FP-1039 / Amgen - LARVOL DELTA

Multicenter, nonrandomized, open-label Phase 1b study of FP-1039/GSK3052230 with chemotherapy: results in malignant pleural mesothelioma (MPM) (ESMO 2017) - P1; "The MTD of FP-1039/GSK3052230 (15 mg/kg) in combination with pemetrexed+cisplatin in MPM was well tolerated, and durable responses were observed. Importantly, AEs associated with small-molecule pan FGFR kinase inhibitors were not observed, as predicted by the unique mechanism of action of this drug. Study sponsored by GSK; clinical trial information: NCT01868022."

P1 data • Mesothelioma

Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated Fibroblast Growth Factor (FGF) Pathway Signaling (clinicaltrials.gov) - P1; N=120; Active, not recruiting; Sponsor: GlaxoSmithKline; Recruiting ➔ Active, not recruiting; Trial primary completion date: Oct 2016 ➔ Apr 2017

Enrollment closed • Trial primary completion date • Biosimilar • Mesothelioma • Non Small Cell Lung Cancer • Oncology

An open-label phase IB study to evaluate GSK3052230 in combination with paclitaxel and carboplatin, or docetaxel, in FGFR1-amplified non-small cell lung cancer. (PubMed, Lung Cancer) - "GSK3052230 is a novel FGFR pathway inhibitor, which is well tolerated in combination with chemotherapy. Importantly, AEs associated with small molecule inhibitors of FGFR were not observed, as predicted by the unique mechanism of action of this drug."

Clinical • Combination therapy • Journal • P1 data • Alopecia • Dermatopathology • Gene Therapies • Hematological Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Nephrology • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pain • Renal Disease • Thoracic Cancer

Five Prime Therapeutics: Q3 2014 Results (Five Prime Therap) - Anticipated completion of dose escalation in at lease one of the arms of the trial for FGFR1 amplified NSCLC by end of 2014 

Anticipated trial completion date • Non Small Cell Lung Cancer • Oncology

Five Prime Therapeutics announces updated data in mesothelioma patients from ongoing phase 1b trial of FP-1039 presented at 2016 ASCO Annual Meeting (GlobeNewswire) - P1b, N=18; "Preliminary Objective Response Rate (ORR) was 39%, with a Disease Control Rate (DCR) of 100%, evaluated per mRECIST 1.1; 7 confirmed Partial Responses (PRs) and 11 Stable Disease (SD); Evaluable patients are defined as patients who enrolled at least 42 days (2 cycles) prior to the cutoff date, which was also the minimum time duration utilized in the calculation of DCR; Median Progression Free Survival (PFS) was 6.8 months."

Conference • P1 data • Oncology

Five Prime Therapeutics: Morgan Stanley Global Healthcare Conference (Five Prime Therap, Morgan Stanley Global Healthcare Conference 2016) - “The preliminary objective response rate (as of April 18, 2016) was 39%, with a disease control rate of 100% (evaluable patients, 10 and 15 mg/kg GSK3052230, confirmed per mRECIST 1.1)”

P1 data • Oncology

Five Prime Therapeutics: Morgan Stanley Global Healthcare Conference (Five Prime Therap, Morgan Stanley Global Healthcare Conference 2016) - “The preliminary objective response rate (as of April 18, 2016) was 39%, with a disease control rate of 100% (evaluable patients, 10 and 15 mg/kg GSK3052230, confirmed per mRECIST 1.1)”

P1 data • Oncology

Five PrimeTherapeutics: Annual Report 2015 (Five Prime Therap) - Anticipated expiry of composition of matter patent in US and foreign in 2026; Anticipated expiry of methods of use patent in US and ex-US in 2031; Anticipated expiry of composition of matter and methods of use patent in Europe in 2026; Anticipated expiry of exclusively licensed patents in US for composition of matter and methods of producing FP-1039 between 2019 and 2020; Anticipated expiry of composition of matter and methods of use patent in US and ex-US between 2026 and 2034

Anticipated patent expiry • Oncology

Five Prime Therapeutics: Annual Report 2013 (Five Prime Therap) - Anticipated patent expiry in US in 2031; Anticipated patent expiry in EU in 2026; Anticipated expiry of patents in US, Europe and Canada between 2026–2034; Anticipated expiry of composition of matter patent in US in 2026; Anticipated expiry of methods of use patent in US in 2031; Anticipated expiry of composition of matter patent in Japan in 2026; Anticipated expiry of composition of matter and methods of use patents in EU, Hong Kong, New Zealand and Australia in 2026; Anticipated expiry of composition of matter and methods of producing patents licensed by UC Regents in US between 2019–2020; Anticipated expiry of composition of matter and methods of producing patents in Korea in 2014

Anticipated patent expiry • Oncology

FP-1039: "Three DLTs observed at 20 mg/kg: Gr 5 bowel perforation/ischemia; Gr 3 elevated creatinine levels; Gr 3 infusion reaction" (Exelixis, Inc) - ESMO 2017: "The majority of patients across all dose levels experienced tumor reduction: Confirmed ORR: 45% (14/31 PRs)"

P1 data • Lung Cancer • Mesothelioma • Oncology • Solid Tumor

Five Prime Therapeutics: Annual Report 2014 (Five Prime Therap) - Anticipated patent expiry for composition of matter in US in 2026; Anticipated patent expiry for methods of use in US in 2031; Anticipated patent expiry for composition of matter in Japan in 2026; Anticipated patent expiry for composition of matter and methods of use in Europe, Hong Kong, Australia and New Zealand in 2026; Anticipated expiry of exclusively licensed patents in US for composition of matter and methods of producing FP-1039 between 2019 and 2020; Anticipated expiry of additional patents for composition of matter and methods of use in US and ex-US between 2026 and 2034; Anticipated expiry of additional patents for composition of matter and methods of use in EU between 2026 and 2034; Anticipated expiry of additional patents for composition of matter and methods of use in Canada between 2026 and 2034

Anticipated patent expiry • Oncology

Five Prime Therapeutics: J.P. Morgan Healthcare Conference (Five Prime Therap) - Anticipated data from P1b trial (NCT01868022) in 1L and previously-treated squamous NSCLC and 1L mesothelioma at ASCO (Jun 3-7, 2016)

Anticipated P1 data • Non Small Cell Lung Cancer • Oncology

Five Prime Therapeutics: Jefferies Global Healthcare Conference (Five Prime Therap) - "FP-1039 Has The Ideal Product For FGFR1 Gene-Amplified Tumors"; "FP-1039 Phase 1 study in unselected solid tumors: No MTD identified, even at high doses, 17 of 39 (44%) patients with stable disease, Expected to combine safety with standard-of-care therapies" 

P1 data • Oncology

Five Prime Therapeutics: Oppenheimer Annual Healthcare Conference (Five Prime Therap) - "Best Tumor Response Across All Arms"

P1 data • Non Small Cell Lung Cancer • Oncology

Five Prime Therapeutics: Q2 2015 Results (Five Prime Therap) - Anticipated preliminary data from P1b trial for squamous NSCLC and mesothelioma at WCLC (Sep 6-9, 2015)

Anticipated P1 data • Non Small Cell Lung Cancer • Oncology

Five Prime Therapeutics reports second quarter 2015 results and provides business update (Five Prime Therap Press Release) - "By the end of 2015, Five Prime expects to complete Phase 1a dose escalation [of FPA-144] in patients with solid tumors, including gastric cancer...The company anticipates preliminary Phase 1a data will be available by the end of 2015 or early 2016....GSK intends to present preliminary safety and efficacy data from the [P1b trial of FP-1039/GSK3052230 in Squamous NSCLC] at the World Conference on Lung Cancer in September."

Anticipated conference • Anticipated P1 data • Trial status • Gastric Cancer • Non Small Cell Lung Cancer • Oncology

FP-1039: Anticipated patent expiry covering compositions of matter, methods of use, including certain combination therapies and dosing regimens, and related biomarkers in US and ex-US between 2026 and 2031 (Five Prime Therap) - Annual Report 2016: Anticipated expiry of U.S. and foreign patent applications covering composition of matter and methods of use  between 2026 and 2034; Anticipated expiry of exclusively licensed patents include issued U.S. patents covering  composition of matter and methods of production between 2019 and 2020

Anticipated patent expiry • Oncology

A phase Ib study of GSK3052230, an FGF ligand trap in combination with pemetrexed and cisplatin in patients with malignant pleural mesothelioma. (PubMed, Invest New Drugs) - "Conclusion At 15 mg/kg weekly, GSK3052230 was well tolerated in combination with pemetrexed/cisplatin and durable responses were observed. Importantly, AEs associated with small molecule inhibitors of FGFR were not observed, as predicted by the unique mechanism of action of this drug."

Clinical • Combination therapy • Journal • P1 data