Sanofi's (SNY) Breast Cancer Candidate Misses Goal in Study
Sanofi SNY announced that its phase II AMEERA-3 study, evaluating amcenestrant for the treatment of ER+/HER2- advanced or metastatic breast cancer, failed to meet the primary endpoint.
The AMEERA-3 study evaluated the safety and efficacy of amcenestrant, its investigational oral selective estrogen receptor degrader or SERD as a monotherapy versus endocrine treatment of physician’s choice in patients with locally advanced or metastatic ER+/HER2- breast cancer whose disease progressed on or after hormonal therapies. The study did not meet the primary endpoint of improving progression-free survival as assessed by an independent central review.
No new safety signals were observed in the AMEERA-3 study.
Shares of Sanofi were down in pre-market trading on Monday following the announcement of the news. The stock has gained 1.2% so far this year against the industry’s decrease of 3.1%.
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The company is also evaluating amcenestrant in patients with earlier stages of breast cancer.
The phase III AMEERA-5 study is evaluating amcenestrant in combination with palbociclib in the first-line treatment of ER+/HER2- metastatic breast cancer. The study has now completed enrollment.
Meanwhile, Sanofi is conducting the phase III AMEERA-6 study to explore the potential of amcenestrant for addressing early-stage breast cancer in the adjuvant setting. The study is currently enrolling patients.
We note that several other companies are also engaged in developing oral SERDs. The target markets hold a lucrative opportunity for these companies in the days ahead.
Sanofi has a robust pipeline to treat several diseases in the fields of oncology, immunology, rare disease and rare blood disorder.
Last week, Sanofi, along with its partner, Swedish Orphan Biovitrum, announced that the phase III study — XTEND-1 — evaluating their investigational factor VIII replacement therapy for treating hemophilia A, efanesoctocog alfa, met its primary as well as secondary endpoints.
Another promising candidate in Sanofi’s pipeline, olipudase alfa, which can be for treating acid sphingomyelinase deficiency/Niemann-Pick B disease, is under review in United States (target action date – Jul 3, 2022). Olipudase alfa is also under review in the EU, with a decision expected in second-half 2022.
Several late-stage studies are ongoing on fitusiran for treating hemophilia A and B; on tolebrutinib for treating multiple sclerosis and myasthenia gravis; and on venglustat for treating GM2 gangliosidoses. Also, phase II studies are ongoing on venglustat for treating Fabry Disease and Gaucher Disease type 3.
Successful development of the candidates will boost the company’s growth prospects.
Zacks Rank & Stocks to Consider
Sanofi currently carries a Zacks Rank of #3 (Hold).
Better-ranked stocks in the healthcare sector include Innoviva, Inc. INVA, Collegium Pharmaceutical, Inc. COLL and Vertex Pharmaceuticals Incorporated VRTX. While Innoviva and Collegium Pharmaceutical sport a Zacks Rank #1 (Strong Buy), Vertex carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Innoviva’s earnings estimates have been revised 20.5% upward for 2022 over the past 60 days. The INVA stock has increased 9.4% in the past year.
Earnings of Innoviva have surpassed estimates in each of the trailing four quarters.
Collegium Pharmaceutical’s earnings estimates have been revised 50% upward for 2022 over the past 60 days.
Earnings of Collegium Pharmaceutical have surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.
Vertex’s earnings estimates have been revised 8.4% upward for 2022 over the past 60 days. The VRTX stock has gained 7.6% year to date.
Earnings of Vertex have surpassed estimates in each of the trailing four quarters.
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