With once-a-week dosing, insulin efsitora alfa delivers similar A1C reduction compared to daily insulin in adults with type 1 diabetes
Eli Lilly and Company (NYSE: LLY) announced detailed results from the QWINT-5 phase 3 trial evaluating once-weekly insulin efsitora alfa compared to once-daily insulin degludec in adults with type 1 diabetes. The study met its primary endpoint of non-inferior A1C reduction at week 26, with efsitora reducing A1C by 0.53% compared to 0.59% for insulin degludec. Key secondary endpoints showed similar time in range and rates of nocturnal hypoglycemic events between the two treatments.
However, efsitora showed higher rates of severe hypoglycemic events (0.14 vs 0.04 per patient-year) compared to insulin degludec, with 64% of these events occurring in the first 12 weeks of treatment. The results highlight the potential of efsitora to offer a once-weekly basal insulin option for type 1 diabetes patients, while also emphasizing the need for careful management of hypoglycemia risk.
Eli Lilly and Company (NYSE: LLY) ha annunciato i risultati dettagliati del trial di fase 3 QWINT-5 che valuta l'insulina efsitora alfa somministrata una volta a settimana rispetto all'insulina degludec somministrata una volta al giorno negli adulti con diabete di tipo 1. Lo studio ha raggiunto il suo obiettivo primario di non inferiorità nella riduzione dell'A1C alla settimana 26, con efsitora che riduce l'A1C dello 0,53% rispetto allo 0,59% dell'insulina degludec. I principali endpoint secondari hanno mostrato tempi in range e tassi di eventi ipoglicemici notturni simili tra i due trattamenti.
Tuttavia, efsitora ha mostrato tassi più elevati di eventi ipoglicemici gravi (0,14 vs 0,04 per anno-paziente) rispetto all'insulina degludec, con il 64% di questi eventi che si sono verificati nelle prime 12 settimane di trattamento. I risultati evidenziano il potenziale di efsitora di offrire un'opzione di insulina basale una volta a settimana per i pazienti con diabete di tipo 1, sottolineando al contempo la necessità di una vigilanza attenta sulla gestione del rischio di ipoglicemia.
Eli Lilly and Company (NYSE: LLY) anunció los resultados detallados del ensayo de fase 3 QWINT-5 que evalúa la insulina efsitora alfa administrada una vez a la semana en comparación con la insulina degludec administrada una vez al día en adultos con diabetes tipo 1. El estudio alcanzó su objetivo primario de no inferioridad en la reducción de A1C a la semana 26, siendo la reducción de A1C con efsitora del 0,53% en comparación con el 0,59% de la insulina degludec. Los indicadores secundarios clave mostraron tiempos en rango y tasas de eventos hipoglucémicos nocturnos similares entre los dos tratamientos.
Sin embargo, efsitora mostró tasas más altas de eventos hipoglucémicos severos (0,14 vs 0,04 por paciente-año) en comparación con la insulina degludec, con el 64% de estos eventos ocurriendo en las primeras 12 semanas de tratamiento. Los resultados destacan el potencial de efsitora para ofrecer una opción de insulina basal una vez a la semana para pacientes con diabetes tipo 1, al mismo tiempo que enfatizan la necesidad de una gestión cuidadosa del riesgo de hipoglucemia.
엘리 릴리와 컴퍼니(NYSE: LLY)는 주 1회 인슐린 에프시토라 알파와 주 1회 인슐린 데글루덱의 효과를 비교한 3상 임상시험 QWINT-5의 상세 결과를 발표했습니다. 이 연구는 제1형 당뇨병 성인에서 26주차에 A1C 감소의 비열등성을 주요 목표로 삼았으며, 에프시토라는 A1C를 0.53% 감소시킨 반면, 인슐린 데글루덱은 0.59% 감소시켰습니다. 주요 2차 목표에서는 두 치료 간의 범위 내 시간과 야간 저혈당 사건 발생률이 유사했습니다.
하지만, 에프시토라는 인슐린 데글루덱에 비해 중증 저혈당 사건 발생률이 더 높았으며(0.14 대 0.04 환자-년), 이러한 사건의 64%가 치료의 처음 12주 동안 발생했습니다. 이러한 결과는 에프시토라가 제1형 당뇨병 환자에게 주 1회의 기저 인슐린 옵션을 제공할 잠재력을 강조하며, 동시에 저혈당 위험 관리에 대한 신중한 접근이 필요함을 강조합니다.
Eli Lilly and Company (NYSE: LLY) a annoncé des résultats détaillés de l'essai de phase 3 QWINT-5 évaluant l'insuline efsitora alfa administrée une fois par semaine par rapport à l'insuline degludec administrée une fois par jour chez des adultes atteints de diabète de type 1. L'étude a atteint son critère principal de non-infériorité dans la réduction de l'A1C à la semaine 26, l'efsitora réduisant l'A1C de 0,53% contre 0,59% pour l'insuline degludec. Les principaux critères secondaires ont montré des temps dans la plage et des taux d'événements hypoglycémiques nocturnes similaires entre les deux traitements.
Cependant, l'efsitora a montré des taux plus élevés d'événements hypoglycémiques sévères (0,14 contre 0,04 par patient-année) par rapport à l'insuline degludec, 64% de ces événements survenant au cours des 12 premières semaines de traitement. Les résultats soulignent le potentiel de l'efsitora pour offrir une option d'insuline basale administrée une fois par semaine pour les patients atteints de diabète de type 1, tout en mettant également en avant la nécessité d'une gestion prudente du risque d'hypoglycémie.
Eli Lilly and Company (NYSE: LLY) hat detaillierte Ergebnisse der QWINT-5 Phase-3-Studie veröffentlicht, die einmal wöchentlich verabreichte Insulin Efsitora Alfa im Vergleich zu einmal täglich verabreichtem Insulin Degludec bei Erwachsenen mit Typ-1-Diabetes bewertet. Die Studie erreichte ihr primäres Ziel der Non-Inferiorität in der A1C-Reduktion nach 26 Wochen, wobei Efsitora die A1C um 0,53% im Vergleich zu 0,59% für Insulin Degludec senkte. Die wichtigsten sekundären Endpunkte zeigten ähnliche Zeit im Zielbereich und Raten von nächtlichen hypoglykämischen Ereignissen zwischen den beiden Behandlungen.
Allerdings zeigte Efsitora höhere Raten schwerer hypoglykämischer Ereignisse (0,14 vs. 0,04 pro Patient-Jahr) im Vergleich zu Insulin Degludec, wobei 64% dieser Ereignisse in den ersten 12 Wochen der Behandlung auftraten. Die Ergebnisse heben das Potenzial von Efsitora hervor, eine einmal wöchentliche Basisinsulinoption für Patienten mit Typ-1-Diabetes anzubieten, während gleichzeitig die Notwendigkeit einer sorgfältigen Verwaltung des Hypoglykämierisikos betont wird.
- Efsitora met the primary endpoint of non-inferior A1C reduction compared to daily insulin
- Similar time in range and rates of nocturnal hypoglycemic events between efsitora and insulin degludec
- Potential to reduce injection frequency from daily to weekly for basal insulin in type 1 diabetes
- Higher rates of severe hypoglycemic events with efsitora (0.14 vs 0.04 per patient-year)
- 64% of severe hypoglycemic events with efsitora occurred in the first 12 weeks of treatment
- Higher incidence of serious adverse events with efsitora, driven by severe hypoglycemic events
Insights
The QWINT-5 phase 3 trial results for Eli Lilly's once-weekly insulin efsitora alfa are promising for type 1 diabetes management. The primary endpoint of non-inferior A1C reduction compared to daily insulin degludec was met, with efsitora reducing A1C by
Key secondary endpoints showed comparable results between efsitora and degludec in time in range and rates of nocturnal hypoglycemic events. However, the higher rate of severe hypoglycemic events with efsitora (
While these results are encouraging, further research is needed to optimize dosing and minimize hypoglycemia risk before efsitora can be considered a game-changer in type 1 diabetes treatment.
The QWINT-5 trial results for efsitora alfa are intriguing from a clinical perspective. The similar A1C reduction and time in range compared to daily insulin degludec suggest potential for improved patient convenience without compromising glycemic control. This could significantly enhance treatment adherence, a common challenge in diabetes management.
However, the increased rate of severe hypoglycemic events is concerning, particularly in the first 12 weeks of treatment. This highlights the need for careful titration and close monitoring during initiation. The similar rates of nocturnal hypoglycemia are reassuring, but the overall hypoglycemia risk needs further evaluation.
While efsitora shows promise, its adoption in clinical practice will depend on balancing improved convenience with potential safety concerns. Personalized treatment approaches and patient education will be important for its successful implementation.
Eli Lilly's efsitora alfa trial results present a mixed picture for investors. The non-inferiority to daily insulin in A1C reduction is a significant milestone, potentially opening a large market for weekly insulin in type 1 diabetes. This could drive substantial revenue growth for Lilly, given the lifelong nature of type 1 diabetes treatment.
However, the higher rate of severe hypoglycemic events is a red flag that could impact regulatory approval or limit market adoption. The fact that
Investors should closely watch for regulatory feedback and potential label restrictions. While efsitora could be a game-changer, its success will hinge on balancing efficacy, safety and patient convenience. The market reaction may be cautiously optimistic, but significant uncertainties remain.
Detailed results were published in The Lancet and simultaneously presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024
In the trial, efsitora met the primary endpoint of non-inferior A1C reduction at week 26. For the efficacy estimand1,2, efsitora reduced A1C by
In a key secondary endpoint, time in range4 as measured by continuous glucose monitoring (CGM) was similar between efsitora and insulin degludec during the four weeks prior to week 26. In an additional key secondary endpoint, the estimated combined rates of patient-reported clinically significant (blood glucose <54 mg/dL) or severe nocturnal5 hypoglycemic events per patient-year of exposure were similar between efsitora and insulin degludec over the 52-week study period.
"People with type 1 diabetes need insulin every day. Currently, they can deliver the insulin using an automated insulin delivery system or by taking a daily basal insulin injection and multiple mealtime insulin injections each day," said Richard Bergenstal, M.D., executive director of the International Diabetes Center, HealthPartners Institute. "This new data shows that with one dose a week of basal insulin, efsitora was able to achieve a similar A1C reduction as taking an injection of one of the most used background insulins every day. I look forward to further evaluation of these data, including ways to minimize hypoglycemia, so once-weekly insulin can be one option for personalizing the management of type 1 diabetes."
Full Results
QWINT-5 Study: Primary and Secondary Endpoints | ||
Efficacy Estimand | Treatment-Regimen | |
Primary Endpoint – A1C Reduction (Resulting A1C) at 26 Weeks | ||
Efsitora | - | - |
Insulin degludec | - | - |
Secondary Endpoint – Percent Time in Range During the 4 Weeks Prior to Week 26 | ||
Efsitora | 52.8 % | 52.5 % |
Insulin degludec | 53.1 % | 52.9 % |
Secondary Endpoint – Estimated Rate of Clinically Significant9 or Severe Nocturnal | ||
Efsitora | 1.99 | |
Insulin degludec | 1.96 | |
In the trial, estimated combined rates of patient-reported clinically significant (blood glucose <54 mg/dL) or severe hypoglycemic events per patient-year of exposure through week 52 were 14.03 with efsitora vs. 11.59 with insulin degludec. There was no evidence of increased duration of hypoglycemia with efsitora compared to insulin degludec based on CGM data.
Estimated rates of severe hypoglycemic events per patient-year of exposure through week 52 were 0.14 with efsitora vs. 0.04 with insulin degludec. More than half (
Overall incidence of treatment-emergent adverse events were comparable across treatment groups. Serious adverse events were higher in efsitora compared to insulin degludec, driven by severe hypoglycemic events.
"When we commercialized insulin more than 100 years ago, it marked the beginning of our commitment to people living with type 1 diabetes – today's announcement continues that legacy," said Jeff Emmick, M.D., Ph.D., senior vice president, product development, Lilly. "These results underscore the potential of efsitora to help some people living with type 1 diabetes lower their A1C with only one basal insulin injection per week, while also highlighting the complexity of treating this chronic disease. With the data we have seen from our phase 3 program so far, we are confident in efsitora's potential to transform diabetes care and will continue to pursue new treatment options until we can eliminate the disease entirely."
Detailed results for QWINT-2 are also being presented at EASD and simultaneously published in The New England Journal of Medicine.
About the QWINT clinical trial program
The QWINT phase 3 global clinical development program for insulin efsitora alfa (efsitora) in diabetes began in 2022 and has enrolled more than 4,000 people living with type 1 or type 2 diabetes across five global registration studies.
QWINT-5 (NCT05463744) is a multicenter, treat-to-target, randomized, parallel-design, open-label study comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec in participants with type 1 diabetes treated with daily basal and multiple daily mealtime insulin injections. The trial consisted of a 52-week treatment period with the primary endpoint measured at 26 weeks. 692 participants across the
About Insulin Efsitora Alfa
Insulin efsitora alfa (efsitora) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, has the potential to provide more stable glucose levels (less glucose variability) throughout the week. Efsitora is in phase 3 development for adults with type 1 and 2 diabetes.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995), including statements about insulin efsitora alfa as a potential treatment for people with type 1 diabetes and the timeline for future readouts, presentations, and other milestones relating to insulin efsitora alfa and its clinical trials, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that insulin efsitora alfa will prove to be a safe and effective treatment for type 1 diabetes, that insulin efsitora alfa will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
1 The efficacy estimand represents the treatment effect had all participants adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia.
2
3 From a baseline A1C of
4 Glucose 70-180 mg/dL.
5 Any event that occurred between midnight and 6 a.m.
6 Treatment-regimen estimand represents the efficacy irrespective of adherence to the investigational medicine or introduction of rescue therapy for persistent severe hyperglycemia.
7 From a baseline A1C of
8
9 Blood glucose <54 mg/dL.
Refer to: | Niki Smithers, smithers_niki@lilly.com; 317-358-9074 (Media) |
Joe Fletcher; jfletcher@lilly.com, 317-296-2884 (Investors) |
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SOURCE Eli Lilly and Company
FAQ
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