Nemvaleukin Alfa Alone or Combined with Pembrolizumab in Advanced Cancers

ASCO 2022 was where Vaishampayan and colleagues presented the preliminary ARTISTRY-1 study results. They showed significant efficacy of the experimental drug nemvaleukin alfa, used alone or in combination with pembrolizumab, in some patients receiving treatment for several types of advanced cancer.

Nemvaleukin alfa is a new synthetic version of interleukin-2, a protein that stimulates the immune system. Nemvaleukin alfa binds to the interleukin-2 receptor on immune cells, stimulating the activity of CD8+ T cells and natural killer (NK) cells.

Interleukin-2 is classified as nonspecific immunotherapy. High-dose interleukin-2 received FDA (US Food and Drug Administration) approval for metastatic renal cell carcinoma in 1992 and metastatic melanoma in 1998, long before immune checkpoint inhibitors.

Existing treatments do not work for every patient, and new generations and combinations of immunotherapies are needed, particularly for patients whose cancer recurs and/or metastasizes after standard treatment.

Study Details

Results from the phase I/II ARTISTRY study showed that nemvaleukin alfa, administered by injection, stopped tumor growth or caused some shrinkage for at least 6 months in 4 of 22 male and female patients (18%) with advanced renal cell carcinoma (kidney cancer) whose cancer had progressed after previous immunotherapy. Some tumor shrinkage was also observed in 4 of 46 patients (8%) with various forms of the aggressive skin cancer melanoma. Side effects were minimal, although some patients experienced chills, shivering and anemia.

The study findings also showed that nemvaleukin alfa demonstrated anticancer activity in combination with pembrolizumab. The researchers found that the drug combination caused a 10-fold increase in and sustained production of CD8+ T cells and natural killer cells. This outcome occurred in 22 of 137 patients (16%) with multiple cancer types, while more than half of them (59%) also had a complete halt in cancer progression. Similar anticancer immune cell activity was observed in 4 of 14 women (28%) with ovarian cancer that had not responded to their first chemotherapy treatment.

Study investigator Associate Professor Dr. Vamsidhar Velcheti, a member of the Perlmutter Cancer Center and NYU Grossman School of Medicine, said: “Our preliminary results demonstrate that nemvaleukin alfa is generally safe, tolerable and potentially effective as a treatment for several different cancer types. If future study results demonstrate success, nemvaleukin alfa, alone or combined with other anticancer drugs, could serve as a valuable option for people with advanced cancer for whom other treatments have not worked or who have limited treatment options.”

Dr. Velcheti, who also directs Perlmutter's Thoracic Medical Oncology Program, emphasized that future results from this ongoing study must demonstrate similar benefits before nemvaleukin alfa can become a standard treatment for patients with advanced cancer.

Nemvaleukin alfa is already being evaluated by the FDA (US Food and Drug Administration) under accelerated approval status for advanced ovarian cancer treatment, partly based on earlier ARTISTRY-1 findings.