FPT155 / Amgen - LARVOL DELTA

FPT155-001: FPT155 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=80 | Terminated | Sponsor: Five Prime Therapeutics, Inc. | Completed ➔ Terminated; Sponsor decision

Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

FPT155-001: A phase Ia/Ib study of FPT155 (CD80-FC) in patients with advanced solid tumors. (ASCO-SITC 2019) - "Key secondary endpoints in Phase 1b include objective response rate, duration of response, progression free survival, and disease control rate. The FPT155-001 trial opened for enrollment in October 2018 and is in progress."

Clinical • P1 data

FPT155-001: FPT155 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=80; Completed; Sponsor: Five Prime Therapeutics, Inc.; Recruiting ➔ Completed; N=322 ➔ 80; Trial completion date: Oct 2022 ➔ Oct 2021; Trial primary completion date: Jun 2022 ➔ Oct 2021

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Magnetic bead extraction with acid dissociation immunoassay for the determination of serum CD80-Fc fusion protein. (PubMed, Bioanalysis) - " A highly sensitive assay to determine serum concentrations of FPT155 using readily available reagents was developed. The results were in conformity with theoretical calculations."

Journal • Immune Modulation • Inflammation • CTLA4

Five Prime Therapeutics Reports Second Quarter 2020 Results (Businesswire) - "Bemarituzumab (anti-FGFR2b)...The Phase 2 FIGHT study is expected to have a sufficient number of progression-free survival (PFS) and overall survival (OS) events to generate clinically meaningful and actionable data by the end of 2020 or in early 2021…Patients with warm/hot tumor types are being enrolled with the aim of generating early clinical evidence of FPT155 single-agent activity by the end of 2020."

Enrollment status • P2 data • GastroEsophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Five Prime Therapeutics reports first quarter 2020 results (Five Prime Therap Press Release) - "The Phase 2 FIGHT study is expected to have a sufficient number of PFS and OS events to generate clinically meaningful and actionable data by the end of the year or early 2021; In parallel with continued dose escalation, patients with warm/hot tumor types are being enrolled with the aim to generate early clinical evidence of FPT155 single-agent activity by the end of 2020. An arm has been added to the ongoing trial to test the combination of escalating doses of FPT155 and pembrolizumab in patients with PD-1 treated non-small cell lung cancer. Five Prime expects to begin enrolling patients in this cohort in the third quarter of 2020."

Enrollment status • P1 data • P2 data • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

FPT155-001: FPT155 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=322; Recruiting; Sponsor: Five Prime Therapeutics, Inc.; Trial completion date: Sep 2021 ➔ Oct 2022

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

Five Prime Therapeutics reports fourth quarter and full year 2019 results (Five Prime Therap Press Release) - “2020 Milestones and Review of 2019 Business Highlights: Bemarituzumab is being evaluated in combination with mFOLFOX6 in the Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial. The company has paused enrollment in the FIGHT trial pending the occurrence of a sufficient number of events to trigger a futility analysis that is expected to occur in mid-2020; The company remains on track to generate data by mid-2020 from the Phase 1 combination of FPA150 plus pembrolizumab in a cohort of ovarian cancer patients with B7-H4 overexpression; FPT155 - The company remains on track to generate early monotherapy efficacy data in 2020.”

Enrollment status • P1 data

Five Prime Therapeutics presents initial safety data from the phase 1 trial of FPT155 at the Society for Immunotherapy of Cancer Annual Meeting (Businesswire) - P1, N=262; NCT04074759; Sponsor: Five Prime Therapeutics, Inc; “Five Prime Therapeutics, Inc….presented initial safety data from the Phase 1 clinical trial of FPT155 in patients with advanced solid tumors in a poster presentation at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting in National Harbor, Maryland….FPT155 was well tolerated at all dose levels, with no dose-limiting toxicities and no grade 4 or higher adverse events. There is no evidence of clinical or laboratory cytokine release syndrome, an adverse event associated with a prior therapy targeting CD28. Dose escalation with FPT155 is ongoing with the study currently enrolling patients at the 70 mg dose level.”

P1 data

A phase 1 study of FPT155, a first-in-class CD80 extracellular domain-Fc fusion protein, in patients with advanced solid tumors (SITC 2019) - "FPT155 as monotherapy has been well tolerated to date. Enrollment of accelerated titration cohorts is complete with dose-escalation in 3+3 cohorts ongoing."

Clinical • P1 data

FPT155-001: FPT155 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=258; Recruiting; Sponsor: Five Prime Therapeutics, Inc.

Clinical • New P1 trial

Five Prime Therapeutics reports first quarter 2019 results (Businesswire) - "...[The company] ha[s] made the decision to conduct an early futility analysis [of] the Phase 3 FIGHT trial testing bemarituzumab in combination with mFOLFOX6 in patients with gastric (GC) or gastroesophageal junction (GEJ)...in the first half of 2020...FPA150: Additional safety data along with preliminary efficacy data from the Phase 1b monotherapy expansion cohorts are expected to be presented at the European Society for Medical Oncology (ESMO) 2019 Annual Congress...FPT155: The company expects to present data from the Phase 1a dose escalation portion of the ongoing Phase 1a/1b trial at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in November 2019."

P1 data • P3 data

FPT155: A first-in-class therapeutic CD80-Fc fusion protein that augments T cell co-stimulation (AACR 2019) - "There is no abstract associated with this presentation."

Five Prime Therapeutics reports fourth quarter and full year 2018 financial results (Businesswire) - "Clinical Pipeline: (i) Expect to open approximately 200 clinical sites in 18 countries in the Phase 3 FIGHT trial...[of bemarituzumab (FPA144)] by year end; (ii) Plan to present data from the Phase 1a/1b trial...[of FPA150] at the ASCO Annual Meeting in June and the European Society for Medical Oncology’s (ESMO) 2019 Annual Congress in September; (iii) Plan to present data from the Phase 1a dose escalation...[clinical trial of FPT155] at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in November."

P1 data • Trial status

FPT155-001: A phase Ia/Ib study of FPT155 (CD80-FC) in patients with advanced solid tumors. (ASCO-SITC 2019) - "Key secondary endpoints in Phase 1b include objective response rate, duration of response, progression free survival, and disease control rate. The FPT155-001 trial opened for enrollment in October 2018 and is in progress."

Clinical • P1 data