alofanib (RPT835) / Russian Pharmaceutical Technologies, R-Pharm - LARVOL DELTA

Overcoming resistance to immunotherapy with FGFR inhibition in GU cancer models (ESMO 2023) - "OM-RCA-01, a anti-FGFR1 humanized antibody, and alofanib, a FGFR2 allosteric inhibitor showed promising results in previous studies...Treatment with ipilimumab (ipi, 200 mcl on days 7, 10, and 13) was initiated in both cohorts when tumor volumes reached 70 mm3...The table summarizes the results of in vivo studies. Table: 1073P Conclusions Inhibition of FGFR1 and FGFR2 following immunotherapy resulted in a twofold suppression of tumor growth, especially in the CAFs+ cohort."

Preclinical • Genito-urinary Cancer • Kidney Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • CAFs • FGFR2 • IFNG • VIM

A phase 1b study of the allosteric extracellular FGFR2 inhibitor alofanib in patients with pretreated advanced gastric cancer. (PubMed, Invest New Drugs) - P1b | "Alofanib showed acceptable tolerability and preliminary signs of clinical activity in the late-line treatment of metastatic gastric cancer. (ClinicalTrials.gov identifier: NCT04071184)."

Journal • Metastases • P1 data • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Musculoskeletal Pain • Oncology • Pain • Solid Tumor • Thrombocytopenia • FGFR2

Alofanib in subsequent therapy of advanced gastric cancer: Final results from the phase Ib clinical trial (ESMO-TAT 2022) - P1b | "Alofanib was feasible and showed early signals of efficacy in heavily-pretreated patients with metastatic gastric cancer."

Clinical • P1 data • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2

A first-in-human phase 1b study of a novel allosteric extracellular FGFR2 inhibitor alofanib in patients with refractory metastatic gastric cancer. (ASCO-GI 2022) - P1b | "The MTD has not been reached and dose of 350 mg/m2 has been declared as RP2D. Alofanib showed acceptable tolerability and preliminary signs of clinical activity in the late-line treatment of metastatic gastric cancer."

Clinical • P1 data • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2

Alofanib in subsequent therapy for advanced gastric cancer: Final results from the phase Ib clinical trial. (ASCO 2022) - P1b | "Alofanib was feasible and showed early signals of efficacy in heavily-pretreated patients with metastatic gastric cancer. A phase 2 randomized trial is planned."

Clinical • P1 data • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2

Pharmacokinetics of alofanib and biomarker analysis in patients with advanced gastric cancer: A phase 1b study (AACR 2022) - "In further studies, the evaluation of FGFR2 amplification seems to be important. >"

Biomarker • Clinical • P1 data • PK/PD data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2

[VIRTUAL] Effect of dose level of the selective FGFR2 inhibitor alofanib on toxicity, pharmacokinetics and preliminary efficacy: a phase 1b study in patients with advanced gastric cancer (RPT835GC1B) (TAT 2021) - P1b | "PK profiles did not correlate with toxicity and efficacy of alofanib. The study is ongoing."

Clinical • P1 data • PK/PD data • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2

[VIRTUAL] Effect of dose level of the selective FGFR2 inhibitor alofanib on toxicity, pharmacokinetics and preliminary efficacy: a phase 1b study in patients with advanced gastric cancer (RPT835GC1B) (TAT 2021) - P1b | "PK profiles did not correlate with toxicity and efficacy of alofanib. The study is ongoing."

Clinical • P1 data • PK/PD data • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2

[VIRTUAL] Preliminary data on a phase 1b, first-in-human study of the allosteric extracellular FGFR2 inhibitor alofanib in patients with refractory metastatic gastric cancer (AACR 2021) - P1b | "The early biologic activity of alofanib in the late-line treatment of metastatic gastric cancer is encouraging. In addition to the above, any updated safety, PK, and efficacy data will be presented at the time of the AACR meeting."

Clinical • P1 data • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2

A phase Ib study of alofanib, an allosteric FGFR2 inhibitor, in patients with advanced or metastatic gastric cancer. (ASCO-GI 2020) - P1b; "Alofanib (RPT835) is a novel selective allosteric inhibitor of FGFR2...Clinical trial information: NCT04071184. Research Funding: Skolkovo Foundation, Ruspharmtech"

Clinical • P1 data • FGFR2