Cue Biopharma Reports New Complete Response and Confirmed 50% Overall Response Rate in Ongoing Phase 1 Trial of CUE-101 and Pembrolizumab in Recurrent/Metastatic HPV+ Head and Neck Cancer
Cue Biopharma (Nasdaq: CUE) reported significant progress in its Phase 1 trial of CUE-101 combined with pembrolizumab for treating recurrent/metastatic HPV+ head and neck cancer. The trial achieved a 50% overall response rate (ORR) in patients with Combined Positive Score (CPS) 鈮�1, including those with low CPS scores.
Key highlights include an additional complete response (CR) in a patient with multiple tumors, 12-month overall survival of 88% compared to 57% with pembrolizumab alone, and a median overall survival (mOS) of 32 months versus 12.3 months in the historical KEYNOTE-048 trial. The results demonstrate a significant reduction in death risk (HR 0.23) compared to historical data.
Cue Biopharma (Nasdaq: CUE) ha riportato progressi significativi nella sua sperimentazione di Fase 1 di CUE-101 in combinazione con pembrolizumab per il trattamento del cancro della testa e del collo HPV+ recidivante/metastatico. Lo studio ha raggiunto un tasso di risposta globale (ORR) del 50% nei pazienti con Combined Positive Score (CPS) 鈮�1, inclusi quelli con punteggi CPS bassi.
I punti salienti includono una risposta completa (CR) aggiuntiva in un paziente con tumori multipli, una sopravvivenza globale a 12 mesi dell'88% rispetto al 57% con solo pembrolizumab, e una sopravvivenza mediana globale (mOS) di 32 mesi contro i 12,3 mesi del trial storico KEYNOTE-048. I risultati mostrano una significativa riduzione del rischio di morte (HR 0,23) rispetto ai dati storici.
Cue Biopharma (Nasdaq: CUE) inform贸 avances significativos en su ensayo de Fase 1 de CUE-101 combinado con pembrolizumab para el tratamiento del c谩ncer de cabeza y cuello recurrente/metast谩sico HPV+. El ensayo logr贸 una tasa de respuesta global (ORR) del 50% en pacientes con Combined Positive Score (CPS) 鈮�1, incluyendo aquellos con puntuaciones bajas de CPS.
Los aspectos m谩s destacados incluyen una respuesta completa (CR) adicional en un paciente con m煤ltiples tumores, una supervivencia global a 12 meses del 88% en comparaci贸n con el 57% con solo pembrolizumab, y una supervivencia global mediana (mOS) de 32 meses frente a 12,3 meses en el ensayo hist贸rico KEYNOTE-048. Los resultados demuestran una reducci贸n significativa del riesgo de muerte (HR 0,23) en comparaci贸n con los datos hist贸ricos.
Cue Biopharma (雮橃姢雼�: CUE)電� 鞛皽/鞝勳澊靹� HPV+ 霊愱步攵�鞎� 旃橂毳� 鞙勴暅 CUE-101瓿� 韼笇搿るΜ欤茧 氤戩毄 1靸� 鞛勳儊鞁滍棙鞐愳劀 欷戩殧頃� 歆勳爠鞚� 氤搓碃頄堨姷雼堧嫟. 鞚� 鞛勳儊鞁滍棙鞚� Combined Positive Score(CPS) 鈮�1鞚� 頇橃瀽, 韸鬼瀳 雮潃 CPS 鞝愳垬毳� 臧�歆� 頇橃瀽霌れ棎靹� 50% 鞝勳泊 氚橃潙毳�(ORR)鞚� 雼劚頄堨姷雼堧嫟.
欤检殧 靹标臣搿滊姅 雼る皽靹� 膦呾枒 頇橃瀽鞐愳劀鞚� 於旉皜 鞕勳爠 氚橃潙(CR), 韼笇搿るΜ欤茧 雼弲 雽�牍� 12臧滌洈 鞝勳泊 靸濎〈鞙� 88%, 攴鸽Μ瓿� 鞐偓鞝� KEYNOTE-048 鞁滍棙鞚� 12.3臧滌洈瓿� 牍勱祼頃� 欷戩暀 鞝勳泊 靸濎〈旮瓣皠(mOS) 32臧滌洈鞚� 韽暔霅╇媹雼�. 瓴瓣臣電� 鞐偓鞝� 雿办澊韯� 雽�牍� 靷 鞙勴棙鞚� 韥矊 臧愳唽鞁滌及鞚岇潉 氤挫棳欷嶋媹雼�(HR 0.23).
Cue Biopharma (Nasdaq : CUE) a annonc茅 des progr猫s significatifs dans son essai de phase 1 de CUE-101 en combinaison avec le pembrolizumab pour le traitement du cancer de la t锚te et du cou HPV+ r茅current/m茅tastatique. L'essai a atteint un taux de r茅ponse globale (ORR) de 50% chez les patients avec un Combined Positive Score (CPS) 鈮�1, y compris ceux avec des scores CPS faibles.
Les points cl茅s incluent une r茅ponse compl猫te (CR) suppl茅mentaire chez un patient pr茅sentant plusieurs tumeurs, une survie globale 脿 12 mois de 88% contre 57% avec le pembrolizumab seul, et une survie globale m茅diane (mOS) de 32 mois contre 12,3 mois lors de l'essai historique KEYNOTE-048. Les r茅sultats montrent une r茅duction significative du risque de d茅c猫s (HR 0,23) par rapport aux donn茅es historiques.
Cue Biopharma (Nasdaq: CUE) meldete bedeutende Fortschritte in seiner Phase-1-Studie mit CUE-101 in Kombination mit Pembrolizumab zur Behandlung von rezidivierendem/metastasiertem HPV+ Kopf-Hals-Karzinom. Die Studie erreichte eine Gesamtansprechrate (ORR) von 50% bei Patienten mit Combined Positive Score (CPS) 鈮�1, einschlie脽lich solcher mit niedrigem CPS.
Wichtige Highlights sind eine zus盲tzliche vollst盲ndige Remission (CR) bei einem Patienten mit mehreren Tumoren, eine 12-Monats-Gesamt眉berlebensrate von 88% im Vergleich zu 57% bei alleiniger Pembrolizumab-Behandlung sowie ein medianes Gesamt眉berleben (mOS) von 32 Monaten gegen眉ber 12,3 Monaten in der historischen KEYNOTE-048-Studie. Die Ergebnisse zeigen eine signifikante Reduktion des Sterberisikos (HR 0,23) im Vergleich zu historischen Daten.
- None.
- Trial still in Phase 1, requiring further studies for full FDA approval
- Results based on comparison to historical data rather than direct control group
Insights
Cue Biopharma's CUE-101 shows impressive 50% response rate and 32-month survival in HPV+ head/neck cancer, significantly outperforming standard therapy.
The new data from Cue Biopharma's Phase 1 trial of CUE-101 combined with pembrolizumab presents remarkable efficacy signals in recurrent/metastatic HPV+ head and neck cancer. The 50% overall response rate (ORR) in CPS 鈮�1 patients represents a substantial improvement over pembrolizumab monotherapy's historical 19% response rate in the KEYNOTE-048 trial.
Particularly impressive is the additional complete response (CR) in a patient with multiple tumor sites, including lung metastases that cleared prior to the target lesion achieving CR. This pattern of delayed but complete tumor eradication aligns with immune-mediated mechanisms rather than direct cytotoxic effects鈥攃onsistent with CUE-101's design to stimulate and expand tumor-specific T cells.
The survival metrics are genuinely compelling. The 32-month median overall survival represents nearly a threefold improvement over pembrolizumab's historical 12.3 months. Similarly, the 88% 12-month survival rate versus 57% historically (HR 0.23) indicates substantial risk reduction. Importantly, the 50% response rate in low PD-L1 expressors (CPS 1-19) suggests CUE-101 may overcome limitations of checkpoint inhibitors in less immunogenic tumors.
This data suggests CUE-101's novel mechanism鈥攕electively engaging tumor-specific T cells鈥攎ay provide unique advantages in managing this difficult-to-treat malignancy. The prolonged disease stabilization eventually leading to complete response also validates the importance of different efficacy assessment timeframes for immunotherapies versus conventional treatments.
- Additional complete response (CR) observed in patient with multiple tumors
- Confirmed overall response rate (ORR) of
50% in patients with combined positive score (CPS) 鈮�1, including50% ORR in patients with low CPS (1-19) - 12-month overall survival of
88% and median overall survival (mOS) of 32 months
BOSTON, July 16, 2025 (GLOBE NEWSWIRE) -- 听(狈补蝉诲补辩: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, today provided a clinical update on its most advanced asset, CUE-101, representative of the CUE-100 series.
鈥淲e are excited to report an additional CR in a patient that had recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) treated with CUE-101 in combination with pembrolizumab (KEYTRUDA庐),鈥� said Matteo Levisetti, chief medical officer at Cue Biopharma. 鈥淭his patient had durable stable disease for close to two years and more recently demonstrated significant tumor reductions and now a complete response. Notably, the patient had multiple sites of disease, including the lungs that cleared prior to the complete response observed in the target lesion. We believe the kinetics of tumor reduction and disease eradication in this patient is due to the repeated stimulation and expansion of tumor-specific T cells given the mechanism of action of CUE-101. It also serves as a clear example of the differences in timing of the clinical activity often observed with immunotherapy compared to traditional cytotoxic therapies and supports the prolonged mOS observed in this trial.鈥�
Key data highlights from the expansion portion of the trial evaluating CUE-101 at the recommended Phase 2 dose (RP2D) of 4mg/kg in combination with pembrolizumab in 1L patients (data cutoff of July 14, 2025) include:
- ORR of
50% (2 CR and 10 partial responses (PR) in patients with CPS 鈮�1, compared to an ORR of19% observed with pembrolizumab alone in the historical third-party KEYNOTE-048 trial). - Survival metrics have continued to mature favorably: 12-month overall survival (OS) of
88% compared to57% with pembrolizumab alone in the historical KEYNOTE-048 trial, representing a reduction in the risk of death (HR 0.23) compared to historical data. - mOS of 32 months compared to 12.3 months in the historical KEYNOTE-048 trial.
- ORR of
50% in patients, including50% with low PD-L1 expression CPS (1-19).
Dan Passeri, chief executive officer at Cue Biopharma, added, "The culmination of maturing data further support our conviction that CUE-101, representative of our approach with the CUE-100 series, demonstrates a potential breakthrough therapeutic approach for establishing a new standard of care. With this maturing data, we are further emboldened in our conviction that our Immuno-STAT庐 platform represents transformative potential for selectively modulating the patient鈥檚 immune system.鈥�
About CUE-101 and the Phase 1 Trial
CUE-101 is Cue Biopharma鈥檚 most advanced clinical stage drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting two signals or 鈥渃ues鈥� to T cells. Signal #1 incorporates the HPV E7 protein, harbored by HPV-induced cancer cells, to provide selectivity through interaction with the HPV-specific T cell receptor. Signal #2 consists of an engineered IL-2 variant to stimulate the activity of T cells. CUE-101 is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study, for the treatment of HPV16+ driven recurrent/metastatic head and neck squamous cell carcinoma in second line (2L) and beyond patients as a monotherapy, and as a first line (1L) therapy in combination with pembrolizumab (KEYTRUDA庐).
About聽Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient鈥檚 body. The company鈥檚 proprietary platform, Immuno-STAT庐 (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body鈥檚 intrinsic immune system without the adverse effects of broad systemic immune modulation.
Headquartered in聽Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.
For more information please visit聽聽and follow us on聽听补苍诲听.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company鈥檚 belief regarding the potential benefits and applications of its drug candidates and programs, including the CUE-100 series and that CUE-101 represents a potential breakthrough therapeutic approach for establishing a new standard of care for treating patients battling HNSCC and that the Immuno-STAT庐 platform represents transformative potential for selectively modulating the patient鈥檚 immune system; and the company鈥檚 business strategies, plans and prospects. Forward-looking statements, which are based on certain assumptions and describe the company鈥檚 future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as 鈥渂elieve,鈥� 鈥渆xpect,鈥� 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥渃ould,鈥� 鈥渟eek,鈥� 鈥渋ntend,鈥� 鈥減lan,鈥� 鈥済oal,鈥� 鈥減roject,鈥� 鈥渆stimate,鈥� 鈥渁nticipate,鈥� 鈥渟trategy,鈥� 鈥渇uture,鈥� 鈥渓ikely,鈥� 鈥減romise鈥� or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company鈥檚 strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company鈥檚 actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company鈥檚 limited operating history, limited cash and a history of losses; the company鈥檚 ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current 鈥済oing concern鈥� determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the company鈥檚 ability to achieve profitability; potential setbacks in the company鈥檚 research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company鈥檚 ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required聽U.S. Food and Drug Administration聽(鈥淔DA鈥�) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company鈥檚 operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company鈥檚 reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company鈥檚 ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company鈥檚 ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company鈥檚 most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investor Contact
Marie Campinell
Senior Director, Corporate Communications
Cue Biopharma, Inc.
Media Contact
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LifeSci Communications
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FAQ
What are the latest results from Cue Biopharma's (CUE) Phase 1 trial of CUE-101?
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