Nemvaleukin Shows Manageable Safety Profile in Advanced Solid Tumors

Treatment with nemvaleukin in patients with advanced solid tumors was shown to have promising antitumor activity and was well-tolerated.

The phase 1/2 ARTISTRY-1 study, published in the Journal for ImmunoTherapy of Cancer, included 243 patients with advanced solid tumors. These tumor types included — but were not limited to — melanoma, kidney cancer, platinum-resistant ovarian cancer, non-small cell lung cancer and esophageal cancer.

The study included three parts: dose-escalation of nemvaleukin (part A), dose-expansion of nevaleukin (part B) and combination therapy of nemavleukin plus Keytruda (pembrolizumab; part C). Among these three parts, 46 patients were treated in part A, 74 were treated in part B and 166 were treated in part C.

When the study researchers finished collecting data on March 27, 2023, they reported that 100%, 96% and 92% of patients in parts A, B, and C discontinued receiving treatment, respectively. They noted that the most common reason for treatment discontinuation was because of disease progression.

“The current primary analysis of ARTISTRY-1 demonstrated a manageable safety and tolerability profile and promising antitumor activity of nemvaleukin alone and in combination with pembrolizumab in heavily pretreated patients with advanced solid tumors,” the researchers wrote in the study.

The main goal of the overall study was to determine the safety and tolerability of nemvaleukin in patients with advanced solid tumors.

Safety and Treatment Responses With Nemvaleukin Alone in Advanced Solid Tumors

Patients with advanced solid tumors who were placed in part A of the study received nemvaleukin alone for 7.6 weeks for a median of two treatment cycles, according to the study.

Patients in part B of the study received treatment for a median of six treatment cycles over 18.1 weeks. However, researchers reported that dose interruptions and dose reductions because of side effects occurred in 37 (50%) and six (8%) of patients, respectively. Of note, 72 patients (97%) experienced at least one treatment-emergent side effect from nemvaleukin.

The most common treatment-related side effects from patients in part B of the study were grades 1 or 2 (mild to serious), researchers noted. Common any-grade treatment-related side effects included fever in 48 patients, neutropenia in 42 patients and chills in 35 patients. Grade 3 or 4 (severe to life-threatening) treatment-related side effects were reported among 56 patients (76%). These included uncomplicated neutropenia in 36 patients and anemia in seven patients, according to the study. No deaths were reported among patients in part B.

“Nemvaleukin exhibited encouraging antitumor activity alone and in combination with [Keytruda], especially in heavily pretreated patients with solid tumors,” the researchers wrote.

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Regarding treatment responses, the researchers determined that the overall responses to nemvaleukin alone were observed in seven out of 68 patients. Specifically, the researchers noted that these seven patients who responded to treatment had partial responses, meaning their tumors shrunk after treatment. Among the patients who responded to treatment, four were patients with melanoma and three had kidney cancer.

Outcomes With Nemvaleukin Plus Keytruda in Advanced Solid Tumors

In part C of the study, patients with advanced solid tumors received a regimen of nemvaleukin plus Keytruda for a median of four treatment cycles over 12.4 weeks. Researchers noted that dose interruptions and dose reductions were reported in 81 (49%) and three (2%) of patients, respectively, because of side effects.

Of note, at least one treatment-related side effect occurred in 162 patients (98%), researchers stated. The most common treatment-related side effects of any grade were chills in 92 patients, fever in 82 patients and fatigue in 48 patients. Grade 3 or 4 treatment-related side effects were reported in 85 patients. The most frequent grade 3 or 4 side effects were neutropenia in 35 patients and anemia in 19, according to the study. One death related to disease progression after the nemvaleukin-Keytruda regimen was reported and assessed as related to nemvaleukin.

“Nemvaleukin exhibited encouraging antitumor activity alone and in combination with [Keytruda], especially in heavily pretreated patients with solid tumors,” the researchers wrote.

Antitumor activity after treatment with nemvaleukin plus Keytruda was observed in patients with various tumor types, researchers stated. Confirmed overall responses to treatment occurred in 19 of 144 patients: five patients showed complete responses and 14 showed partial responses. The median duration of response to the treatment regimen was 65 weeks.

“ARTISTRY-1 demonstrated proof of the principle of nemvaleukin antitumor activity alone and in combination with [Keytruda] in a broad range of refractory, pretreated malignancies,” the researchers wrote in the study. “The manageable safety profile enables nemvaleukin application in the majority of patients with cancer regardless of their cardiovascular fitness.”

Reference

“Nemvaleukin alfa, a modified interleukin-2 cytokine, as monotherapy and with pembrolizumab in patients with advanced solid tumors (ARTISTRY-1)” by Dr. Ulka N. Vaishampayan, et al. Journal for ImmunoTherapy of Cancer.

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