Ionis Pharmaceuticals’ IONIS-STAT3-2.5 (AZD9150) showed promising results when given in combination with AstraZeneca’s Imfinzi (durvalumab) to patients with refractory and metastatic head and neck cancer in a small clinical trial.
The data, presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, showed that 29 percent of treated patients responded to the treatment.
“Today’s positive data with IONIS-STAT3-2.5 are exciting, demonstrating robust activity that is comparable to other promising late-stage checkpoint inhibitor combination therapies for cancer,” Brett Monia, PhD, senior vice president of drug discovery and franchise leader for oncology and rare diseases at Ionis, said in a press release.
The combination of IONIS-STAT3-2.5 and Imfinzi was studied in a Phase 1/2 clinical trial (NCT02499328) that recruited patients with squamous cell carcinoma of the head and neck that had metastasized or was refractory to treatment.
While the study included several treatment groups, the presentation, “Phase 1b/2 Study (SCORES) Assessing Safety, Tolerability, and Preliminary Anti-tumor Activity of Durvalumab Plus AZD9150 or AZD5069 in Patients With Advanced Solid Tumors and Refractory and Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (R/M-SCCHN),” focused on 28 patients who had not received PD-L1 treatment earlier.
Among them, four had a partial response and four had a complete response — of which one was seen only in the target lesion. In addition, eight patients had stable disease at 12 weeks, researchers said.
IONIS-STAT3-2.5 is a so-called Generation 2.5 antisense therapy that prevents the production of a factor called STAT3, found in increased levels in several cancers. STAT3 contributes to tumor growth and helps tumors to evade the immune system. Researchers believe that IONIS-STAT3-2.5 might provide a benefit when added to treatments with checkpoint inhibitors such as Imfinzi, which allows the immune system to “discover” the tumor.
“We continue to be encouraged by the substantial antitumor activity of our Generation 2.5 antisense drugs. Our Generation 2.5 chemistry increases the potency of our antisense drugs, thereby creating opportunities for drugs like IONIS-STAT3-2.5Rx to be effective in targeting more diseases with high unmet need, such as cancers,” Monia said.
“We are encouraged by the anti-tumor activity and safety profile observed in patients with head and neck cancer with AZD9150 in combination with Imfinzi,” said Susan Galbraith, MB, PhD, senior vice president and head of the oncology innovative medicines unit at AstraZeneca. “We believe this combination therapy supports further study in this group as well as patients with other cancers.”