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Roche's Breast Cancer Drug Cuts Risk of Death by 30% in Phase III
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Key Takeaways
Roche reports giredestrant cut invasive disease recurrence or death risk by 30% v/s standard therapy.
92.4% of patients on giredestrant were disease-free at three years versus 89.6% on standard care.
Roche data showed a 31% reduction in distant recurrence-free interval with manageable safety.
Roche (RHHBY - Free Report) announced positive new data from a pre-specified interim analysis of its late-stage breast cancer study on pipeline candidate giredestrant, an investigational, oral, potent next-generation SERD and full antagonist.
Last month, Roche reported separate interim analysis data, demonstrating that the phase III lidERA Breast Cancer study met its primary endpoint of invasive disease-free survival (iDFS), with statistically significant and clinically meaningful improvement upon giredestrant treatment compared to standard-of-care endocrine therapy (SoC ET). However, the extent of the benefit was not disclosed.
In the latest press release, Roche announced that treatment with giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% (iDFS) in the lidERA Breast Cancer study compared with SoC ET. RHHBY shares gained 3.6% on Wednesday, following the encouraging news.
More on RHBBY’s Interim Data From Breast Cancer Study
Roche’s lidERA Breast Cancer is a phase III study evaluating the efficacy and safety of adjuvant giredestrant compared to SoC ET in approximately 4,100 patients with medium- or high-risk stage I-III ER-positive, HER2-negative breast cancer.
RHBBY reported that at the three-year mark, 92.4% of patients treated with giredestrant were alive and free of invasive disease compared with 89.6% on SoC ET, and this iDFS advantage was consistent across all key subgroups. Although overall survival data remain immature, the analysis showed a positive trend, with further follow-up ongoing. The therapy also demonstrated a 31% risk reduction of distant recurrence-free interval, reinforcing its potential clinical impact. Safety remained manageable and aligned with the candidate’s established profile, supporting its viability as a competitive next-generation endocrine therapy option.
Roche’s shares have risen 41.7% in the past year compared with the industry’s growth of 7.2%.
Image Source: Zacks Investment Research
ER-positive breast cancer represents about 70% of breast cancer cases, most of which are detected early, yet up to a third of patients still face recurrence despite adjuvant endocrine therapy. Many also discontinue treatment early due to tolerability issues, heightening mortality risk. These challenges highlight the need for more effective and better-tolerated therapies that support adherence and reduce the likelihood of disease returning.
Per Roche, giredestrant has emerged as the first oral SERD to demonstrate superior iDFS in the adjuvant setting, with lidERA marking its second positive phase III outcome after the evERA Breast Cancer study results in the metastatic setting. Its scientific foundation is reinforced by earlier neoadjuvant data, including the coopERA study, which showed stronger suppression of tumor cell proliferation compared to an aromatase inhibitor. Together, these findings build a consistent body of evidence that giredestrant may deliver improved outcomes over SOC ET across both early-stage and advanced ER-positive breast cancer.
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.
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, 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 studies that span multiple treatment settings and lines of therapy.
In September, the FDA approved Eli Lilly’s (LLY - Free Report) imlunestrant, an estrogen receptor antagonist, for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Eli Lilly obtained FDA approval of the drug under the brand name Inluriyo. LLY is also currently evaluating the drug in combination with Verzenio (abemaciclib) for advanced breast cancer and as an adjuvant treatment in early breast cancer.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has gained 30.7% in the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $7.29 to $7.54 for 2025. During the same time, EPS estimates for 2026 have improved from $7.79 to $8.15. In the past year, shares of ANIP have rallied 45.1%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.
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Roche's Breast Cancer Drug Cuts Risk of Death by 30% in Phase III
Key Takeaways
Roche (RHHBY - Free Report) announced positive new data from a pre-specified interim analysis of its late-stage breast cancer study on pipeline candidate giredestrant, an investigational, oral, potent next-generation SERD and full antagonist.
Last month, Roche reported separate interim analysis data, demonstrating that the phase III lidERA Breast Cancer study met its primary endpoint of invasive disease-free survival (iDFS), with statistically significant and clinically meaningful improvement upon giredestrant treatment compared to standard-of-care endocrine therapy (SoC ET). However, the extent of the benefit was not disclosed.
In the latest press release, Roche announced that treatment with giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% (iDFS) in the lidERA Breast Cancer study compared with SoC ET. RHHBY shares gained 3.6% on Wednesday, following the encouraging news.
More on RHBBY’s Interim Data From Breast Cancer Study
Roche’s lidERA Breast Cancer is a phase III study evaluating the efficacy and safety of adjuvant giredestrant compared to SoC ET in approximately 4,100 patients with medium- or high-risk stage I-III ER-positive, HER2-negative breast cancer.
RHBBY reported that at the three-year mark, 92.4% of patients treated with giredestrant were alive and free of invasive disease compared with 89.6% on SoC ET, and this iDFS advantage was consistent across all key subgroups. Although overall survival data remain immature, the analysis showed a positive trend, with further follow-up ongoing. The therapy also demonstrated a 31% risk reduction of distant recurrence-free interval, reinforcing its potential clinical impact. Safety remained manageable and aligned with the candidate’s established profile, supporting its viability as a competitive next-generation endocrine therapy option.
Roche’s shares have risen 41.7% in the past year compared with the industry’s growth of 7.2%.
Image Source: Zacks Investment Research
ER-positive breast cancer represents about 70% of breast cancer cases, most of which are detected early, yet up to a third of patients still face recurrence despite adjuvant endocrine therapy. Many also discontinue treatment early due to tolerability issues, heightening mortality risk. These challenges highlight the need for more effective and better-tolerated therapies that support adherence and reduce the likelihood of disease returning.
Per Roche, giredestrant has emerged as the first oral SERD to demonstrate superior iDFS in the adjuvant setting, with lidERA marking its second positive phase III outcome after the evERA Breast Cancer study results in the metastatic setting. Its scientific foundation is reinforced by earlier neoadjuvant data, including the coopERA study, which showed stronger suppression of tumor cell proliferation compared to an aromatase inhibitor. Together, these findings build a consistent body of evidence that giredestrant may deliver improved outcomes over SOC ET across both early-stage and advanced ER-positive breast cancer.
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.
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, 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 studies that span multiple treatment settings and lines of therapy.
In September, the FDA approved Eli Lilly’s (LLY - Free Report) imlunestrant, an estrogen receptor antagonist, for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Eli Lilly obtained FDA approval of the drug under the brand name Inluriyo. LLY is also currently evaluating the drug in combination with Verzenio (abemaciclib) for advanced breast cancer and as an adjuvant treatment in early breast cancer.
Roche Holding AG Price and Consensus
Roche Holding AG price-consensus-chart | Roche Holding AG Quote
RHHBY’s Zacks Rank and Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector include CorMedix (CRMD - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has gained 30.7% in the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.
In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $7.29 to $7.54 for 2025. During the same time, EPS estimates for 2026 have improved from $7.79 to $8.15. In the past year, shares of ANIP have rallied 45.1%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.