A patient in a phase 2 trial has received the first dose of a novel cancer vaccine in combination with Keytruda (pembrolizumab) as neoadjuvant (treatment before main treatment) and adjuvant (treatment after main treatment) therapy in patients with solid tumors, according to IO Biotech, the manufacturing company of the cancer vaccine.
Keytruda is a type of monoclonal antibody and an immune checkpoint inhibitor, which is a type of treatment that binds to a protein called PD-1 and helps the immune system destroy cancer cells, according to the National Cancer Institute.
IO102-IO103 is a novel cancer vaccine that works to destroy both tumor cells and immune-suppressive cells that are present in the tumor microenvironment. The novel vaccine is also being evaluated in other trials in combination with Keytruda as a first-line treatment for advanced non-small cell lung cancer, a news release stated.
The phase 2 trial, IOB-032/PN-E40, is intended to specifically identify how IO102-IO103 plus Keytruda as neoadjuvant and adjuvant therapy will benefit patients with solid tumors.
Patients in the study had two different cancer types, which included resectable (surgically removable) melanoma and squamous cell carcinoma of the head and neck (SCCHN) before and after surgery with the intent to cure the disease, according to the news release.
The study, which is currently recruiting participants, will include approximately 30 patients, with approximately 15 patients with melanoma and 15 with SCCHN, according to the study’s listing on ClinicalTrials.gov.
For neoadjuvant treatment, the listing explained, patients will receive the novel cancer vaccine along with Keytruda. Patients with melanoma are set to receive three doses of the neoadjuvant treatment and patients with SCCHN are set to receive two or three doses of neoadjuvant treatment.
Patients in the study are to receive surgery one to three weeks after the last dose of their neoadjuvant treatment, the listing stated. After surgery, all patients will continue receiving IO102-IO103 plus Keytruda.
“The importance of systemic immunotherapy before surgery is becoming a critical area of research, with the potential to change early treatment paradigms. In this perioperative disease setting, the IOB-032 study will provide clinical and translational data on the activity of IO102-IO103 in combination with (Keytruda) in patients with resectable melanoma and squamous cell carcinoma of the head and neck,” Dr. Qasim Ahmad, chief medical officer of IO Biotech, said in the news release.
“Dosing the first patient in this trial demonstrates our commitment to further explore the potential our therapeutic cancer vaccine may offer to a broader group of patients with cancer,” Ahmad continued. “Leading global experts from centers of excellence in this field in the U.S., Australia and Europe are involved in this clinical trial. We look forward to following the progress of this study.”
The study’s primary endpoint (main result measured at the end of a study to see if treatment worked) is the percentage of major pathologic response (10% residual tumor after neoadjuvant therapy). The secondary endpoint of the study includes disease-free survival at two years following surgery (time after surgery when a patient survives without signs of cancer), ClinicalTrials.gov noted.
“We continue to see promising data and a favorable safety profile supporting use of our lead investigational therapeutic cancer vaccine candidate, IO102-IO103, combined with PD-1 inhibitors to treat various types of cancer, including melanoma, lung cancer and head and neck cancer,” Mai-Britt Zocca, president and chief executive officer of IO Biotech, said in the news release.
“In patients with advanced melanoma, the activity and tolerability profile of IO102-IO103 and a PD-1 inhibitor has been demonstrated in the Phase 1/2 trial and we are now conducting a pivotal Phase 3 trial in patients with advanced melanoma, with enrollment completed in that study and an interim analysis planned in 2024,” she added. “We are embarking on this neoadjuvant/adjuvant trial with the goal of also helping patients in earlier disease settings.”
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