Innovent Presents Updated Data From Innovative Anti-CLDN18.2 ADC (IBI343) Phase 1 Study in Patients with Advanced Pancreatic Cancer at the ESMO Asia Congress 2024
Innovent Biologics presented updated Phase 1 study results for IBI343, an anti-CLDN18.2 ADC, in treating advanced pancreatic cancer at ESMO Asia Congress 2024. The study involved 43 CLDN18.2-positive patients who received IBI343 6 mg/kg Q3W monotherapy, all with at least one prior therapy line.
Key results showed an overall objective response rate of 32.6%, confirmed objective response rate of 23.3%, and confirmed disease control rate of 81.4%. The median duration of response was 7.0 months, with median progression-free survival of 5.3 months. Safety profile was favorable with 97.7% experiencing treatment-emergent adverse events, mainly including anemia and decreased neutrophil count.
The FDA has granted Fast Track designation for IBI343, and patient enrollment for Phase 1 trials in the United States will begin soon.
Innovent Biologics ha presentato i risultati aggiornati dello studio di Fase 1 per IBI343, un ADC anti-CLDN18.2, nella cura del cancro pancreatico avanzato al Congresso ESMO Asia 2024. Lo studio ha coinvolto 43 pazienti positivi per CLDN18.2 che hanno ricevuto IBI343 6 mg/kg ogni 3 settimane in monoterapia, tutti con almeno una linea di terapia precedente.
I risultati chiave hanno mostrato un tasso di risposta obiettiva complessivo del 32,6%, un tasso di risposta obiettiva confermata del 23,3% e un tasso di controllo della malattia confermato dell'81,4%. La durata mediana della risposta 猫 stata di 7,0 mesi, con una sopravvivenza libera da progressione mediana di 5,3 mesi. Il profilo di sicurezza 猫 stato favorevole, con il 97,7% dei pazienti che ha sperimentato eventi avversi emergenti dal trattamento, principalmente anemia e riduzione del conteggio dei neutrofili.
La FDA ha concesso la designazione Fast Track per IBI343, e l'arruolamento dei pazienti per le prove di Fase 1 negli Stati Uniti avverr脿 a breve.
Innovent Biologics present贸 los resultados actualizados del estudio de Fase 1 para IBI343, un ADC anti-CLDN18.2, en el tratamiento del c谩ncer de p谩ncreas avanzado en el Congreso ESMO Asia 2024. El estudio incluy贸 a 43 pacientes positivos para CLDN18.2 que recibieron IBI343 6 mg/kg cada 3 semanas en monoterapia, todos con al menos una l铆nea de terapia previa.
Los resultados clave mostraron una tasa de respuesta objetiva general del 32,6%, una tasa de respuesta objetiva confirmada del 23,3% y una tasa de control de la enfermedad confirmada del 81,4%. La duraci贸n mediana de la respuesta fue de 7,0 meses, con una supervivencia libre de progresi贸n mediana de 5,3 meses. El perfil de seguridad fue favorable, con el 97,7% experimentando efectos adversos emergentes del tratamiento, principalmente anemia y disminuci贸n del conteo de neutr贸filos.
La FDA ha concedido la designaci贸n de V铆a R谩pida para IBI343, y la inscripci贸n de pacientes para los ensayos de Fase 1 en los Estados Unidos comenzar谩 pronto.
Innovent Biologics電� ESMO 鞎勳嫓鞎� 旎犯霠堨姢 2024鞐愳劀 歆勴枆靹� 旆岇灔鞎� 旃橂毳� 鞙勴暅 IBI343鞚� 鞐呺嵃鞚错姼霅� 1靸� 鞐瓣惮 瓴瓣臣毳� 氚滍憸頄堨姷雼堧嫟. 鞚� 鞐瓣惮電� IBI343 6 mg/kg鞚� 3欤茧雼� 雼弲 韴棳氚涭潃 CLDN18.2 鞏戩劚 頇橃瀽 43氇呾澊 韽暔霅橃棃鞙茧┌, 氇憪 斓滌唽 1臧滌潣 鞚挫爠 旃橂毳� 氚涭潃 瓴巾棙鞚� 鞛堨棃鞀惦媹雼�.
欤检殧 瓴瓣臣電� 鞝勳泊 臧濌磤鞝� 氚橃潙毳犾澊 32.6%, 頇曥澑霅� 臧濌磤鞝� 氚橃潙毳犾澊 23.3%, 頇曥澑霅� 歆堧硲 臁办爤毳犾澊 81.4%鞓�鞚岇潉 氤挫棳欤检棃鞀惦媹雼�. 氚橃潙鞚� 欷戧皠 歆�靻� 旮瓣皠鞚� 7.0臧滌洈鞚挫棃鞙茧┌, 欷戧皠 氍挫頄� 靸濎〈 旮瓣皠鞚� 5.3臧滌洈鞚挫棃鞀惦媹雼�. 鞎堨爠靹� 頂勲頃勳潃 旮嶌爼鞝侅澊鞐堨溂氅�, 97.7%臧� 旃橂鞐愳劀 氚滌儩頃� 鞚挫儊 氚橃潙鞚� 瓴巾棙頃橃榾瓿�, 欤茧 牍堩槇瓿� 順胳甑� 靾� 臧愳唽臧� 韽暔霅橃棃鞀惦媹雼�.
FDA電� IBI343鞐� 雽�頃� 鞁犾啀 鞁偓 歆�鞝曥潉 攵�鞐晿鞓�鞙茧┌, 氙戈淡鞐愳劀鞚� 1靸� 鞁滍棙 頇橃瀽 霌彪鞚� 瓿� 鞁滌瀾霅� 鞓堨爼鞛呺媹雼�.
Innovent Biologics a pr茅sent茅 les r茅sultats actualis茅s de l'茅tude de Phase 1 pour IBI343, un ADC anti-CLDN18.2, dans le traitement du cancer du pancr茅as avanc茅 au Congr猫s ESMO Asia 2024. L'茅tude a impliqu茅 43 patients positifs pour CLDN18.2 qui ont re莽u IBI343 脿 6 mg/kg toutes les 3 semaines en monoth茅rapie, tous ayant re莽u au moins une ligne de traitement pr茅alable.
Les r茅sultats cl茅s ont montr茅 un taux de r茅ponse objective global de 32,6 %, un taux de r茅ponse objective confirm茅e de 23,3 % et un taux de contr么le de la maladie confirm茅 de 81,4 %. La dur茅e m茅diane de la r茅ponse 茅tait de 7,0 mois, avec une survie sans progression m茅diane de 5,3 mois. Le profil de s茅curit茅 茅tait favorable, avec 97,7 % des patients ayant 茅prouv茅 des effets ind茅sirables survenant pendant le traitement, principalement de l'an茅mie et une diminution du nombre de neutrophiles.
La FDA a accord茅 le statut Fast Track 脿 IBI343, et l'inscription des patients pour les essais de Phase 1 aux 脡tats-Unis commencera bient么t.
Innovent Biologics hat aktualisierte Ergebnisse der Phase-1-Studie f眉r IBI343, einen anti-CLDN18.2 ADC, zur Behandlung von fortgeschrittenem Bauchspeicheldr眉senkrebs beim ESMO Asia Kongress 2024 pr盲sentiert. In der Studie wurden 43 CLDN18.2-positive Patienten untersucht, die IBI343 in einer Dosis von 6 mg/kg alle 3 Wochen als Monotherapie erhielten, wobei alle Patienten mindestens eine vorherige Therapie erhalten hatten.
Die wichtigsten Ergebnisse zeigten eine allgemeine objektive Ansprechrate von 32,6%, eine best盲tigte objektive Ansprechrate von 23,3% und eine best盲tigte Krankheitskontrollrate von 81,4%. Die mediane Ansprechdauer betrug 7,0 Monate, w盲hrend die mediane progressionsfreie 脺berlebenszeit 5,3 Monate betrug. Das Sicherheitsprofil war g眉nstig, wobei 97,7% der Patienten behandlungsbedingte Nebenwirkungen erlebten, haupts盲chlich An盲mie und eine verringerte Neutrophilenzahl.
Die FDA hat f眉r IBI343 die Fast Track-Bezeichnung erteilt, und die Patientenanmeldung f眉r Phase-1-Studien in den Vereinigten Staaten wird bald beginnen.
- Overall objective response rate of 32.6% in advanced pancreatic cancer patients
- High disease control rate of 81.4%
- Median progression-free survival of 5.3 months
- FDA granted Fast Track designation
- Favorable safety profile with manageable adverse events
- 4 out of 10 confirmed response patients had disease progression
- 51.2% of participants experienced grade 3 or higher adverse events
Pancreatic cancer is one of the most aggressive malignancies worldwide. Most patients are diagnosed in the middle and late stages and often develop resistance to standard chemotherapy, resulting in a 5-year survival rate of less than
This Phase 1/1b study is a multi-regional, dose escalation and expansion clinical trial (NCT05458219). Preliminary data were presented 听and the updated results from the study's dose-expansion cohort were presented at the 2024 ESMO Asia Congress as follows:
- As of September 6, 2024, a total of 43 patients with CLDN18.2-positive (鈮�
60% tumor cells with membranous staining intensity 鈮�1+ by IHC) advanced PDAC received IBI343 6 mg/kg Q3W monotherapy. All participants had previously received at least 1 line of prior therapy, and60.5% had received 2 or more lines of anticancer treatment. - 43 patients were efficacy evaluable with overall objective response rate (ORR) of
32.6% ,听confirmed objective response rate听(cORR) of23.3% , and confirmed disease control rate (cDCR) of81.4% . - As the data cutoff date, 4 out of 10听cORR patients had progressed, the median duration of response (mDoR) was 7.0 (4.0-NC) months, and the 6-month DoR rate was
63% . 26 patients occurred PFS events, with a median progression-free survival (mPFS) of 5.3 (4.1-7.4) months, and OS data is not yet mature. - The updated safety results demonstrated the favorable safety profile of IBI343 with a consistently low rate of gastrointestinal toxicity and no new safety signals.
97.7% of the participants experienced treatment-emergent adverse events (TEAEs), with the most common TEAEs being anemia, neutrophil count decreased, decreased appetite, nausea, and white blood cell count decreased.51.2% of the participants experienced 鈮� grade 3 TEAEs, and no 鈮� grade 3 nausea and vomiting occurred. No TEAE led to death.
Professor Xianjun Yu from Fudan University Cancer Hospital, said, "Pancreatic cancer is one of the most malignant tumors of the digestive tract. Most patients are already in the advanced stage when diagnosed, and the 5-year survival rate is only about
Dr. Hui Zhou, Senior Vice President of Innovent, said,听"We are pleased to share the updated clinical data for IBI343. With the unique Fc-silent antibody design, stable linker and potent TOPO1i payload, IBI343 is the first ADC candidate globally to demonstrate encouraging efficacy and a favorable safety profile in the treatment of advanced pancreatic cancer. IBI343 offers a new direction and renewed hope for pancreatic cancer treatment. It is worth mentioning that, the FDA has approved IBI343's IND application for this indication and granted Fast Track designation, and we will initiate patient enrollment for IBI343's Phase 1 trial in
About IBI343锛�Anti-CLDN18.2 ADC锛�
IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the CLDN18.2-expressing tumor cells, the CLDN18.2 dependent ADC internalization will occur and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in "bystander killing effect".
As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric and pancreatic cancer.
In May 2024,听China's National Medical Products Administration (NMPA) granted breakthrough therapy designation (BTD) to IBI343 for use as a single agent in patients with CLDN18.2鈥損ositive gastric or gastroesophageal junction (GEJ) adenocarcinoma who experienced disease progression following two prior lines of systemic treatment. The Phase 3 trial (NCT06238843) of IBI343 for this indication is ongoing.
In June 2024, IBI343 received Fast Track Designation by the
About Innovent Biologics
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow听Innovent on Facebook and LinkedIn.
厂迟补迟别尘别苍迟:听 |
(1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). |
(2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) were developed by Eli Lilly and Company. |
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References
1 Siegel RL, Miller KD, Fuchs HE, et al. Cancer statistics, 2022. CA Cancer J Clin. 2022;72:7-33. doi: 10.3322/caac.21708.
2 Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263.
3 Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin, 2011, 61(2): 69-90.
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