atigotatug (BMS-986012) / BMS - LARVOL DELTA

BMS-986012, an Anti-Fucosyl-GM1 Monoclonal Antibody as Monotherapy or in Combination With Nivolumab in Relapsed/Refractory SCLC: Results From a First-in-Human Phase 1/2 Study. (PubMed, JTO Clin Res Rep) - P2 | "BMS-986012 in combination with nivolumab represents a well-tolerated, potential new therapy for relapsed or refractory SCLC. BMS-986012 is currently being explored in combination with carboplatin, etoposide, and nivolumab as a first-line therapy in extensive-stage SCLC (NCT04702880)."

Combination therapy • Journal • Monotherapy • P1/2 data • Dermatology • Lung Cancer • Neuroendocrine Tumor • Oncology • Pruritus • Small Cell Lung Cancer • Solid Tumor

BMS-986012 (anti-fucosyl-monosialoganglioside-1 [fuc-GM1]) with carboplatin + etoposide + nivolumab (CE/NIVO) as first-line (1L) therapy in extensive-stage small cell lung cancer (ES-SCLC): Interim analysis (IA) of a randomized phase II study (ESMO 2024) - P2 | "BMS-986012 + CE/NIVO showed a tolerable safety profile as 1L ES-SCLC Tx, alongside a promising signal of improved OS vs CE/NIVO alone."

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Atigotatug: Data readout from P3 TIGOS trial (NCT06646276) for 1L ES-SCLC in 2028 (Bristol-Myers Squibb) - Q2 2026 Results

P3 data • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer

CA001-050: A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=135 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed | Trial primary completion date: Dec 2025 ➔ May 2025

Trial completion • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

TIGOS Trial: A Randomized, Double-Blind, Phase III Trial of Atigotatug and Nivolumab Fixed-Dose Combination With Chemotherapy Versus Atezolizumab With Chemotherapy as First-Line Therapy in Patients With Extensive-Stage Small Cell Lung Cancer. (PubMed, Clin Lung Cancer) - P3 | "Recruitment is ongoing at 182 sites across 26 countries with an estimated primary completion date of April 2028, with study completion in September 2031."

Clinical • Journal • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Trial of BMS-986012 in Combination With Platinum and Etoposide (clinicaltrials.gov) - P1/2 | N=12 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Feb 2022 ➔ Aug 2022

Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Trial of BMS-986012 in Combination With Platinum and Etoposide (clinicaltrials.gov) - P1/2 | N=12 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Aug 2022 ➔ Dec 2023

Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Trial of BMS-986012 in Combination With Platinum and Etoposide (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Trial of BMS-986012 in Combination With Platinum and Etoposide (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Phase classification: P1/2 ➔ P1 | Trial completion date: Dec 2023 ➔ Jun 2024

Phase classification • Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Trial of BMS-986012 in Combination With Platinum and Etoposide (clinicaltrials.gov) - P1/2 | N=14 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Jul 2021 ➔ Feb 2022

Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Trial of BMS-986012 in Combination With Platinum and Etoposide (clinicaltrials.gov) - P1/2 | N=120 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Trial of BMS-986012 in Combination With Platinum and Etoposide (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Combination therapy • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Trial of BMS-986012 in Combination With Platinum and Etoposide (clinicaltrials.gov) - P1/2 | N=120 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1/2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Multidimensional comparative evaluation of first-line therapies for extensive-stage small cell lung cancer: a systematic review and network meta-analysis of clinical efficacy and safety profiles. (PubMed, BMC Cancer) - "Incorporating anlotinib into the Chemo + PD-L1 regimen can be a viable first-line option for patients with high tumor burden, but cannot fully replace the current first-line standard-of-care (SOC). Chemoimmunotherapy combined with immune-related targeting drugs demonstrates the potential to improve overall survival."

Clinical • Journal • Retrospective data • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Atigotatug: Data readout from P3 TIGOS trial (NCT06646276) for 1L ES-SCLC in 2028 (Bristol-Myers Squibb) - Q2 2025 Results

P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer

Interim analysis of a randomized study of 1L BMS-986012 (anti-fucosyl-GM-1) with Chemotherapy and nivolumab in ES-SCLC (JSMO 2025) - No abstract available

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS). (clinicaltrials.gov) - P3 | N=530 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

Combination therapy • New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Expression analysis of Fuc-GM1 ganglioside in first-line therapy for extensive-stage small cell lung cancer (ES-SCLC) with BMS-986012, nivolumab, and carboplatin-etoposide (ESMO 2024) - P2 | "Fuc-GM1 is highly expressed in SCLC from this study but levels do not appear to correlate with the clinical activity of BMS-986012."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Frontline BMS-986012 Plus Nivolumab/Chemotherapy Shows Promise in ES-SCLC (OncLive) - P2 | N=120 | NCT04702880 | Sponsor: Bristol-Myers Squibb | "At a data cutoff date of August 28, 2023, and a median follow-up of 11.2 months, the median PFS with the BMS-986012 regimen (n = 66) was 5.8 months (95% CI, 5.0-7.9) by blinded independent central review (BICR) vs 5.2 months (95% CI, 4.8-6.6) with nivolumab/chemotherapy alone (n = 66; HR, 0.89; 95% CI, 0.57-1.40; P = .61). At a later cutoff of February 26, 2024, and with a median follow-up of 17.2 months, the median PFS with the respective regimens was 5.8 months (95% CI, 5.0-7.9) and 5.1 months (95% CI, 4.8-6.6), respectively (HR, 0.81; 95% CI, 0.53-1.23; P = .32); the 12-month PFS rates were 22% (95% CI, 12%-33%) and 19% (95% CI, 9%-31%), respectively."

P2 data • Small Cell Lung Cancer

A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Mar 2025 ➔ Dec 2025 | Trial primary completion date: Feb 2024 ➔ Dec 2025

Combination therapy • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial primary completion date: Sep 2023 ➔ Feb 2024

Combination therapy • IO biomarker • Trial primary completion date • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

Preclinical assessment of imaging agents for identification of fucosyl-GM1 expression in vivo (AACR 2022) - P2 | "In vitro cell binding, in vivo fluorescence and PET imaging, and ex vivo ARG studies demonstrated that 89Zr-BMS-986279 was sensitive and specific for detecting FucGM1 expression in tumor cells. Specificity to the intended target in animal disease models coupled with kinetics typical of antibody-based tracers further support the utility of 89Zr-BMS-986279 as a potential FucGM1 imaging agent. A phase 2 study is evaluating safety and efficacy of BMS-986012 combined with carboplatin, etoposide, or nivolumab in patients with newly diagnosed extensive-stage SCLC (NCT04702880)."

Preclinical • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

BMS-986012 in Relapsed/Refractory SCLC (clinicaltrials.gov) - P1/2 | N=106 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

[VIRTUAL] A phase II randomized study of BMS-986012, an anti-fucosyl-GM1 monoclonal antibody, plus carboplatin, etoposide, and nivolumab (NIVO) as first-line (1L) therapy in patients with extensive-stage small cell lung cancer (ES-SCLC) (ESMO 2021) - P2 | "Secondary endpoints are additional efficacy parameters (including response rate, duration of response, and overall survival), tumor fucosyl-GM1 and PD-L1 expression and associations with antitumor activity, and BMS-986012 immunogenicity. The first pt was treated in March 2021., funded by Bristol Myers Squibb."

Clinical • IO biomarker • P2 data • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1