European Commission approves Roche鈥檚 Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation
Roche (OTCQX:RHHBY) has received European Commission approval for Itovebi鈩� (inavolisib), in combination with palbociclib and fulvestrant, for treating PIK3CA-mutated, ER-positive, HER2-negative advanced breast cancer. The approval follows significant results from the phase III INAVO120 trial.
The Itovebi-based regimen demonstrated a 57% reduction in disease progression risk, extending progression-free survival to 15.0 months versus 7.3 months for the control group. Final analysis showed a 33% reduction in death risk and delayed chemotherapy necessity by approximately two years. The treatment targets PIK3CA mutations, present in up to 40% of ER-positive breast cancers.
Roche (OTCQX:RHHBY) ha ottenuto l'approvazione della Commissione Europea per Itovebi鈩� (inavolisib), in combinazione con palbociclib e fulvestrant, per il trattamento del carcinoma mammario avanzato con mutazione PIK3CA, positivo per ER e negativo per HER2. L'approvazione segue i risultati significativi dello studio di fase III INAVO120.
Il regime a base di Itovebi ha mostrato una riduzione del 57% del rischio di progressione della malattia, prolungando la sopravvivenza libera da progressione a 15,0 mesi contro 7,3 mesi nel gruppo di controllo. L'analisi finale ha evidenziato una riduzione del 33% del rischio di morte e un ritardo nell'esigenza di chemioterapia di circa due anni. Il trattamento 猫 mirato alle mutazioni PIK3CA, presenti fino al 40% dei tumori al seno ER-positivi.
Roche (OTCQX:RHHBY) ha recibido la aprobaci贸n de la Comisi贸n Europea para Itovebi鈩� (inavolisib), en combinaci贸n con palbociclib y fulvestrant, para el tratamiento del c谩ncer de mama avanzado con mutaci贸n PIK3CA, ER positivo y HER2 negativo. La aprobaci贸n sigue a los resultados significativos del ensayo de fase III INAVO120.
El r茅gimen basado en Itovebi demostr贸 una reducci贸n del 57% en el riesgo de progresi贸n de la enfermedad, extendiendo la supervivencia libre de progresi贸n a 15,0 meses frente a 7,3 meses en el grupo de control. El an谩lisis final mostr贸 una reducci贸n del 33% en el riesgo de muerte y retras贸 la necesidad de quimioterapia aproximadamente dos a帽os. El tratamiento se dirige a las mutaciones PIK3CA, presentes en hasta el 40% de los c谩nceres de mama ER positivos.
搿涤妶(翱罢颁蚕齿:搁贬贬叠驰)电� 滨迟辞惫别产颈鈩�(鞚措倶氤茧Μ鞁�)毳� 韺旊炒鞁滍伌毽� 氚� 頀�氩犾姢韸鸽瀫韸胳檧 氤戩毄頃橃棳 PIK3CA 霃岇棸氤�鞚搓皜 鞛埖鐢 ER 鞏戩劚, HER2 鞚岇劚 歆勴枆靹� 鞙犽癌鞎� 旃橂鞐� 雽�頃� 鞙犽熃鞐绊暕 歆戫枆鞙勳洂須岇潣 鞀轨澑鞚� 氚涭晿鞀惦媹雼�. 鞚措矆 鞀轨澑鞚� 3靸� INAVO120 鞛勳儊鞁滍棙鞚� 欷戩殧頃� 瓴瓣臣鞐� 霐半ジ 瓴冹瀰雼堧嫟.
Itovebi 旮半皹 旃橂氩曥潃 歆堧硲 歆勴枆 鞙勴棙鞚� 57% 臧愳唽鞁滌及鞙茧┌, 氍挫頄� 靸濎〈旮瓣皠鞚� 雽�臁瓣蛋鞚� 7.3臧滌洈 雽�牍� 15.0臧滌洈搿� 鞐办灔頄堨姷雼堧嫟. 斓滌 攵勳劃鞐愳劀电� 靷 鞙勴棙鞚� 33% 臧愳唽鞁滍偆瓿� 頇旐暀鞖旊矔 頃勳殧靹膘潉 鞎� 2雲� 歆�鞐�鞁滌及鞀惦媹雼�. 鞚� 旃橂氩曥潃 ER 鞏戩劚 鞙犽癌鞎旍潣 斓滊寑 40%鞐愳劀 氚滉铂霅樀鐢 PIK3CA 霃岇棸氤�鞚措ゼ 響滌爜鞙茧 頃╇媹雼�.
Roche (OTCQX:RHHBY) a obtenu l'approbation de la Commission europ茅enne pour Itovebi鈩� (inavolisib), en association avec le palbociclib et le fulvestrant, pour le traitement du cancer du sein avanc茅 mut茅 PIK3CA, ER positif et HER2 n茅gatif. Cette approbation fait suite aux r茅sultats significatifs de l'essai de phase III INAVO120.
Le traitement 脿 base d'Itovebi a montr茅 une r茅duction de 57 % du risque de progression de la maladie, prolongeant la survie sans progression 脿 15,0 mois contre 7,3 mois dans le groupe t茅moin. L'analyse finale a r茅v茅l茅 une r茅duction de 33 % du risque de d茅c猫s et un retard d'environ deux ans avant la n茅cessit茅 d'une chimioth茅rapie. Ce traitement cible les mutations PIK3CA, pr茅sentes dans jusqu'脿 40 % des cancers du sein ER positifs.
Roche (OTCQX:RHHBY) hat die Zulassung der Europ盲ischen Kommission f眉r Itovebi鈩� (Inavolisib) in Kombination mit Palbociclib und Fulvestrant zur Behandlung von PIK3CA-mutiertem, ER-positivem, HER2-negativem fortgeschrittenem Brustkrebs erhalten. Die Zulassung folgt auf bedeutende Ergebnisse der Phase-III-Studie INAVO120.
Das auf Itovebi basierende Regime zeigte eine 57%ige Reduktion des Krankheitsprogressionsrisikos und verl盲ngerte das progressionsfreie 脺berleben auf 15,0 Monate gegen眉ber 7,3 Monaten in der Kontrollgruppe. Die Endanalyse zeigte eine 33%ige Reduktion des Sterberisikos und verz枚gerte die Notwendigkeit einer Chemotherapie um etwa zwei Jahre. Die Behandlung zielt auf PIK3CA-Mutationen ab, die bei bis zu 40% der ER-positiven Brustkrebserkrankungen vorkommen.
- Significant 57% reduction in disease progression or death risk
- 33% reduction in death risk in final overall survival analysis
- Extended progression-free survival to 15.0 months vs 7.3 months in control group
- Delayed time to chemotherapy by approximately two years
- Well-tolerated treatment with no new safety signals
- First PI3K-targeted therapy to significantly extend survival
- Limited to specific breast cancer subtype (PIK3CA-mutated, ER-positive, HER2-negative)
- Only approved for patients with recurrence within 12 months of adjuvant endocrine treatment
- Approval based on INAVO120 data showing the Itovebi鈩� (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone1
- Up to
40% of ER-positive breast cancers have a PIK3CA mutation and are associated with poor prognosis; this approval helps address an urgent unmet need2-4 - Itovebi is the first PI3K-targeted therapy to significantly extend survival, reinforcing the need for biomarker testing at diagnosis5
Basel, 23 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved听Itovebi鈩� (inavolisib), in combination with palbociclib (Ibrance庐) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.
鈥淚tovebi is the first treatment of its kind to improve survival outcomes for those living with PIK3CA-mutated, ER-positive advanced breast cancer,鈥� said Levi Garraway, MD, PhD, Roche鈥檚 Chief Medical Officer and Head of Global Product Development. 鈥淭herefore, the Itovebi-based regimen may help address an important unmet need for people with this subtype of breast cancer.鈥�
The approval is based on results from the phase III INAVO120 trial, published in the in October 2024, which showed a
These results were reinforced by the INAVO120 final overall survival analysis that showed the Itovebi-based regimen reduced the risk of death by
Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations.6-8 We are exploring additional studies in breast cancer and other tumour types with the hope of providing the benefit of this targeted therapy to more people with PIK3CA mutations.
About Itovebi TM (inavolisib)
Itovebi is an oral, targeted treatment that has been shown to provide well-tolerated and durable disease control in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced breast cancer, who often have a poor prognosis and are in urgent need of new treatment options.1,4,9 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.10,11
In addition to the European Commission鈥檚 approval, the Itovebi-based regimen is also approved for the treatment of adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer in the United States, Switzerland, Canada, Australia, United Arab Emirates, China and Taiwan, with data from INAVO120 under review with several other global health authorities.
About the INAVO120 study
The INAVO120 study [] is a phase III, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi鈩� (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.12
The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm.12 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.12 Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.12
Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations:
- in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine combination therapy (INAVO121; ).6
- 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; ).7
- in combination with CDK4/6 inhibitor and letrozole versus placebo plus a CDK4/6 inhibitor and letrozole in the first-line setting in PIK3CA-mutated HR-positive/HER2-negative, endocrine-sensitive breast cancer (INAVO123; ).8
About oestrogen receptor (ER)-positive breast cancer
ER-positive is a subtype of hormone receptor (HR)-positive breast cancer, the most prevalent type of all breast cancers, accounting for approximately
People diagnosed with ER-positive and HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options.14,16,17 The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors.9
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.13,14
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world鈥檚 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鈥檚 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 .
All trademarks used or mentioned in this release are protected by law.
References
[1] Turner NC, et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. NEJM. 2024;391(17):1584-96.
[2] Cizkova M, et al. Gene expression profiling reveals new aspects of PIK3CA mutation in ERalpha-positive breast cancer: major implication of the Wnt signaling pathway. PLoS One. 2010;30;5(12):e15647.
[3] Schagerholm C, et al. PIK3CA mutations in endocrine-resistant breast cancer. Scientific Reports. 2024;14:12542.
[4] 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(1):1002.
[5] Jhaveri KL, et al. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. 2025;40454641.
[6] 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 June]. Available from: .
[7] 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 (INAVO122) [Internet; cited 2025 June]. Available from: .
[8] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/鈥�6 Inhibitor and Letrozole vs Placebo + CDK4/鈥�6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123) [Internet; cited 2025 June]. Available from: .
[9] Anderson E, et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2鈥� Metastatic Breast Cancer. Int J Breast Cancer. 2020;2020:3759179.
[10] 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鈥�) metastatic breast cancer. Presented at San Antonio Breast Cancer Symposium, 2020 December 7-10; San Antonio, USA. Abstract #P5-17-05.
[11] 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.
[12] 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 June]. Available from: 听.
[13] National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2025 June]. Available from: .
[14] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696.
[15] Wu VS, et al. From bench to bedside: What do we know about hormone receptor-positive and human epidermal growth factor receptor 2-positive breast cancer? J Steroid Biochem Mol Biol. 2015 Sep;153:45-53.
[16] 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.
[17] 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.
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: [email protected]
| Hans Trees, PhD Phone: +41 79 407 72 58 | Sileia Urech Phone: +41 79 935 81 48 |
| Nathalie Altermatt Phone: +41 79 771 05 25 | Lorena Corfas Phone: +41 79 568 24 95 |
| Simon Goldsborough Phone: +44 797 32 72 915 | Karsten Kleine Phone: +41 79 461 86 83 |
| Kirti Pandey Phone: +49 172 6367262 | Yvette Petillon Phone: +41 79 961 92 50 |
| Dr Rebekka Schnell Phone: +41 79 205 27 03 | 听 |
Roche Investor Relations
| Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: [email protected] | Dr Sabine Borngr盲ber Phone: +41 61 68-88027 e-mail: [email protected] |
| Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: [email protected] | 听 |
Investor Relations North America
| Loren Kalm Phone: +1 650 225 3217 e-mail: [email protected] | 听 |
Attachment
FAQ
What is the significance of Roche's Itovebi approval by the European Commission?
What are the key clinical trial results for Roche's Itovebi (RHHBY)?
How effective is Itovebi for breast cancer treatment?
What type of breast cancer patients can receive Itovebi treatment?
What percentage of breast cancer patients could benefit from Itovebi?
