Study: New oral drug treatment for some advanced breast cancer
Summary
The FDA has approved a new oral drug called Oserdu for the treatment of HR-positive, HER2-negative advanced breast cancer. A blood test was also approved to help doctors identify patients who would benefit most from this new treatment. (Posted 3/20/23)
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Printer Friendly Page Read the Original ArticleRELEVANCE
Most relevant for: People with HR-positive, HER2-negative advanced breast cancer.
It may also be relevant for:
- people with breast cancer
- people with metastatic or advanced cancer
- people with ER/PR + cancer
Relevance: High
Strength of Science: High
Research Timeline: Post Approval
What is this study about?
A research study (called the EMERALD study) looked at how well people with breast cancer did when treated with a new drug called Oserdu (elacestrant).
The study looked at people with breast cancer that:
- was
- was
- was
- came back or got worse after standard treatment
People in the study had received up to two types of treatment before joining the study. Study participants were separated into 2 groups:
- half of the people receive Oserdu
- half received standard hormone therapy
Researchers compared how well people in the Oserdu group did compared to people in the standard hormone therapy group.
During the EMERALD study, a blood test was used to look for a marker found in the cancer known as an ESR1 mutation. ESR1 mutations are made by breast cancers that no longer respond to treatment with a type of hormone therapy known as an aromatase inhibitor (AI).
- half of the participants had a mutation in ERS1.
What type of treatment is Oserdu?
Oserdu is a type of hormone therapy drug called a selective receptor degrader (SERD).
Why is this study important?
People with , , breast cancer that comes back or gets worse after treatment have few additional treatment options.
Study findings
The EMERALD study findings included:
- people who received Orserdu had a longer time until cancer came back or became worse (progression free survival) than people who did not receive Oserdu
- among people with an ESR1 mutation, those who received Orserdu had a longer time until cancer came back or became worse than people who did not receive Oserdu
- early results suggest that Orserdu may also increase how long people lived (overall survival) compared to the standard of care but the final overall survival results are not yet available
Side effects
Side effects occurred in most participants, regardless of treatment type. The most common side effects while taking Orserdu included nausea, fatigue, decreased appetite and joint pain.
Side effect | Orserdu | Hormone therapy |
---|---|---|
Any | 92% | 86% |
Nausea | 35% | 19% |
Fatigue | 19% | 19% |
Decreased appetite | 15% | 9% |
Joint pain | 14% | 16% |
approval
Based on the results of EMERALD, the has approved Orserdu to treat advanced , breast cancer. The has also approved a blood test called Guardant360, which tests for tumor mutations in the ESR1 gene. People with an ESR1 tumor mutation benefit most from treatment with Orserdu.
What does this mean for me?
If you have , metastatic breast cancer that has come back or worsened after treatment with hormone therapy and a CDK4/6 inhibitor, you may benefit from the drug Orserdu.
Orserdu improved progression-free survival and may also improve overall survival, particularly for people who have an ESR1 tumor mutation.
Reference
Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective receptor degrader) Versus Standard Endocrine Therapy for Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Phase III EMERALD Trial. J Clin Oncol. 2022 Oct 1;40(28):3246-3256.
Kaklamani V, Bidard FC, Neven P, et al: EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2– breast cancer: Updated results by duration of prior CDK4/6 inhibitor in setting. 2022 San Antonio Breast Cancer Symposium. Abstract GS3-01. Presented December 8, 2022.
Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
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posted 3/20/23
The following studies look at treatment for people with ER-positive breast cancer.
- NCT04673448: Combining the Dostarlimab and Niraparib for Advanced or Breast, Ovarian or Pancreatic Cancer with an Inherited or Tumor Mutation. This study is looking at the effectiveness of combining the , and the dostarlimab for treating people with an inherited mutation (found with genetic testing) or a tumor mutation (found through tumor testing) who have advanced breast, pancreatic or ovarian cancer.
- NCT05501886: Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or HR+/HER2- Breast Cancer (VIKTORIA-1). This study is looking at the efficacy and safety of the selective receptor degrader (SERD) gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.
- NCT04975308: A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3). This study will evaluate the efficacy and safety of the selective receptor degrader (SERD) imlunestrant, how it works compared to standard hormone therapy, and how well imlunestrant with abemaciclib works compared to imlunestrant in participants with breast cancer that is ER-positive and .
- NCT05306340: A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With Exemestane Plus Everolimus in Participants With Receptor-Positive, , Locally Advanced or Breast Cancer (evERA Breast Cancer). This study will evaluate the efficacy and safety of the selective receptor degrader (SERD) giredestrant, plus everolimus compared with exemestane plus everolimus in people with receptor ER-positive, locally advanced or breast cancer who have had previous treatment with a CDK4/6 inhibitor and hormone therapy.
- NCT03344965: Expanded - Treating Breast Cancer in People without gBRCA Mutations. This study will look at whether is also effective for treating breast cancer in people who do not have an inherited mutation. The study is enrolling people with an in or an acquired (tumor) mutation in or .
- NCT03685331: , Palbociclib and Fulvestrant for BRCA-Associated, ER/PR+/HER2-Negative Breast Cancer. This study is looking at the side effects and best dose of palbociclib when given with and fulvestrant for people with HR+/HER2-negative mBC who have a or mutation.
- NCT04072952: ARV-471 Alone and in Combination With Palbociclib in Patients With ER+/HER2- Locally Advanced or Breast Cancer. This is a dose escalation and expansion study to learn the safety and tolerability of ARV-471 alone and combined with palbociclib in people with ER+/HER2- locally advanced or breast cancer who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.
- NCT04448886: Sacituzumab Govitecan +/- Pembrolizumab In HR+ / - MBC. This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in HR+/HER2- breast cancer.
- NCT04563507: Combined Immunotherapies in ER+ Breast Cancer. Patients receiving standard therapy for HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation Therapy(SBRT) to each lesion.
- NCT04895358: Pembrolizumab Plus Chemotherapy Versus Plus Chemotherapy for HR+/HER2- Inoperable or Breast Cancer (KEYNOTE-B49). The study will look at the safety and efficacy of pembrolizumab plus chemotherapy compared to chemotherapy alone in the treatment of HR+/HER2- locally recurrent inoperable or breast cancer.
Other clinical trials for people with breast cancer can be found here.
Updated: 12/22/2023
Study findings
The EMERALD trial was a worldwide large study that looked at how well the drug Orserdu worked to treat people with advanced, breast cancer that worsened after first- or second-line treatment with hormone therapy and a CDK4/6 inhibitor. All participants received a CDK4/6 inhibitor and hormone therapy for up to 18 months before being assigned to Orserdu or hormone therapy treatment.
Outcomes from all participants
- 239 participants were randomly chosen to receive Orserdu; 238 participants received standard hormone therapy.
- Participants had longer intervals of progression-free survival with Orserdu than they did with hormone therapy.
- Longer pretreatment with a CDK4/6 inhibitor and hormone therapy benefited both groups of participants.
Progression-free survival among all participants
Pretreatment time on CDK 4/6 inhibitor |
|||
6 months |
12 months |
18 months |
|
Orserdu* | 2.8 months | 3.8 months | 25.5 months |
Hormone therapy** | 1.9 months | 1.9 months | 3.3 months |
Outcomes among participants with ESR1 tumor mutations
- Participants also had a blood test to screen for tumor mutations in the ERS1 gene. About half of the participants (228) had a mutation in ERS1.
- Among participants with ESR1 tumor mutations who were pre-treated for at least 12 months, the cancers of those who received hormone therapy worsened about 2 months later, while those who received Orserdu experienced worsened cancer about 9 months later.
Progression-free survival among participants with an ESR1 mutation
Pretreatment time on |
|||
6 months |
12 months |
18 months |
|
Orserdu* | 4.1 months | 8.6 months | 8.6 months |
Hormone therapy** | 1.9 months | 1.9 months | 2.1 months |
These early results suggest that Orserdu may increase overall survival compared to the standard of care but the final overall survival results are not yet available.
Side effects
Side effects occurred in most participants, regardless of treatment type. The most common side effects while taking Orserdu included nausea, fatigue, decreased appetite and joint pain.
Side effect | Orserdu | Hormone therapy |
Any | 92% | 86% |
Nausea | 35% | 19% |
Fatigue | 19% | 19% |
Decreased appetite | 15% | 9% |
Joint pain | 14% | 16% |
Strengths and limitations
Strengths
- This study required that all participants had already received treatment with a CDK4/6 inhibitor and hormone therapy, which is what current guidelines recommend.
Limitations
- Most participants were white. It is not known whether other racial or ethnic groups would benefit the same from treatment with Orserdu.
- While men were allowed to participate in the trial, almost all participants were female (one man participated). It is not known whether men would benefit the same from treatment with Orserdu.
Context
Almost 20 years have passed since the SERD fulvestrant was approved to treat people with metastatic breast cancer.
Orserdu is the first oral SERD to show improved progression-free survival compared with the standard of care for people with advanced breast cancer. Orserdu is an oral medication, which makes it easier to take than fulvestrant, which is given as an injection.
The following organizations offer peer support services for people with, or at high risk for breast cancer:
- FORCE peer support:
- Our Message Boards allow people to connect with others who share their situation. Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Our Peer Navigation Program will match you with a volunteer who shares your mutation and situation.
- Connect online with our Private Facebook Group.
- Join our virtual and in-person support meetings.
- Other organizations that offer breast cancer support:
Updated: 05/07/2024
Who covered this study?
MEDPAGETODAY
Promising Phase III Results in HR+/HER2- Breast Cancer This article rates 4.0 out of 5 stars
OncLive
Elacestrant Secures a Place for ER+, HER2–, ESR1-Mutated Advanced/Metastatic Breast Cancer This article rates 3.0 out of 5 stars