Health Canada authorizes Itovebi® (inavolisib film-coated tablets), a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation Français
The approval provides another treatment option for breast cancer patients with a PIK3CA mutation, one of the most commonly mutated genes in hormone receptor-positive disease, associated with poor prognosis.1,2
MISSISSAUGA, ON, Feb. 19, 2025 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) today announced that Health Canada has granted authorization for Itovebi® (inavolisib film-coated tablets) in combination with palbociclib and fulvestrant, for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine treatment.3
"The Itovebi-based regimen offers a new treatment option for patients with HR-positive breast cancer with a PIK3CA mutation. As leaders in science and innovation, it builds on our longstanding commitment to advancing breast cancer care, and reflects our long-term strategic focus on the disease," said Dr. Dan Edgcumbe, Vice-President, Medical and Regulatory Affairs, Roche Canada. "As our first treatment targeting HR-positive, HER2-negative breast cancer, it is a key development in our mission to provide healthcare innovations to Canadians."
Breast cancer is the second leading cause of death from cancer in Canadian women.4 Mutations in the PIK3CA gene are found in approximately 40% of HR-positive breast cancers and are associated with poor prognosis.1 Study results showed that the Itovebi-based treatment regimen more than doubled progression-free survival in the patient population.3
"New drug treatment options are needed for patients with HR+, HER2- advanced breast cancer," said Dr. Phillipe Bedard, Medical Oncologist, Princess Margaret Cancer Centre, University Health Network Toronto. "Itovebi has shown improved outcomes for selected patients with endocrine resistant, PIK3CA mutation positive, HR+, HER2- advanced breast cancer with manageable side effects."
Health Canada's authorization of Itovebi is based on results of the pivotal Phase III INAVO120 study, which showed that the Itovebi-based treatment reduced the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the first-line metastatic setting, demonstrating a statistically significant benefit.3,5
Roche Canada is committed to working with the provincial and territorial jurisdictions to make Itovebi available as soon as possible through public and private drug plans for the patients who need it.
About Itovebi® (inavolisib)3
Itovebi is an oral, targeted treatment for people with PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer.Inavolisib is a selective inhibitor of phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) and also led to the degradation of mutated p110α (encoded by the PIK3CA gene). In PIK3CA-mutated breast cancer xenograft models, inavolisib reduced tumor growth, which increased when combined with the CDK4/6 inhibitor palbociclib and the endocrine therapy fulvestrant, as compared to any treatment alone or in doublet combinations.
About the INAVO120 study3
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, HR-positive, 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.6
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: INAVO121, INAVO122, INAVO123.7,8,9 Roche continues to evaluate opportunities to expand our clinical development programme to address patient unmet needs in various tumour types across oncology.
About hormone receptor (HR)-positive breast cancer
HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases.10-11 A defining feature of HR-positive breast cancer is that its tumour cells have receptors that attach to one or both hormones – oestrogen or progesterone – which can contribute to tumour growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options.10,12,13 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.2
About Roche Canada
At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies.
With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone.
And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries.
Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec.
For more information, please visit www.RocheCanada.com or follow Roche Canada on LinkedIn.
References
[1] 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. |
[2] 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. |
[3] Itovebi Product Monograph, February 14, 2025 |
[4] Canadian Cancer Society, Breast Cancer Statistics, May 2024. Available from: https://cancer.ca/en/cancer-information/cancer-types/breast/statistics |
[6] 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. |
[7] 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. |
[8] 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 January]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05894239. |
[9] 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. |
[10] 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. |
[11] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696. |
[12] 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. |
[13] 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. |
SOURCE Hoffmann-La Roche Limited (Roche Canada)
Media Contact: Jennifer Mota, Communications Manager, Hoffmann-La Roche Limited (Roche Canada), 437-219-7806, [email protected]
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