Innate Pharma SA: Monalizumab Data From NeoCOAST-2 Phase 2 Study in Early-Stage NSCLC Presented at the WCLC 2024
Innate Pharma SA announced interim results from AstraZeneca's NeoCOAST-2 Phase 2 study presented at the 2024 World Conference on Lung Cancer. The study evaluates neoadjuvant durvalumab alone or combined with novel agents and chemotherapy in resectable, early-stage non-small cell lung cancer (NSCLC). Preliminary data from Arm 2 showed that monalizumab added to durvalumab plus platinum-based chemotherapy induced a pathological complete response rate of 26.7% and a major pathological response rate of 53.3%, numerically higher than the approved regimen. The treatment demonstrated a manageable safety profile with no impact on surgical rate. Innate Pharma's Chief Medical Officer expressed excitement about the potential of extending durvalumab's clinical benefit with monalizumab in NSCLC patients.
Innate Pharma SA ha annunciato i risultati intermedi dello studio NeoCOAST-2 di Fase 2 di AstraZeneca presentati alla Conferenza Mondiale sul Cancro ai Polmoni del 2024. Lo studio valuta durvalumab neoadiuvante da solo o combinato con nuovi agenti e chemioterapia in pazienti con carcinoma polmonare non a piccole cellule (NSCLC) resecabile e in fase precoce. I dati preliminari del Braccio 2 hanno mostrato che monalizumab aggiunto a durvalumab più chemioterapia a base di platino ha indotto una percentuale di risposta patologica completa del 26,7% e una percentuale di risposta patologica maggiore del 53,3%, numericamente superiore al regime approvato. Il trattamento ha dimostrato un profilo di sicurezza gestibile senza impatto sulla percentuale di interventi chirurgici. Il Chief Medical Officer di Innate Pharma ha espresso entusiasmo riguardo al potenziale di estendere il beneficio clinico di durvalumab con monalizumab nei pazienti con NSCLC.
Innate Pharma SA anunció resultados intermedios del estudio NeoCOAST-2 de Fase 2 de AstraZeneca presentados en la Conferencia Mundial sobre Cáncer de Pulmón 2024. El estudio evalúa durvalumab neoadyuvante solo o combinado con nuevos agentes y quimioterapia en cáncer de pulmón no microcítico (NSCLC) resecable en etapas tempranas. Los datos preliminares del Brazo 2 mostraron que monalizumab añadido a durvalumab más quimioterapia basada en platino indujo una tasa de respuesta patológica completa del 26,7% y una tasa de respuesta patológica mayor del 53,3%, numéricamente superior al régimen aprobado. El tratamiento demostró un perfil de seguridad manejable sin impacto en la tasa quirúrgica. El Chief Medical Officer de Innate Pharma expresó su entusiasmo por el potencial de extender el beneficio clínico de durvalumab con monalizumab en pacientes con NSCLC.
Innate Pharma SA는 2024 세계 폐암 회의에서 발표된 AstraZeneca의 NeoCOAST-2 2상 연구 중간 결과를 발표했습니다. 이 연구는 neoadjuvant durvalumab 단독 또는 새로운 약제 및 화학요법과 병합하여 절제 가능한 초기 단계 비소세포 폐암 (NSCLC)을 평가합니다. 2군의 초기 데이터에 따르면 monalizumab가 durvalumab과 플래티넘 기반 화학요법에 추가되었을 때 병리학적 완전 반응 비율이 26.7%로 나타났으며, 주요 병리학적 반응 비율이 53.3%로, 승인된 요법보다 수치적으로 높았습니다. 이 치료법은 관리 가능한 안전성 프로필을 보여주었으며 수술 비율에 영향을 미치지 않았습니다. Innate Pharma의 최고 의학 책임자는 NSCLC 환자에서 monalizumab과 함께 durvalumab의 임상적 이점을 확장할 잠재력에 대해 흥분을 표했습니다.
Innate Pharma SA a annoncé des résultats intermédiaires de l'étude de phase 2 NeoCOAST-2 d'AstraZeneca présentés lors de la Conférence mondiale sur le cancer du poumon de 2024. L'étude évalue durvalumab néoadjuvant seul ou combiné avec de nouveaux agents et une chimiothérapie chez les patients atteints de cancer du poumon non à petites cellules (NSCLC) résécable à un stade précoce. Les données préliminaires du bras 2 ont montré que monalizumab ajouté au durvalumab et à la chimiothérapie à base de platine a induit un taux de réponse pathologique complète de 26,7% et un taux de réponse pathologique majeure de 53,3%, numériquement supérieur au régime approuvé. Le traitement a montré un profil de sécurité gérable sans impact sur le taux chirurgical. Le directeur médical d'Innate Pharma s'est dit enthousiaste quant au potentiel d'étendre le bénéfice clinique du durvalumab avec le monalizumab chez les patients atteints de NSCLC.
Innate Pharma SA gab die vorläufigen Ergebnisse der NeoCOAST-2-Studie der Phase 2 von AstraZeneca bekannt, die auf der 2024 Weltkonferenz zum Lungenkrebs präsentiert wurden. Die Studie bewertet neoadjuvantes Durvalumab allein oder in Kombination mit neuen Mitteln und Chemotherapie bei resektablem, frühem nicht-kleinzelligem Lungenkrebs (NSCLC). Vorläufige Daten aus Arm 2 zeigten, dass Monalizumab in Kombination mit Durvalumab und platinhaltiger Chemotherapie eine pathologische komplette Ansprechrate von 26,7% und eine Haupt-Pathologieanprechrate von 53,3% induzierte, was numerisch höher war als die genehmigte Therapie. Die Behandlung zeigte ein handhabbares Sicherheitsprofil ohne Einfluss auf die chirurgische Rate. Der Chief Medical Officer von Innate Pharma äußerte sich begeistert über das Potenzial, den klinischen Nutzen von Durvalumab mit Monalizumab bei NSCLC-Patienten zu erweitern.
- Monalizumab combined with durvalumab and chemotherapy showed higher response rates than the approved regimen
- Treatment demonstrated a manageable safety profile
- No impact on surgical rate observed
- Potential to extend clinical benefit of durvalumab in neoadjuvant/adjuvant setting for NSCLC patients
- None.
Insights
The NeoCOAST-2 Phase 2 study results for monalizumab in early-stage NSCLC are promising. The 26.7% pathological complete response rate and 53.3% major pathological response rate are numerically higher than the approved durvalumab plus platinum doublet regimen. This suggests potential enhanced efficacy when adding monalizumab to the standard treatment.
Monalizumab's unique mechanism as an NKG2A checkpoint inhibitor targeting both NK and CD8 T cells could explain these improved outcomes. The manageable safety profile and lack of impact on surgical rates are also encouraging, indicating that this combination might be well-tolerated in the neoadjuvant setting.
However, it's important to await the final analysis and, more importantly, the Event Free Survival (EFS) data to fully assess the clinical benefit. These preliminary results warrant further investigation but should be interpreted cautiously until more robust, long-term data are available.
For Innate Pharma, these preliminary results from the NeoCOAST-2 study are potentially significant. The numerically higher response rates for monalizumab in combination with durvalumab and chemotherapy could position this drug as a valuable addition to the current standard of care in early-stage NSCLC.
If further validated, this could represent a substantial market opportunity. The NSCLC market is projected to reach
The partnership with AstraZeneca adds credibility and resources to the development process, which is a positive factor for Innate Pharma's prospects. Nonetheless, the company's financial performance will depend on the final study results and subsequent regulatory decisions.
The NeoCOAST-2 study's preliminary results for monalizumab are intriguing from a research perspective. The 26.7% pathological complete response rate and 53.3% major pathological response rate in the neoadjuvant setting are promising indicators of potential efficacy. These outcomes suggest that targeting NKG2A on both NK cells and CD8 T cells might enhance the anti-tumor immune response in early-stage NSCLC.
However, it's important to consider the study's limitations. With only 60 out of 72 patients analyzed, the sample size is relatively small. The confidence intervals are quite wide, indicating a degree of uncertainty in these results. Moreover, the lack of direct comparison to a control arm in this presentation makes it challenging to draw definitive conclusions about superiority over the current standard of care.
The upcoming Event Free Survival (EFS) data will be critical in determining the true clinical benefit of this combination. Researchers should also focus on identifying biomarkers that could predict which patients are most likely to benefit from this approach, potentially leading to more personalized treatment strategies in early-stage NSCLC.
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that AstraZeneca (LSE/STO/Nasdaq: AZN) presented interim results from the randomized NeoCOAST-2 (NCT05061550) Phase 2 platform study during the 2024 World Conference on Lung Cancer on September 8, 2024.
The NeoCOAST-2 platform study is intended to assess the safety and efficacy of neoadjuvant durvalumab alone or combined with novel agents and chemotherapy in resectable, early-stage non-small cell lung cancer (NSCLC), followed by adjuvant treatment with durvalumab with or without the novel agents. The preliminary data of three arms were presented at WCLC, namely:
- Arm 1: oleclumab in combination with durvalumab and platinum doublet chemotherapy in the neoadjuvant setting and durvalumab plus oleclumab in the adjuvant setting;
- Arm 2: monalizumab in combination with durvalumab and platinum doublet chemotherapy in the neoadjuvant setting and durvalumab plus monalizumab in the adjuvant setting and;
- Arm 4: datopotamab deruxtecan in combination with durvalumab and single agent platinum chemotherapy in the neoadjuvant setting, and durvalumab alone in the adjuvant setting.
In this preliminary analysis on the first 60 of 72 patients randomized to Arm 2, monalizumab added to durvalumab plus platinum-based chemotherapy doublet induced a pathological complete response rate of
The presentation will be available on Innate’s website, in the publications section.
“We’re pleased to see the preliminary results from the NeoCOAST-2 Phase 2 trial presented at WCLC and the encouraging clinical outcomes for patients with early-stage non-small cell lung cancer across all treatment arms,” said Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma. “Monalizumab is the first checkpoint inhibitor targeting the inhibitory receptor NKG2A on NK cells and CD8 T cells. Based on these preliminary results, we remain excited about the potential of extending the clinical benefit of durvalumab in the neoadjuvant/adjuvant setting with the addition of monalizumab in patients with non-small cell lung cancer. We look forward to the final analysis and the translation of these preliminary data to Event Free Survival (EFS) data in due course.”
About NSCLC:
In 2022, an estimated 2.5 million people were diagnosed with lung cancer worldwide1. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80
Stage III (locally advanced) NSCLC is commonly divided into three subcategories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally.
About Monalizumab
Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.
NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may reestablish a broad anti-tumor response mediated by NK and T cells and may enhance the cytotoxic potential of other therapeutic antibodies6.
AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in NSCLC and other malignancies.
About Innate Pharma
Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform.
Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET® multi-specific NK cell engagers to address multiple tumor types.
Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.
Headquartered in
Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.
Information about Innate Pharma shares
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FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 |
Disclaimer on forward-looking information and risk factors
This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website (http://www.amf-france.org) or on Innate Pharma’s website (www.innate-pharma.com), and public filings and reports filed with the
This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.
1 Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer Observatory: Cancer Today.
2 Provencio M, et al. Inoperable Stage III Non-Small Cell Lung Cancer: Current Treatment and Role Of Vinorelbine. J Thorac Dis. 2011;3:197-204
3 Cheema PK, et al. Perspectives on Treatment Advances for Stage III Locally Advanced Unresectable Non-Small-Cell Lung Cancer. Curr Oncol. 2019;26(1):37–42.
4 LUNGevity Foundation. Types of Lung Cancer. Available at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. Accessed September 2021.
5 EpiCast Report: NSCLC Epidemiology Forecast to 2025. GlobalData. 2016.
6 André et al, Cell 2018
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Source: Innate Pharma SA
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