Roche Wins FDA Nod for Breast Cancer Drug in First-Line Setting

Roche RHHBY announced that the FDA has approved pipeline candidate, inavolisib, for the treatment of breast cancer, under the brand name Itovebi.

The drug is approved in combination with Pfizer’s Ibrance (palbociclib) 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.

Year to date, Roche’s shares have risen 8.2% compared with the industry’s 21.4% growth.

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Roche’s Breast Cancer Portfolio Gets a Boost

Itovebi is Roche’s first targeted therapy approved for people with HR-positive disease.

HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of total cases. This approval should allow Roche to cater to breast cancer patients with a PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease, associated with poor prognosis.

The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers.

The approval is based on the phase III INAVO120 study results, which showed that Itovebi- based regimen more than doubled progression-free survival compared with Ibrance and fulvestrant alone in the first-line setting and also maintained a manageable safety and tolerability profile.

Overall survival (OS) data were immature at the time of the primary analysis, but a clear positive trend was observed. OS follow-up will continue to the next analysis.

We remind investors that the Itovebi-based regimen was granted Priority Review by the FDA. It was also granted the Breakthrough Therapy Designation in May 2024 based on the INAVO120 study results.

Data from the INAVO120 study are also being used to file submissions to other global health authorities, including the European Medicines Agency.

Roche has a dominant position in the breast cancer market. The HER2 franchise includes Herceptin, Perjeta and Kadcyla. While Herceptin is being affected by biosimilar competition, the increased patient demand for Perjeta for adjuvant early breast cancer therapy maintains momentum. Kadcyla is also performing well. The approval of the fixed-dose combination of Perjeta and Herceptin as Phesgo strengthened the portfolio.

Approval of Itovebi should strengthen this franchise.

Itovebi is currently being investigated in various combinations across three late-stage studies (INAVO120, INAVO121 and INAVO122) in PIK3CA-mutated locally advanced or metastatic breast cancer.

Approval of New Drugs Important for Roche

Approval of new drugs should be helpful for Roche as competition from biosimilars for established drugs like Avastin, MabThera/Rituxan and Herceptin continues to hurt sales.

Meanwhile, drugs like Vabysmo, Ocrevus, Hemlibra and Polivy fuel Roche’s top line as the company looks to fill up the dent in revenues caused by a decline in COVID-19-related sales.

However, competition in the breast cancer space is stiff, which might limit market share gains.

Itovebi will face competition from Novartis’ NVS Piqray in its targeted market. Piqray is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

Novartis' strong breast cancer portfolio has the top drug Kisqali, which has put up a spectacular performance.

Zacks Rank & Stocks to Consider

Roche currently has a Zacks Rank #3 (Hold).

Some better-ranked large-cap pharma companies are Sanofi SNY and Bayer BAYRY, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Zacks Consensus Estimate for Sanofi’s earnings has risen from $4.21 to $4.25 per share for 2024 over the past 60 days, while that for 2025 has risen from $4.77 to $4.81. Sanofi’s shares have risen 10.5% year to date.

Sanofi beat on earnings in two of the trailing four quarters, missed once and met in the other, delivering an average surprise of 0.46%.

Estimates for Bayer’s 2024 earnings per share have increased from $1.35 to $1.38 over the past 90 days, while the same for 2025 has risen from $1.42 to $1.44. Bayer’s shares have lost 21.4% year to date.    

 

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