Nemvaleukin Alfa + Pembrolizumab Earn Fast Track Designation for Ovarian Cancer

Sometimes, treatments used in conjunction with each other can confer benefits for patients. According to the Cancer Network, for example, treating platinum-resistant ovarian cancer using nemvaleukin alfa and pembrolizumab (Keytruda) showed promise. Now, the FDA granted Fast Track designation to this treatment combination. Fast Track designation is designed to facilitate the development and review of therapies designed to fill an unmet need or treat rare, serious, and life-threatening conditions. As new therapeutic options are urgently needed for patients with platinum-resistant ovarian cancer, the nemvaleukin alfa and pembrolizumab combination could significantly improve patient outcomes if eventually approved.

Nemvaleukin Alfa

So what exactly are these therapies? In an unrelated news release, in which nemvaleukin alfa also received Fast Track designation for mucosal melanoma, the treatment is described as:

a fusion protein consisting of modified IL-2 and the high-affinity IL-2 alpha receptor chain. This combination is designed to expand tumor-destroying immune cells while not activating immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex.

Additionally, the National Cancer Institute (NCI) defines pembrolizumab as:

A humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities.

Currently, the therapies are being evaluated in a number of clinical trials:

  • Phase 1/2 ARTISTRY-1 clinical trial. Within this trial, nemvaleukin alfa is being evaluated as both a monotherapy and in conjunction with pembrolizumab. This particular trial centers around patients with a variety of solid tumors. 14 patients with platinum-resistant ovarian cancer enrolled. Of these, 6 patients (42.8%) achieved a stable disease state. 3 patients (21.4%) saw a partial response to treatment, while 1 patient (7.1%) had a complete response. The therapy showed similar benefits for patients with mucosal melanoma and renal cell carcinoma (RCC).
  • Phase 1/2 ARTISTRY-2 clinical trial. In this clinical trial, researchers are exploring nemvaleukin alfa and pembrolizumab for patients with solid tumors. Researchers discovered that the treatment helped raise natural kill (NK) cells and T-cells.
  • Phase 3 ARTISTRY-7 clinical trial. Altogether, 376 patients enrolled. Patients received either a combination of nemvaleukin alfa and pembrolizumab, either of the therapies by themselves, or chemotherapy. Researchers hope to use the data to understand whether nemvaleukin alfa and pembrolizumab provide benefits for patients with ovarian, Fallopian tube, or peritoneal cancer. Ultimately, the data will help spur the review process, although it is not yet ready.

Ovarian Cancer

As the name suggests, ovarian cancer begins in an ovary or ovaries, almond-shaped organs which produce hormones and store eggs. While doctors are unsure of the cause of ovarian cancer in many cases, some patients have BRCA gene mutations which spur its development. However, BRCA-mutated ovarian cancer is considered a rare and hereditary form. Ovarian cancer may consist of epithelial tumors (90% of diagnoses), germ cell carcinoma tumors (5%), stromal carcinoma tumors (5%), or small cell carcinoma of the ovary (0.1%). This cancer can spread to other organs and throughout the body. Symptoms can include:

  • Appetite loss
  • Changes in urinary urgency or frequency
  • Pelvic pain
  • Abdominal swelling (mass & girth)
  • Abnormal uterine bleeding or vaginal secretions
  • Menstrual irregularities
  • Breast tenderness
  • Increased testosterone
  • Endometrial hyperplasia

Learn more about ovarian cancer.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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