Dr Yilmaz on HB-200 Arenavirus Plus Pembrolizumab in HPV16+ Head and Neck Cancer

Emrullah Yilmaz, MD, PhD, clinical assistant professor, Hematology and Medical Oncology, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; member, Immune Oncology Program, Case Comprehensive Cancer Center, discusses a study investigating HB-200 arenavirus–based immunotherapy plus pembrolizumab (Keytruda) in the first-line treatment of patients with recurrent/metastatic human papillomavirus type 16 (HPV16)–positive head and neck cancer.

, investigators presented findings from the phase 2 cohort of a phase 1/2 trial (NCT04180215) that enrolled 46 patients, primarily those with oropharyngeal primary tumors and prior exposure to chemoradiation. Initial results demonstrated a manageable safety profile and clinical activity with HB-200 plus pembrolizumab. Notably, responses were more pronounced in patients with a PD-L1 combined positive score (CPS) of 20 or higher, indicating a correlation between PD-L1 expression and treatment efficacy. These findings have prompted the initiation of the randomized, phase 2/3 H-200-004 trial to further evaluate HB-200 in combination with pembrolizumab in patients with HPV16-positive oropharyngeal squamous cell carcinoma.

HPV16 is the most common subtype of the HPV virus seen in HPV-positive oropharyngeal cancer, with more than 90% of these patients having HPV16, Yilmaz begins. This prevalence is why the HB-200 arenavirus was specifically designed to target HPV16, he says. Essentially, this drug is an RNA virus vector that induces an immune response specific to HPV16, thereby enhancing the immune system’s ability to target cancer-specific cells. The aim of this phase 1/2 trial was to make immunotherapy more effective by combining the HB-200 arenavirus with pembrolizumab, he reports.

The most exciting findings from the study are the enhanced responses observed with the combination therapy compared with single-agent pembrolizumab, Yilmaz continues. For patients with a PD-L1 CPS of at least 1 (n = 35), the overall response rate (ORR) was 37.1%, and for those with a PD-L1 CPS of 20 or more (n = 17), the ORR was 52.9%, he says. Additionally, patients could tolerate the treatment for extended periods, resulting in a longer duration of response compared with single-agent immunotherapy, Yilmaz explains. These promising results highlight the potential of this combination therapy to improve outcomes for patients with HPV-positive oropharyngeal cancer, Yilmaz concludes.

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Emrullah Yilmaz, MD, PhD, discusses HB-200 arenavirus–based immunotherapy plus pembrolizumab in recurrent/metastatic HPV16+ head and neck cancer.

Musa Yilmaz, MD, assistant professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses composite complete remission (CRc) and bone marrow transplant rates observed in a phase 1/2 trial (NCT03661307) in patients with 

-ITD–mutated acute myeloid leukemia (AML).

This trial evaluated the efficacy and safety of decitabine plus quizartinib and venetoclax (Venclexta) in patients with newly diagnosed or relapsed/refractory 

-ITD–mutated AML who are ineligible for intensive induction chemotherapy.

The CRc rate in patients with relapsed/refractory disease was 82%, Yilmaz says. Additionally, bone marrow biopsies conducted by day 14 of the regimen revealed that 46% of these patients had bone marrow blasts of 5% or less, displaying an encouraging response rate in the relapsed/refractory cohort, Yilmaz notes.

Regarding safety, the 30-day mortality rate in this cohort was 0%, showing this regimen to be tolerable, with no induction mortality, Yilmaz says. A total of 43% of these patients proceeded to allogeneic bone marrow transplant, which are promising results, as transplant is the only practical way to treat this disease, Yilmaz concludes.

Musa Yilmaz, MD, discusses composite complete remission and bone marrow transplant rates observed in a phase 1/2 trial in patients with FLT3-ITD–mutated acute myeloid leukemia.

Musa Yilmaz, MD

Articles

Dr Yilmaz on HB-200 Arenavirus Plus Pembrolizumab in HPV16+ Head and Neck Cancer

Dr. Yilmaz on the Benefit of Quizartinib Triplet in AML