NextCure Presented Results of the Phase 1b Study of NC410 in Combination with Pembrolizumab at ESMO 2024
NextCure (Nasdaq: NXTC) presented clinical data from the Phase 1b portion of a Phase 1b/2 study evaluating NC410, a LAIR-2 fusion protein, in combination with pembrolizumab at ESMO 2024. The trial demonstrated clinical activity in hard-to-treat cancers, including ovarian cancer and immune checkpoint inhibitor (ICI) naïve microsatellite stable (MSS)/microsatellite instability-low (MSI-L) colorectal cancer (CRC).
Key results include:
- 5 partial responses (PRs) out of 20 evaluable ovarian cancer patients
- 3 PRs out of 43 evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis
- Biomarker data supporting the proposed mechanism of action of NC410
The combination showed durable responses in both tumor types, which are generally unresponsive to immunotherapy. NextCure plans to provide an update on patients remaining in the study later this year.
NextCure (Nasdaq: NXTC) ha presentato dati clinici dalla parte 1b di uno studio di fase 1b/2 che valuta NC410, una proteina di fusione LAIR-2, in combinazione con pembrolizumab durante ESMO 2024. Lo studio ha dimostrato un'attività clinica in tumori difficili da trattare, compreso il cancro ovarico e il cancro colorettale microsatellite stabile (MSS)/a bassa instabilità dei microsatelliti (MSI-L), naïve agli inibitori dei checkpoint immunitari (ICI).
I risultati chiave includono:
- 5 risposte parziali (PR) su 20 pazienti affetti da cancro ovarico valutabili
- 3 PR su 43 pazienti con CRC MSS/MSI-L naïve agli ICI e senza metastasi epatiche
- Dati sui biomarker a supporto del meccanismo d'azione proposto per NC410
La combinazione ha mostrato risposte durevoli in entrambi i tipi di tumore, che generalmente non rispondono all'immunoterapia. NextCure prevede di fornire un aggiornamento sui pazienti ancora nello studio entro la fine di quest'anno.
NextCure (Nasdaq: NXTC) presentó datos clínicos de la parte 1b de un estudio de fase 1b/2 que evalúa NC410, una proteína de fusión LAIR-2, en combinación con pembrolizumab en ESMO 2024. El estudio demostró actividad clínica en cánceres difíciles de tratar, incluidos el cáncer de ovario y el cáncer colorrectal microsatélite estable (MSS)/de baja inestabilidad de microsatélites (MSI-L) naïve a los inhibidores de puntos de control inmunitarios (ICI).
Los resultados clave incluyen:
- 5 respuestas parciales (PR) de 20 pacientes evaluables con cáncer de ovario
- 3 PR de 43 pacientes evaluables con CRC MSS/MSI-L naïve a ICI sin metástasis hepáticas
- Datos de biomarcadores que respaldan el mecanismo de acción propuesto de NC410
La combinación mostró respuestas duraderas en ambos tipos de tumores, que generalmente no responden a la inmunoterapia. NextCure planea proporcionar una actualización sobre los pacientes que permanecen en el estudio más adelante este año.
넥스트큐어(NextCure, 나스닥: NXTC)는 ESMO 2024에서 펨브롤리주맙과 함께 LAIR-2 융합 단백질 NC410을 평가하는 1b/2상 연구의 1b 부분에서 임상 데이터를 발표했습니다. 이 임상 시험은 난치성 암, 특히 난소암과 면역 체크포인트 억제제(ICI)에 비면역적인 마이크로새틀라이트 안정성(MSS) 및 낮은 마이크로새틀라이트 불안정성(MSI-L) 대장암(CRC)에서 임상 활성을 보여주었습니다.
주요 결과는 다음과 같습니다:
- 20명의 평가 가능한 난소암 환자 중 5명의 부분 반응(PR)
- 간 전이가 없는 43명의 평가 가능한 ICI 비면역적인 MSS/MSI-L CRC 환자 중 3명의 PR
- NC410의 제안된 작용 기전을 지원하는 바이오마커 데이터
이 조합은 일반적으로 면역 요법에 반응하지 않는 두 가지 종양 유형에서 내구성 있는 반응을 나타냈습니다. 넥스트큐어는 올해 말 연구에 남아 있는 환자에 대한 업데이트를 제공할 계획입니다.
NextCure (Nasdaq: NXTC) a présenté des données cliniques de la partie phase 1b d'une étude de phase 1b/2 évaluant NC410, une protéine de fusion LAIR-2, en combinaison avec pembrolizumab lors de ESMO 2024. L'essai a démontré une activité clinique dans des cancers difficiles à traiter, y compris le cancer de l'ovaire et le cancer colorectal microsatellite stable (MSS)/à faible instabilité des microsatellites (MSI-L) naïf aux inhibiteurs de points de contrôle immunitaire (ICI).
Les résultats clés comprennent :
- 5 réponses partielles (PR) sur 20 patients atteints d'un cancer de l'ovaire évaluables
- 3 PR sur 43 patients évaluables avec un CRC MSS/MSI-L naïfs aux ICI sans métastases hépatiques
- Données de biomarqueurs soutenant le mécanisme d'action proposé pour NC410
La combinaison a montré des réponses durables dans les deux types de tumeurs, qui sont généralement peu réactifs à l'immunothérapie. NextCure prévoit de fournir une mise à jour sur les patients restant dans l'étude plus tard cette année.
NextCure (Nasdaq: NXTC) präsentierte klinische Daten aus dem Abschnitt Phase 1b einer Phase 1b/2-Studie zur Bewertung von NC410, einem LAIR-2-Fusionsprotein, in Kombination mit Pembrolizumab auf der ESMO 2024. Die Studie zeigte klinische Aktivität bei schwer behandelbaren Krebserkrankungen, einschließlich Eierstockkrebs und mikrosatellitenstabilem (MSS)/mikrosatelliteninstabil niedrigem (MSI-L) Kolorektalkrebs (CRC), der naïv gegenüber Immun-Checkpoint-Inhibitoren (ICI) ist.
Wichtige Ergebnisse umfassen:
- 5 partielle Remissionen (PR) bei 20 bewertbaren Patienten mit Eierstockkrebs
- 3 PR bei 43 bewertbaren Patienten mit ICI-naivem MSS/MSI-L CRC ohne Lebermetastasen
- Biomarker-Daten zur Unterstützung des vorgeschlagenen Wirkmechanismus von NC410
Die Kombination zeigte anhaltende Reaktionen in beiden Tumortypen, die in der Regel nicht auf Immuntherapie ansprechen. NextCure plant, später in diesem Jahr ein Update zu den verbleibenden Patienten in der Studie bereitzustellen.
- Clinical activity demonstrated in hard-to-treat cancers (ovarian and MSS/MSI-L CRC)
- 5 partial responses out of 20 evaluable ovarian cancer patients
- 3 partial responses out of 43 evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis
- Durable responses observed in both tumor types
- Biomarker data supports proposed mechanism of action of NC410
- None.
Insights
The Phase 1b study results for NC410 in combination with pembrolizumab show promising clinical activity in difficult-to-treat cancers. In ovarian cancer,
The durability of responses in both cancer types is particularly encouraging, suggesting potential for long-term clinical benefit. The biomarker data supporting NC410's mechanism of action adds credibility to its therapeutic potential. However, it's important to note that this is still early-phase research and larger studies will be needed to confirm efficacy and safety profiles.
The combination of NC410 and pembrolizumab demonstrates intriguing activity in traditionally immunotherapy-resistant cancers. For ovarian cancer, a
The durability of responses is a key factor, potentially offering extended progression-free survival for responders. However, we must interpret these results cautiously. The sample sizes are small and we need to see more data on progression-free survival, overall survival and safety profiles. The biomarker data is encouraging, but further validation is necessary to confirm NC410's mechanism in the tumor microenvironment.
These early-stage results could potentially boost investor confidence in NextCure's pipeline. The company's focus on hard-to-treat cancers addresses significant unmet medical needs, which could translate to substantial market opportunities if NC410 continues to show promise in larger trials.
However, it's important to note that NextCure is still in the clinical-stage, without approved products. The path to potential commercialization is long and uncertain. Investors should closely monitor cash burn rates and the company's ability to fund further development. While these results are encouraging, they are early-stage and the stock may remain volatile as more data emerges. The company's financial health and ability to advance NC410 through later-stage trials will be important factors in its long-term prospects.
- Of the 20 evaluable ovarian cancer patients, there were 5 PRs
- Of the 43 evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis, there were 3 PRs
- Biomarker data support proposed mechanism of action of NC410
BELTSVILLE, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, today announced that clinical data from the Phase 1b portion of a Phase 1b/2 study evaluating NC410, a LAIR-2 fusion protein, in combination with pembrolizumab was presented at ESMO 2024. The trial, which is evaluating the combination in ovarian cancer and immune checkpoint inhibitor (ICI) naïve and refractory microsatellite stable (MSS)/microsatellite instability-low (MSI-L) colorectal cancer (CRC), demonstrated clinical activity in these hard-to-treat cancers. The data were presented by clinical trial investigators Emese Zsiros, M.D., Ph.D., Associate Professor of Oncology, Chair, Department of Gynecologic Oncology, Roswell Park Comprehensive Cancer Center (ovarian) and Eric S. Christenson, M.D., Assistant Professor of Oncology at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (CRC). The presentations are available on the NextCure website (www.nextcure.com).
“The combination of NC410 and pembrolizumab continues to demonstrate clinical activity against ovarian cancer and MSS/MSI-L CRC, recalcitrant cancers that are generally unresponsive to immunotherapy. In both tumor types, study subjects who achieved clinical benefit of partial response or stable disease demonstrated durability of their responses that was clinically meaningful for these patient populations,” said Udayan Guha, M.D., Ph.D., NextCure’s Senior Vice President, Clinical and Translational Development. “We are continuing to follow the patients who remain on study and look forward to providing an update later this year.”
Presentation details:
Title: Results of the Phase 1b Study of NC410 Combined with Pembrolizumab in ovarian Cancer Patients
Lead Author: Emese Zsiros, M.D., Ph.D.
Presentation Number: 758P
Title: Results of the Phase 1b Study of NC410 Combined with Pembrolizumab in MSS/MSI-L Colorectal Cancer Patients
Lead Author: Eric S. Christenson, M.D.
Presentation Number: 577P
About NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates, antibodies and proteins. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. www.nextcure.com
Cautionary Statement Regarding Forward-Looking Statements
Statements made in this press release that are not historical facts are forward-looking statements. Words such as “expects,” “believes,” “intends,” “hope,” “forward” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: our limited operating history and no products approved for commercial sale; our history of significant losses; our need to obtain additional financing; risks related to clinical development, including that early clinical data may not be confirmed by later clinical results; risks that pre-clinical research may not be confirmed in clinical trials; risks related to marketing approval and commercialization; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described in NextCure’s filings with the Securities and Exchange Commission (the “SEC”), including NextCure’s most recent Form 10-K and subsequent Form 10-Q. You should not place undue reliance on any forward-looking statements. NextCure assumes no obligation to update any forward-looking statements, even if expectations change.
Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com
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