alsevalimab (FPA150) / Amgen - LARVOL DELTA

FPA150-001: FPA150 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=95 | Terminated | Sponsor: Five Prime Therapeutics, Inc. | Phase classification: P1a/1b ➔ P1 | Completed ➔ Terminated; The Sponsor terminated the study for reasons unrelated to safety.

Metastases • Phase classification • Trial termination • Breast Cancer • Endometrial Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • VTCN1

FPA150 (B7-H4 antibody) phase I update in advanced solid tumours: Monotherapy and in combination with pembrolizumab (ESMO 2019) - P1a/1b; "FPA150 RD for phase Ib mono identified as 20 mg/kg (Sachdev, ASCO 2019). Mono appears well tolerated during dose escalation/exploration allowing evaluation in combination therapy. Sachdev, J et al."

Combination therapy • Monotherapy • P1 data • Genito-urinary Cancer • Oncology • Solid Tumor

FPA150-001: FPA150 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b; N=95; Completed; Sponsor: Five Prime Therapeutics, Inc.; Active, not recruiting ➔ Completed; N=278 ➔ 95; Trial completion date: Jan 2022 ➔ May 2021; Trial primary completion date: Jan 2022 ➔ May 2021

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Hormone Receptor Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • VTCN1

Phase 1a/1b study of first-in-class B7-H4 antibody, FPA150, as monotherapy in patients with advanced solid tumors. (ASCO 2019) - P1a/1b; "FPA150 monotherapy demonstrated a favorable safety profile and evaluation of anti-tumor activity is ongoing. 20 mg/kg Q3W was selected as the recommended dose. Phase 1b enrollment of FPA150 monotherapy in patients with B7-H4+ breast, ovarian and endometrial cancer began in February 2019."

Clinical • Monotherapy • P1 data

FPA150-001: FPA150 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b; N=278; Active, not recruiting; Sponsor: Five Prime Therapeutics, Inc.; Trial completion date: Jan 2024 ➔ Jan 2022; Trial primary completion date: Jan 2023 ➔ Jan 2022

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Hormone Receptor Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • 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

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

FPA150-001: FPA150 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b; N=278; Active, not recruiting; Sponsor: Five Prime Therapeutics, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Five Prime Therapeutics presents updated data from the phase 1a/1b trial of FPA150 at the European Society for Medical Oncology 2019 Congress (Businesswire) - P1, N=278; NCT03514121; Sponsor: Five Prime Therapeutics; "Five Prime Therapeutics...presented updated data from the Phase 1a/1b clinical trial of FPA150 in patients with advanced solid tumors in a poster presentation at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain....The FPA150 data presented at ESMO included preliminary efficacy results from the Phase 1b monotherapy expansion portion of the study in patients preselected for B7-H4 tumor overexpression across breast, endometrial and ovarian cancers, and early safety results from the Phase 1a Keytruda® (pembrolizumab, a PD1 antibody) combination portion of the study in patients preselected for B7-H4 tumor overexpression in ovarian cancer."

P1 data

Five Prime Therapeutics reports second quarter 2019 results (Businesswire) - "Bemarituzumab and mFOLFOX6 are being evaluated in combination with mFOLFOX6 in the Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial....The company expects the pause in enrollment to occur during the fourth quarter of 2019. Five Prime will present a poster at the European Society for Medical Oncology (ESMO) Congress that will include preliminary FPA150 data from the monotherapy Phase 1b expansion cohorts at the 20 mg/kg dose in patients with breast, ovarian or endometrial cancers that overexpress B7-H4 and early safety data from the Phase 1a lead-in testing FPA150 in combination with Keytruda."

Enrollment status • P1 data

Five Prime Therapeutics presents monotherapy data from the phase 1a/1b trial of FPA150 in patients with advanced solid tumors at the 2019 ASCO Annual Meeting (Five Prime Therap Press Release) - P1, N=278; FPA150-001 (NCT03514121); Sponsor: Five Prime Therapeutics, Inc; "FPA150 monotherapy demonstrated a favorable safety profile with no dose-limiting toxicities or treatment-related serious adverse events. Evaluation of anti-tumor activity is ongoing. A recommended dose of 20 mg/kg every three weeks was selected based on safety and pharmacokinetics...A safety lead-in of the combination of Keytruda® (pembrolizumab), a PD1 antibody, and FPA150 has also begun enrolling patients with B7-H4 positive ovarian cancer. The company expects to present preliminary efficacy results from the monotherapy expansion cohorts and early safety results from the FPA150-Keytruda combination at the European Society of Medical Oncology in September 2019."

Enrollment status • P1 data

Five Prime Therapeutics announces FPA150 poster presentation at the 2019 ASCO Annual Meeting (Businesswire) - P1a/1b; N=278; NCT03514121; Sponsor: Five Prime Therapeutics; "Five Prime Therapeutics...announced an upcoming poster presentation at the 2019 ASCO Annual Meeting being held in Chicago, May 31 – June 4, 2019. Data will be presented from the Phase 1a/1b study of FPA150, which is a first-in-class B7-H4 antibody. The Phase 1a dose escalation portion of the study is being conducted in patients with advanced solid tumors and the Phase 1b expansion is enrolling patients with breast, ovarian and endometrial tumors that overexpress B7-H4."

P1 data

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

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

Five Prime Therapeutics doses first patient in phase 1b trial of FPA150 (Businesswire) - "Five Prime Therapeutics...announced that it initiated patient dosing in the Phase 1b dose expansion portion of the Phase 1a/1b clinical trial of FPA150 (FPA150-001; NCT03514121), a first-in-class immuno-oncology antibody that targets B7-H4...The objective of the Phase 1b dose expansion is to evaluate the safety, tolerability, pharmacokinetics (PK) and potential preliminary clinical benefit of FPA150 monotherapy in patients with breast, ovarian and endometrial cancers that over-express B7-H4."

Enrollment open