A new Phase 1b clinical trial testing a combination treatment of Hu5F9-G4 with avelumab in patients with ovarian cancer is set to begin as part of an agreement between Forty Seven and Merck KGaA, Darmstadt, Germany.
“Ovarian cancer patients have limited treatment options, especially as they are often diagnosed at a late stage in their disease,” Alise Reicin, head of global clinical development at Merck KGaA, Darmstadt, Germany — which in the U.S. and Canada operates as EMD Serono — said in a press release. “This collaboration enhances our strategic approach to novel [immuno-oncology] combinations in this disease setting. We are hopeful that through these efforts we will discover viable options to help patients with this hard-to-treat cancer.”
Avelumab is a human programmed death ligand-1 (PD-L1) antibody that blocks PD-L1 interaction with its receptor PD-1, enabling immune system cells known as T-cells to attack cancer cells. The medicine is already approved as Bavencio for metastatic merkel cell carcinoma, an aggressive skin cancer, and metastatic urothelial carcinoma, a form of cancer of the bladder or urinary tract.
“PD-L1 inhibitors, like avelumab, belong to a class of new immunological therapies for cancer known as checkpoint inhibitors that offer the opportunity for long-term remissions in some cancer patients,” said Chris Takimoto, chief medical officer of Forty Seven. “Not all patients however, respond to checkpoint inhibitors, so additional scientifically driven combination approaches are required.”
Hu5F9-G4 is a CD-47-targeting antibody. Similar to PD-L1, CD47 is used by cancer cells to prevent an immune attack. But in this case, the molecule works to suppress the function of macrophages, large cells of our immune system that engulf and digest target cells.
Combining inhibitors for both molecules could unleash the immune system in a stronger and more effective manner, researchers hypothesized.
To address this, the companies will be testing avelumab in combination with the CD47 inhibitor, Hu5F9-G4, in ovarian cancer patients. Trial information was not yet disclosed.
Avelumab is currently being studied in the JAVELIN clinical development program, which includes nine Phase 3 clinical trials and more than 7,000 patients across over 15 different tumor types, including ovarian cancer, non-small cell lung cancer, renal cell carcinoma, and others.
In February 2017, avelumab also started being evaluated as part of a combination regimen in a Phase 1/2 trial (NCT02943317) studying avelumab and defactinib, a FAK inhibitor, in patients with advanced ovarian cancer (still recruiting). This study’s primary endpoint is to assess the safety and overall response. Secondary endpoints include progression-free survival, overall survival, time to treatment response, and duration of response.
The study is being conducted by Verastem.
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