Roche’s Itovebi demonstrated statistically significant and clinically meaningful overall survival benefit in a certain type of HR-positive advanced breast cancer
Roche announced positive topline results from the overall survival (OS) analysis of the phase III INAVO120 study for their Itovebi drug combination. The treatment, which combines Itovebi with palbociclib and fulvestrant, demonstrated statistically significant survival benefits for patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer.
The study met its key secondary endpoint, building upon previous primary analysis results which showed the Itovebi-based regimen reduced disease progression risk by 57% (15.0 vs 7.3 months). The FDA approved this treatment in October 2024 for endocrine-resistant cases.
Itovebi is currently being investigated in four phase III clinical studies (INAVO120-123) for various combinations in PIK3CA-mutated breast cancer. The full OS analysis results will be presented at an upcoming medical meeting.
Roche ha annunciato risultati positivi dai risultati preliminari dell'analisi della sopravvivenza globale (OS) dello studio di fase III INAVO120 per la loro combinazione di farmaci Itovebi. Il trattamento, che combina Itovebi con palbociclib e fulvestrant, ha dimostrato benefici significativi in termini di sopravvivenza per i pazienti con cancro al seno avanzato di tipo HR-positivo e HER2-negativo con mutazione PIK3CA.
Lo studio ha raggiunto il suo obiettivo secondario chiave, costruendo sui risultati dell'analisi primaria precedente, che mostrava come il regime a base di Itovebi riducesse il rischio di progressione della malattia del 57% (15,0 contro 7,3 mesi). La FDA ha approvato questo trattamento nell'ottobre 2024 per casi resistenti agli ormoni.
Itovebi è attualmente oggetto di indagine in quattro studi clinici di fase III (INAVO120-123) per varie combinazioni nel cancro al seno con mutazione PIK3CA. I risultati completi dell'analisi OS saranno presentati a un prossimo incontro medico.
Roche anunció resultados positivos de los análisis de supervivencia global (OS) del estudio de fase III INAVO120 para su combinación de fármacos Itovebi. El tratamiento, que combina Itovebi con palbociclib y fulvestrant, demostró beneficios significativos en la supervivencia para los pacientes con cáncer de mama avanzado HR-positivo y HER2-negativo que tienen mutaciones en PIK3CA.
El estudio cumplió con su objetivo secundario clave, apoyándose en los resultados del análisis primario anterior que mostraron que el régimen basado en Itovebi reduce el riesgo de progresión de la enfermedad en un 57% (15.0 frente a 7.3 meses). La FDA aprobó este tratamiento en octubre de 2024 para casos resistentes a las hormonas.
Actualmente, Itovebi se está investigando en cuatro estudios clínicos de fase III (INAVO120-123) para varias combinaciones en el cáncer de mama con mutaciones en PIK3CA. Los resultados completos del análisis de OS se presentarán en una próxima reunión médica.
로슈는 그들의 이토베비 약물 조합에 대한 3상 INAVO120 연구의 전체 생존율(OS) 분석에서 긍정적인 초기 결과를 발표했습니다. 이 치료법은 이토베비와 팔보시클립 및 풀베스트란트를 조합하여 PIK3CA 변이가 있는 HR 양성, HER2 음성의 진행성 유방암 환자에게 통계적으로 유의미한 생존 이점을 보여주었습니다.
이 연구는 주요 이차 목표를 달성하였고, 이토베비 기반 요법이 질병 진행 위험을 57%(15.0개월 대 7.3개월) 감소시켰다는 이전의 주요 분석 결과를 기반으로 하고 있습니다. FDA는 2024년 10월에 호르몬 저항성 사례에 대해 이 치료법을 승인했습니다.
이토베비는 현재 PIK3CA 변이가 있는 유방암에 대해 다양한 조합으로 4개의 3상 임상 연구(INAVO120-123)에서 조사되고 있습니다. OS 분석의 전체 결과는 다가오는 의학 회의에서 발표될 예정입니다.
Roche a annoncé des résultats préliminaires positifs concernant l'analyse de la survie globale (OS) de l'étude de phase III INAVO120 pour leur combinaison de médicaments Itovebi. Le traitement, qui associe Itovebi à palbociclib et fulvestrant, a démontré des bénéfices significatifs en matière de survie pour les patients atteints de cancer du sein avancé HR-positif et HER2-négatif porteurs d'une mutation PIK3CA.
L'étude a atteint son objectif secondaire clé, s'appuyant sur les résultats de l'analyse primaire précédente qui montrait que le régime basé sur Itovebi réduisait le risque de progression de la maladie de 57 % (15,0 contre 7,3 mois). La FDA a approuvé ce traitement en octobre 2024 pour les cas résistants aux traitements hormonaux.
Itovebi est actuellement étudié dans quatre études cliniques de phase III (INAVO120-123) pour diverses combinaisons dans le cancer du sein avec mutation PIK3CA. Les résultats complets de l'analyse OS seront présentés lors d'une prochaine réunion médicale.
Roche hat positive vorläufige Ergebnisse aus der Analyse der Gesamtüberlebensrate (OS) der Phase-III-Studie INAVO120 für ihre Itovebi-Medikamentenkombination angekündigt. Die Behandlung, die Itovebi mit Palbociclib und Fulvestrant kombiniert, zeigte statistisch signifikante Überlebensvorteile für Patienten mit PIK3CA-mutiertem, HR-positivem, HER2-negativem fortgeschrittenem Mammakarzinom.
Die Studie erreichte ihr wichtigstes sekundäres Ziel und baute auf den Ergebnissen der vorherigen Primäranalyse auf, die zeigte, dass das auf Itovebi basierende Regime das Risiko des Fortschreitens der Erkrankung um 57 % (15,0 vs. 7,3 Monate) verringerte. Die FDA genehmigte diese Behandlung im Oktober 2024 für hormonresistente Fälle.
Itovebi wird derzeit in vier klinischen Phase-III-Studien (INAVO120-123) für verschiedene Kombinationen bei PIK3CA-mutiertem Brustkrebs untersucht. Die vollständigen Ergebnisse der OS-Analyse werden auf einer bevorstehenden medizinischen Konferenz vorgestellt.
- Achieved statistically significant overall survival benefit in phase III INAVO120 study
- Demonstrated 57% reduction in disease progression risk (15.0 vs 7.3 months)
- FDA approval already secured in October 2024
- No new safety signals observed in latest analysis
- None.
- Updated overall survival (OS) results - a key secondary endpoint - reinforce the significant benefit of the ItovebiTM (inavolisib)-based regimen for patients with advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer in the first-line setting
- Primary analysis showed the Itovebi-based regimen reached statistical significance, more than doubling progression-free survival in this patient population1
- Full OS results from the phase III INAVO120 study will be presented at an upcoming medical meeting
Basel, 28 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline results from the overall survival (OS) analysis of the phase III INAVO120 study investigating ItovebiTM (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant for people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The study met its key secondary endpoint, showing a statistically significant and clinically meaningful OS benefit with the Itovebi-based regimen compared with palbociclib and fulvestrant alone.
"The INAVO120 overall survival results show that the Itovebi-based regimen not only delayed disease progression, but also helped people with advanced HR-positive, PIK3CA-mutated breast cancer live longer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “These findings underscore our ambition to improve survival rates for people with breast cancer. The Itovebi-based regimen has the potential to become the new standard of care for these patients.”
These OS results build upon the previously reported primary analysis, which showed that the Itovebi-based regimen reduced the risk of disease worsening or death by
The U.S. Food and Drug Administration (FDA) approved the Itovebi-based regimen in October 2024 for the treatment of adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.2 Data from INAVO120, recently published in the New England Journal of Medicine, are also being reviewed by other global health authorities, including the European Medicines Agency.
Itovebi is currently being investigated in four company-sponsored phase III clinical studies (INAVO120, INAVO121, INAVO122, INAVO123) in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations.3-6 We are exploring additional studies in breast cancer and other tumour types with the hope of bringing the benefit of this targeted therapy to more people with PIK3CA-mutated cancer and addressing patient unmet needs.
About Itovebi TM (inavolisib)
Itovebi is an oral, targeted treatment with best-in-class potential that could provide well-tolerated, durable disease control and potentially improved outcomes for people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, who often have a poor prognosis and are in urgent need of new treatment options.1,7,8 Itovebi has been designed to help minimise the overall burden and toxicity of treatment and is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms, and unique mechanism of action that facilitates the degradation of mutated PI3K alpha.9,10
About the INAVO120 study
The INAVO120 study [NCT04191499] is a phase III, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.3
The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm.3 The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomisation in the clinical trial to the time when the disease progresses, or a patient dies from any cause.3 Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.3
Beyond INAVO120, Itovebi is currently being investigated in three additional company-sponsored phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations:4,5,6
- in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) and endocrine combination therapy (INAVO121; NCT05646862).
- in combination with pertuzumab plus trastuzumab for subcutaneous injection (SC) versus pertuzumab plus trastuzumab for SC and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239).
- in combination with CDK4/6i and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in endocrine-sensitive, PIK3CA-mutated HR-positive/HER2-negative breast cancer (INAVO123; NCT06790693).
About hormone receptor (HR)-positive breast cancer
HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately
About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including oestrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.11,12
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
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References
[1] Turner NC, et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. NEJM. 2024;391(17):1584-96.
[2] Roche. FDA approves Roche’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation [Internet; cited 2025 January]. Available from: https://www.roche.com/investors/updates/inv-update-2024-10-11b.
[3] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) [Internet; cited 2025 January]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT04191499.
[4] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) [Internet; cited 2025 January]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05646862.
[5] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer [Internet; cited 2025 January]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05894239.
[6] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123) [Internet; cited 2025 January]. Available from: https://clinicaltrials.gov/study/NCT06790693.
[7] Fillbrunn M, et al. PIK3CA mutation status, progression and survival in advanced HR+/HER2- breast cancer: a meta-analysis of published clinical trials. BMC Cancer. 2022;22:1002.
[8] Anderson E, et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer. Int J Breast Cancer. 2020;2020:3759179.
[9] Juric D, et al. A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA-mutated hormone receptor-positive/HER2-negative (HR+/HER2–) metastatic breast cancer. Presented at San Antonio Breast Cancer Symposium, 2020 December 7-10; San Antonio, USA. Abstract #P5-17-05.
[10] Hong R, et al. GDC-0077 is a selective PI3K alpha inhibitor that demonstrates robust efficacy in PIK3CA mutant breast cancer models as a single agent and in combination with standard of care therapies. Cancer Res. 2018;78(4):4-14.
[11] National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2025 January]. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.html.
[12] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696.
[13] Tomas R and Barrios CH. Optimal management of hormone receptor positive metastatic breast cancer in 2016. Ther Adv Med Oncol. 2015;7(6):304-20.
[14] Galipeau N, et al. Understanding key symptoms, side effects, and impacts of HR+/HER- advanced breast cancer: qualitative study findings. J Patient-Rep Outcomes. 2019;3(1):10.
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