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Incyte (INCY) announced promising early clinical data for INCB123667, a highly selective CDK2 inhibitor, in patients with advanced solid tumors. The trial results, presented at ESMO 2024 and during Incyte’s investor event, show potential for treating cancers with increased Cyclin E1 activity. Key findings include:
– In platinum-resistant ovarian cancer patients (n=37), a 24.3% overall response rate was observed across three dose levels.
– The highest response rate of 31.3% was found in the 50mg BID cohort.
– A disease control rate of 75.7% was achieved in ovarian cancer patients.
– INCB123667 demonstrated a manageable safety profile with common adverse events including thrombocytopenia, anemia, and neutropenia.
Incyte plans to initiate a pivotal study in ovarian cancer in 2025 and explore combination treatments.
Incyte (INCY) ha annunciato dati clinici precoci promettenti per INCB123667, un inibitore altamente selettivo della CDK2, in pazienti con tumori solidi avanzati. I risultati dello studio, presentati all’ESMO 2024 e durante l’evento per investitori di Incyte, mostrano un potenziale nel trattamento dei tumori con attività aumentata di Cyclin E1. I principali risultati includono:
– Nei pazienti con carcinoma ovarico resistente al platino (n=37), è stata osservata una percentuale di risposta globale del 24,3% su tre livelli di dose.
– La percentuale di risposta più alta di 31,3% è stata trovata nel gruppo da 50 mg BID.
– È stata raggiunta una percentuale di controllo della malattia del 75,7% nei pazienti con carcinoma ovarico.
– INCB123667 ha dimostrato un profilo di sicurezza gestibile con eventi avversi comuni, tra cui trombocitopenia, anemia e neutropenia.
Incyte prevede di avviare uno studio fondamentale sul carcinoma ovarico nel 2025 ed esplorare trattamenti combinati.
Incyte (INCY) anunció datos clínicos tempranos prometedores para INCB123667, un inhibidor altamente selectivo de CDK2, en pacientes con tumores sólidos avanzados. Los resultados del ensayo, presentados en ESMO 2024 y durante el evento para inversores de Incyte, muestran el potencial para tratar cánceres con actividad aumentada de Cyclin E1. Hallazgos clave incluyen:
– En pacientes con cáncer de ovario resistente al platino (n=37), se observó una tasa de respuesta global del 24,3% en tres niveles de dosis.
– La tasa de respuesta más alta de 31,3% se encontró en el grupo de 50 mg BID.
– Se logró una tasa de control de enfermedad del 75,7% en pacientes con cáncer de ovario.
– INCB123667 demostró un perfil de seguridad manejable con eventos adversos comunes, incluidos trombocitopenia, anemia y neutropenia.
Incyte planea iniciar un estudio pivotal en cáncer de ovario en 2025 y explorar tratamientos combinados.
Incyte (INCY)는 고도로 선택적인 CDK2 억제제인 INCB123667에 대한 유망한 초기 임상 데이터를 발표했습니다. 이 데이터는 고급 고형 종양 환자에서 수집되었으며, ESMO 2024와 Incyte의 투자자 행사에서 발표되었습니다. Cyclin E1 활성도가 증가된 암을 치료할 가능성을 보여줍니다. 주요 발견 사항은 다음과 같습니다:
– 백금 내성 난소암 환자(n=37)에서 24.3%의 전체 응답률이 세 가지 용량 수준에서 관찰되었습니다.
– 가장 높은 응답률인 31.3%는 50mg BID 군에서 나타났습니다.
– 난소암 환자에서 질병 조절률 75.7%을 달성했습니다.
– INCB123667는 혈소판감소증, 빈혈, 호중구감소증을 포함한 일반적인 부작용이 있는 관리 가능한 안전성 프로파일을 보여주었습니다.
Incyte는 2025년에 난소암에 대한 주요 연구를 시작할 계획이며, 병합 치료를 탐색할 것입니다.
Incyte (INCY) a annoncé des données cliniques précoces prometteuses pour INCB123667, un inhibiteur CDK2 hautement sélectif, chez des patients atteints de tumeurs solides avancées. Les résultats de l’essai, présentés à l’ESMO 2024 et lors de l’événement pour investisseurs d’Incyte, montrent un potentiel pour traiter des cancers avec une activité accrue de Cycline E1. Les principales conclusions comprennent :
– Chez les patients atteints de cancer de l’ovaire résistant au platine (n=37), un taux de réponse global de 24,3% a été observé à trois niveaux de dose.
– Le taux de réponse le plus élevé de 31,3% a été trouvé dans le groupe de 50 mg BID.
– Un taux de contrôle de la maladie de 75,7% a été atteint chez les patientes atteintes d’un cancer de l’ovaire.
– INCB123667 a montré un profil de sécurité gérable avec des événements indésirables courants, notamment une thrombocytopénie, une anémie et une neutropénie.
Incyte envisage de lancer une étude pivot en cancérologie ovarienne en 2025 et d’explorer les traitements combinés.
Incyte (INCY) hat vielversprechende frühe klinische Daten für INCB123667, einen hochselektiven CDK2-Inhibitor, bei Patienten mit fortgeschrittenen soliden Tumoren angekündigt. Die Studienergebnisse, die auf der ESMO 2024 und während der Investorenveranstaltung von Incyte vorgestellt wurden, zeigen Potenzial bei der Behandlung von Krebserkrankungen mit erhöhter Cyclin E1-Aktivität. Wichtige Ergebnisse umfassen:
– Bei Patienten mit platinresistentem Ovarialkarzinom (n=37) wurde eine gesamtansprechrate von 24,3% über drei Dosierungsstufen beobachtet.
– Die höchste Ansprechrate von 31,3% fand sich in der 50 mg BID-Gruppe.
– Eine Krankheitskontrollrate von 75,7% wurde bei Ovarialkarzinom-Patienten erreicht.
– INCB123667 zeigte ein handhabbares Sicherheitsprofil mit häufigen unerwünschten Ereignissen wie Thrombozytopenie, Anämie und Neutropenie.
Incyte plant, 2025 eine entscheidende Studie zu Ovarialkarzinom zu beginnen und Kombinationstherapien zu erkunden.
Positive
- 24.3% overall response rate in platinum-resistant ovarian cancer patients
- 31.3% response rate in the 50mg BID cohort for ovarian cancer
- 75.7% disease control rate achieved in ovarian cancer patients
- Manageable safety profile observed in the trial
- Plans for pivotal study in ovarian cancer in 2025
- Potential for combination treatments being explored
Negative
- Most common adverse events include thrombocytopenia (35%), anemia (30%), and neutropenia (26%)
- Early-stage clinical data, requiring further validation in larger trials
The early clinical data for INCB123667, Incyte’s CDK2 inhibitor, shows promising antitumor activity in advanced solid tumors, particularly in ovarian and endometrial cancers. Key findings include:
- In platinum-resistant ovarian cancer, a 24.3% overall response rate was observed across selected dose levels, with the highest rate of 31.3% in the 50mg BID cohort.
- A notable 75.7% disease control rate in ovarian cancer patients.
- Efficacy in endometrial cancer with 4 partial responses reported.
- Strong CDK2 inhibition evidenced by ctDNA reduction in 39 out of 48 patients.
These results suggest INCB123667 could become a foundational treatment for platinum-resistant ovarian cancer, addressing a significant unmet need. The planned pivotal trial in 2025 and potential combination studies could further solidify its position in the treatment landscape.
The safety profile of INCB123667 appears manageable, which is important for potential long-term treatment. The most common hematologic adverse events were thrombocytopenia, anemia and neutropenia, mostly Grade 1-2. Non-hematologic events like nausea and fatigue were predominantly mild. This tolerability, combined with the observed efficacy, particularly in ovarian cancer, is encouraging.
The 24.3% overall response rate in platinum-resistant ovarian cancer is noteworthy, as these patients typically have options. The disease control rate of 75.7% further underscores the potential clinical benefit. The activity in endometrial cancer also warrants attention.
The correlation between Cyclin E1 overexpression and response suggests a potential biomarker-driven approach, which could optimize patient selection and improve outcomes. This targeted therapy approach aligns with the trend towards personalized medicine in oncology.
Incyte’s INCB123667 shows promising potential in the lucrative oncology market, particularly for ovarian and endometrial cancers. The positive early clinical data could translate into significant revenue opportunities if the drug advances successfully through later-stage trials and gains approval.
Key financial implications include:
- Potential for first-in-class status as a selective CDK2 inhibitor, which could command premium pricing.
- Addressing the unmet need in platinum-resistant ovarian cancer could lead to rapid market adoption.
- Planned pivotal trial in 2025 suggests a clear development path, potentially accelerating time-to-market.
- Combination therapy plans could expand the drug’s market reach and increase its value proposition.
Investors should monitor the progress of the pivotal trial and any partnership announcements, as these could significantly impact Incyte’s market valuation and future revenue projections.
- New antitumor response data from a range of doses and regimens unveiled today at Incyte investor event
- These results build upon safety and tolerability data presented earlier today during a mini-oral presentation at the European Society of Medical Oncology (ESMO) Congress 2024
- Findings support the initiation of a pivotal trial in ovarian cancer, expected to begin in 2025; additional plans to evaluate INCB123667 in combination with other treatments are underway
WILMINGTON, Del.–(BUSINESS WIRE)– Incyte (Nasdaq:INCY) today announced new early clinical data for INCB123667, a highly selective, potential first-in-class CDK2 inhibitor, in patients with advanced solid tumors. The trial results, presented during a mini-oral presentation at the European Society of Medical Oncology (ESMO) with new, updated data shared during the Company’s investor event, highlight the potential of INCB123667 as a differentiated treatment option for cancers with increased Cyclin E1 activity, amplification and/or overexpression in cells predictive of CDK2 dependency.
In the trial, patients with advanced or metastatic solid tumors (n=205) – including ovarian cancer, endometrial cancer, gastrointestinal cancer, HR+/HER2- breast cancer and triple negative breast cancer, among others – received varying doses of INCB123667 ranging from 50mg to 150mg using once-daily (QD) and twice-daily (BID) dosing schedules.
New data from the Phase 1b dose expansion portion of the trial (data cut-off August 26, 2024) presented today during Incyte’s investor event, demonstrate single-agent antitumor activity, and decreases in circulating tumor DNA (ctDNA) across a range of doses and regimens, notably in patients with ovarian cancer and endometrial cancer whose tumors overexpress Cyclin E1. The trial is ongoing, and the data will continue to mature.
- Of the 37 evaluable participants with platinum-resistant ovarian cancer treated at three (3) selected dose levels (50mg BID, 100mg QD and 125mg QD) in the expansion portion of the trial, nine participants (24.3%) experienced an overall response (OR; 2 complete responses [CR] and 7 partial responses [PRs]). The highest OR rate of 31.3% (5 responders, including 2 CRs) was found in the 50mg BID cohort (16 evaluable participants). Additionally, a disease control rate (DCR) of 75.7% (28/37) was achieved in patients with ovarian cancer.
- In addition, 4 PRs were reported among patients with endometrial cancer.
“The early-stage clinical activity of INCB123667 represents an exciting and promising breakthrough for patients with ovarian cancer. We believe this novel CDK2 inhibitor has the potential to be a foundational treatment for platinum-resistant ovarian cancer, offering a new and differentiated treatment for patients who currently have limited treatment options,” said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte. “We look forward to advancing the development of INCB123667 for the treatment of patients with ovarian cancer both as a single agent and in combination.”
The Part 1b data build on results from the dose escalation portion (Part 1a) of the trial evaluating the safety and tolerability of INCB123667 presented during a mini-oral presentation (Mini oral session: Developmental therapeutics) at ESMO.
Results from the Part 1a dose escalation portion of the trial (data cut-off July 15, 2024) include:
- INCB123667 demonstrated a manageable safety profile (n=84). The most common hematologic treatment-related adverse events (TRAEs) were thrombocytopenia (35%, 13% Grade 3), anemia (30%, 7% Grade 3) and neutropenia (26%, 8% Grade 3). The most common non-hematologic TRAEs were nausea (42%), fatigue (23%) and vomiting (17%); all of which were Grade 1 and 2 except one case of Grade 3 vomiting and one case of Grade 3 fatigue.
- Strong selective inhibition of CDK2 was observed resulting in circulating tumor DNA (ctDNA) reduction at all dose levels. During dose escalation, 39 out of 48 patients who had ctDNA measurements at cycle 1, day 1 and cycle 2, day 1 showed reductions in ctDNA.
“Results from this study presented today at ESMO reinforce the idea that the novel and highly selective CDK2 inhibitor INCB123667 may provide a potential new treatment option for cancers with increased Cyclin E1 signaling (CCNE1 amplification and Cyclin E1 overexpression), predictive of CDK2 dependency,” said Dr. Matteo Simonelli, Head of Early-Drug Development in Solid Tumors at IRCCS Humanitas Research Hospital. “The data speak to the potential of INCB123667 as an active and selective targeted therapy for different cancer types, particularly ovarian cancer, and I look forward to seeing further results in later stages of development.”
The study is ongoing. Plans are underway to initiate a pivotal study in ovarian cancer next year and evaluate INCB123667 in combination with other treatments.
Conference Call and Webcast Information
Incyte will host an in-person analyst and investor event today from 1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST) to discuss key data presentations at ESMO including data from the POD1UM-303 Presidential Symposia and its CDK2 inhibitor program. The CDK2 data will include updated results from a later data cut-off, as well as the data included in the ESMO accepted abstract and mini-oral presentation.
To access the conference call, please dial 877-407-8037 for domestic callers or +1 201-689-8037 for international callers. When prompted, provide the conference identification number, 13748627.
The conference call will also be webcast live and can be accessed at investor.incyte.com.
About the Trial (NCT05238922)
This open-label, dose-escalation and dose-expansion Phase 1 study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of INCB123667 when administered as monotherapy at the recommended dose for expansion (RDE[s]) in participants with selected advanced or metastatic solid tumors. Part 1A (dose escalation) determined the recommended dose of INCB123667 for expansion and the maximum tolerated dose (MTD). Part 1B (cohort dose expansion phase) will further explore antitumor activity of INCB123667 as a monotherapy in six tumor-specific cohorts at the RDEs defined in Part 1A.
For more information about the study, please visit: https://clinicaltrials.gov/study/NCT05238922.
About INCB123667
INCB123667 is a novel, potent and selective oral small molecule inhibitor of CDK2 which has been shown to suppress tumor growth as monotherapy and in combination with standard of care, in Cyclin E amplified tumor models. Cyclin E amplification and overexpression has been reported to be associated with CDK4/6 resistance and poor clinical outcomes in ovarian, gastric, endometrial and breast cancers. INCB123667 has the potential to be a highly targeted and efficacious treatment for advanced solid tumors, including gynecologic tumors, endometrial, uterine, gastric and triple negative breast cancer, among others.
About Incyte
A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.
For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.
Incyte Forward-looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data for Incyte’s CDK2 inhibitor (INCB123667), the potential this CDK2 inhibitor offers for patients, and expectations regarding ongoing and future clinical trials contain predictions, estimates, and other forward-looking statements.
These forward-looking statements are based on our current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and regulatory agencies outside of the United States; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended June 30, 2024. We disclaim any intent or obligation to update these forward-looking statements.
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FAQ
What is the overall response rate for INCB123667 in platinum-resistant ovarian cancer patients?
The overall response rate for INCB123667 in platinum-resistant ovarian cancer patients was 24.3% across three selected dose levels in the expansion portion of the trial.
When does Incyte (INCY) plan to initiate a pivotal trial for INCB123667 in ovarian cancer?
Incyte (INCY) plans to initiate a pivotal trial for INCB123667 in ovarian cancer in 2025.
What was the disease control rate achieved with INCB123667 in ovarian cancer patients?
The disease control rate achieved with INCB123667 in ovarian cancer patients was 75.7% (28 out of 37 patients).
What are the most common hematologic treatment-related adverse events of INCB123667?
The most common hematologic treatment-related adverse events of INCB123667 were thrombocytopenia (35%), anemia (30%), and neutropenia (26%).
