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 è stata di 7,0 mesi, con una sopravvivenza libera da progressione mediana di 5,3 mesi. Il profilo di sicurezza è 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 avverrà a breve.
Innovent Biologics presentó los resultados actualizados del estudio de Fase 1 para IBI343, un ADC anti-CLDN18.2, en el tratamiento del cáncer de páncreas avanzado en el Congreso ESMO Asia 2024. El estudio incluyó a 43 pacientes positivos para CLDN18.2 que recibieron IBI343 6 mg/kg cada 3 semanas en monoterapia, todos con al menos una línea 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 duración mediana de la respuesta fue de 7,0 meses, con una supervivencia libre de progresión mediana de 5,3 meses. El perfil de seguridad fue favorable, con el 97,7% experimentando efectos adversos emergentes del tratamiento, principalmente anemia y disminución del conteo de neutrófilos.
La FDA ha concedido la designación de Vía Rápida para IBI343, y la inscripción de pacientes para los ensayos de Fase 1 en los Estados Unidos comenzará pronto.
Innovent Biologics는 ESMO 아시아 컨그레스 2024에서 진행성 췌장암 치료를 위한 IBI343의 업데이트된 1상 연구 결과를 발표했습니다. 이 연구는 IBI343 6 mg/kg을 3주마다 단독 투여받은 CLDN18.2 양성 환자 43명이 포함되었으며, 모두 최소 1개의 이전 치료를 받은 경험이 있었습니다.
주요 결과는 전체 객관적 반응률이 32.6%, 확인된 객관적 반응률이 23.3%, 확인된 질병 조절률이 81.4%였음을 보여주었습니다. 반응의 중간 지속 기간은 7.0개월이었으며, 중간 무진행 생존 기간은 5.3개월이었습니다. 안전성 프로필은 긍정적이었으며, 97.7%가 치료에서 발생한 이상 반응을 경험하였고, 주로 빈혈과 호중구 수 감소가 포함되었습니다.
FDA는 IBI343에 대해 신속 심사 지정을 부여하였으며, 미국에서의 1상 시험 환자 등록이 곧 시작될 예정입니다.
Innovent Biologics a présenté les résultats actualisés de l'étude de Phase 1 pour IBI343, un ADC anti-CLDN18.2, dans le traitement du cancer du pancréas avancé au Congrès ESMO Asia 2024. L'étude a impliqué 43 patients positifs pour CLDN18.2 qui ont reçu IBI343 à 6 mg/kg toutes les 3 semaines en monothérapie, tous ayant reçu au moins une ligne de traitement préalable.
Les résultats clés ont montré un taux de réponse objective global de 32,6 %, un taux de réponse objective confirmée de 23,3 % et un taux de contrôle de la maladie confirmé de 81,4 %. La durée médiane de la réponse était de 7,0 mois, avec une survie sans progression médiane de 5,3 mois. Le profil de sécurité était favorable, avec 97,7 % des patients ayant éprouvé des effets indésirables survenant pendant le traitement, principalement de l'anémie et une diminution du nombre de neutrophiles.
La FDA a accordé le statut Fast Track à IBI343, et l'inscription des patients pour les essais de Phase 1 aux États-Unis commencera bientôt.
Innovent Biologics hat aktualisierte Ergebnisse der Phase-1-Studie für IBI343, einen anti-CLDN18.2 ADC, zur Behandlung von fortgeschrittenem Bauchspeicheldrüsenkrebs beim ESMO Asia Kongress 2024 präsentiert. 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 bestätigte objektive Ansprechrate von 23,3% und eine bestätigte Krankheitskontrollrate von 81,4%. Die mediane Ansprechdauer betrug 7,0 Monate, während die mediane progressionsfreie Überlebenszeit 5,3 Monate betrug. Das Sicherheitsprofil war günstig, wobei 97,7% der Patienten behandlungsbedingte Nebenwirkungen erlebten, hauptsächlich Anämie und eine verringerte Neutrophilenzahl.
Die FDA hat für IBI343 die Fast Track-Bezeichnung erteilt, und die Patientenanmeldung für 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 at 2024 ASCO 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 (≥
60% tumor cells with membranous staining intensity ≥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% , confirmed objective response rate (cORR) of23.3% , and confirmed disease control rate (cDCR) of81.4% . - As the data cutoff date, 4 out of 10 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 ≥ grade 3 TEAEs, and no ≥ 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, "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（Anti-CLDN18.2 ADC）
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, 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–positive 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 www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
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(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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