PDS Biotech reports 29.5 months of mOS in low PD-L1 expression patients with head and neck cancer.

• Median Overall Survival (mOS) 29.5 months in digital data analysis. • Combination therapy with Keytruda® + chemotherapy, standard of care. • 10.8 months mOS with Keytruda® alone in patients with CPS 1-19. • Encouraging efficacy signal in difficult to treat head and neck cancer patients. • PDS0101 (Versamune® HPV) + Keytruda® in HPV16-positive 1L R/M HNSCC patients.

PDS Biotechnology Corporation (PDSB) recently announced significant findings from a sub-analysis of its VERSATILE-002 Phase 2 clinical trial. The study evaluated the combination of PDS0101 (Versamune® HPV) with Keytruda® (pembrolizumab) in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer (1L R/M HNSCC). The results indicate that the median overall survival (mOS) for patients with low PD-L1 expression (CPS 1-19) was 29.5 months, which is a notable improvement over the standard of care. The mOS for Keytruda® alone in this patient group was 10.8 months, and for Keytruda® plus chemotherapy, it was 12.3 months PDS Biotech Sets Significant Benchmark in Head and Neck Cancer by Achieving Extended Survival in Low PD-L1 Expression (CPS 1–19) Cohort in VERSATILE-002 Trial, Potentially Eliminating Need for Chemotherapy in the Population^[1].

The sub-analysis, which included approximately 60% of the patients enrolled in the VERSATILE-002 trial, suggests that the multifunctional T cell immune response of PDS0101 may overcome the limitations of immune checkpoint inhibitor therapy, thereby significantly improving survival in a difficult-to-treat patient population. This finding is particularly encouraging for patients with low levels of PD-L1 expression, who typically show poor responses to immune checkpoint inhibitor therapy PDS Biotech Sets Significant Benchmark in Head and Neck Cancer by Achieving Extended Survival in Low PD-L1 Expression (CPS 1–19) Cohort in VERSATILE-002 Trial, Potentially Eliminating Need for Chemotherapy in the Population^[1].

The full data set for the VERSATILE-002 trial is expected to be published later this year. This study is part of PDS Biotechnology's broader effort to transform how the immune system targets and kills cancers. The company's lead investigational targeted immunotherapy, PDS0101, is being developed in combination with a standard-of-care immune checkpoint inhibitor and is also being evaluated in a triple combination with PDS01ADC, an IL-12 fused antibody drug conjugate (ADC) PDS Biotech Sets Significant Benchmark in Head and Neck Cancer by Achieving Extended Survival in Low PD-L1 Expression (CPS 1–19) Cohort in VERSATILE-002 Trial, Potentially Eliminating Need for Chemotherapy in the Population^[1].

Additionally, Nanobiotix announced new results from a Phase 1 study evaluating JNJ-1900 (Nbtxr3) in combination with immune checkpoint inhibitors as a second-line therapy for patients with primary cutaneous melanoma resistant to anti-PD-1. The study showed a favorable safety profile and early efficacy signals, with a best observed objective response rate (ORR) of 47.4% and a median overall survival (mOS) of 14.6 months in all patients treated NANOBIOTIX Announces New Results From a Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Combination With Immune Checkpoint Inhibitors as a 2L+ Therapy for Patients With Primary Cutaneous Melanoma Resistant to Anti-PD-1^[2].

These results highlight the potential of combination therapies in improving treatment outcomes for patients with advanced cancers. While further clinical trials are needed to confirm these findings, the encouraging data from PDS Biotechnology and Nanobiotix suggest promising avenues for future research and development in the field of cancer immunotherapy.