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Roche (RHHBY) Breast Cancer Drug Meets Primary Goal in Phase III
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Roche (RHHBY - Free Report) announced that the late-stage INAVO120 study, in patients suffering from PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer, met its primary endpoint.
This phase III, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of experimental candidate inavolisib in combination with Pfizer’s (PFE - Free Report) Ibrance (palbociclib) and Faslodex (fulvestrant) compared with placebo in combination with Ibrance and Faslodex in 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.
The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm.
The study met its primary goal of progression-free survival, demonstrating a statistically significant and clinically meaningful improvement compared with palbociclib and fulvestrant alone. Roche stated that a clear positive trend has been observed in the overall survival data. However, the data was immature at that time and follow-up will continue with the following analysis.
Inavolisib is an oral therapy with high in vitro potency and selectivity for PI3Kα inhibition and the ability to specifically trigger the breakdown of mutant PI3Kα protein. Inavolisib is currently being investigated in three phase III clinical studies in people with PIK3CA-mutated metastatic breast cancer (INAVO120, INAVO121, INAVO122) in various combinations.
HR-positive breast cancer is the most prevalent type of breast cancer wherein tumor cells have receptors that attach to one or both hormones – estrogen or progesterone – which can contribute to tumor growth. Patients diagnosed with the same often face the risk of disease progression and treatment side effects, creating a need for additional treatment options.
Per Roche, the PI3K signaling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism for resistance to endocrine therapy and CDK4/6 inhibitors.
Roche had a leading breast cancer franchise, which included Herceptin, Perjeta and Kadcyla. However, Herceptin is being affected by biosimilar competition. Kadcyla is performing well, driven by increased demand from patients with residual disease after surgery. The approval of the fixed-dose combination of Perjeta and Herceptin as Phesgo has strengthened the portfolio.
The approval of additional drugs will boost the franchise.
Pfizer’s Ibrance is one of the leading drugs approved for HR+, HER2- breast cancer that has spread to other parts of the body (metastatic) in combination with an aromatase inhibitor as the first hormonal-based therapy or fulvestrant in people with disease progression following hormonal therapy.
Roche's shares have lost 9.5% year to date against the industry’s growth of 5.5%.
Image Source: Zacks Investment Research
The company recently announced that it will acquire the privately owned U.S.-based company Carmot Therapeutics for $2.7 billion in a bid to foray into the lucrative obesity market. Shares gained 3.08% on the news.
Roche’s performance in 2023 has been impacted by a sharp decline in COVID-19 test sales and exchange rate fluctuations, even though the diagnostics base business and newer drugs maintained their growth.
New drugs, namely Ocrevus, Hemlibra, Evrysdi and Tecentriq, boosted growth and the uptake of the new eye drug Vabysmo (launched at the beginning of 2022) was outstanding.
However, competition from biosimilars for established cancer medicines like Avastin, MabThera/Rituxan and Herceptin hurt sales.
Entrada’s loss per share estimates for 2023 have narrowed from $2.07 to 9 cents in the past 30 days. During the same period, loss estimates for 2024 narrowed to $2.04 from $2.35.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 12 cents in the past 30 days. During the same period, earnings estimates for 2024 rose from 8 cents to 18 cents. Shares of DVAX have gained 30.8% year to date.
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Roche (RHHBY) Breast Cancer Drug Meets Primary Goal in Phase III
Roche (RHHBY - Free Report) announced that the late-stage INAVO120 study, in patients suffering from PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer, met its primary endpoint.
This phase III, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of experimental candidate inavolisib in combination with Pfizer’s (PFE - Free Report) Ibrance (palbociclib) and Faslodex (fulvestrant) compared with placebo in combination with Ibrance and Faslodex in 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.
The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm.
The study met its primary goal of progression-free survival, demonstrating a statistically significant and clinically meaningful improvement compared with palbociclib and fulvestrant alone. Roche stated that a clear positive trend has been observed in the overall survival data. However, the data was immature at that time and follow-up will continue with the following analysis.
Inavolisib is an oral therapy with high in vitro potency and selectivity for PI3Kα inhibition and the ability to specifically trigger the breakdown of mutant PI3Kα protein. Inavolisib is currently being investigated in three phase III clinical studies in people with PIK3CA-mutated metastatic breast cancer (INAVO120, INAVO121, INAVO122) in various combinations.
HR-positive breast cancer is the most prevalent type of breast cancer wherein tumor cells have receptors that attach to one or both hormones – estrogen or progesterone – which can contribute to tumor growth. Patients diagnosed with the same often face the risk of disease progression and treatment side effects, creating a need for additional treatment options.
Per Roche, the PI3K signaling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism for resistance to endocrine therapy and CDK4/6 inhibitors.
Roche had a leading breast cancer franchise, which included Herceptin, Perjeta and Kadcyla. However, Herceptin is being affected by biosimilar competition. Kadcyla is performing well, driven by increased demand from patients with residual disease after surgery. The approval of the fixed-dose combination of Perjeta and Herceptin as Phesgo has strengthened the portfolio.
The approval of additional drugs will boost the franchise.
Pfizer’s Ibrance is one of the leading drugs approved for HR+, HER2- breast cancer that has spread to other parts of the body (metastatic) in combination with an aromatase inhibitor as the first hormonal-based therapy or fulvestrant in people with disease progression following hormonal therapy.
Roche's shares have lost 9.5% year to date against the industry’s growth of 5.5%.
Image Source: Zacks Investment Research
The company recently announced that it will acquire the privately owned U.S.-based company Carmot Therapeutics for $2.7 billion in a bid to foray into the lucrative obesity market. Shares gained 3.08% on the news.
Roche’s performance in 2023 has been impacted by a sharp decline in COVID-19 test sales and exchange rate fluctuations, even though the diagnostics base business and newer drugs maintained their growth.
New drugs, namely Ocrevus, Hemlibra, Evrysdi and Tecentriq, boosted growth and the uptake of the new eye drug Vabysmo (launched at the beginning of 2022) was outstanding.
However, competition from biosimilars for established cancer medicines like Avastin, MabThera/Rituxan and Herceptin hurt sales.
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #4 (Sell).
A couple of better-ranked stocks in the overall healthcare sector are Entrada Therapeutics (TRDA - Free Report) and Dynavax Technologies (DVAX - Free Report) . While TRDA sports a Zacks Rank #1 (Strong Buy), DVAX carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Entrada’s loss per share estimates for 2023 have narrowed from $2.07 to 9 cents in the past 30 days. During the same period, loss estimates for 2024 narrowed to $2.04 from $2.35.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 12 cents in the past 30 days. During the same period, earnings estimates for 2024 rose from 8 cents to 18 cents. Shares of DVAX have gained 30.8% year to date.