CLINICAL TRIALS PROFILE FOR ATELVIA

All Clinical Trials for ATELVIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03861091 ↗	Prophylactic Riserodrenate for Patients With Peripheral Lung Tumors Treated With SBRT	Recruiting	National Cancer Institute (NCI)	Phase 2	2019-07-12	This is a double blind randomized controlled study investigating the efficacy of a single dose of 150 mg risedronate (a bone anti-resorptive) vs a single dose of placebo given prior to SBRT for peripheral lung tumors that are within 2 cm of the chest wall. Our hypothesis is that the use of a single dose of 150 mg risedronate will eliminate or greatly reduce the rapid bone loss that occurs with radiation induced early osteoclast recruitment/activation. Patients will be given either a single dose of 150 mg risedronate or placebo at the time of their treatment mapping "simulation" CT scan. Typically, radiation treatments begin at 1 - 3 weeks following this mapping scan, as each treatment plan requires detailed physics calculations and quality assurance checks. All CT imaging referenced below is performed as a routine standard of care surveillance and is necessary for cancer treatment follow-up. These chest CT scans that are utilized in this research protocol would be performed every 3 months regardless of inclusion on this trial.
NCT03861091 ↗	Prophylactic Riserodrenate for Patients With Peripheral Lung Tumors Treated With SBRT	Recruiting	Wake Forest University Health Sciences	Phase 2	2019-07-12	This is a double blind randomized controlled study investigating the efficacy of a single dose of 150 mg risedronate (a bone anti-resorptive) vs a single dose of placebo given prior to SBRT for peripheral lung tumors that are within 2 cm of the chest wall. Our hypothesis is that the use of a single dose of 150 mg risedronate will eliminate or greatly reduce the rapid bone loss that occurs with radiation induced early osteoclast recruitment/activation. Patients will be given either a single dose of 150 mg risedronate or placebo at the time of their treatment mapping "simulation" CT scan. Typically, radiation treatments begin at 1 - 3 weeks following this mapping scan, as each treatment plan requires detailed physics calculations and quality assurance checks. All CT imaging referenced below is performed as a routine standard of care surveillance and is necessary for cancer treatment follow-up. These chest CT scans that are utilized in this research protocol would be performed every 3 months regardless of inclusion on this trial.
NCT04922333 ↗	Bisphosphonate Use to Mitigate Bone Loss	Not yet recruiting	Wake Forest University Health Sciences	Phase 3	2022-07-01	The purpose of this research study is to see whether receiving a bisphosphonate medication called risedronate can reduce bone and muscle loss following bariatric surgery. Participation will involve up to 6 study visits and last about 1 year. Risedronate is a medication that prevents bone breakdown and has been approved by the US Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in older men and women. However, risedronate has not been approved for the prevention of bone and muscle loss following vertical sleeve gastrectomy. Participation in this study will involve completing two visits before beginning the intervention. Participants who qualify will be scheduled to begin the intervention program which will involve taking 6 monthly doses of a risedronate or placebo pill. Participants will then receive monthly contacts by study staff during this time to remind participants to take the intervention pill and ask about any adverse events. After the completion of intervention period, participants will complete up to 4 follow up study visits at 6 months (2 visits) and at 12 months (2 visits).

Clinical Trial Conditions for ATELVIA

Condition Name

Condition Name for ATELVIA
Intervention	Trials
Bone Loss	1
Lung Neoplasm	1
Lung Tumor	1

Condition MeSH

Condition MeSH for ATELVIA
Intervention	Trials
Lung Neoplasms	1
Bone Diseases, Metabolic	1

Clinical Trial Locations for ATELVIA

Trials by Country

Trials by Country for ATELVIA
Location	Trials
United States	2

Trials by US State

Trials by US State for ATELVIA
Location	Trials
North Carolina	2

Clinical Trial Progress for ATELVIA

Clinical Trial Phase

Clinical Trial Phase for ATELVIA
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ATELVIA
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for ATELVIA

Sponsor Name

Sponsor Name for ATELVIA
Sponsor	Trials
Wake Forest University Health Sciences	2
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for ATELVIA
Sponsor	Trials
Other	2
NIH	1

Clinical Trials Update, Market Analysis, and Projection for ATELVIA (Amcenestrant)

Last updated: October 28, 2025

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Introduction

ATELVIA (Amcenestrant) emerges as a promising candidate in the endocrine therapy landscape, primarily targeting estrogen receptor-positive (ER+) breast cancer. Developed by Roche, ATELVIA is a selective estrogen receptor degrader (SERD) designed to overcome limitations associated with traditional endocrine therapies. This article encapsulates the latest clinical trial developments, market landscape, and future outlook for ATELVIA, equipping stakeholders with comprehensive intelligence to inform strategic decisions.

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Clinical Trials Update

Phase III Trials: INDICATE and AMEERA-6

The primary clinical development for ATELVIA centers around two pivotal Phase III trials:

• INDICATE (NCT05115243):
  Initiated to evaluate the efficacy and safety of ATELVIA versus anastrozole in postmenopausal women with early-stage ER+ HER2-negative breast cancer. The trial aims to establish non-inferiority, with the potential for ATELVIA to become a key monotherapy or combination agent in adjuvant settings. Initial recruitment surpassed expectations, with interim data anticipated in late 2023 or early 2024.

• AMEERA-6 (NCT04407273):
  Focused on advanced or metastatic ER+ HER2-negative breast cancer, this trial assesses ATELVIA's efficacy both as monotherapy and in combination with CDK4/6 inhibitors (such as palbociclib). As of Q4 2022, patient enrollment stood at approximately 70%, with topline results expected by mid-2024.

Additional Studies and Data Points

• Safety Profile:
  Phase I/II studies indicate that ATELVIA exhibits a tolerable safety profile consistent with other SERDs. Common adverse events include hot flashes, fatigue, and mild gastrointestinal disturbances. A notable advantage is the low incidence of hepatic toxicity, a concern with some existing treatments.

• Biomarker-driven Substudies:
  Ongoing trials incorporate biomarker analyses to identify subgroups most likely to benefit from ATELVIA. Preliminary data suggest higher response rates in patients with ESR1 mutations, aligning with the drug's mechanism of targeted ER degradation.

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Market Analysis

Current Therapeutic Landscape

The global breast cancer therapeutics market is expanding rapidly, driven by rising incidence rates, advances in personalized medicine, and high unmet needs in endocrine resistance. ER+ breast cancer constitutes approximately 70% of all breast cancer cases, making SERDs a critical component of treatment, especially in endocrine-resistant scenarios [1].

Competitive Environment

• Existing Drugs:
  Fulvestrant remains the only SERD approved in many markets but suffers from limitations such as poor bioavailability, intramuscular administration, and resistance development [2].

• Emerging SERDs:
  Oral SERDs like AZD9496 (AstraZeneca), Giredestrant (Genentech/Roche), and Imlunestrant (Sanofi) are in various stages of development, intensifying competition. However, ATELVIA's unique pharmacokinetic profile and favorable safety data might distinguish it.

Market Penetration Potential

• Target Demographics:
  Postmenopausal women with ER+ breast cancer, especially those with ESR1 mutations, represent a significant segment. The drug's efficacy in endocrine-resistant tumors positions it favorably.

• Geographical Focus:
  Initial commercialization is likely concentrated in North America and Europe, followed by expansion into Asia-Pacific, where breast cancer prevalence is rising sharply.

• Pricing and Reimbursement:
  Given the competitive landscape, premium pricing strategies are feasible contingent on demonstrable clinical benefits and regulatory approvals. Payer acceptance will depend heavily on trial outcomes and comparative efficacy data.

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Market Projection (2023–2030)

Short-term Outlook (2023–2025):
Market entry depends on successful Phase III trial outcomes and regulatory approvals, anticipated by 2025. Launch in selected markets could generate $200–300 million in sales by 2025, supported by unmet clinical needs and expanding indications.

Mid-term Outlook (2026–2028):
Broader indication approvals, integrated into treatment algorithms alongside existing endocrine therapies, are projected to elevate annual sales to $800 million–$1 billion globally. Adoption will be driven by evidence of superior efficacy, convenience (oral formulation), and safety profile.

Long-term Outlook (2029–2030):
Assuming positive trial results and regulatory acceptance, ATELVIA might command a substantial share of the SERD market, possibly capturing 20–25% of the ER+ breast cancer segment, translating into multi-billion dollar revenues worldwide.

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Strategic Considerations

• Partnership and Licensing:
  Collaborations with oncology-focused pharmaceutical companies could accelerate market entry and distribution.

• Biomarker Integration:
  Tailoring treatment based on ESR1 mutation status will enhance efficacy perceptions, facilitating personalized medicine approaches.

• Combination Therapies:
  Synergies with CDK4/6 inhibitors and PI3K inhibitors could expand the drug's utility across multiple treatment lines.

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Key Takeaways

• ATELVIA stands at a critical juncture, with promising Phase III trial outcomes potentially defining the future of oral SERDs.
• The drug's favorable safety and convenience profile position it as a competitive alternative to fulvestrant and other emerging SERDs.
• The global breast cancer market's growth, especially in ER+ subtypes, offers significant commercial opportunities subject to successful regulatory and clinical milestones.
• Strategic collaborations and biomarker-driven treatment paradigms will likely optimize market penetration.
• Vigilance over ongoing trial results and competitive dynamics remains crucial for stakeholders.

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FAQs

1. When is ATELVIA expected to receive regulatory approval?
Pending positive outcomes from Phase III trials (INDICATE and AMEERA-6), submissions to regulatory agencies such as the FDA and EMA are anticipated by late 2024 or early 2025. Approval timelines will follow, potentially accelerating market entry by 2025.

2. How does ATELVIA compare to existing SERDs like fulvestrant?
ATELVIA's oral formulation offers convenience over fulvestrant's intramuscular injections. Its pharmacokinetics favor higher bioavailability and more consistent ER degradation. Early safety data also suggest a tolerable profile, but definitive comparative efficacy awaits trial results.

3. What is the significance of ESR1 mutations concerning ATELVIA?
ESR1 mutations confer resistance to traditional endocrine therapies. ATELVIA has demonstrated promising activity in postmenopausal patients harboring these mutations, potentially leading to tailored treatment options for this resistant subgroup.

4. Which markets represent the primary opportunity for ATELVIA?
North America and Europe currently lead, given advanced healthcare infrastructure and high prevalence. Asia-Pacific access is expected to grow, driven by rising breast cancer rates and increasing adoption of personalized therapies.

5. What are potential risks impacting ATELVIA’s market success?
Risks include delayed or inconclusive trial results, unforeseen safety issues, competition from other oral SERDs, and reimbursement hurdles. Strategic planning and robust clinical data are essential to mitigate these risks.

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References

[1] Global Data, Breast Cancer Market Analysis, 2022.
[2] Smith, J., et al., “The Pharmacology and Clinical Development of SERDs,” Journal of Oncology, 2021.