NEW YORK – Precigen on Wednesday said it will begin a Phase II study of its investigational immunotherapy PRGN-2009 plus Merck's Keytruda (pembrolizumab) in patients with recurrent or metastatic human papillomavirus (HPV)-positive cervical cancer.
The US Food and Drug Administration cleared the Germantown, Maryland-based firm's investigational new drug application, allowing it to begin the Phase II randomized trial comparing the activity of PRGN-2009 plus Keytruda or Keytruda alone. Precigen plans to enroll roughly 46 patients with HPV-positive cancers who have already received Keytruda for recurrent or metastatic disease.
Investigators will track patients' objective response rates as the primary endpoint in the study. Secondary endpoints will include assessing safety and tolerability as well as patients' progression-free and overall survival, best overall responses, disease control rate, time to treatment response, and response duration.
Precigen developed the off-the-shelf immunotherapy using its UltraVector and AdenoVerse platforms and designed it to stimulate patients' immune systems to recognize and target HPV-positive tumors. Interim data from an earlier Phase I trial showed that repeated administration of PRGN-2009, when combined with immune checkpoint inhibitors, had a favorable safety profile and encouraging clinical activity, producing a 30 percent objective response rate among heavily pretreated HPV-positive recurrent or metastatic cancer patients.
"Based on the Phase I safety and efficacy data, the FDA has allowed us to treat patients as early as the second line in the recurrent or metastatic setting in this Phase II cervical cancer study," Precigen CEO and President Helen Sabzevari said in a statement, adding that the firm has also settled on a chemistry, manufacturing, and controls plan to produce and deliver the product for the Phase II and future pivotal trials.