Agenus Announces Publication in the Journal of Clinical Oncology Highlighting Data from Botensilimab Plus Balstilimab in Relapsed/Refractory Metastatic Sarcomas
Agenus (NASDAQ: AGEN) published results in the Journal of Clinical Oncology from its study of botensilimab (BOT) combined with balstilimab (BAL) in patients with relapsed/refractory metastatic sarcomas. The Phase 1 trial demonstrated significant efficacy across multiple sarcoma subtypes, including traditionally resistant forms.
Key results include an overall response rate of 19.2% in the study population (n=52), with 27.8% response rate in angiosarcoma patients (n=18). The disease control rate reached 65.4%, with 4.4 months median progression-free survival. The treatment showed a remarkable median duration of response of 21.7 months and 69% overall survival rate at 12 months.
The combination therapy demonstrated a manageable safety profile, with diarrhea/colitis (grade 3, 6.3%) as the most common treatment-related adverse event, effectively managed with steroids and TNF-alpha inhibitors. No Grade 4 or 5 adverse events were reported.
Agenus (NASDAQ: AGEN) ha pubblicato i risultati sul Journal of Clinical Oncology riguardanti uno studio su botensilimab (BOT) combinato con balstilimab (BAL) in pazienti con sarcomi metastatici in recidiva/ricoverati. Il trial di Fase 1 ha dimostrato un'efficacia significativa attraverso molteplici sottotipi di sarcoma, inclusi quelli tradizionalmente resistenti.
I risultati chiave includono un tasso di risposta globale del 19,2% nella popolazione dello studio (n=52), con un tasso di risposta del 27,8% nei pazienti con angiosarcoma (n=18). Il tasso di controllo della malattia ha raggiunto il 65,4%, con una sopravvivenza senza progressione mediana di 4,4 mesi. Il trattamento ha mostrato una durata mediana della risposta di 21,7 mesi e un tasso di sopravvivenza globale del 69% a 12 mesi.
La terapia combinata ha dimostrato un profilo di sicurezza gestibile, con diarrea/colite (grado 3, 6,3%) come l'evento avverso più comune correlato al trattamento, gestito efficacemente con steroidi e inibitori del TNF-alfa. Non sono stati riportati eventi avversi di Grado 4 o 5.
Agenus (NASDAQ: AGEN) publicó resultados en el Journal of Clinical Oncology de su estudio sobre botensilimab (BOT) combinado con balstilimab (BAL) en pacientes con sarcomas metastásicos en recaída/refractarios. El ensayo de Fase 1 demostró una eficacia significativa a través de múltiples subtipos de sarcoma, incluyendo formas tradicionalmente resistentes.
Los resultados clave incluyen una tasa de respuesta general del 19,2% en la población del estudio (n=52), con una tasa de respuesta del 27,8% en pacientes con angiosarcoma (n=18). La tasa de control de la enfermedad alcanzó el 65,4%, con una mediana de supervivencia libre de progresión de 4,4 meses. El tratamiento mostró una duración mediana de respuesta de 21,7 meses y una tasa de supervivencia global del 69% a los 12 meses.
La terapia combinada demostró un perfil de seguridad manejable, con diarrea/colitis (grado 3, 6,3%) como el evento adverso relacionado con el tratamiento más común, gestionado efectivamente con esteroides e inhibidores de TNF-alfa. No se informaron eventos adversos de Grado 4 o 5.
아게너스 (NASDAQ: AGEN)는 재발/난치성 전이성 육종 환자에서 보텐실리맙 (BOT)와 발스틸리맙 (BAL)을 병용한 연구 결과를 임상 종양학 저널에 발표했습니다. 1상 시험은 전통적으로 저항성이 있는 형태를 포함한 여러 육종 아형에서 유의미한 효능을 나타냈습니다.
주요 결과로는 연구 인구(n=52)에서 19.2%의 전체 반응률이 나타났으며, 혈관육종 환자에서 27.8%의 반응률 (n=18)이 기록되었습니다. 질병 조절률은 65.4%에 도달했으며, median 무진행 생존 기간은 4.4개월이었습니다. 치료는 반응 지속 시간의 중앙값이 21.7개월 이었고, 12개월 시점에서 전체 생존률은 69%로 나타났습니다.
복합 요법은 관리 가능한 안전성 프로필을 보여주었으며, 가장 흔한 치료 관련 부작용으로는 설사/대장염 (3등급, 6.3%)이 있으며, 이는 스테로이드와 TNF-알파 억제제로 효과적으로 관리되었습니다. 4 또는 5등급의 부작용은 보고되지 않았습니다.
Agenus (NASDAQ: AGEN) a publié des résultats dans le Journal of Clinical Oncology concernant son étude sur botensilimab (BOT) combiné avec balstilimab (BAL) chez des patients atteints de sarcomes métastatiques en rechute/réfractaires. L'essai de Phase 1 a démontré une efficacité significative à travers plusieurs sous-types de sarcomes, y compris ceux traditionnellement résistants.
Les résultats clés incluent un taux de réponse global de 19,2% dans la population de l'étude (n=52), avec un taux de réponse de 27,8% chez les patients atteints d'angiosarcome (n=18). Le taux de contrôle de la maladie a atteint 65,4%, avec une survie sans progression médiane de 4,4 mois. Le traitement a montré une durée médiane de réponse de 21,7 mois et un taux de survie global de 69% à 12 mois.
La thérapie combinée a démontré un profil de sécurité gérable, avec de la diarrhée/colite (grade 3, 6,3%) étant l'effet indésirable le plus courant lié au traitement, efficacement géré avec des stéroïdes et des inhibiteurs de TNF-alpha. Aucun événement indésirable de grade 4 ou 5 n'a été signalé.
Agenus (NASDAQ: AGEN) hat Ergebnisse in der Zeitschrift für klinische Onkologie zu seiner Studie über Botensilimab (BOT) in Kombination mit Balstilimab (BAL) bei Patienten mit rezidivierenden/refraktären metastasierten Sarkomen veröffentlicht. Die Phase-1-Studie zeigte eine signifikante Wirksamkeit bei mehreren Sarkom-Subtypen, einschließlich traditionell resistenter Formen.
Wichtige Ergebnisse umfassen eine insgesamt Ansprechraten von 19,2% in der Studienpopulation (n=52), mit einer Ansprechrate von 27,8% bei Angiosarkom-Patienten (n=18). Die Krankheitskontrollrate erreichte 65,4%, mit einem medianen progressionsfreien Überleben von 4,4 Monaten. Die Behandlung zeigte eine bemerkenswerte median Dauer des Ansprechens von 21,7 Monaten und eine Gesamtüberlebensrate von 69% nach 12 Monaten.
Die Kombinationstherapie zeigte ein handhabbares Sicherheitsprofil, wobei Durchfall/Kolitiden (Grad 3, 6,3%) die häufigste behandlungsbedingte unerwünschte Ereignis darstellt, die effektiv mit Steroiden und TNF-alpha-Inhibitoren behandelt wurde. Es wurden keine Grade 4 oder 5 unerwünschten Ereignisse berichtet.
- Overall response rate of 19.2% in heavily pretreated patients
- Strong 27.8% response rate in angiosarcoma patients
- Impressive 21.7 months median duration of response
- High disease control rate of 65.4%
- 69% overall survival rate at 12 months
- No Grade 4 or 5 treatment-related adverse events reported
- Only 4.4 months median progression-free survival
- 6.3% of patients experienced Grade 3 diarrhea/colitis
Insights
The clinical data published in JCO represents a significant advancement in treating refractory sarcomas, a notoriously challenging cancer type with historically poor outcomes. The 19.2% overall response rate and 65.4% disease control rate are particularly noteworthy given that these patients had received a median of three prior therapies, with some failing previous PD(L)-1 treatment.
Most striking is the durability of responses, with a median duration of response of 21.7 months. This is exceptional for sarcoma patients, where typical responses to later-line therapies are often measured in weeks to months. The 69% overall survival rate at 12 months suggests a meaningful extension of life for these patients.
The results in angiosarcoma are particularly compelling, with a 27.8% response rate across subtypes. This is remarkable for a 'cold' tumor type that historically shows minimal response to immunotherapy. The ability to generate responses in both visceral (33.3%) and cutaneous (22.2%) subtypes indicates broad activity across disease presentations.
These results strengthen Agenus's position in the immuno-oncology space, as the BOT/BAL combination has now demonstrated consistent activity across multiple tumor types. The favorable safety profile, with manageable grade 3 events and no grade 4/5 toxicities, suggests potential for combination strategies and earlier treatment lines.
These findings further reinforce the consistency of the BOT/BAL combination, which has already shown activity and a favorable safety profile across both multiple “warm and cold” tumor types, including colon cancer, lung cancer, melanoma and ovarian cancers.
Patients with advanced sarcomas face poor outcomes and have limited treatment options, underscoring the urgent need for innovative therapies. This Phase 1 study evaluated the safety and efficacy of botensilimab (BOT), an Fc-enhanced anti-CTLA-4 antibody, in combination with balstilimab (BAL), an anti-PD-1 antibody, in this challenging patient population.
“The publication in the Journal of Clinical Oncology further underscores the significant potential of botensilimab and balstilimab to address ‘cold’ tumors like certain subtypes of refractory sarcomas,” said Dr. Breelyn A. Wilky, University of Colorado Cancer Center. “These findings highlight the ability of this combination to deliver meaningful clinical benefits, including durable responses and extended survival, for patients who previously had very limited treatment options.”
Publication Highlights
Study Overview
-
This open-label multicenter trial (NCT03860272) enrolled patients across multiple sarcoma subtypes, including angiosarcoma and leiomyosarcoma—tumor types historically resistant to traditional checkpoint inhibitors. Patients were heavily pretreated with a median of three prior lines of therapy and
15% received previous PD(L)-1 therapy. -
In this expansion cohort, BOT was administered intravenously at 1 mg/kg or 2 mg/kg every 6 weeks in combination with BAL at 3 mg/kg every 2 weeks for up to 2 years.
- All patients were evaluable for safety and 52 patients for efficacy.
Efficacy Highlights
- Durable responses were observed across immunologically "cold" soft tissue sarcoma types, including visceral angiosarcoma and leiomyosarcoma.
-
Overall response rate (ORR) was
19.2% for the overall study population (n=52). Among angiosarcoma patients (n=18), ORR was27.8% , with33.3% in visceral and22.2% in cutaneous subtypes. -
Disease control rate (DCR) was
65.4% , with a median progression-free survival (PFS) of 4.4 months and a36% PFS rate at 6-months. -
At a median follow-up of 9.1 months, median overall survival (OS) was not reached; the 12-month OS was
69% . - Median Duration of Response (DOR) of 21.7 months, underscoring durable efficacy in heavily pretreated patients.
Safety Highlights
- The BOT/BAL combination was well tolerated, with a manageable safety profile consistent with earlier findings across tumor types.
-
The most common treatment-related adverse event (TRAE) was diarrhea/colitis (grade 3,
6.3% ), generally managed successfully with early intervention using steroids and TNF-alpha inhibitors. - No Grade 4 or 5 TRAEs were reported in this cohort.
These results add to a growing body of evidence supporting the potential of botensilimab plus balstilimab to deliver meaningful, durable benefit in multiple tumor types—especially those resistant to existing checkpoint inhibitors. As this data continues to show consistency and tolerability in colon, lung, melanoma, ovarian, and now sarcoma, it strengthens the rationale for broader investigation of this combination.
For more details, read the full publication in the Journal of Clinical Oncology here.
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies.
Approximately 1,100 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.
About Balstilimab (BAL)
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2023, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
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