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
PDS Biotech (Nasdaq: PDSB) announced breakthrough results from its VERSATILE-002 Phase 2 clinical trial, showing exceptional survival outcomes for head and neck cancer patients with low PD-L1 expression. The combination of PDS0101 with Keytruda® achieved a remarkable median overall survival (mOS) of 29.5 months in patients with CPS 1-19, significantly outperforming current standards of care.
The results are particularly significant as they demonstrate nearly triple the survival time compared to Keytruda® alone (10.8 months) or Keytruda® plus chemotherapy (12.3 months) in this difficult-to-treat patient population. Approximately 60% of enrolled patients (n=53) had low PD-L1 expression, with 32 patients in the CPS 1-19 cohort showing these remarkable results.
PDS Biotech (Nasdaq: PDSB) ha annunciato risultati rivoluzionari dal suo trial di fase 2 VERSATILE-002, mostrando esiti di sopravvivenza eccezionali nei pazienti con cancro testa e collo e bassa espressione di PD-L1. La combinazione di PDS0101 con Keytruda® ha raggiunto una notevole mediana di sopravvivenza globale (mOS) di 29,5 mesi nei pazienti con CPS 1-19, superando significativamente gli standard di cura attuali.
I risultati sono particolarmente significativi poiché dimostrano quasi il triplo del tempo di sopravvivenza rispetto a Keytruda® da solo (10,8 mesi) o Keytruda® più chemioterapia (12,3 mesi) in questa popolazione di pazienti difficile da trattare. Circa 60% dei pazienti arruolati (n=53) aveva bassa espressione di PD-L1, con 32 pazienti nella coorte CPS 1-19 che mostrano questi risultati straordinari.
PDS Biotech (Nasdaq: PDSB) anunció resultados innovadores de su ensayo de fase 2 VERSATILE-002, mostrando resultados de supervivencia excepcionales en pacientes con cáncer de cabeza y cuello y baja expresión de PD-L1. La combinación de PDS0101 con Keytruda® logró una notable mediana de supervivencia global (mOS) de 29,5 meses en pacientes con CPS 1-19, superando significativamente los estándares actuales de atención.
Los resultados son especialmente significativos ya que muestran casi el triple del tiempo de supervivencia en comparación con Keytruda® solo (10,8 meses) o Keytruda® más quimioterapia (12,3 meses) en esta población de pacientes de difícil tratamiento. Aproximadamente el 60% de los pacientes inscritos (n=53) tenía baja expresión de PD-L1, con 32 pacientes en la cohorte CPS 1-19 demostrando estos resultadosNotables.
PDS Biotech (Nasdaq: PDSB)는 VERSATILE-002 2상 임상 시험의 획기적인 결과를 발표했다. PD-L1 발현이 낮은 두경부암 환자에서 생존 결과가 탁월하다. PDS0101과 Keytruda®의 조합은 CPS 1-19 환자에서 중간 전체 생존 기간(mOS) 29.5개월을 달성했고, 현재 치료 표준을 크게 능가했다.
이 결과는 이 어려운 환자군에서 Keytruda® 단독(10.8개월) 또는 Keytruda®와 화학요법의 조합(12.3개월)과 비교해 거의 생존 시간이 3배 가까이 증가했다는 점에서 특히 의미가 있다. 등록된 환자의 약 60%가 PD-L1 발현이 낮았으며(n=53), CPS 1-19 코호트의 32명 환자에서 이러한 주목할 만한 결과가 관찰되었다.
PDS Biotech (Nasdaq: PDSB) a annoncé des résultats révolutionnaires de son essai de Phase 2 VERSATILE-002, montrant des résultats de survie exceptionnels chez les patients atteints de cancer de la tête et du cou avec une faible expression de PD-L1. La combinaison PDS0101 avec Keytruda® a atteint une médiane de survie globale (mOS) de 29,5 mois chez les patients CPS 1-19, dépassant largement les standards de soins actuels.
Les résultats sont particulièrement significatifs car ils démontrent presque le triple du temps de survie par rapport à Keytruda® seul (10,8 mois) ou Keytruda® plus chimiothérapie (12,3 mois) dans cette population de patients difficiles à traiter. Environ 60% des patients recrutés (n=53) présentaient une faible expression de PD-L1, avec 32 patients de la cohorte CPS 1-19 montrant ces résultats remarquables.
PDS Biotech (Nasdaq: PDSB) gab bahnbrechende Ergebnisse aus seiner Phase-2-Studie VERSATILE-002 bekannt, die außergewöhnliche Überlebensdaten bei Kopf- und Halstumoren mit niedriger PD-L1-Expression zeigen. Die Kombination PDS0101 mit Keytruda® erzielte eine bemerkenswerte mediane Gesamtüberlebenszeit (mOS) von 29,5 Monaten bei Patienten mit CPS 1-19 und übertraf damit deutlich die aktuellen Behandlungsstandards.
Die Ergebnisse sind besonders bedeutsam, da sie nahezu das Dreifache der Überlebenszeit im Vergleich zu Keytruda® allein (10,8 Monate) oder Keytruda® plus Chemotherapie (12,3 Monate) in dieser schwer zu behandelnden Patientengruppe zeigen. Ungefähr 60% der eingeschriebenen Patienten (n=53) wiesen eine niedrige PD-L1-Expression auf, wobei 32 Patienten in der CPS-1-19-Kohorte diese bemerkenswerten Ergebnisse zeigten.
PDS Biotech (Nasdaq: PDSB) أعلنت عن نتائج رائدة من تجربة المرحلة الثانية VERSATILE-002، أظهرت نتائج بقاء استثنائية للمرضى المصابين بسرطان الرأس والرقبة مع تعبير منخفض لـ PD-L1. توليفة PDS0101 مع Keytruda® حققت متوسط البقاء على قيد الحياة الإجمالي (mOS) يبلغ 29.5 شهراً في المرضى من CPS 1-19، متفوقة بشكل كبير على معايير الرعاية الحالية.
وتكتسب النتائج أهمية خاصة لأنها تُظهر تقريباً ثلاثة أضعاف فترة البقاء مقارنةً بـ Keytruda® وحده (10.8 أشهر) أو Keytruda® زائد العلاج الكيميائي (12.3 أشهر) في هذه الفئة من المرضى صعبة المعالجة. نحو 60% من المرضى المشتركين (n=53) كان لديهم تعبير منخفض لـ PD-L1، مع 32 مريضاً في Cohort CPS 1-19 يظهرون هذه النتائج اللافتة.
PDS Biotech (纳斯达克代码：PDSB) 宣布其VERSATILE-002 2期临床试验取得突破性结果，在低PD-L1表达的头颈癌患者中显示出卓越的生存结果。PDS0101与Keytruda®的联合治疗在CPS 1-19患者中实现了显著的中位总生存期(mOS)为29.5个月，显著优于现有的护理标准。
这一结果尤为重要，因为在这一治疗困难的患者人群中，生存时间几乎达到了与Keytruda®单药相比的三倍以上（Keytruda®单药10.8个月，Keytruda®+化疗12.3个月）。约有60%的受试者(n=53)PD-L1表达较低，在CPS 1-19队列中有32名患者展现出这些显著结果。
- Achieved exceptional 29.5 months median overall survival in hard-to-treat low PD-L1 expression patients
- Nearly tripled survival time compared to current standard treatments
- Potential to eliminate need for chemotherapy in treatment regimen
- Strong efficacy demonstrated in traditionally poor-responding patient population
- None.
Insights
PDS0101+Keytruda shows remarkable 29.5-month survival in low PD-L1 head/neck cancer patients - nearly triple standard therapies.
The VERSATILE-002 Phase 2 trial results for PDS0101 (Versamune® HPV) combined with Keytruda® represent a potentially transformative development in treating HPV16-positive head and neck cancer patients with low PD-L1 expression (CPS 1-19). The reported 29.5-month median overall survival in this difficult-to-treat population dramatically outperforms the current standards: Keytruda® alone (10.8 months) and Keytruda® plus chemotherapy (12.3 months).
This nearly three-fold survival improvement is particularly significant because patients with low PD-L1 expression typically respond poorly to immune checkpoint inhibitors alone. The combination appears to overcome the immunosuppressive tumor microenvironment that limits Keytruda's effectiveness in these patients. Approximately 60% of the trial participants fell into this challenging CPS 1-19 category, making these results relevant to a substantial patient population.
Beyond the impressive survival extension, this regimen could potentially eliminate the need for chemotherapy in these patients – a meaningful quality-of-life benefit given chemotherapy's significant toxicity profile. The company previously reported 39.3-month median overall survival across the full study population, suggesting even better outcomes in high PD-L1 expressors.
These results highlight PDS0101's potential mechanism – its Versamune® platform appears to generate a robust T-cell response that synergizes with Keytruda's checkpoint inhibition, potentially converting "cold" tumors (immunologically unresponsive) to "hot" tumors that respond to immunotherapy.
First combination therapy to report 29.5 months of Median Overall Survival (mOS); Standard of care Keytruda® (pembrolizumab) alone (10.8 months) and Keytruda® + chemotherapy (12.3 months) in patients with CPS 1-19*
Encouraging efficacy signal observed in difficult to treat category of advanced head and neck cancer patients
PRINCETON, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced details of a sub-analysis of the cohort of patients with low PD-L1 expression (CPS 1-19) from the final data for its recently completed VERSATILE-002 Phase 2 clinical trial. The VERSATILE-002 trial evaluated PDS0101 (Versamune® HPV) + Keytruda® in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer (“1L R/M HNSCC”).
“This is great news for these patients who may now have the possibility of a well-tolerated treatment without chemotherapy” stated Prof. Kevin Harrington, M.D., Head of the Division of Radiotherapy, The Institute of Cancer Research, London.
“Patients with low levels of PD-L1 expression have typically shown poor response to immune checkpoint inhibitor therapy, leaving HNSCC patients in this sub-type with few viable treatment options and a poor prognosis,” said Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. “This sub-analysis of survival data from the CPS 1-19 patient cohort appears to show that the multifunctional T cell immune response of PDS0101 treatment may overcome the documented limitations of immune checkpoint inhibitor therapy and significantly improve survival in one of the most difficult-to-treat patient populations. This is a very encouraging finding, pointing to the potential of PDS0101 to improve treatment outcomes in a patient group that has historically derived limited benefit from current standards of care.”
Approximately
- Median overall survival (mOS) for patients within the CPS 1-19 cohort (n=32) was 29.5 months.
- Published mOS in this CPS cohort was 10.8 months with Keytruda® monotherapy and 12.3 months with Keytruda® plus chemotherapy*
The Company announced mOS results for the full study population of 39.3 months from the VERSATILE-002 trial on August 25, 2025, and the full data set for the trial is expected to be published later this year.
*No head-to-head studies have been performed comparing Keytruda® (pembrolizumab) monotherapy and Keytruda® plus chemotherapy with PDS0101 *
About the VERSATILE-002 Trial
VERSATILE-002 (NCT04260126) is an open-label, multi-center Phase 2 clinical trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted immunotherapy, in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive HNSCC. The trial is designed to assess the combination therapy's impact on patients who are either naive to or refractory to immune checkpoint inhibitors.
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy PDS0101 (Versamune® HPV) is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of care.
For more information, please visit www.pdsbiotech.com
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® is a registered trademark of PDS Biotechnology Corporation.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email: david.schull@russopartnersllc.com
FAQ
What are the survival results for PDS Biotech's VERSATILE-002 trial in head and neck cancer?
How does PDSB's PDS0101 combination therapy compare to existing treatments?
What percentage of patients in PDSB's VERSATILE-002 trial had low PD-L1 expression?
What is the significance of PDS Biotech's trial results for head and neck cancer treatment?
When will the full VERSATILE-002 trial data be published?
