[8-K] IO Biotech, Inc. Reports Material Event
IO Biotech disclosed topline results from its Phase 3 IOB-013 study evaluating Cylembio plus pembrolizumab versus pembrolizumab alone as first-line treatment for unresectable or metastatic melanoma. The randomized trial enrolled 407 patients (203 combination, 204 monotherapy). The primary endpoint, progression-free survival assessed by blinded independent review per RECIST v1.1, showed early and sustained separation with a hazard ratio (HR) of 0.77 (95% CI: 0.58鈥�1.00; p=0.056), and median PFS of 19.4 months versus 11.0 months. The primary result falls short of the prespecified significance threshold.
Notable subgroup findings include a pronounced benefit in PD-L1 negative tumors (HR 0.54; mPFS 16.6 vs 3.0 months; nominal p=0.006) and in patients without prior anti鈥揚D-1 therapy (post hoc HR 0.74; mPFS 24.8 vs 11.0 months; nominal p=0.037). Overall survival trends were favorable but immature (HR 0.79; 95% CI: 0.57鈥�1.10). The combination was generally well tolerated; injection site reactions were most common (reported in 56% of combination arm patients) and resolved on treatment. The company plans regulatory discussions about a potential BLA and will present more detailed data. It disclosed an estimated cash balance of approximately $28.1 million plus a 鈧�12.5 million tranche drawn under a term loan, which it expects to fund operations into the first quarter of 2026, subject to final close procedures.
IO Biotech ha comunicato i risultati topline dello studio di Fase 3 IOB-013 che ha valutato Cylembio in combinazione con pembrolizumab rispetto a pembrolizumab in monoterapia come trattamento di prima linea per melanoma non resecabile o metastatico. Lo studio randomizzato ha arruolato 407 pazienti (203 braccio combinazione, 204 braccio monoterapia). L'endpoint primario, la sopravvivenza libera da progressione (PFS) valutata da una revisione indipendente in cieco secondo RECIST v1.1, ha mostrato una separazione precoce e sostenuta con un hazard ratio (HR) di 0.77 (95% CI: 0.58鈥�1.00; p=0.056) e una mPFS di 19.4 mesi versus 11.0 mesi. Il risultato primario non ha raggiunto la soglia di significativit脿 prespecificata.
Tra i sottogruppi degni di nota si osserva un beneficio marcato nei tumori PD-L1 negativi (HR 0.54; mPFS 16.6 vs 3.0 mesi; p nominale=0.006) e nei pazienti senza precedente terapia anti鈥揚D-1 (analisi post hoc HR 0.74; mPFS 24.8 vs 11.0 mesi; p nominale=0.037). I trend della sopravvivenza globale erano favorevoli ma i dati sono immaturi (HR 0.79; 95% CI: 0.57鈥�1.10). La combinazione 猫 stata generalmente ben tollerata; le reazioni nel sito di iniezione sono state le pi霉 comuni (riportate nel 56% dei pazienti del braccio combinazione) e si sono risolte durante il trattamento. La societ脿 prevede discussioni regolatorie su una possibile BLA e presenter脿 dati pi霉 dettagliati. Ha dichiarato un saldo di cassa stimato di circa $28.1 million pi霉 una tranche di 鈧�12.5 million utilizzata nell'ambito di un prestito a termine, che dovrebbe finanziare le operazioni fino al primo trimestre del 2026, soggetto alle procedure di chiusura finale.
IO Biotech hizo p煤blicos los resultados topline de su estudio de fase 3 IOB-013 que evalu贸 Cylembio m谩s pembrolizumab frente a pembrolizumab solo como tratamiento de primera l铆nea para melanoma irresecable o metast谩sico. El ensayo aleatorizado incluy贸 a 407 pacientes (203 combinaci贸n, 204 monoterapia). El endpoint primario, la supervivencia libre de progresi贸n (PFS) evaluada por revisi贸n independiente ciega seg煤n RECIST v1.1, mostr贸 una separaci贸n temprana y sostenida con una raz贸n de riesgos (HR) de 0.77 (95% CI: 0.58鈥�1.00; p=0.056) y una mediana de mPFS de 19.4 meses frente a 11.0 meses. El resultado primario no alcanz贸 el umbral de significaci贸n prespecificado.
Entre los subgrupos destacables, se observ贸 un beneficio pronunciado en tumores PD-L1 negativos (HR 0.54; mPFS 16.6 vs 3.0 meses; p nominal=0.006) y en pacientes sin terapia previa anti鈥揚D-1 (an谩lisis post hoc HR 0.74; mPFS 24.8 vs 11.0 meses; p nominal=0.037). Las tendencias de supervivencia global fueron favorables pero inmaduras (HR 0.79; 95% CI: 0.57鈥�1.10). La combinaci贸n fue en general bien tolerada; las reacciones en el lugar de la inyecci贸n fueron las m谩s frecuentes (reportadas en el 56% de los pacientes del brazo combinado) y se resolvieron durante el tratamiento. La compa帽铆a planea conversaciones regulatorias sobre una posible BLA y presentar谩 datos m谩s detallados. Revel贸 un saldo de caja estimado de aproximadamente $28.1 million m谩s una tranche de 鈧�12.5 million dispuesta bajo un pr茅stamo a plazo, que espera financiar las operaciones hasta el primer trimestre de 2026, sujeto a los procedimientos de cierre final.
IO Biotech電� 靾橃垹 攵堦皜電ロ晿瓯半倶 鞝勳澊靹� 頋戩儔膦呾潣 1彀� 旃橂搿� Cylembio鞕� 韼笇搿るΜ欤茧 氤戩毄鞖旊矔鞚� 韼笇搿るΜ欤茧 雼弲瓿� 牍勱祼頃� 3靸� IOB-013 鞐瓣惮鞚� 韱彪澕鞚� 瓴瓣臣毳� 瓿店皽頄堨姷雼堧嫟. 氍挫瀾鞙� 氚办爼霅� 鞚� 鞐瓣惮鞐愲姅 407氇�(氤戩毄 203氇�, 雼弲 204氇�)鞚� 霌彪霅橃棃鞀惦媹雼�. 欤检殧 韽夑皜氤�靾橃澑 氍挫頄夓儩臁搓赴臧�(PFS)鞚� RECIST v1.1鞐� 霐半澕 霃呺鞝� 敫旊澕鞚鸽摐 毽钒搿� 韽夑皜頃� 瓴瓣臣 齑堦赴攵�韯� 歆�靻嶌爜鞚� 攵勲Μ臧� 甏�彀半悩鞐堦碃, 鞙勴棙牍�(HR) 0.77(95% CI: 0.58鈥�1.00; p=0.056)搿� 氤戩毄甑办潣 欷戩暀臧� PFS電� 19.4臧涤洈 雽� 雼弲甑办潣 11.0臧涤洈鞚挫棃鞀惦媹雼�. 欤检殧 瓴瓣臣電� 靷爠 歆�鞝曤悳 鞙犾潣靹� 旮办鞚� 於╈”頃橃 氇豁枅鞀惦媹雼�.
欤茧頃� 頃橃渼甑� 瓴瓣臣搿滊姅 PD-L1 鞚岇劚 膦呾枒鞐愳劀鞚� 霘滊牱頃� 鞚措摑(HR 0.54; mPFS 16.6 vs 3.0臧滌洈; 氇呺 p=0.006)瓿� 鞚挫爠 頃�揚D-1 旃橂毳� 氚涭 鞎婌潃 頇橃瀽鞐愳劀鞚� 鞚措摑(靷泟 攵勳劃 HR 0.74; mPFS 24.8 vs 11.0臧涤洈; 氇呺 p=0.037)鞚� 韽暔霅╇媹雼�. 鞝勳泊靸濎〈(OS) 於旍劯電� 鞖绊樃鞝侅澊歆�毵� 鞎勳 雿办澊韯� 靹膘垯霃勱皜 雮姷雼堧嫟(HR 0.79; 95% CI: 0.57鈥�1.10). 氤戩毄鞖旊矔鞚� 鞝勲皹鞝侅溂搿� 雮挫暯靹膘澊 膦嬱晿鞙茧┌, 欤检偓 攵�鞙� 氚橃潙鞚� 臧�鞛� 頋旐晿瓴� 氤搓碃霅橃棃瓿�(氤戩毄甑办潣 56% 氤搓碃) 旃橂 欷� 頃挫唽霅橃棃鞀惦媹雼�. 須岇偓電� 鞛犾灛鞝� BLA鞐� 雽�頃� 攴滌牅 雲检潣毳� 瓿勴殟頃橁碃 鞛堨溂氅� 氤措嫟 靸侅劯頃� 雿办澊韯半ゼ 氚滍憸頃� 鞓堨爼鞛呺媹雼�. 鞎� $28.1 million鞚� 於旍爼 順勱笀 鞛旍暋瓿� 旮绊暅攵� 雽�於滌棎靹� 鞚胳稖頃� 鈧�12.5 million 韸鸽灉旃橁皜 鞛堧嫟瓿� 瓿店皽頄堨溂氅�, 鞚措姅 斓滌 毵堦皭 鞝堨皑毳� 鞝勳牅搿� 2026雲� 1攵勱赴旯岇 鞖挫榿 鞛愱笀鞚� 歆�鞗愴暊 瓴冹溂搿� 鞓堨儊頃╇媹雼�.
IO Biotech a communiqu茅 les r茅sultats topline de son essai de phase 3 IOB-013 茅valuant Cylembio en association avec pembrolizumab versus pembrolizumab seul en premi猫re ligne pour le m茅lanome non r茅s茅cable ou m茅tastatique. L'essai randomis茅 a enr么l茅 407 patients (203 en combinaison, 204 en monoth茅rapie). Le crit猫re principal, la survie sans progression (PFS) 茅valu茅e par revue ind茅pendante en aveugle selon RECIST v1.1, a montr茅 une s茅paration pr茅coce et soutenue avec un hazard ratio (HR) de 0.77 (95% CI: 0.58鈥�1.00; p=0.056) et une m茅diane de mPFS de 19.4 mois contre 11.0 mois. Le r茅sultat primaire n'atteint pas le seuil de significativit茅 pr茅d茅termin茅.
Les analyses de sous-groupes notables montrent un b茅n茅fice marqu茅 dans les tumeurs PD-L1 n茅gatives (HR 0.54; mPFS 16.6 vs 3.0 mois; p nominal=0.006) et chez les patients sans traitement ant茅rieur anti鈥揚D-1 (analyse post hoc HR 0.74; mPFS 24.8 vs 11.0 mois; p nominal=0.037). Les tendances en survie globale 茅taient favorables mais immatures (HR 0.79; 95% CI: 0.57鈥�1.10). L'association a 茅t茅 g茅n茅ralement bien tol茅r茅e; les r茅actions au site d'injection 茅taient les plus fr茅quentes (signal茅es chez 56% des patients du bras combinaison) et se sont r茅solues sous traitement. La soci茅t茅 pr茅voit des discussions r茅glementaires au sujet d'une 茅ventuelle BLA et pr茅sentera des donn茅es plus d茅taill茅es. Elle a indiqu茅 un solde de tr茅sorerie estim茅 d'environ $28.1 million plus une tranche de 鈧�12.5 million tir茅e dans le cadre d'un pr锚t 脿 terme, qui devrait financer les op茅rations jusqu'au premier trimestre 2026, sous r茅serve des proc茅dures de cl么ture finale.
IO Biotech ver枚ffentlichte Topline-Ergebnisse der Phase-3-Studie IOB-013, in der Cylembio plus Pembrolizumab versus Pembrolizumab allein als Erstlinienbehandlung bei nicht resektablem oder metastasiertem Melanom untersucht wurde. Die randomisierte Studie schloss 407 Patienten ein (203 Kombination, 204 Monotherapie). Der prim盲re Endpunkt, das progressionsfreie 脺berleben (PFS) bewertet durch ein verblindetes unabh盲ngiges Review nach RECIST v1.1, zeigte eine fr眉he und anhaltende Trennung mit einem Hazard Ratio (HR) von 0.77 (95% CI: 0.58鈥�1.00; p=0.056) und einer medianen PFS von 19.4 Monaten 驳别驳别苍眉产别谤 11.0 Monaten. Das prim盲re Ergebnis verfehlte die vorab festgelegte Signifikanzgrenze.
Bemerkenswerte Subgruppenbefunde umfassen einen ausgepr盲gten Nutzen bei PD-L1-negativen Tumoren (HR 0.54; mPFS 16.6 vs 3.0 Monate; nominal p=0.006) und bei Patienten ohne vorherige Anti鈥揚D-1-Therapie (post-hoc HR 0.74; mPFS 24.8 vs 11.0 Monate; nominal p=0.037). Die Gesamt眉berlebens-Trends waren vorteilhaft, aber noch nicht ausgereift (HR 0.79; 95% CI: 0.57鈥�1.10). Die Kombination war insgesamt gut vertr盲glich; Reaktionen an der Injektionsstelle waren am h盲ufigsten (bei 56% der Patienten in der Kombinationsgruppe berichtet) und klangen w盲hrend der Behandlung ab. Das Unternehmen plant beh枚rdliche Gespr盲che zu einer m枚glichen BLA und wird detailliertere Daten pr盲sentieren. Es gab einen gesch盲tzten Kassenbestand von ungef盲hr $28.1 million zuz眉glich einer unter einem Terminkredit abgerufenen Tranche von 鈧�12.5 million, die voraussichtlich die Gesch盲ftst盲tigkeit bis ins erste Quartal 2026 finanzieren wird, vorbehaltlich der endg眉ltigen Abschlussverfahren.
- Median PFS improved to 19.4 months with the combination versus 11.0 months with pembrolizumab alone
- Strong subgroup benefit in PD-L1 negative patients (HR 0.54; mPFS 16.6 vs 3.0 months; nominal p=0.006)
- Post hoc anti鈥揚D-1 naive subgroup showed improved PFS (HR 0.74; mPFS 24.8 vs 11.0 months; nominal p=0.037)
- No new safety signals; combination generally well tolerated with mostly transient injection site reactions
- Regulatory engagement planned to discuss potential BLA submission based on the totality of data
- Primary endpoint narrowly missed statistical significance (HR 0.77; p=0.056; prespecified threshold p鈮�0.045)
- Overall survival immature with only a trend observed (HR 0.79; 95% CI: 0.57鈥�1.10)
- Several key analyses are post hoc or nominally significant, which limits their regulatory weight
- Limited cash runway: estimated ~$28.1 million plus a 鈧�12.5 million tranche expected to fund into Q1 2026, indicating near-term financing need
- Preliminary cash estimate may change because financial closing procedures for the period are incomplete
Insights
TL;DR: Positive PFS signals across key subgroups, but the primary endpoint narrowly missed statistical significance.
The trial enrolled 407 patients and showed an overall PFS HR of 0.77 (p=0.056), demonstrating an early and sustained separation of curves and a clinically meaningful median PFS increase to 19.4 months versus 11.0 months. The most compelling evidence is in PD-L1 negative patients (HR 0.54; mPFS 16.6 vs 3.0 months) and in anti鈥揚D-1 naive patients (post hoc HR 0.74; mPFS 24.8 vs 11.0 months). However, the nominal subgroup p-values and a post hoc analysis do not replace a statistically significant primary outcome, so regulatory discussions will hinge on the totality of evidence, consistency of effect, and durability of OS as it matures.
TL;DR: Encouraging clinical signals tempered by missed primary significance and limited near-term cash runway.
The topline PFS improvement suggests clinical value that could support regulatory engagement, especially given strong PD-L1 negative and anti鈥揚D-1 naive subgroup results. Nonetheless, missing the prespecified p-value raises regulatory and commercial risk; confirmatory evidence and mature OS will be pivotal. Financially, the company reports approximately $28.1 million in cash plus a 鈧�12.5 million loan tranche expected to fund operations into Q1 2026, indicating a need to secure additional capital within the next several quarters unless revenues or additional financing materialize. Investors should view this as a mixed outcome with both upside potential and near-term funding pressure.
IO Biotech ha comunicato i risultati topline dello studio di Fase 3 IOB-013 che ha valutato Cylembio in combinazione con pembrolizumab rispetto a pembrolizumab in monoterapia come trattamento di prima linea per melanoma non resecabile o metastatico. Lo studio randomizzato ha arruolato 407 pazienti (203 braccio combinazione, 204 braccio monoterapia). L'endpoint primario, la sopravvivenza libera da progressione (PFS) valutata da una revisione indipendente in cieco secondo RECIST v1.1, ha mostrato una separazione precoce e sostenuta con un hazard ratio (HR) di 0.77 (95% CI: 0.58鈥�1.00; p=0.056) e una mPFS di 19.4 mesi versus 11.0 mesi. Il risultato primario non ha raggiunto la soglia di significativit脿 prespecificata.
Tra i sottogruppi degni di nota si osserva un beneficio marcato nei tumori PD-L1 negativi (HR 0.54; mPFS 16.6 vs 3.0 mesi; p nominale=0.006) e nei pazienti senza precedente terapia anti鈥揚D-1 (analisi post hoc HR 0.74; mPFS 24.8 vs 11.0 mesi; p nominale=0.037). I trend della sopravvivenza globale erano favorevoli ma i dati sono immaturi (HR 0.79; 95% CI: 0.57鈥�1.10). La combinazione 猫 stata generalmente ben tollerata; le reazioni nel sito di iniezione sono state le pi霉 comuni (riportate nel 56% dei pazienti del braccio combinazione) e si sono risolte durante il trattamento. La societ脿 prevede discussioni regolatorie su una possibile BLA e presenter脿 dati pi霉 dettagliati. Ha dichiarato un saldo di cassa stimato di circa $28.1 million pi霉 una tranche di 鈧�12.5 million utilizzata nell'ambito di un prestito a termine, che dovrebbe finanziare le operazioni fino al primo trimestre del 2026, soggetto alle procedure di chiusura finale.
IO Biotech hizo p煤blicos los resultados topline de su estudio de fase 3 IOB-013 que evalu贸 Cylembio m谩s pembrolizumab frente a pembrolizumab solo como tratamiento de primera l铆nea para melanoma irresecable o metast谩sico. El ensayo aleatorizado incluy贸 a 407 pacientes (203 combinaci贸n, 204 monoterapia). El endpoint primario, la supervivencia libre de progresi贸n (PFS) evaluada por revisi贸n independiente ciega seg煤n RECIST v1.1, mostr贸 una separaci贸n temprana y sostenida con una raz贸n de riesgos (HR) de 0.77 (95% CI: 0.58鈥�1.00; p=0.056) y una mediana de mPFS de 19.4 meses frente a 11.0 meses. El resultado primario no alcanz贸 el umbral de significaci贸n prespecificado.
Entre los subgrupos destacables, se observ贸 un beneficio pronunciado en tumores PD-L1 negativos (HR 0.54; mPFS 16.6 vs 3.0 meses; p nominal=0.006) y en pacientes sin terapia previa anti鈥揚D-1 (an谩lisis post hoc HR 0.74; mPFS 24.8 vs 11.0 meses; p nominal=0.037). Las tendencias de supervivencia global fueron favorables pero inmaduras (HR 0.79; 95% CI: 0.57鈥�1.10). La combinaci贸n fue en general bien tolerada; las reacciones en el lugar de la inyecci贸n fueron las m谩s frecuentes (reportadas en el 56% de los pacientes del brazo combinado) y se resolvieron durante el tratamiento. La compa帽铆a planea conversaciones regulatorias sobre una posible BLA y presentar谩 datos m谩s detallados. Revel贸 un saldo de caja estimado de aproximadamente $28.1 million m谩s una tranche de 鈧�12.5 million dispuesta bajo un pr茅stamo a plazo, que espera financiar las operaciones hasta el primer trimestre de 2026, sujeto a los procedimientos de cierre final.
IO Biotech電� 靾橃垹 攵堦皜電ロ晿瓯半倶 鞝勳澊靹� 頋戩儔膦呾潣 1彀� 旃橂搿� Cylembio鞕� 韼笇搿るΜ欤茧 氤戩毄鞖旊矔鞚� 韼笇搿るΜ欤茧 雼弲瓿� 牍勱祼頃� 3靸� IOB-013 鞐瓣惮鞚� 韱彪澕鞚� 瓴瓣臣毳� 瓿店皽頄堨姷雼堧嫟. 氍挫瀾鞙� 氚办爼霅� 鞚� 鞐瓣惮鞐愲姅 407氇�(氤戩毄 203氇�, 雼弲 204氇�)鞚� 霌彪霅橃棃鞀惦媹雼�. 欤检殧 韽夑皜氤�靾橃澑 氍挫頄夓儩臁搓赴臧�(PFS)鞚� RECIST v1.1鞐� 霐半澕 霃呺鞝� 敫旊澕鞚鸽摐 毽钒搿� 韽夑皜頃� 瓴瓣臣 齑堦赴攵�韯� 歆�靻嶌爜鞚� 攵勲Μ臧� 甏�彀半悩鞐堦碃, 鞙勴棙牍�(HR) 0.77(95% CI: 0.58鈥�1.00; p=0.056)搿� 氤戩毄甑办潣 欷戩暀臧� PFS電� 19.4臧涤洈 雽� 雼弲甑办潣 11.0臧涤洈鞚挫棃鞀惦媹雼�. 欤检殧 瓴瓣臣電� 靷爠 歆�鞝曤悳 鞙犾潣靹� 旮办鞚� 於╈”頃橃 氇豁枅鞀惦媹雼�.
欤茧頃� 頃橃渼甑� 瓴瓣臣搿滊姅 PD-L1 鞚岇劚 膦呾枒鞐愳劀鞚� 霘滊牱頃� 鞚措摑(HR 0.54; mPFS 16.6 vs 3.0臧滌洈; 氇呺 p=0.006)瓿� 鞚挫爠 頃�揚D-1 旃橂毳� 氚涭 鞎婌潃 頇橃瀽鞐愳劀鞚� 鞚措摑(靷泟 攵勳劃 HR 0.74; mPFS 24.8 vs 11.0臧涤洈; 氇呺 p=0.037)鞚� 韽暔霅╇媹雼�. 鞝勳泊靸濎〈(OS) 於旍劯電� 鞖绊樃鞝侅澊歆�毵� 鞎勳 雿办澊韯� 靹膘垯霃勱皜 雮姷雼堧嫟(HR 0.79; 95% CI: 0.57鈥�1.10). 氤戩毄鞖旊矔鞚� 鞝勲皹鞝侅溂搿� 雮挫暯靹膘澊 膦嬱晿鞙茧┌, 欤检偓 攵�鞙� 氚橃潙鞚� 臧�鞛� 頋旐晿瓴� 氤搓碃霅橃棃瓿�(氤戩毄甑办潣 56% 氤搓碃) 旃橂 欷� 頃挫唽霅橃棃鞀惦媹雼�. 須岇偓電� 鞛犾灛鞝� BLA鞐� 雽�頃� 攴滌牅 雲检潣毳� 瓿勴殟頃橁碃 鞛堨溂氅� 氤措嫟 靸侅劯頃� 雿办澊韯半ゼ 氚滍憸頃� 鞓堨爼鞛呺媹雼�. 鞎� $28.1 million鞚� 於旍爼 順勱笀 鞛旍暋瓿� 旮绊暅攵� 雽�於滌棎靹� 鞚胳稖頃� 鈧�12.5 million 韸鸽灉旃橁皜 鞛堧嫟瓿� 瓿店皽頄堨溂氅�, 鞚措姅 斓滌 毵堦皭 鞝堨皑毳� 鞝勳牅搿� 2026雲� 1攵勱赴旯岇 鞖挫榿 鞛愱笀鞚� 歆�鞗愴暊 瓴冹溂搿� 鞓堨儊頃╇媹雼�.
IO Biotech a communiqu茅 les r茅sultats topline de son essai de phase 3 IOB-013 茅valuant Cylembio en association avec pembrolizumab versus pembrolizumab seul en premi猫re ligne pour le m茅lanome non r茅s茅cable ou m茅tastatique. L'essai randomis茅 a enr么l茅 407 patients (203 en combinaison, 204 en monoth茅rapie). Le crit猫re principal, la survie sans progression (PFS) 茅valu茅e par revue ind茅pendante en aveugle selon RECIST v1.1, a montr茅 une s茅paration pr茅coce et soutenue avec un hazard ratio (HR) de 0.77 (95% CI: 0.58鈥�1.00; p=0.056) et une m茅diane de mPFS de 19.4 mois contre 11.0 mois. Le r茅sultat primaire n'atteint pas le seuil de significativit茅 pr茅d茅termin茅.
Les analyses de sous-groupes notables montrent un b茅n茅fice marqu茅 dans les tumeurs PD-L1 n茅gatives (HR 0.54; mPFS 16.6 vs 3.0 mois; p nominal=0.006) et chez les patients sans traitement ant茅rieur anti鈥揚D-1 (analyse post hoc HR 0.74; mPFS 24.8 vs 11.0 mois; p nominal=0.037). Les tendances en survie globale 茅taient favorables mais immatures (HR 0.79; 95% CI: 0.57鈥�1.10). L'association a 茅t茅 g茅n茅ralement bien tol茅r茅e; les r茅actions au site d'injection 茅taient les plus fr茅quentes (signal茅es chez 56% des patients du bras combinaison) et se sont r茅solues sous traitement. La soci茅t茅 pr茅voit des discussions r茅glementaires au sujet d'une 茅ventuelle BLA et pr茅sentera des donn茅es plus d茅taill茅es. Elle a indiqu茅 un solde de tr茅sorerie estim茅 d'environ $28.1 million plus une tranche de 鈧�12.5 million tir茅e dans le cadre d'un pr锚t 脿 terme, qui devrait financer les op茅rations jusqu'au premier trimestre 2026, sous r茅serve des proc茅dures de cl么ture finale.
IO Biotech ver枚ffentlichte Topline-Ergebnisse der Phase-3-Studie IOB-013, in der Cylembio plus Pembrolizumab versus Pembrolizumab allein als Erstlinienbehandlung bei nicht resektablem oder metastasiertem Melanom untersucht wurde. Die randomisierte Studie schloss 407 Patienten ein (203 Kombination, 204 Monotherapie). Der prim盲re Endpunkt, das progressionsfreie 脺berleben (PFS) bewertet durch ein verblindetes unabh盲ngiges Review nach RECIST v1.1, zeigte eine fr眉he und anhaltende Trennung mit einem Hazard Ratio (HR) von 0.77 (95% CI: 0.58鈥�1.00; p=0.056) und einer medianen PFS von 19.4 Monaten 驳别驳别苍眉产别谤 11.0 Monaten. Das prim盲re Ergebnis verfehlte die vorab festgelegte Signifikanzgrenze.
Bemerkenswerte Subgruppenbefunde umfassen einen ausgepr盲gten Nutzen bei PD-L1-negativen Tumoren (HR 0.54; mPFS 16.6 vs 3.0 Monate; nominal p=0.006) und bei Patienten ohne vorherige Anti鈥揚D-1-Therapie (post-hoc HR 0.74; mPFS 24.8 vs 11.0 Monate; nominal p=0.037). Die Gesamt眉berlebens-Trends waren vorteilhaft, aber noch nicht ausgereift (HR 0.79; 95% CI: 0.57鈥�1.10). Die Kombination war insgesamt gut vertr盲glich; Reaktionen an der Injektionsstelle waren am h盲ufigsten (bei 56% der Patienten in der Kombinationsgruppe berichtet) und klangen w盲hrend der Behandlung ab. Das Unternehmen plant beh枚rdliche Gespr盲che zu einer m枚glichen BLA und wird detailliertere Daten pr盲sentieren. Es gab einen gesch盲tzten Kassenbestand von ungef盲hr $28.1 million zuz眉glich einer unter einem Terminkredit abgerufenen Tranche von 鈧�12.5 million, die voraussichtlich die Gesch盲ftst盲tigkeit bis ins erste Quartal 2026 finanzieren wird, vorbehaltlich der endg眉ltigen Abschlussverfahren.
FAQ
What were the primary topline results from IO Biotech (IOBT) Phase 3 IOB-013 trial?
Did IOB-013 meet its primary endpoint?
Were any subgroups showing stronger benefit in the IOB-013 study?
What did the company report about overall survival (OS)?
What safety findings were reported for the combination treatment?
How long is IO Biotech's reported cash runway expected to last?
