PDS Biotech Announces Final Topline Survival Data from聽VERSATILE-002 Phase 2 Trial in Head and Neck Cancer
PDS Biotechnology (Nasdaq: PDSB) has announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial evaluating PDS0101 + Keytruda庐 in HPV16-positive first-line recurrent/metastatic head and neck cancer patients. The study demonstrated a remarkable median overall survival (mOS) of 39.3 months in patients with CPS 鈮� 1, significantly outperforming the best published standard of care result of 17.9 months.
The trial enrolled 53 patients and showed durable patient survival promoted by high levels of long-lasting HPV16-specific CD8+ T cells. The treatment combination was well-tolerated with no patients discontinuing due to treatment-related adverse events. The company plans to publish the full dataset later this year, while its VERSATILE-003 Phase 3 trial is currently in progress.
PDS Biotechnology (Nasdaq: PDSB) ha annunciato i dati finali principali sulla sopravvivenza dello studio VERSATILE-002 di fase 2, che valuta PDS0101 + Keytruda庐 in pazienti con carcinoma testa-collo ricorrente/metastatico HPV16-positivo in prima linea. Lo studio ha mostrato un notevole overall survival mediano (mOS) di 39,3 mesi nei pazienti con CPS 鈮� 1, superando nettamente il miglior risultato di riferimento pubblicato di 17,9 mesi.
Al trial hanno partecipato 53 pazienti; 猫 stata osservata una sopravvivenza duratura correlata ad alti livelli di cellule CD8+ specifiche per HPV16 a lunga persistenza. La combinazione terapeutica 猫 risultata ben tollerata e nessun paziente ha interrotto il trattamento per eventi avversi correlati. L鈥檃zienda prevede di pubblicare il set di dati completo entro la fine dell鈥檃nno, mentre il trial di fase 3 VERSATILE-003 猫 attualmente in corso.
PDS Biotechnology (Nasdaq: PDSB) ha anunciado los datos definitivos principales de supervivencia del ensayo VERSATILE-002 de fase 2, que eval煤a PDS0101 + Keytruda庐 en pacientes con c谩ncer de cabeza y cuello recurrente/metast谩sico HPV16-positivo en primera l铆nea. El estudio mostr贸 una notable supervivencia global mediana (mOS) de 39,3 meses en pacientes con CPS 鈮� 1, superando claramente el mejor resultado publicado del est谩ndar de atenci贸n de 17,9 meses.
El ensayo reclut贸 a 53 pacientes y mostr贸 una supervivencia duradera vinculada a altos niveles de c茅lulas CD8+ espec铆ficas para HPV16 de larga duraci贸n. La combinaci贸n de tratamiento fue bien tolerada y ning煤n paciente interrumpi贸 por eventos adversos relacionados con el tratamiento. La compa帽铆a planea publicar el conjunto de datos completo m谩s adelante este a帽o, mientras que el ensayo de fase 3 VERSATILE-003 est谩 en curso.
PDS Biotechnology (Nasdaq: PDSB)電� HPV16 鞏戩劚 1彀� 鞛皽/鞝勳澊靹� 霊愱步攵�鞎� 頇橃瀽毳� 雽�靸侅溂搿� PDS0101 + Keytruda庐毳� 韽夑皜頃� VERSATILE-002 2靸� 鞛勳儊鞁滍棙鞚� 斓滌 欤检殧 靸濎〈 雿办澊韯� 瓴瓣臣毳� 氚滍憸頄堨姷雼堧嫟. 鞐瓣惮鞐愳劀 CPS 鈮� 1 頇橃瀽鞚� 欷戩暀 鞝勳泊 靸濎〈旮瓣皠(mOS)鞚� 39.3臧滌洈搿� 氤搓碃霅橃棃鞙茧┌, 鞚措姅 旮办〈鞐� 氚滍憸霅� 斓滌劆鞚� 響滌 旃橂 瓴瓣臣鞚� 17.9臧滌洈鞚� 韥矊 靸來殞頃╇媹雼�.
鞛勋儊鞐愲姅 53氇�鞚� 霌彪霅橃棃瓿�, 鞛リ赴 歆�靻嶋悩電� HPV16 韸轨澊鞝� CD8+ T靹疙彫鞚� 雴掛潃 靾橃鞐� 鞚橅暣 歆�歆�霅橂姅 歆�靻嶌爜鞚� 頇橃瀽 靸濎〈鞚� 甏�彀半悩鞐堨姷雼堧嫟. 旃橂 臁绊暕鞚� 雮挫暯靹膘澊 鞏戫樃頃橃棳 旃橂 甏�霠� 鞚挫儊氚橃潙鞙茧 欷戨嫧頃� 頇橃瀽電� 鞐嗢棃鞀惦媹雼�. 須岇偓電� 鞐半偞 鞝勳泊 雿办澊韯办厠鞚� 氚滍憸頃� 瓿勴殟鞚措┌, VERSATILE-003 3靸� 鞁滍棙鞚� 順勳灛 歆勴枆 欷戩瀰雼堧嫟.
PDS Biotechnology (Nasdaq: PDSB) a annonc茅 les donn茅es finales principales de survie de son essai VERSATILE-002 de phase 2 茅valuant PDS0101 + Keytruda庐 chez des patients atteints d鈥檜n cancer de la t锚te et du cou r茅current/m茅tastatique HPV16-positif en premi猫re ligne. L鈥櫭﹖ude a montr茅 une survie globale m茅diane (mOS) remarquable de 39,3 mois chez les patients ayant un CPS 鈮� 1, d茅passant nettement le meilleur r茅sultat publi茅 du standard de soins de 17,9 mois.
Le essai a inclus 53 patients et a r茅v茅l茅 une survie durable favoris茅e par des niveaux 茅lev茅s de cellules CD8+ sp茅cifiques du HPV16 脿 longue persistance. La combinaison th茅rapeutique a 茅t茅 bien tol茅r茅e et aucun patient n鈥檃 arr锚t茅 le traitement en raison d鈥櫭﹙茅nements ind茅sirables li茅s au traitement. La soci茅t茅 pr茅voit de publier l鈥檈nsemble des donn茅es plus tard cette ann茅e, tandis que l鈥檈ssai de phase 3 VERSATILE-003 est en cours.
PDS Biotechnology (Nasdaq: PDSB) hat die finalen Topline-脺berlebensdaten der VERSATILE-002 Phase鈥�2-Studie ver枚ffentlicht, die PDS0101 + Keytruda庐 bei HPV16-positiven, in erster Linie rezidivierenden/metastasierten Kopf-Hals-Tumoren untersucht. Die Studie zeigte ein bemerkenswertes medianes Gesamt眉berleben (mOS) von 39,3 Monaten bei Patienten mit CPS 鈮� 1 und 眉bertraf damit deutlich das bisher beste publizierte Standard鈥憃f鈥慍are鈥慐rgebnis von 17,9 Monaten.
An der Studie nahmen 53 Patienten teil; es wurde eine dauerhafte 脺berlebensrate beobachtet, beg眉nstigt durch hohe, langanhaltende HPV16-spezifische CD8+-T鈥慫ell鈥慙evel. Die Kombinationsbehandlung wurde gut vertragen, und kein Patient brach die Behandlung aufgrund behandlungsbedingter Nebenwirkungen ab. Das Unternehmen plant, den vollst盲ndigen Datensatz noch in diesem Jahr zu ver枚ffentlichen; die Phase鈥�3鈥慡tudie VERSATILE鈥�003 l盲uft derzeit.
- None.
- No head-to-head studies comparing pembrolizumab and PDS0101
- Upper limit of the 95% confidence interval not yet estimable
Insights
PDS0101 with Keytruda shows groundbreaking 39.3-month survival in HPV16+ head/neck cancer, significantly outperforming standard care's 17.9 months.
The final survival data from PDS Biotech's VERSATILE-002 Phase 2 trial represents a potentially transformative development in treating HPV16-positive head and neck cancer. The reported 39.3-month median overall survival is remarkably superior to the best published results with standard care (17.9 months), suggesting more than a
What's particularly impressive is the durability of the response. The lower confidence interval bound of 23.9 months still substantially exceeds standard care outcomes, while the upper limit remains unestablished - indicating some patients are experiencing even longer survival benefits. The company attributes this durability to the high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101, which appears effective across various patient demographics and clinical characteristics.
The combination therapy's administration protocol is straightforward: subcutaneous PDS0101 injections alongside pembrolizumab infusions for the first 4 treatment cycles, followed by a final PDS0101 dose at cycle 12, with pembrolizumab monotherapy continuing between PDS0101 administrations.
Importantly, the safety profile appears favorable, with no patients discontinuing due to treatment-related adverse events - a significant advantage in oncology where treatment toxicity often limits therapeutic options.
The data aligns with two other recently published studies (IMMUNOCERV and the NCI-led study), providing consistent evidence across multiple investigations. With the Phase 3 VERSATILE-003 trial already in progress, this therapy is positioned to potentially address a significant unmet need in the fastest-growing segment of head and neck cancers.
Median Overall Survival (mOS) of 39.3 months in patients with CPS 鈮� 1 鈥� best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy is 17.9 months*
VERSATILE-003 Phase 3 trial in progress
PRINCETON, N.J., Aug. 25, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (鈥淧DS Biotech鈥� or the 鈥淐ompany鈥�), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced final topline survival data from its Phase 2 clinical trial. VERSATILE-002 evaluated PDS0101 (Versamune庐聽HPV) + Keytruda庐聽(pembrolizumab) in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer (鈥�1L R/M HNSCC鈥�).
- 53 patients were enrolled in the 1L R/M HNSCC arm of the trial.
- PDS0101 was administered by subcutaneous injection together with IV infusion of pembrolizumab during the first 4 treatment cycles. The 5th and final subcutaneous dose of PDS0101 was administered on cycle 12. On every other cycle where PDS0101 was not administered, pembrolizumab monotherapy was administered. This continued until disease progression, death, or to cycle 35.
- The median overall survival (mOS) is 39.3 months in patients with CPS 鈮� 1. The lower limit of the
95% confidence interval is 23.9 months, and the upper limit is not yet estimable.
- The median overall survival (mOS) is 39.3 months in patients with CPS 鈮� 1. The lower limit of the
- Durable patient survival is promoted by high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101 and was similar across patient demographics and clinical characteristics such as age, CPS status, and prior treatment.
鈥淲e believe this final readout of topline survival data from our VERSATILE-002 clinical trial supports the durable clinical effect of PDS0101 with similarly promising survival outcomes reported in two other recently published studies, the IMMUNOCERV study, and the NCI-led study in HPV16-positive recurrent and/or metastatic cancers,鈥� said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. 鈥淲e believe PDS0101, which is simple and easy to administer, brings new hope to the rapidly growing population of HPV16-positive head and neck cancer patients. We look forward to publishing the full data set for this trial later this year.鈥�
鈥淲ith these results, PDS Biotech is well positioned for leadership in the largest and most rapidly growing segment of HNSCC in the US and Europe. HPV16-positive HNSCC constitutes a significant and rapidly growing unmet medical need, and a targeted therapy to treat the underlying cause of the disease is urgently needed. We believe that oncologists will continue to prioritize therapies that give their patients the best chance for survival. With PDS0101 plus pembrolizumab, an added benefit appears to be that the combination is well tolerated, and no patients discontinued the trial due to treatment-related adverse events,鈥� said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech.
*No head-to-head studies have been performed comparing pembrolizumab and PDS0101
About the VERSATILE-002 Trial
VERSATILE-002 () is聽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,聽recurrent or metastatic HPV16-positive HNSCC.聽The trial is designed to assess the combination therapy's impact on patients who are either naive to or refractory to聽immune checkpoint inhibitors.聽
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鈥檚 lead investigational targeted immunotherapy PDS0101 (Versamune庐 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.
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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 鈥淐ompany鈥�) 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鈥檚 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 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥渆xpect,鈥� 鈥渁nticipate,鈥� 鈥減lan,鈥� 鈥渓ikely,鈥� 鈥渂elieve,鈥� 鈥渆stimate,鈥� 鈥減roject,鈥� 鈥渋ntend,鈥� 鈥渇orecast,鈥� 鈥済uidance鈥�, 鈥渙utlook鈥� 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鈥檚 ability to protect its intellectual property rights; the Company鈥檚 anticipated capital requirements, including the Company鈥檚 anticipated cash runway and the Company鈥檚 current expectations regarding its plans for future equity financings; the Company鈥檚 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鈥檚 operations or require the Company to relinquish rights to the Company鈥檚 technologies or product candidates; the Company鈥檚 limited operating history in the Company鈥檚 current line of business, which makes it difficult to evaluate the Company鈥檚 prospects, the Company鈥檚 business plan or the likelihood of the Company鈥檚 successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0101 (Versamune庐聽HPV), PDS01ADC, PDS0103 (Versamune庐聽MUC1) and other Versamune庐 based product candidates; the future success of such trials; the successful implementation of the Company鈥檚 research and development programs and collaborations, including any collaboration studies concerning PDS0101 (Versamune庐聽HPV), PDS01ADC, PDS0103 (Versamune庐聽MUC1) and other Versamune庐 based product candidates and the Company鈥檚 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鈥檚 product candidates; the success, timing and cost of the Company鈥檚 or its partners鈥� ongoing clinical trials and anticipated clinical trials for the Company鈥檚 current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company鈥檚 ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company鈥檚 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鈥檚 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鈥檚 ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company鈥檚 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 鈥淩isk Factors,鈥� 鈥淢anagement鈥檚 Discussion and Analysis of Financial Condition and Results of Operations鈥� 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.鈥��
Versamune庐 is a registered trademark of PDS Biotechnology Corporation.
Keytruda庐 is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
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FAQ
What were the survival results in PDS Biotech's (PDSB) VERSATILE-002 Phase 2 trial?
How many patients were enrolled in PDSB's VERSATILE-002 Phase 2 trial?
What was the safety profile of PDS0101 + Keytruda in the VERSATILE-002 trial?
How was PDS0101 administered in the VERSATILE-002 trial?
What is the current development status of PDS Biotech's HPV cancer treatment?
