Utomilumab (PF-05082566) is an investigational antibody-based therapy, being developed by Pfizer to treat advanced cancers either alone or in combination with other therapies.

How utomilumab works

Utomilumab consists of a monoclonal antibody that binds specifically to 4-1BB (CD-137), a receptor protein found in many immune cells, such as T-cells (killer T-cells and helper T-cells) and natural killer cells.

When utomilumab is injected into a person’s bloodstream, it binds to 4-1BB on immune cells and stimulates them. This may result in enhanced immune action against tumors.

Utomilumab in clinical trials                                                    

A Phase 1b trial (NCT02179918) assessed the safety and anti-tumor activity of utomilumab in combination with Keytruda (pembrolizumab) in 23 patients with advanced solid tumors (non-small cell lung cancer, renal cell carcinoma, head and neck cancer, pancreatic cancer, thyroid cancer, small cell lung cancer, colon cancer, sarcoma, thymoma, and melanoma).

Results showed that the combination was safe, with early indications of anti-tumor activity. There were no toxicities observed with increasing doses of utomilumab.

A Phase 1 study (NCT01307267) is currently recruiting 270 people in the U.S., Australia, Europe, and Japan to evaluate utomilumab  as a single therapy in patients with advanced solid tumors or B-cell lymphomas. It is also being evaluated in combination with Rituxan (rituximab) in patients with a certain type of non-Hodgkin’s lymphoma (NHL), known as CD20-positive NHL, whose cancer has returned or did not respond to treatment.

Results so far show that utomilumab in combination with Rituxan was well tolerated, with anti-tumor activity in 48 patients with NHL unresponsive to Rituxan. The combination had no serious side effects and none of the patients discontinued the treatment.

This study is expected to be completed by 2019.

A Phase 1b/2 study (NCT02951156), in collaboration with EMD Serono, aims to evaluate utomilumab in combination with other therapies, including Bavencio (avelumab), Rituxan (rituximab), and chemotherapies. The study will enroll over 300 patients with diffuse large B-cell lymphoma (DLBCL) that failed to respond to other treatments or has returned at sites in the U.S., Australia, and Europe. It is expected to finish in 2021.

Another Phase 1b/2 study (NCT02554812), also recruiting, will evaluate the combination of utomilumab, Bavencio and, PF-04518600 in patients with locally advanced or metastatic solid tumors. This study aims to enroll over 670 patients in the U.S., Australia, Canada, Japa, and Europe, and finish in 2020.

An open-label, dose-escalation Phase 1 study (NCT02315066) aims to assess the safety and tolerability of utomilumab in combination with PF-04518600, or of PF-04518600 alone, in patients with select advanced or metastatic cancer. The study that is recruiting participants in the U.S., Japan, and Europe is expected to be completed by 2020.

Finally, an open-label Phase 1 study (NCT02444793) is evaluating the safety of escalating doses of utomilumab in combination with mogamulizumab in about 70 patients with advanced solid tumors. It’s goal is to determine an optimal dose for a Phase 2 study that intends to include some of the same patients.


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