ONO-7807 / BMS, Ono Pharma, Amgen - LARVOL DELTA

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread (clinicaltrials.gov) - P1/2 | N=92 | Terminated | Sponsor: Bristol-Myers Squibb | Trial completion date: Apr 2025 ➔ Aug 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Aug 2024; Business objectives have changed

Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread (clinicaltrials.gov) - P1/2 | N=92 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Dec 2024 ➔ Apr 2025

Combination therapy • Metastases • Trial completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread (clinicaltrials.gov) - P1/2 | N=92 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Mar 2023 ➔ Dec 2024 | Trial primary completion date: Mar 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Preclinical studies of TIM-3 blockade supporting clinical development of BMS-986258, an anti‒TIM-3 monoclonal antibody (SITC 2018) - P1/2; "Conclusions These results support the notion that TIM-3 blockade promotes CD8+ T-cell functions in tumors. Preclinical characterization of BMS-986258 supports its evaluation alone and in combination with nivolumab in patients with advanced cancers (NCT03446040)."

IO biomarker • PD(L)-1 Biomarker • Oncology

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread (clinicaltrials.gov) - P1/2 | N=92 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting | N=248 ➔ 92

Combination therapy • Enrollment change • Enrollment closed • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread (clinicaltrials.gov) - P1/2; N=248; Recruiting; Sponsor: Bristol-Myers Squibb; Trial completion date: Jul 2024 ➔ Mar 2023; Trial primary completion date: Jul 2024 ➔ Mar 2023

Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread (clinicaltrials.gov) - P1/2; N=248; Recruiting; Sponsor: Bristol-Myers Squibb; N=368 ➔ 248; Trial completion date: Mar 2025 ➔ Jul 2024; Trial primary completion date: Mar 2025 ➔ Jul 2024

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread (clinicaltrials.gov) - P1/2; N=368; Recruiting; Sponsor: Bristol-Myers Squibb; Trial completion date: Jul 2023 ➔ Mar 2025; Trial primary completion date: Jul 2023 ➔ Mar 2025

Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Five Prime Therapeutics reports first quarter 2020 results (Five Prime Therap Press Release) - "FPA150: Five Prime is in the process of completing the Phase 1a/1b study. The company does not currently plan to independently advance the clinical development of FPA150 as either a monotherapy or in combination with pembrolizumab; BMS-986258: In light of the coronavirus pandemic, Five Prime is withdrawing its guidance that this trial may advance from Phase 1 to Phase 2 in 2020."

Clinical • Trial status • Oncology • Solid Tumor

BMS-986258: Data from P1 part of P1/2 trial (NCT03446040) for advanced malignant tumors in 2019 (Five Prime Therap) - Corporate Overview

P1 data

ONO-7807: Initiation of P2 part of P1/2 trial (NCT03446040) for advanced malignant tumors in 2019 (Five Prime Therap) - Guggenheim Healthcare Talks Idea Forum

Trial initiation date