IDEAYA Biosciences and Hengrui Pharma Present Positive Phase 1 Data for IDE849 (SHR-4849), a Potential First-in-Class DLL3 TOP1 ADC, in Small Cell Lung Cancer at the IASLC 2025 World Conference on Lung Cancer
IDEAYA Biosciences (NASDAQ:IDYA) and Hengrui Pharma presented positive Phase 1 data for IDE849, a potential first-in-class DLL3 TOP1 ADC for Small Cell Lung Cancer (SCLC) at WCLC 2025. The study showed impressive efficacy with a 77.1% overall response rate (ORR) in second-line SCLC patients and 73.2% ORR across all treatment lines at expansion doses.
Key highlights include a 6.7-month median progression-free survival across all lines, with median PFS not yet reached in second-line patients. The drug demonstrated particular efficacy in patients with brain metastases, achieving an 83.3% confirmed ORR at the 2.4 mg/kg dose. The safety profile was manageable, with a low 2% treatment-related discontinuation rate.
IDEAYA Biosciences (NASDAQ:IDYA) e Hengrui Pharma hanno presentato dati positivi di Fase 1 per IDE849, un potenziale ADC di prima classe che mira a DLL3 e TOP1 per il carcinoma polmonare a piccole cellule (SCLC) al WCLC 2025. Lo studio ha mostrato un'efficacia notevole, con un tasso di risposta complessiva (ORR) del 77,1% nei pazienti SCLC in seconda linea e un 73,2% di ORR su tutte le linee di trattamento alle dosi di espansione.
I punti chiave includono una median PFS (sopravvivenza libera da progressione) di 6,7 mesi considerando tutte le linee, mentre la mediana di PFS non è ancora stata raggiunta nei pazienti in seconda linea. Il farmaco ha mostrato particolare efficacia nei pazienti con metastasi cerebrali, raggiungendo un 83,3% di ORR confermato alla dose di 2,4 mg/kg. Il profilo di sicurezza è risultato gestibile, con un basso tasso di interruzione del trattamento correlata al farmaco pari al 2%.
IDEAYA Biosciences (NASDAQ:IDYA) y Hengrui Pharma presentaron datos positivos de fase 1 sobre IDE849, un posible ADC de primera clase dirigido a DLL3 y TOP1 para el cáncer de pulmón de células pequeñas (SCLC) en el WCLC 2025. El estudio mostró una eficacia notable, con una tasa de respuesta global (ORR) del 77,1% en pacientes con SCLC en segunda línea y un 73,2% de ORR en todas las líneas de tratamiento a las dosis de expansión.
Entre los puntos destacados figura una supervivencia libre de progresión mediana (PFS) de 6,7 meses en todas las líneas, mientras que la mediana de PFS aún no se ha alcanzado en los pacientes de segunda línea. El fármaco demostró especial actividad en pacientes con metástasis cerebrales, logrando un 83,3% de ORR confirmada a la dosis de 2,4 mg/kg. El perfil de seguridad fue manejable, con una baja tasa de interrupción del tratamiento relacionada con el fármaco del 2%.
IDEAYA Biosciences (NASDAQ:IDYA)와 Hengrui Pharma는 WCLC 2025에서 IDE849의 긍정적인 1상 결과를 발표했습니다. IDE849는 DLL3와 TOP1을 표적으로 하는 잠재적 퍼스트인클래스 ADC로 소세포폐암(SCLC) 치료를 목표로 합니다. 연구에서는 2차 치료 환자에서 전체 반응률(ORR) 77.1%을 보였고, 확장 용량에서는 모든 치료 라인에서 ORR 73.2%를 기록해 인상적인 효능을 나타냈습니다.
주요 내용으로는 모든 라인을 통틀어 무진행 생존(median PFS) 중앙값 6.7개월이 보고되었고, 2차 치료군에서는 아직 중앙값에 도달하지 않았습니다. 뇌 전이가 있는 환자에서 특히 효과적이었으며, 2.4 mg/kg 용량에서 확인된 ORR 83.3%를 달성했습니다. 안전성 프로필은 관리 가능한 수준이었고, 약물 관련 치료 중단률은 낮은 2%였습니다.
IDEAYA Biosciences (NASDAQ:IDYA) et Hengrui Pharma ont présenté des données de phase 1 positives pour IDE849, un ADC potentiellement de première classe ciblant DLL3 et TOP1 pour le cancer du poumon à petites cellules (SCLC), lors du WCLC 2025. L'étude a montré une efficacité remarquable, avec un taux de réponse globale (ORR) de 77,1% chez les patients SCLC en deuxième ligne et un ORR de 73,2% toutes lignes confondues aux doses d'expansion.
Les points clés incluent une survie sans progression médiane (PFS) de 6,7 mois toutes lignes confondues, la médiane de PFS n'ayant pas encore été atteinte chez les patients en deuxième ligne. Le médicament a montré une efficacité particulière chez les patients présentant des métastases cérébrales, atteignant un ORR confirmé de 83,3% à la dose de 2,4 mg/kg. Le profil d'innocuité était gérable, avec un faible taux d'arrêt du traitement imputable au médicament de 2%.
IDEAYA Biosciences (NASDAQ:IDYA) und Hengrui Pharma stellten beim WCLC 2025 positive Phase‑1‑Daten zu IDE849 vor, einem potenziellen First‑in‑Class DLL3/TOP1‑gerichteten ADC für kleinzelliges Lungenkarzinom (SCLC). Die Studie zeigte eine beeindruckende Wirksamkeit mit einer Gesamtansprechrate (ORR) von 77,1% bei Patienten in der zweiten Therapielinie und 73,2% ORR über alle Therapielinien bei den Expansionsdosen.
Zu den wichtigsten Ergebnissen gehört eine medianes progressionsfreies Überleben (PFS) von 6,7 Monaten über alle Linien hinweg, während das mediane PFS bei Patienten in der zweiten Linie noch nicht erreicht wurde. Der Wirkstoff war besonders bei Patienten mit Hirnmetastasen wirksam und erzielte bei der Dosis von 2,4 mg/kg eine bestätigte ORR von 83,3%. Das Sicherheitsprofil war beherrschbar, mit einer geringen behandlungsbedingten Abbruchrate von 2%.
- Strong efficacy with 77.1% ORR in second-line SCLC patients
- Impressive 83.3% confirmed ORR in patients with brain metastases at 2.4 mg/kg dose
- Favorable safety profile with only 2% treatment-related discontinuation rate
- High disease control rate of 93-100% across different patient groups
- Potential first-in-class and best-in-class status in DLL3 TOP1 ADC space
- 48% of patients experienced Grade 3 or higher treatment-related adverse events
- 15% of patients required dose reduction due to adverse events
- Study data not yet fully mature with 14.1% of responses pending confirmation
Insights
IDEAYA's IDE849 shows exceptional 70-77% response rates in small cell lung cancer with manageable safety - potentially best-in-class DLL3-targeting ADC.
The Phase 1 data for IDE849 (SHR-4849) presented at WCLC 2025 demonstrates remarkably strong efficacy in small cell lung cancer (SCLC), a notoriously aggressive malignancy with limited treatment options. The
These response rates substantially exceed historical benchmarks for second-line SCLC treatments, which typically show response rates of
The median progression-free survival (PFS) of 6.7 months across all lines is clinically meaningful, with second-line patients not yet reaching median PFS at data cutoff. The relatively short median follow-up of 3.5 months suggests response durability data will mature with longer follow-up, potentially strengthening the already impressive efficacy profile.
The safety profile appears manageable, with predominantly hematologic adverse events typical of topoisomerase inhibitor-based ADCs. The treatment-related discontinuation rate of just
The DLL3-targeting approach is scientifically sound, as DLL3 is expressed in
80.0% (8/10) ORR and70.0% (7/10) confirmed ORR in 2L SCLC; a73.7% (14/19) ORR and57.9% (11/19) confirmed ORR (1 pending confirmation) were observed across all lines of SCLC at the 2.4 mg/kg expansion dose of IDE84977.1% (27/35) ORR and60.0% (21/35) confirmed ORR (4 pending confirmation) in 2L SCLC; a73.2% (52/71) ORR and47.9% (34/71) confirmed ORR (10 pending confirmation) were observed across all lines of SCLC at all expansion doses of IDE849- In patients with baseline brain metastases, a
83.3% (5/6) confirmed ORR at the 2.4 mg/kg dose was observed; across all doses ≥2.4 mg/kg (n=18), a66.7% (12/18) confirmed ORR (1 pending confirmation) was observed 14.1% (10/71) of patients across all doses >2.4 mg/kg are still pending confirmation, as well as multiple patients that have had limited follow-up (e.g. one post-baseline scan) highlighting the study has not yet achieved a fully mature confirmed ORR%- 6.7 month median progression free survival (PFS) across all lines of SCLC across all dose levels (≥2.4 mg/kg); mPFS not reached in 2L SCLC patients
- Manageable safety profile observed across multiple expansion cohorts, including the 2.4 mg/kg, 3.0 mg/kg, and 3.5 mg/kg dose levels with a once every 3-week dosing interval
"We believe the ORR, median PFS, and overall safety data presented at WCLC 2025 in over 70 efficacy evaluable SCLC patients provides a potential best-in-class DLL3 TOP1 ADC profile," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. "We look forward to advancing the global clinical development of IDE849 in SCLC, NETs, and additional DLL3 upregulated solid tumors, as both a potential first-in-class and best-in-class DLL3 TOP1 ADC to address areas of high unmet medical need in cancer."
Data in the presentation were as of a cut-off date of June 20, 2025, and included 87 patients with small-cell lung cancer (SCLC) and 13 patients with other neuroendocrine carcinomas (NEC). All patients had progressed after front-line therapy, with
Key data highlights from the presentation
Efficacy (n=71 evaluable SCLC patients treated with IDE849)
IDE849 Dose Level | ||||
2.4 mg/kg | Total (≥2.4 mg/kg) | |||
Treatment setting | 2L | All-lines | 2L | All-lines |
ORR (%, n) | ||||
Confirmed ORR (%, n) | ||||
Pending confirmation | -- | |||
DCR | ||||
- Robust overall response rate (ORR) and disease control rate (DCR) were consistently observed across all expansion doses evaluated and in patients across all lines of therapy, with a modest reduction in ORR/DCR observed in later-line patients, consistent with their more advanced stage of disease.
14.1% (10/71) of patients across all doses >2.4 mg/kg are still pending confirmation, as well as multiple patients who have had limited follow-up (e.g. one post-baseline scan) highlighting the study has not yet achieved a fully mature confirmed ORR%.- In patients with baseline brain metastasis, a confirmed ORR of
83.3% (5/6) and a DCR of100% (6/6) was observed at the 2.4 mg/kg dose. Across all doses ≥2.4 mg/kg (n=18) with baseline brain metastasis, the confirmed ORR was66.7% (12/18) with a DCR of100% (18/18). A confirmation scan for one unconfirmed partial response is pending, which if confirmed, would increase the confirmed ORR to72.2% (13/18). - Median PFS was 6.7 months across all lines of treatment at doses of IDE849 ≥2.4 mg/kg (n=86); median PFS was not yet reached (NR) in 2L patients (n=42).
- As of the cut-off date of June 20, 2025 the median length of follow-up was 3.5 months.
Safety (n=100 SCLC and NEC patients treated with IDE849)
- Across all patients and all dose levels (n=100), Grade 3 or higher (Gr>3) treatment-related adverse events (TRAEs) occurred in
48% (48/100) and serious TRAEs in16% (16/100) of patients. The most common TRAEs were white blood cell reduction (27% Gr>3), neutropenia (33% Gr>3), anemia (6% Gr>3) and nausea (0% Gr>3). - TRAEs leading to dose reduction in
15% (15/100) of patients; treatment-related discontinuation rate of2% (2/100) with no treatment-related deaths reported.
IDEAYA will review the data that was presented by Hengrui at their 10-Year Anniversary R&D Day on September 8th in
In December 2024, Hengrui Pharma granted IDEAYA an exclusive worldwide license to develop and commercialize SHR-4849 (IDE849) outside of
About IDEAYA Biosciences
IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) the potential therapeutic benefits of IDE849, including combination therapies; and (ii) the timing of and potential of clinical trials to evaluate TOP1-payload based ADCs in SCLC, NETs, and other DLL3-upregulated solid tumors. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 18, 2025 and any current and periodic reports filed with the
Investor and Media Contact
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