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RHHBY Reports Positive Phase III Data on Breast Cancer Drug
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Key Takeaways
Roche's giredestrant showed significant invasive disease-free survival benefit in the phase III lidERA study.
This is the first SERD study in the adjuvant setting to deliver a meaningful advantage over standard therapy.
Positive interim data follow an earlier phase III win and support giredestrant's breast cancer program
Roche (RHHBY - Free Report) announced positive data from the late-stage lidERA Breast Cancer study on pipeline candidate giredestrant.
Giredestrant is an investigational, oral, potent next-generation selective oestrogen receptor degrader (SERD) and full antagonist.
At interim analysis, giredestrant demonstrated a statistically significant and clinically meaningful benefit versus standard-of-care endocrine monotherapy.
More on RHHBY’s Breast Cancer Study
lidERA Breast Cancer is a phase III, randomized, open-label, multicentre study evaluating the efficacy and safety of adjuvant giredestrant versus standard-of-care endocrine therapy in patients with medium- or high-risk stage I-III oestrogen receptor(ER)-positive, human epidermal growth factor receptor 2- (HER2)- negative breast cancer.
The study enrolled approximately 4,100 patients. The primary endpoint of this study is invasive disease-free survival (iDFS), excluding unrelated cancers in other organs (second primary non-breast cancers). Key secondary endpoints include overall survival and iDFS, including second primary non-breast cancers, disease-free survival and safety.
The study met its primary endpoint at a pre-planned interim analysis. Data showed a statistically significant and clinically meaningful improvement in iDFS with giredestrant versus standard-of-care endocrine therapy.
Per RHHBY, lidERA is the first phase III trial of a SERD to demonstrate a significant benefit in the adjuvant setting.
The positive results also demonstrate the potential of giredestrant as a new endocrine therapy of choice for early-stage breast cancer patients who stand a chance of getting cured.
While overall survival data were immature at the time of interim analysis, a clear positive trend was observed.
lidERA is the second positive phase III readout for giredestrant following the evERA Breast Cancer study.
The successful development of giredestrant will boost RHHBY’s breast cancer franchise as ER-positive breast cancer accounts for approximately 70% of cases diagnosed.
RHHBY’s Strong Breast Cancer Franchise
Roche breast cancer franchise includes Herceptin, Perjeta and Kadcyla. While 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.
Roche’s shares have risen 27.8% year to date compared with the industry’s growth of 14.3%.
Image Source: Zacks Investment Research
The approval of inavolisib for the treatment of breast cancer, under the brand name Itovebi, further bolstered the franchise. The drug is approved in combination with Ibrance (palbociclib) and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (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.
Roche is also evaluating giredestrant in an extensive clinical development program in five company-sponsored phase III clinical trials that span multiple treatment settings and lines of therapy.
The FDA recently approved Eli Lilly’s (LLY - Free Report) imlunestrant, an estrogen receptor antagonist, for adults with ER-positive, HER2-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
LLY obtained FDA approval of the drug under the brand name Inluriyo. The drug is also currently being studied in combination with abemaciclib for advanced breast cancer and as an adjuvant treatment in early breast cancer
Alkermes’ EPS estimates for 2025 have increased to $1.96 from $1.83, while those for 2026 have risen from $1.70 to $1.77 in the past 30 days. The stock has gained 2% year to date.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 4.58%.
Bayer’s shares have risen 64.2% so far this year. Estimates for its 2025 EPS have increased from $1.37 to $1.40 over the past 60 days, while those for 2026 EPS have risen from $1.44 to $1.45.
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RHHBY Reports Positive Phase III Data on Breast Cancer Drug
Key Takeaways
Roche (RHHBY - Free Report) announced positive data from the late-stage lidERA Breast Cancer study on pipeline candidate giredestrant.
Giredestrant is an investigational, oral, potent next-generation selective oestrogen receptor degrader (SERD) and full antagonist.
At interim analysis, giredestrant demonstrated a statistically significant and clinically meaningful benefit versus standard-of-care endocrine monotherapy.
More on RHHBY’s Breast Cancer Study
lidERA Breast Cancer is a phase III, randomized, open-label, multicentre study evaluating the efficacy and safety of adjuvant giredestrant versus standard-of-care endocrine therapy in patients with medium- or high-risk stage I-III oestrogen receptor(ER)-positive, human epidermal growth factor receptor 2- (HER2)- negative breast cancer.
The study enrolled approximately 4,100 patients. The primary endpoint of this study is invasive disease-free survival (iDFS), excluding unrelated cancers in other organs (second primary non-breast cancers). Key secondary endpoints include overall survival and iDFS, including second primary non-breast cancers, disease-free survival and safety.
The study met its primary endpoint at a pre-planned interim analysis. Data showed a statistically significant and clinically meaningful improvement in iDFS with giredestrant versus standard-of-care endocrine therapy.
Per RHHBY, lidERA is the first phase III trial of a SERD to demonstrate a significant benefit in the adjuvant setting.
The positive results also demonstrate the potential of giredestrant as a new endocrine therapy of choice for early-stage breast cancer patients who stand a chance of getting cured.
While overall survival data were immature at the time of interim analysis, a clear positive trend was observed.
lidERA is the second positive phase III readout for giredestrant following the evERA Breast Cancer study.
The successful development of giredestrant will boost RHHBY’s breast cancer franchise as ER-positive breast cancer accounts for approximately 70% of cases diagnosed.
RHHBY’s Strong Breast Cancer Franchise
Roche breast cancer franchise includes Herceptin, Perjeta and Kadcyla. While 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.
Roche’s shares have risen 27.8% year to date compared with the industry’s growth of 14.3%.
Image Source: Zacks Investment Research
The approval of inavolisib for the treatment of breast cancer, under the brand name Itovebi, further bolstered the franchise. The drug is approved in combination with Ibrance (palbociclib) and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (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.
Roche is also evaluating giredestrant in an extensive clinical development program in five company-sponsored phase III clinical trials that span multiple treatment settings and lines of therapy.
The FDA recently approved Eli Lilly’s (LLY - Free Report) imlunestrant, an estrogen receptor antagonist, for adults with ER-positive, HER2-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
LLY obtained FDA approval of the drug under the brand name Inluriyo. The drug is also currently being studied in combination with abemaciclib for advanced breast cancer and as an adjuvant treatment in early breast cancer
RHHBY’s Zacks Rank and Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold). A couple of better-ranked pharma/biotech stocks are Alkermes (ALKS - Free Report) and Bayer (BAYRY - Free Report) . While ALKS currently sports a Zacks Rank #1 (Strong Buy), Bayer carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ EPS estimates for 2025 have increased to $1.96 from $1.83, while those for 2026 have risen from $1.70 to $1.77 in the past 30 days. The stock has gained 2% year to date.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 4.58%.
Bayer’s shares have risen 64.2% so far this year. Estimates for its 2025 EPS have increased from $1.37 to $1.40 over the past 60 days, while those for 2026 EPS have risen from $1.44 to $1.45.