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2025 ASCO Presentation: Innovent Biologics Announces Updated Data of IBI354 (Novel anti-HER2 ADC) From the Phase 1/2 Clinical Study in Advanced Ovarian Cancer, Breast Cancer and Other Solid Tumors

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Innovent Biologics presented updated Phase 1/2 clinical data for IBI354, their novel anti-HER2 ADC, at ASCO 2025. The study enrolled 368 patients with advanced solid tumors, including 178 breast cancer, 92 ovarian cancer, and other tumor types. In HER2-positive breast cancer (n=88), IBI354 showed a 59.1% ORR and 90.9% DCR, with 9mg/kg dose achieving 72.4% ORR. Median PFS was 14.1 months. In ovarian cancer (n=92), the treatment demonstrated 41.2% ORR and 82% DCR, with 12mg/kg dose reaching 55% ORR. The drug showed a favorable safety profile with only 1.9% incidence of ILD (all grade 1-2), and 27.4% of patients experiencing grade 3+ TRAEs. The Phase 3 study for platinum-resistant ovarian cancer has been initiated, marking a significant milestone in Innovent's IO+ADC oncology strategy.
Innovent Biologics ha presentato dati aggiornati di fase 1/2 per IBI354, il loro nuovo ADC anti-HER2, durante l'ASCO 2025. Lo studio ha arruolato 368 pazienti con tumori solidi avanzati, inclusi 178 con cancro al seno, 92 con cancro ovarico e altri tipi tumorali. Nel cancro al seno HER2-positivo (n=88), IBI354 ha mostrato un ORR del 59,1% e un DCR del 90,9%, con la dose di 9 mg/kg che ha raggiunto un ORR del 72,4%. La PFS mediana è stata di 14,1 mesi. Nel cancro ovarico (n=92), il trattamento ha evidenziato un ORR del 41,2% e un DCR dell'82%, con la dose di 12 mg/kg che ha raggiunto un ORR del 55%. Il farmaco ha mostrato un profilo di sicurezza favorevole, con solo l'1,9% di incidenza di ILD (tutti di grado 1-2) e il 27,4% dei pazienti che ha manifestato TRAE di grado 3 o superiore. È stato avviato uno studio di fase 3 per il cancro ovarico resistente al platino, segnando un importante traguardo nella strategia oncologica IO+ADC di Innovent.
Innovent Biologics presentó datos clínicos actualizados de fase 1/2 para IBI354, su nuevo ADC anti-HER2, en ASCO 2025. El estudio incluyó a 368 pacientes con tumores sólidos avanzados, incluyendo 178 con cáncer de mama, 92 con cáncer de ovario y otros tipos tumorales. En cáncer de mama HER2 positivo (n=88), IBI354 mostró una tasa de respuesta objetiva (ORR) del 59.1% y una tasa de control de la enfermedad (DCR) del 90.9%, con la dosis de 9 mg/kg alcanzando un ORR del 72.4%. La mediana de supervivencia libre de progresión (PFS) fue de 14.1 meses. En cáncer de ovario (n=92), el tratamiento demostró un ORR del 41.2% y un DCR del 82%, con la dosis de 12 mg/kg alcanzando un ORR del 55%. El fármaco mostró un perfil de seguridad favorable, con solo un 1.9% de incidencia de ILD (todos grados 1-2) y un 27.4% de pacientes con eventos adversos relacionados al tratamiento de grado 3 o superior. Se ha iniciado un estudio de fase 3 para cáncer de ovario resistente al platino, marcando un hito importante en la estrategia oncológica IO+ADC de Innovent.
Innovent Biologics는 ASCO 2025에서 IBI354라는 새로운 항-HER2 ADC의 1/2상 임상 업데이트 데이터를 발표했습니다. 이 연구에는 진행성 고형암 환자 368명이 등록되었으며, 그 중 유방암 178명, 난소암 92명 및 기타 종양 유형이 포함되었습니다. HER2 양성 유방암 환자(n=88)에서 IBI354는 59.1%의 객관적 반응률(ORR)과 90.9%의 질병 조절률(DCR)을 보였으며, 9mg/kg 용량에서는 72.4%의 ORR을 달성했습니다. 중앙 무진행 생존기간(PFS)은 14.1개월이었습니다. 난소암 환자(n=92)에서는 치료가 41.2%의 ORR과 82%의 DCR을 나타냈으며, 12mg/kg 용량에서는 55%의 ORR을 기록했습니다. 약물은 1.9%의 간질성 폐질환(ILD) 발생률(모두 1-2등급)과 27.4%의 3등급 이상 치료 관련 부작용(TRAE) 발생률로 우수한 안전성을 보였습니다. 백금 내성 난소암을 대상으로 한 3상 연구가 시작되어 Innovent의 IO+ADC 종양 치료 전략에서 중요한 이정표가 되었습니다.
Innovent Biologics a présenté des données cliniques mises à jour de phase 1/2 pour IBI354, leur nouvel ADC anti-HER2, lors de l'ASCO 2025. L'étude a inclus 368 patients atteints de tumeurs solides avancées, dont 178 cancers du sein, 92 cancers de l'ovaire et d'autres types tumoraux. Dans le cancer du sein HER2-positif (n=88), IBI354 a montré un taux de réponse objective (ORR) de 59,1 % et un taux de contrôle de la maladie (DCR) de 90,9 %, avec une dose de 9 mg/kg atteignant un ORR de 72,4 %. La survie sans progression médiane (PFS) était de 14,1 mois. Dans le cancer de l'ovaire (n=92), le traitement a démontré un ORR de 41,2 % et un DCR de 82 %, avec une dose de 12 mg/kg atteignant un ORR de 55 %. Le médicament a présenté un profil de sécurité favorable, avec seulement 1,9 % d'incidence de pneumopathie interstitielle diffuse (ILD) (tous grades 1-2) et 27,4 % des patients présentant des événements indésirables liés au traitement de grade 3 ou plus. L'étude de phase 3 pour le cancer de l'ovaire résistant au platine a été lancée, marquant une étape importante dans la stratégie oncologique IO+ADC d'Innovent.
Innovent Biologics präsentierte aktualisierte Phase-1/2-Klinikdaten für IBI354, ihren neuartigen anti-HER2-ADC, auf der ASCO 2025. Die Studie umfasste 368 Patienten mit fortgeschrittenen soliden Tumoren, darunter 178 Brustkrebspatienten, 92 Eierstockkrebspatienten und weitere Tumorarten. Bei HER2-positivem Brustkrebs (n=88) zeigte IBI354 eine objektive Ansprechrate (ORR) von 59,1 % und eine Krankheitskontrollrate (DCR) von 90,9 %, wobei die 9 mg/kg-Dosis eine ORR von 72,4 % erreichte. Die mediane progressionsfreie Überlebenszeit (PFS) betrug 14,1 Monate. Bei Eierstockkrebs (n=92) zeigte die Behandlung eine ORR von 41,2 % und eine DCR von 82 %, wobei die 12 mg/kg-Dosis eine ORR von 55 % erreichte. Das Medikament zeigte ein günstiges Sicherheitsprofil mit nur 1,9 % Auftreten von ILD (alle Grad 1-2) und 27,4 % der Patienten mit Grad 3 oder höher behandlungsbedingten Nebenwirkungen (TRAEs). Die Phase-3-Studie für platinresistenten Eierstockkrebs wurde eingeleitet, was einen bedeutenden Meilenstein in Innovents IO+ADC-Onkologiestrategie darstellt.
Positive
  • Strong efficacy in HER2-positive breast cancer with 72.4% ORR at 9mg/kg dose
  • Promising results in ovarian cancer with 55% ORR at 12mg/kg dose
  • Favorable safety profile with low incidence of serious adverse events
  • Advancement to Phase 3 trials for platinum-resistant ovarian cancer
  • Demonstrated efficacy in HER2 low-expression (IHC 1+) tumors
Negative
  • 27.4% of patients experienced grade 3 or higher treatment-related adverse events
  • 17.7% of patients required dose interruption due to adverse events
  • Overall survival data still immature for both breast and ovarian cancer cohorts

SAN FRANCISCO and SUZHOU, China, June 2, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, updated the clinical data of IBI354 (HER2 monoclonal antibody-camptothecin derivative conjugate) in advanced solid tumors at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

IBI354 has demonstrated promising anti-tumor efficacy and favorable safety profiles across multiple solid tumors. It not only holds potential to deliver a new generation of ADC therapies characterized by "high potency and low-toxicity" for tumor types such as ovarian cancer and breast cancer, but also validates the advantages of Innovent's ADC technology platform. The results of IBI354 lays the foundation for the subsequent development of Innovent's next-generation of bispecific ADCs and dual-payload ADCs, marking a milestone in Innovent's next-generation "IO+ADC" oncology development strategy.

The data presented is from a Phase 1/2 clinical study (NCT05636215) aimed at evaluating the safety, tolerability, and preliminary efficacy of IBI354 in participants with advanced solid tumors. As of March 24, 2025, a total of 368 participants with advanced solid tumors were enrolled and received different doses of IBI354 monotherapy, the median follow-up duration was 11.5 months (range: 0.7-19.6), the median treatment duration was 27.0 weeks (range: 3.1-81.3) and 74 (20.1%) pts were still on treatment. The tumor types including 178 with breast cancer, 92 with ovarian cancer, 38 with colorectal cancer, and 60 with other tumors.

IBI354 monotherapy demonstrated excellent safety profile

  • The dosage was escalated to 18mg/kg, with no DLT events observed.
  • The most common treatment-related adverse events (TRAEs) were anemia, nausea, and white blood cell count decreased. The incidence of interstitial lung disease (ILD) was only 1.9%, all were grade 1-2.
  • Overall, 27.4% of patients experienced TRAEs ≥ grade 3, 17.7% experienced TRAEs leading to dose interruption, 2.7% experienced TRAEs leading to dose reduction and 1.6% experienced TRAEs leading to discontinuation, with no TRAEs leading to death.

IBI354 monotherapy showed promising efficacy signals in multiple tumor types

  • In HER2-positive breast cancer cohort (n= 88, treated at 6~15mg/kg, the median prior treatment lines was 4), the confirmed objective response rate (ORR) and the disease control rate (DCR) were 59.1% and 90.9%, respectively. In 9 mg/kg Q3W subgroup (n=29), the ORR and the DCR were 72.4% and 89.7%, respectively. The median progression-free survival (PFS) was 14.1 months (95% CI: 8.3-not calculable [NC]) with events of 48.3%. The median overall survival (OS) was immature with events of 3.4%.
  • In ovarian cancer cohort (n=92, treated at 2~12mg/kg, the median prior treatment lines was 3), the cORR was 41.2% and the DCR was 82.0%. In the 12mg/kg Q3W subgroup (n=40), the cORR reached 55.0% and the DCR was 90.0%. In participants with HER2 1+ (n=27), the ORR reached 55.6% and the DCR was 88.9%. As of the data cutoff date, the median follow-up time was 11.9 months, and the median PFS was 7.1 months (95% CI: 5.2−10.8) in 12mg/kg Q3W dose group. The median OS was not mature with events in 14 (34.1%) pts and a 12-month OS rate of 63.9% (95% CI: 45.0−77.8).

Professor Qi Zhou, Chief Physician at the Gynecologic Oncology Center of Chongqing University Affiliated Cancer Hospital and the Principal Investigator of the gynecologic oncology cohort study, stated, "The treatment of platinum-resistant recurrent ovarian cancer is difficult and the prognosis is poor, threatening the life and health of women. Extending PFS and OS in platinum-resistant recurrent ovarian cancer patients remains a clinical challenge for gynecological oncologists. ADC drugs provide a new direction for overcoming resistance mechanisms by precisely delivering cytotoxic agents. HER2, as a validated solid tumor target, has made breakthroughs in breast and gastric cancer fields, while the novel ADC drug IBI354 shows broad-spectrum antitumor activity through unique design in HER2 low-expression (IHC 1+) platinum-resistant ovarian cancer. In the Phase 1 study with a dose of 12mg/kg Q3W, IBI354 demonstrated an ORR of 55.0% and DCR of 90.0%, with a median PFS reaching 7.1 months. The safety profile was very good without common severe interstitial lung disease or ocular toxicity seen in other ADCs. These results significantly outperform traditional chemotherapy regimens, suggesting its potential breakthrough efficacy in the platinum-resistant population. The Phase 3 study of IBI354 in platinum-resistant ovarian cancer (HeriCare-Ovarian01) has been initiated, and I am looking forward to the results, as well as the further validation of the long-term benefits for patients receiving IBI354."

Doctor Charlotte Rose Lemech from Scientia Clinical Research Ltd, Australia, stated: "Breast cancer is one of the most common malignant tumors among women globally and remains a leading cause of cancer-related deaths. The amplification or overexpression of HER2 (human epidermal growth factor receptor 2) is recognized as a key driver in the development, progression, and metastasis of breast cancer, with approximately 15%-20% of breast cancer patients exhibiting HER2 overexpression. ADCs have become the new standard treatment for later line HER2 positive breast cancer. In this Phase 1 study, IBI354 has demonstrated encouraging efficacy and safety data, achieving high ORR and DCR especially in 9 mg/kg Q3W subgroup. Long term survival was also achieved with the median PFS of 14.1 months. IBI354 also differentiates itself from other HER2 targeted therapies with its safety profile. The incidence of interstitial lung disease was extremely low and most of the hematological toxicity and gastrointestinal adverse events were mild to moderate and can be effectively managed with standard supportive care. This favorable safety profile enhances the clinical application potential of IBI354 and we look forward to IBI354 achieving more breakthroughs in the field of breast cancer treatment."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "With the rapid development of ADC drugs in the field of tumor treatment, Innovent is steadily advancing its strategic layout in the ADC field. At this year's ASCO conference, we update the safety and efficacy data of IBI354 across various advanced solid tumors. These clinical results not only confirm the potential therapeutic value of IBI354 but also demonstrating Innovent's innovative strength and technological advantages in ADC drug development. The phase 3 study of IBI354 in platinum-resistant ovarian cancer has been initiated, and more clinical studies are also planned. We will continue to invest in next-generation ADC molecules, aiming to address unmet clinical needs and bring patients with more effective and safer treatment options."

About IBI354 (Anti-HER2 Antibody-Camptothecin Derivative Conjugate)

IBI354 is an innovative HER2-targeted antibody–camptocinin derivative conjugate developed by Innovent's proprietary SoloTx ADC platform. With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors. Innovent Biologics is conducting clinical studies to assess the efficacy and safety of IBI354 for multiple advanced solid tumors.

About Innovent

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 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 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.

Statement:

（1）Innovent does not recommend the use of any unapproved drug (s)/indication (s).

（2）Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

Cision View original content:https://www.prnewswire.com/news-releases/2025-asco-presentation-innovent-biologics-announces-updated-data-of-ibi354-novel-anti-her2-adc-from-the-phase-12-clinical-study-in-advanced-ovarian-cancer-breast-cancer-and-other-solid-tumors-302470509.html

SOURCE Innovent Biologics

FAQ

What are the key efficacy results of IBI354 in HER2-positive breast cancer?

In HER2-positive breast cancer, IBI354 showed 59.1% ORR and 90.9% DCR overall, with the 9mg/kg dose achieving 72.4% ORR and 14.1 months median PFS

How effective is IBI354 in treating ovarian cancer?

In ovarian cancer, IBI354 demonstrated 41.2% ORR and 82% DCR overall, with the 12mg/kg dose achieving 55% ORR and 90% DCR

What are the main side effects of IBI354 reported in the clinical trial?

The most common side effects were anemia, nausea, and decreased white blood cell count, with 27.4% experiencing grade 3+ adverse events and only 1.9% showing low-grade ILD

How many patients were enrolled in the IBI354 Phase 1/2 clinical trial?

The trial enrolled 368 patients with advanced solid tumors, including 178 breast cancer, 92 ovarian cancer, 38 colorectal cancer, and 60 other tumor patients

What is the current development stage of IBI354 for ovarian cancer?

IBI354 has advanced to Phase 3 clinical trials (HeriCare-Ovarian01) for platinum-resistant ovarian cancer following promising Phase 1/2 results
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