Benzinga | Sep 21, 2021 09:03AM EDT

Nektar Therapeutics Reports New Clinical Collab With Merck In Germany, Pfizer To Combine NKTR-255 With Avelumab In JAVELIN Bladder Medley Study

Nektar Therapeutics (NASDAQ:NKTR) announced it has entered into a new oncology clinical collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the maintenance regimen of NKTR-255, Nektar's interleukin-15 (IL-15) receptor agonist, in combination with avelumab, a PD-L1 inhibitor, in patients with locally advanced or metastatic urothelial carcinoma (UC) in the Phase II JAVELIN Bladder Medley study.



NKTR-255 is wholly owned by Nektar and is currently being evaluated in two separate clinical studies in both liquid and solid tumors. The novel IL-15 agonist is designed to activate the IL-15 pathway to expand both natural killer (NK) cells and memory CD8+ T cell populations.1 Avelumab, which is marketed in the U.S. as BAVENCIO(r), is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

"We are excited to partner with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the combination of NKTR-255 with avelumab in urothelial carcinoma," said Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar. "Preclinical studies suggest that avelumab may induce lysis of tumor cells via antibody-dependent cell-mediated cytotoxicity, or ADCC, indicating an additional mechanism of action, and providing an opportunity for potential synergy when combined with an NK cell stimulator, such as NKTR-255."

Under the new collaboration, Merck KGaA, Darmstadt, Germany and Pfizer Inc. will include the combination of NKTR-255 plus avelumab in the new JAVELIN Bladder Medley study. The study is a recently designed global, multi-center Phase II umbrella trial evaluating different avelumab-based combinations, compared with avelumab monotherapy, as potential maintenance therapy regimens for patients with locally advanced or metastatic UC that has not progressed with a first-line platinum-containing chemotherapy regimen. Nektar will supply NKTR-255 for the trial. Nektar and the Merck KGaA, Darmstadt, Germany-Pfizer alliance will each maintain existing global commercial rights to their respective medicines. The study is expected to begin enrolling patients in the first quarter of 2022.

BAVENCIO(r) (avelumab) is indicated in the U.S. and Europe for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

NKTR-255 is an investigational agent in clinical development and is not approved alone or in combination with avelumab (or any other agent) for use in any country.