NuCana Announces Update for Phase 2 Randomized Colorectal Cancer Study
NuCana plc (NASDAQ: NCNA) announced the discontinuation of its NuTide:323 study following a pre-planned analysis and recommendation from the Steering Committee. The study, which aimed to develop NUC-3373 as a replacement for 5-FU in second-line colorectal cancer treatment, was unlikely to achieve its primary objective of superior Progression Free Survival compared to the control arm.
Despite this setback, NuCana remains committed to its ongoing development programs. The company will continue with the NuTide:701 and NuTide:303 studies, focusing on NUC-7738 in combination with pembrolizumab. Encouraging data from these studies will be presented at the ESMO Annual Conference in September 2024.
NuCana plc (NASDAQ: NCNA) ha annunciato l'interruzione dello studio NuTide:323 dopo un'analisi pianificata e la raccomandazione del Comitato Direttivo. Lo studio, che mirava a sviluppare NUC-3373 come sostituto del 5-FU nel trattamento del cancro colorettale di secondo linea, era improbabile raggiungere il suo obiettivo primario di una sopravvivenza libera da progressione superiore rispetto al braccio di controllo.
Nonostante questo contrattempo, NuCana rimane impegnata nei suoi programmi di sviluppo in corso. L'azienda continuerà con gli studi NuTide:701 e NuTide:303, concentrandosi su NUC-7738 in combinazione con pembrolizumab. Dati incoraggianti provenienti da questi studi saranno presentati alla Conferenza Annuale ESMO nel settembre 2024.
NuCana plc (NASDAQ: NCNA) anunció la interrupción de su estudio NuTide:323 tras un análisis preplanificado y una recomendación del Comité Directivo. El estudio, que tenía como objetivo desarrollar NUC-3373 como reemplazo del 5-FU en el tratamiento del cáncer colorrectal de segunda línea, era poco probable que lograra su objetivo principal de una supervivencia libre de progresión superior en comparación con el grupo de control.
A pesar de este contratiempo, NuCana se mantiene comprometida con sus programas de desarrollo en curso. La compañía continuará con los estudios NuTide:701 y NuTide:303, centrándose en NUC-7738 en combinación con pembrolizumab. Datos alentadores de estos estudios se presentarán en la Conferencia Anual ESMO en septiembre de 2024.
NuCana plc (NASDAQ: NCNA)는 계획된 분석과 운영 위원회의 권고에 따라 NuTide:323 연구의 중단을 발표했습니다. 본 연구는 2차 대장암 치료에서 5-FU의 대체제로 NUC-3373을 개발하는 것을 목표로 하였으나, 대조군에 비해 우수한 질병 진행 없는 생존율의 주요 목표를 달성할 가능성이 낮았습니다.
이러한 좌절에도 불구하고 NuCana는 현재 진행 중인 개발 프로그램에 전념하고 있습니다. 회사는 NUC-7738와 pembrolizumab의 병용에 초점을 맞춘 NuTide:701 및 NuTide:303 연구를 계속 진행할 예정입니다. 이 연구에서의 고무적인 데이터는 2024년 9월 ESMO 연례 회의에서 발표될 것입니다.
NuCana plc (NASDAQ: NCNA) a annoncé l'arrêt de son étude NuTide:323 suite à une analyse préconçue et à la recommandation du Comité de Pilotage. L'étude visait à développer NUC-3373 comme substitut au 5-FU dans le traitement du cancer colorectal en deuxième ligne, mais il était peu probable qu'elle atteigne son objectif principal de survie sans progression supérieure par rapport au bras de contrôle.
Malgré ce revers, NuCana reste engagée dans ses programmes de développement en cours. La société continuera avec les études NuTide:701 et NuTide:303, en se concentrant sur NUC-7738 en combinaison avec pembrolizumab. Des données encourageantes provenant de ces études seront présentées lors de la Conférence Annuelle ESMO en septembre 2024.
NuCana plc (NASDAQ: NCNA) gab die Einstellung seiner Studie NuTide:323 nach einer vorab geplanten Analyse und Empfehlung des Lenkungsausschusses bekannt. Die Studie hatte zum Ziel, NUC-3373 als Ersatz für 5-FU in der Zweitlinientherapie von Kolorektalkrebs zu entwickeln, jedoch war es unwahrscheinlich, dass sie ihr primäres Ziel einer überlegenen progressionsfreien Überlebensrate im Vergleich zur Kontrollgruppe erreichen würde.
Trotz dieses Rückschlags bleibt NuCana engagiert in seinen laufenden Entwicklungsprogrammen. Das Unternehmen wird mit den Studien NuTide:701 und NuTide:303 fortfahren, wobei der Fokus auf NUC-7738 in Kombination mit Pembrolizumab liegt. Ermutigende Daten aus diesen Studien werden auf der ESMO-Jahrestagung im September 2024 präsentiert.
- NuTide:701 and NuTide:303 studies continue unchanged
- Encouraging data on NUC-7738 plus pembrolizumab to be presented at ESMO Annual Conference
- All treatment regimens in NuTide:323 study showed favorable safety profiles
- NuTide:323 study discontinued due to unlikely achievement of primary objective
- Unexpected outcome in colorectal cancer treatment development
- Potential setback in NUC-3373 development for colorectal cancer
The discontinuation of the NuTide:323 study is a significant setback for NuCana's colorectal cancer program. The failure to demonstrate superior Progression Free Survival (PFS) with NUFIRI+bev compared to FOLFIRI+bev suggests that NUC-3373 may not offer a substantial advantage over the current standard of care. This outcome underscores the challenges in developing new treatments for complex cancers like metastatic colorectal cancer.
However, it's important to note that the safety profile was favorable across all arms, which could be a silver lining for future development. The company's pivot to focus on NUC-7738, particularly its combination with pembrolizumab in melanoma, indicates a strategic shift towards potentially more promising avenues. The upcoming data presentation at ESMO could provide important insights into NUC-7738's efficacy and future prospects.
This news is likely to have a negative impact on NuCana's stock price in the short term. The discontinuation of a Phase 2 study is a significant event that often leads to investor concern. However, the company's diversified pipeline, particularly the ongoing NuTide:303 and NuTide:701 studies, may mitigate some of the downside risk.
Investors should focus on the upcoming ESMO conference in September, where data on NUC-7738 will be presented. Positive results could potentially offset the negative sentiment from the NuTide:323 discontinuation. The company's cash position and burn rate will be critical factors to monitor, as the failure of this study may raise questions about the efficiency of capital allocation and the timeline to potential commercialization.
The discontinuation of NuTide:323 highlights the inherent risks in oncology drug development, particularly in highly competitive indications like colorectal cancer. NuCana's strategy to pivot towards NUC-7738 and its combination with pembrolizumab is prudent, given the growing importance of immunotherapy in cancer treatment.
The company's ability to quickly analyze and adapt its pipeline strategy demonstrates agility, which is important in the fast-paced oncology field. The focus on NUC-7738's impact on gene expression and the tumor microenvironment aligns with current trends in personalized medicine and targeted therapies. This shift could potentially open new partnership opportunities or attract interest from larger pharmaceutical companies looking to bolster their oncology portfolios.
NuTide:323 Study to be Discontinued Following Pre-Planned Initial Analysis and Recommendation from the Steering Committee
NuTide:701 and NuTide:303 Studies Continue Unchanged with Encouraging Data on NUC-7738 plus Pembrolizumab to be Presented at the ESMO Annual Conference in September
EDINBURGH, United Kingdom, Aug. 29, 2024 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced that the NuTide:323 study is being discontinued following a pre-planned initial analysis and recommendation from the NuTide:323 Study Steering Committee. While there were prognostic imbalances favoring the control arm, the Steering Committee believed that the combination of NUC-3373 with leucovorin, irinotecan and bevacizumab (NUFIRI+bev) was unlikely to achieve the study’s primary objective of superior Progression Free Survival (PFS) compared to the control arm of 5-FU, leucovorin, irinotecan and bevacizumab (FOLFIRI+bev) in the final analysis. In all three arms, the treatment regimens were observed to have a favorable safety profile and to be generally well tolerated, with only 12 of the 175 patients (four patients in each arm) discontinuing treatment due to adverse events.
“While we are disappointed with this unexpected outcome, especially for people living with colorectal cancer, we gained valuable knowledge from the NuTide:323 study which will inform our ongoing development programs. We are extremely grateful to the study participants, their families, the investigators and study teams for their participation and efforts,” said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. “These results highlight the challenges associated with developing new medicines for patients with complex and heterogenous cancers such as metastatic colorectal cancer. We will leverage insights from these data to identify future potential development options for NUC-3373 in colorectal cancer.”
Professor Josep Tabernero, MD, PhD, Head of the Medical Oncology Department at the Vall d´Hebron University Hospital, Barcelona and Chair of the NuTide:323 Study Steering Committee, stated: “In the NuTide:323 study, we were aiming to develop NUC-3373 as a replacement for 5-FU, in combination with leucovorin, irinotecan and bevacizumab in patients with second-line colorectal cancer. The premise of this ambitious goal was based on robust non-clinical and clinical data and the NuTide:323 study team are very disappointed with this outcome.”
Mr. Griffith continued: “NuCana remains committed to improving survival outcomes for patients with cancer. The results of the NuTide:323 study do not impact the ongoing NuTide:303 study, in which NUC-3373 is being combined with either pembrolizumab in solid tumors or docetaxel in patients with lung cancer. Furthermore, we are excited about the potential of NUC-7738, a novel agent that profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. We look forward to sharing the latest data from the Phase 2 part of the NuTide:701 study of NUC-7738 in combination with pembrolizumab in patients with melanoma at the ESMO annual conference in September 2024.”
About NuCana
NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer by applying our ProTide technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines. While these conventional agents remain part of the standard of care for the treatment of many solid and hematological tumors, they have significant shortcomings that limit their efficacy and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome the key limitations of nucleoside analogs and generate much higher concentrations of anti-cancer metabolites in cancer cells. NuCana’s pipeline includes NUC-3373 and NUC-7738. NUC-3373 is a new chemical entity derived from the nucleoside analog 5-fluorouracil, a widely used chemotherapy agent. NUC-3373 is currently being evaluated in two ongoing clinical studies: a Phase 1b/2 study (NuTide:302) in combination with leucovorin, irinotecan or oxaliplatin, and bevacizumab in patients with metastatic colorectal cancer and a Phase 1b/2 modular study (NuTide:303) of NUC-3373 in combination with the PD-1 inhibitor pembrolizumab for patients with advanced solid tumors and in combination with docetaxel for patients with lung cancer. NUC-7738 is a novel anti-cancer agent that disrupts RNA polyadenylation, profoundly impacts gene expression in cancer cells and targets multiple aspects of the tumor microenvironment. NUC-7738 is in the Phase 2 part of a Phase 1/2 study (NuTide:701) which is evaluating NUC-7738 as a monotherapy in patients with advanced solid tumors and in combination with pembrolizumab in patients with melanoma.
Forward-Looking Statements
This press release may contain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NuCana plc (the “Company”). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning the Company’s planned and ongoing clinical studies for the Company’s product candidates and the potential advantages of those product candidates, including NUC-3373 and NUC-7738; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; the Company’s goals with respect to the development, regulatory pathway and potential use, if approved, of each of its product candidates; and the utility of prior non-clinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, and subsequent reports that the Company files with the SEC. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.
For more information, please contact:
NuCana plc
Hugh S. Griffith
Chief Executive Officer
+44 131-357-1111
info@nucana.com
ICR Westwicke
Chris Brinzey
+1 339-970-2843
chris.brinzey@westwicke.com
FAQ
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