FDA approves Roche’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
Roche has received FDA approval for Itovebi™ (inavolisib), a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. The approval is based on the Phase III INAVO120 study results, which showed that the Itovebi-based regimen more than doubled progression-free survival compared to standard treatment in the first-line setting.
Itovebi, in combination with palbociclib and fulvestrant, is approved for adults with endocrine-resistant, PIK3CA-mutated breast cancer following recurrence on or after adjuvant endocrine therapy. The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers.
The INAVO120 study demonstrated that the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone. Itovebi will be available in the US in the coming weeks, marking an important step in Roche's efforts to bring innovative medicines to more people with breast cancer.
Roche ha ricevuto l'approvazione della FDA per Itovebi™ (inavolisib), un trattamento mirato per il carcinoma mammario avanzato positivo ai recettori ormonali e negativo per HER2 con una mutazione PIK3CA. L'approvazione si basa sui risultati dello studio di Fase III INAVO120, che ha dimostrato che il regime basato su Itovebi ha più che raddoppiato la sopravvivenza libera da progressione rispetto al trattamento standard in prima linea.
Itovebi, in combinazione con palbociclib e fulvestrant, è approvato per adulti con carcinoma mammario resistente agli ormoni e mutato per PIK3CA dopo recidiva a seguito di terapia endocrina adiuvante. La mutazione PIK3CA si trova in circa il 40% dei carcinomi mammari metastatizzati HR-positivi.
Lo studio INAVO120 ha dimostrato che il regime basato su Itovebi ha ridotto il rischio di aggravamento della malattia o morte del 57% rispetto a palbociclib e fulvestrant da soli. Itovebi sarà disponibile negli Stati Uniti nelle prossime settimane, segnando un passo importante negli sforzi di Roche per portare medicine innovative a un numero maggiore di persone affette da carcinoma mammario.
Roche ha recibido la aprobación de la FDA para Itovebi™ (inavolisib), un tratamiento dirigido para el cáncer de mama avanzado positivo a receptores hormonales y negativo para HER2 con una mutación PIK3CA. La aprobación se basa en los resultados del estudio de Fase III INAVO120, que mostró que el régimen basado en Itovebi más que duplicó la supervivencia libre de progresión en comparación con el tratamiento estándar en la primera línea.
Itovebi, en combinación con palbociclib y fulvestrant, está aprobado para adultos con cáncer de mama resistente a los endocrinos y mutado para PIK3CA después de la recurrencia tras terapia endocrina adyuvante. La mutación PIK3CA se encuentra en aproximadamente el 40% de los cánceres de mama metastásicos positivos a HR.
El estudio INAVO120 demostró que el régimen basado en Itovebi redujo el riesgo de empeoramiento de la enfermedad o muerte en un 57% en comparación con palbociclib y fulvestrant solos. Itovebi estará disponible en los EE. UU. en las próximas semanas, marcando un paso importante en los esfuerzos de Roche para llevar medicamentos innovadores a más personas con cáncer de mama.
로슈(Roche)는 Itovebi™ (이나볼리시브)에 대한 FDA 승인을 받았습니다. 이 약물은 호르몬 수용체 양성, HER2 음성 유방암으로 PIK3CA 변이가 있는 진행된 환자를 위한 표적 치료입니다. 승인은 3상 INAVO120 연구 결과에 기반하고 있으며, Itovebi 기반의 요법이 1차 치료에서 표준 치료에 비해 무진행 생존 기간을 두 배 이상 연장했음을 보여주었습니다.
Itovebi는 팔보시클립과 풀베스트란트와 함께 성전환 요법 후 재발한 내분비 저항성 PIK3CA 변이 유방암 성인 환자에게 승인되었습니다. PIK3CA 변이는 약 40%의 HR 양성 전이성 유방암에서 발견됩니다.
INAVO120 연구는 Itovebi 기반 요법이 단독으로 팔보시클립과 풀베스트란트를 사용했을 때에 비해 질병 악화 또는 사망 위험을 57% 감소시켰음을 입증했습니다. Itovebi는 앞으로 몇 주 내에 미국에서 출시될 예정이며, 이는 유방암 환자들에게 혁신적인 약물을 제공하기 위한 로슈의 중요한 진전을 의미합니다.
Roche a reçu l'approbation de la FDA pour Itovebi™ (inavolisib), un traitement ciblé pour le cancer du sein avancé positif aux récepteurs hormonaux et négatif pour HER2 avec une mutation PIK3CA. L'approbation est basée sur les résultats de l'étude de phase III INAVO120, qui ont montré que le régime basé sur Itovebi a plus que doublé la survie sans progression par rapport au traitement standard en première ligne.
Itovebi, en association avec palbociclib et fulvestrant, est approuvé pour les adultes présentant un cancer du sein muté PIK3CA et résistant aux endocrines après récurrence à la suite d'une thérapie endocrine adjuvante. La mutation PIK3CA se trouve dans environ 40% des cancers du sein métastatiques positifs aux HR.
L'étude INAVO120 a démontré que le régime basé sur Itovebi a réduit le risque d'aggravation de la maladie ou de décès de 57% par rapport à palbociclib et fulvestrant seuls. Itovebi sera disponible aux États-Unis dans les prochaines semaines, marquant une étape importante dans les efforts de Roche pour apporter des médicaments innovants à un plus grand nombre de personnes atteintes de cancer du sein.
Roche hat die FDA-Zulassung für Itovebi™ (Inavolisib) erhalten, eine gezielte Behandlung für fortgeschrittenen hormonrezeptor-positiven, HER2-negativen Brustkrebs mit einer PIK3CA-Mutation. Die Zulassung basiert auf den Ergebnissen der Phase-III-Studie INAVO120, die gezeigt hat, dass das auf Itovebi basierende Regime die progressionsfreie Überlebenszeit mehr als verdoppelt hat im Vergleich zu der Standardbehandlung in der Erstlinie.
Itovebi, in Kombination mit Palbociclib und Fulvestrant, ist für Erwachsene mit endokrin-resistentem, PIK3CA-mutiertem Brustkrebs nach einem Rezidiv während oder nach einer adjuvanten endokrinen Therapie zugelassen. Die PIK3CA-Mutation findet sich in etwa 40% der HR-positiven metastatischen Brustkrebserkrankungen.
Die INAVO120-Studie hat gezeigt, dass das auf Itovebi basierende Regime das Risiko einer Verschlechterung der Erkrankung oder eines Todes um 57% im Vergleich zu Palbociclib und Fulvestrant allein verringert hat. Itovebi wird in den kommenden Wochen in den USA erhältlich sein und stellt einen wichtigen Schritt in Roches Bemühungen dar, innovative Medikamente für mehr Menschen mit Brustkrebs verfügbar zu machen.
- FDA approval for Itovebi, a new targeted treatment for advanced HR-positive, HER2-negative breast cancer with PIK3CA mutation
- Itovebi-based regimen more than doubled progression-free survival compared to standard treatment
- 57% reduction in risk of disease worsening or death compared to palbociclib and fulvestrant alone
- Positive trend observed in overall survival data, though immature at primary analysis
- Granted FDA Priority Review and Breakthrough Therapy Designation in May 2024
- Overall survival data were immature at the time of primary analysis
- Approval is based on Phase III INAVO120 results, showing the Itovebi™ (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting1
- This approval helps address an urgent unmet need in breast cancer for people with a PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease, associated with poor prognosis2,3
- Itovebi is Roche’s first targeted therapy approved for people with HR-positive disease, the most prevalent breast cancer subtype, marking an important step in our ambition to continue bringing innovative medicines to more people with breast cancer4,5
Basel, 11 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (FDA) approved Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. The PIK3CA mutation is found in approximately
“The PI3K pathway plays a pivotal role in disease progression and has been challenging to target,” said Komal Jhaveri, M.D., section head for the endocrine therapy research portfolio and clinical director of the early drug development service at Memorial Sloan Kettering Cancer Center, and one of the principal investigators of the INAVO120 study. “The Itovebi-based regimen more than doubled progression-free survival and maintained a manageable safety and tolerability profile, adding a new standard in how PIK3CA-mutated breast cancers are treated."
"With the approval of this Itovebi-based regimen, we continue our long-standing track record of cancer therapeutic discovery by offering an important new first-line option for people living with HR-positive breast cancer with a PIK3CA mutation,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Despite the high prevalence of PIK3CA mutations in this setting, treatment options have thus far remained limited, which makes today’s approval all the more significant.”
This approval is based on results of the pivotal Phase III INAVO120 study, which showed that the Itovebi-based regimen reduced the risk of disease worsening or death by
“We are thrilled by the approval of the Itovebi-based regimen, which is a huge step forward for advanced breast cancer patients with a PIK3CA mutation,” said Jean Sachs, CEO of Living Beyond Breast Cancer. “It remains critical that all patients have access to early, comprehensive biomarker testing so they can better understand what treatment options may be most beneficial for them and their tumour type.”
The Itovebi-based regimen was granted FDA Priority Review and Breakthrough Therapy Designation in May 2024 based on the INAVO120 study results.6,7 Data from INAVO120 are also being used for filing submissions to other global health authorities, including the European Medicines Agency. Itovebi will be available in the US in the coming weeks. Early, comprehensive biomarker testing with an FDA-approved test, such as Foundation Medicine’s FoundationOne®Liquid CDx, can help identify people with HR-positive, HER2-negative breast cancer with a PIK3CA mutation.
Itovebi is currently being investigated in various combinations across three company-sponsored Phase III clinical studies (INAVO120, INAVO121, INAVO122) in PIK3CA-mutated locally advanced or metastatic breast cancer.8-10 We continue to evaluate opportunities to expand our clinical development programme to address patient unmet needs in various tumour types across oncology.
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.8
The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm.8 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.8 Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.8
Beyond INAVO120, Itovebi is currently being investigated in two additional company-sponsored Phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations:9,10
- in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 inhibitor and endocrine combination therapy (INAVO121; NCT05646862), and
- 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).
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.4,5
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.
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References
[1] Jhaveri K, et al. Phase III study of inavolisib or placebo in combination with palbociclib and fulvestrant in patients with PIK3CA-mutant, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer: INAVO120 primary analysis. Presented at San Antonio Breast Cancer Symposium, 2023 December 5-9; San Antonio, USA. Abstract #GS03-13.
[2] 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.
[3] 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.
[4] National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2024 October]. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.html.
[5] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696.
[6] Roche. FDA grants Priority Review to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation [Internet; cited 2024 October]. Available from: https://www.roche.com/media/releases/med-cor-2024-05-29.
[7] Roche. FDA grants Breakthrough Therapy Designation to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation [Internet; cited 2024 October]. Available from: https://www.roche.com/media/releases/med-cor-2024-05-21.
[8] 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 2024 October]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT04191499.
[9] 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 2024 October]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05646862.
[10] 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 2024 October]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05894239.
[11] 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.
[12] 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.
Dr. Jhaveri has financial interests related to Roche and Genentech.
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