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Gilead (GILD) Breast Cancer Drug Gets Positive CHMP Opinion
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Gilead Sciences, Inc. (GILD - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for the breast cancer drug Trodelvy (sacituzumab govitecan).
The CHMP recommended approval of the drug as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in an advanced setting.
The European Commission generally takes the CHMP opinion into account when reviewing a drug but is not bound by it. A final decision is anticipated later in 2023.
The CHMP’s positive opinion is supported by results from the late-stage TROPiCS-02 study, where Trodelvy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months vis-à-vis comparator single-agent chemotherapy. Treatment with the drug also demonstrated a 34% reduction in the risk of disease progression or death. Three times as many people treated with Trodelvy were progression-free after a year as compared to those treated with chemotherapy.
Trodelvy also significantly improved additional secondary endpoint measures, including objective response rate and time to deterioration (TTD) assessed by the Global Health Status/Quality of Life and Fatigue scale per EORTC-QLQ-C30 in the study.
Treatment options are limited for patients with HR+/HER2- metastatic breast cancer who develop resistance to endocrine-based therapies. Per management, Trodelvy can become an option for these patients.
The positive opinion could lead to a second indication for Trodelvy based on OS data in metastatic breast cancer in Europe.
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate. Trodelvy is approved for treating adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one for metastatic disease.
The drug is also approved in the United States for treating adult patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting and has an accelerated approval for the treatment of certain patients with second-line metastatic urothelial cancer.
Breast cancer is one of the most prevalent cancers. HR+/HER2- breast cancer is the most common type of breast cancer and accounts for approximately 70% of all new cases.
While there are many approved drugs for this cancer, the constant need for improved drugs becomes imperative as almost one in three cases of early-stage breast cancer eventually becomes metastatic. Per estimates, among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 34%.
Trodelvy is also being evaluated in other TNBC and HR+/HER2- metastatic and adjuvant breast cancer populations. It is also being investigated across a range of tumors, including metastatic urothelial cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer and endometrial cancer.
Shares of Gilead lost 11.7% in the year so far compared with the industry’s decline of 8.2%.
Image Source: Zacks Investment Research
Gilead is looking to diversify in the lucrative oncology space. The oncology business put up a stellar performance in the first quarter, fuelling its top line. The Cell Therapy franchise, comprising Yescarta and Tecartus, also continues to witness a steady increase in sales, primarily due to higher demand for Yescarta in R/R LBCL and Tecartus in R/R ALL and MCL.
The uptake of the breast cancer drug Trodelvy has been strong as well.
Gilead is making efforts to strengthen its pipeline in this space through strategic collaborations. In May 2023, Gilead acquired XinThera, a privately held biotech company in San Diego. The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets in oncology and inflammation.
Earlier, it entered into a strategic collaboration with Arcellx, Inc. (ACLX) to co-develop and co-commercialize CART-ddBMCA, a late-stage clinical asset in development for the treatment of multiple myeloma.
However, Arcellx recently announced that the FDA placed a clinical hold on its iMMagine-1 program, designed to evaluate the lead program, CART-ddBCMA, for treating adult patients with relapsed or refractory multiple myeloma (rrMM). The hold was placed on Jun 16 after a patient died.
Arcellx believes limitations on bridging therapy are a contributing factor and is working with the FDA to amend the protocol to expand options for patients that are consistent with current clinical practice.
Zacks Rank and Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) .
Over the past 30 days, earnings estimates for LGND have increased by $1.09 to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.74 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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Gilead (GILD) Breast Cancer Drug Gets Positive CHMP Opinion
Gilead Sciences, Inc. (GILD - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for the breast cancer drug Trodelvy (sacituzumab govitecan).
The CHMP recommended approval of the drug as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in an advanced setting.
The European Commission generally takes the CHMP opinion into account when reviewing a drug but is not bound by it. A final decision is anticipated later in 2023.
The CHMP’s positive opinion is supported by results from the late-stage TROPiCS-02 study, where Trodelvy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months vis-à-vis comparator single-agent chemotherapy. Treatment with the drug also demonstrated a 34% reduction in the risk of disease progression or death. Three times as many people treated with Trodelvy were progression-free after a year as compared to those treated with chemotherapy.
Trodelvy also significantly improved additional secondary endpoint measures, including objective response rate and time to deterioration (TTD) assessed by the Global Health Status/Quality of Life and Fatigue scale per EORTC-QLQ-C30 in the study.
Treatment options are limited for patients with HR+/HER2- metastatic breast cancer who develop resistance to endocrine-based therapies. Per management, Trodelvy can become an option for these patients.
The positive opinion could lead to a second indication for Trodelvy based on OS data in metastatic breast cancer in Europe.
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate. Trodelvy is approved for treating adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one for metastatic disease.
The drug is also approved in the United States for treating adult patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting and has an accelerated approval for the treatment of certain patients with second-line metastatic urothelial cancer.
Breast cancer is one of the most prevalent cancers. HR+/HER2- breast cancer is the most common type of breast cancer and accounts for approximately 70% of all new cases.
While there are many approved drugs for this cancer, the constant need for improved drugs becomes imperative as almost one in three cases of early-stage breast cancer eventually becomes metastatic. Per estimates, among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 34%.
Trodelvy is also being evaluated in other TNBC and HR+/HER2- metastatic and adjuvant breast cancer populations. It is also being investigated across a range of tumors, including metastatic urothelial cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer and endometrial cancer.
Shares of Gilead lost 11.7% in the year so far compared with the industry’s decline of 8.2%.
Image Source: Zacks Investment Research
Gilead is looking to diversify in the lucrative oncology space. The oncology business put up a stellar performance in the first quarter, fuelling its top line. The Cell Therapy franchise, comprising Yescarta and Tecartus, also continues to witness a steady increase in sales, primarily due to higher demand for Yescarta in R/R LBCL and Tecartus in R/R ALL and MCL.
The uptake of the breast cancer drug Trodelvy has been strong as well.
Gilead is making efforts to strengthen its pipeline in this space through strategic collaborations. In May 2023, Gilead acquired XinThera, a privately held biotech company in San Diego. The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets in oncology and inflammation.
Earlier, it entered into a strategic collaboration with Arcellx, Inc. (ACLX) to co-develop and co-commercialize CART-ddBMCA, a late-stage clinical asset in development for the treatment of multiple myeloma.
However, Arcellx recently announced that the FDA placed a clinical hold on its iMMagine-1 program, designed to evaluate the lead program, CART-ddBCMA, for treating adult patients with relapsed or refractory multiple myeloma (rrMM). The hold was placed on Jun 16 after a patient died.
Arcellx believes limitations on bridging therapy are a contributing factor and is working with the FDA to amend the protocol to expand options for patients that are consistent with current clinical practice.
Zacks Rank and Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) .
LGND currently sports a Zacks Rank #1 (Strong Buy) and Novartis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings estimates for LGND have increased by $1.09 to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.74 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.