Camizestrant
- Generic Name
- Camizestrant
AstraZeneca Showcases Groundbreaking Cancer Research at ASCO 2025 with Two Plenary Presentations
• AstraZeneca will present over 80 abstracts at ASCO 2025, including two plenary presentations featuring camizestrant for HR-positive breast cancer and IMFINZI for early gastric cancer, marking their seventh consecutive year with plenary data.
• The SERENA-6 trial is the first positive Phase III study for a next-generation oral SERD in first-line HR-positive breast cancer, pioneering the use of circulating tumor DNA to guide treatment decisions.
• DESTINY-Breast09 data shows ENHERTU plus pertuzumab is the first treatment in over a decade to demonstrate superiority over standard care in first-line HER2-positive metastatic breast cancer.
AstraZeneca Exits Neuroscience Research to Focus on Core Therapeutic Areas
• AstraZeneca has officially closed its neuroscience research group, discontinuing programs for Alzheimer's disease, migraine, and pain conditions to redirect resources toward higher-value projects.
• The strategic shift allows the pharmaceutical giant to concentrate on its core therapeutic areas including oncology, cardiovascular, respiratory diseases, weight management, and immunology.
• Despite recording 10% revenue growth in Q1 2025 with nearly $13.6 billion in sales, AstraZeneca executives emphasized they "cannot be everywhere," stating CNS research is "better managed by other companies."
Novel BCMA-Directed CAR T-Cell Therapy Shows Promising Efficacy in Relapsed/Refractory Multiple Myeloma and AL Amyloidosis
• A second-generation BCMA-directed CAR T-cell therapy, MDC-CAR-BCMA001, demonstrated remarkable efficacy in patients with relapsed/refractory multiple myeloma and AL amyloidosis, achieving a 5/6 overall response rate with 4 complete responses.
• The novel therapy showed a favorable safety profile with manageable toxicity, including low incidence of severe cytokine release syndrome and no neurotoxicity, even in patients with significant organ dysfunction.
• These promising results have prompted further investigation through ongoing clinical trials, including CARLOTTA001 (NCT05836896) and the CLEAR AL trial, potentially offering new hope for difficult-to-treat hematologic malignancies.
ESR1 Mutations in Breast Cancer: Emerging Biomarker Reshapes Treatment Strategies
• ESR1 mutations are rare (<5%) in newly diagnosed breast cancer but develop in 30-40% of patients after aromatase inhibitor therapy, enabling tumors to remain active without estrogen.
• Circulating tumor DNA testing for ESR1 mutations is typically performed at disease progression, but emerging research suggests earlier detection could optimize treatment decisions.
• The presence of ESR1 mutations helps guide therapy selection, with oral selective estrogen receptor degraders like elacestrant showing improved efficacy compared to standard treatments.
Pharmaceutical Industry Braces for $236 Billion Patent Cliff by 2030: Strategic Responses from Major Players
• The global pharmaceutical industry faces a $236 billion patent cliff between 2025-2030, with nearly 70 blockbuster drugs losing exclusivity and exposing major companies to significant revenue losses.
• Key drugs approaching patent expiration include Merck's Keytruda ($25B), Bristol-Myers Squibb's Eliquis ($12B), and Johnson & Johnson's Stelara ($10.9B), forcing companies to rapidly adapt through pipeline diversification and cost-cutting measures.
• Companies are responding with increased M&A activity, AI-driven R&D efficiency, and strategic pivots to high-growth therapeutic areas, while the cliff will likely improve drug affordability but potentially slow innovation.
GSK's Novel Treatment Shows Promising Results in Phase III Trials for Chronic Rhinosinusitis with Nasal Polyps
• GSK announced positive results from two Phase III clinical trials evaluating their investigational treatment for chronic rhinosinusitis with nasal polyps (CRSwNP), demonstrating significant improvement in patient outcomes.
• The trials showed notable reduction in nasal congestion and polyp size, meeting primary endpoints and suggesting a potential new therapeutic option for CRSwNP patients.
• The treatment demonstrated a favorable safety profile across both studies, positioning it as a promising candidate for addressing this challenging chronic condition.
FDA Grants Fast Track Status to Pyxis Oncology's PYX-201 for Advanced Head and Neck Cancer
• Pyxis Oncology's novel antibody-drug conjugate PYX-201, targeting Extradomain-B Fibronectin, receives FDA Fast Track Designation for treating recurrent or metastatic head and neck squamous cell carcinoma.
• The designation addresses a critical unmet need in head and neck cancer treatment, particularly for patients who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy.
• Two clinical trials are currently recruiting patients: a monotherapy study and a combination trial with Merck's KEYTRUDA, highlighting the drug's potential in multiple treatment approaches.
Datopotamab Deruxtecan's Role in HR+/HER2- Breast Cancer Treatment: Sequencing and Safety Considerations
• Datopotamab deruxtecan (Dato-DXd) is poised to become a standard treatment for metastatic hormone receptor-positive, HER2-negative breast cancer after prior systemic therapy.
• Optimal sequencing of antibody-drug conjugates (ADCs) like Dato-DXd, sacituzumab govitecan, and trastuzumab deruxtecan remains uncertain, especially considering overlapping toxicities.
• Real-world toxicity profiles suggest sacituzumab govitecan may cause more cytopenias and diarrhea, while Dato-DXd and trastuzumab deruxtecan are linked to interstitial lung disease.
• The lack of overall survival difference in the TROPION-Breast01 trial raises questions about efficacy issues or the impact of crossover between treatment arms.
Sanofi Halts Amcenestrant Development After Disappointing First-Line Breast Cancer Trial
• Sanofi discontinues the development of amcenestrant, an oral selective estrogen receptor degrader (SERD), after it failed in the AMEERA-5 phase 3 trial.
• The AMEERA-5 trial compared amcenestrant plus palbociclib to letrozole plus palbociclib as a first-line treatment for HR-positive/HER2-negative advanced breast cancer.
• This failure raises concerns about the potential of SERDs in the first-line treatment of breast cancer, impacting other developers in the field.
• Sanofi will discontinue all amcenestrant studies, including the AMEERA-6 trial in early-stage HR+ breast cancer patients.
Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones
• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor.
• Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025.
• Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025.
• Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.
Bayer's Elinzanetant Shows Promise in Reducing Hot Flashes for Breast Cancer Patients
• Elinzanetant met primary endpoints in the Phase III OASIS 4 trial, significantly reducing the frequency of moderate to severe vasomotor symptoms (VMS) in women undergoing endocrine therapy for breast cancer.
• The study also achieved secondary endpoints, demonstrating a reduction in the severity of VMS, improvements in sleep disturbances, and enhanced menopause-related quality of life compared to placebo.
• Elinzanetant is a dual neurokinin-1 and 3 receptor antagonist, representing a potential non-hormonal treatment option for VMS in breast cancer patients and women at high risk.
• Bayer is advancing regulatory submissions for elinzanetant in the US, EU, and other global markets, with potential launch expected later this year, pending regulatory approvals.
Enhertu Approved for HER2-Low and HER2-Ultralow Metastatic Breast Cancer
• The FDA has approved Enhertu for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer after endocrine therapy progression.
• DESTINY-Breast06 trial data showed a 36% reduction in disease progression or death risk compared to chemotherapy.
• Patients on Enhertu had a median progression-free survival of 13.2 months versus 8.1 months on chemotherapy.
• This approval expands Enhertu's use to an earlier treatment setting and a broader patient population.
AbbVie's Telisotuzumab Vedotin Shows Promise in c-Met Overexpressing NSCLC
• AbbVie's telisotuzumab vedotin (Teliso-V) demonstrated a 35% overall response rate in patients with high c-Met expression in the LUMINOSITY trial.
• The FDA granted breakthrough therapy designation to Teliso-V, highlighting its potential to significantly improve outcomes in NSCLC patients.
• A phase 3 trial (TeliMET-NSCLC-01) is underway, comparing Teliso-V to docetaxel in c-Met-positive, non-squamous NSCLC patients.
• Teliso-V targets c-Met, a protein involved in cancer progression and resistance to therapies like EGFR inhibitors, offering a novel approach.
Datroway (Datopotamab Deruxtecan) Receives Global Approvals for Advanced Breast Cancer
• Datroway (Dato-DXd) gains first global approval in Japan for previously treated, unresectable, or recurrent HR-positive, HER2-negative breast cancer, offering a new alternative to conventional chemotherapy.
• The FDA has approved Datroway for advanced breast cancer, marking the first U.S. approval for the antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo.
• EMA endorsed Dato-DXd as a late-line option for certain breast cancer cases, adding to approvals in the U.S. and Japan and expanding treatment options in Europe.
• Clinical trials, including TROPION-Breast01, demonstrated that Datroway significantly delayed cancer progression compared to standard chemotherapy, with manageable safety profiles.
Active Monitoring Shows Promise for Low-Risk DCIS Breast Cancer
• A recent study suggests active monitoring may be a safe alternative to standard treatment for low-risk ductal carcinoma in situ (DCIS).
• The COMET trial found that women with low-risk DCIS who underwent active monitoring had similar cancer development rates compared to those treated with surgery and radiation.
• Active monitoring included regular mammograms and hormone therapy, offering a less invasive approach for suitable candidates.
• Experts emphasize the need for longer-term follow-up to validate these findings and refine treatment strategies for DCIS.
Camizestrant Outperforms Fulvestrant in ER+, HER2- Breast Cancer
Camizestrant significantly improved progression-free survival compared to fulvestrant in patients with ER-positive, HER2-negative breast cancer, according to results from the phase 2 SERENA-2 trial published in The Lancet Oncology.
Imlunestrant Shows Promise in Advanced ER+/HER2- Breast Cancer Treatment
• Imlunestrant monotherapy significantly improved progression-free survival (PFS) in advanced breast cancer patients with ESR1 mutations compared to standard endocrine therapy.
• The combination of imlunestrant and abemaciclib demonstrated a statistically significant improvement in PFS compared to imlunestrant alone, regardless of ESR1 mutation status.
• The EMBER-3 trial results suggest imlunestrant, particularly in combination with abemaciclib, could offer a new all-oral targeted therapy option for pre-treated advanced breast cancer.
• Safety data from the trial indicated that imlunestrant, both as a monotherapy and in combination, was generally well-tolerated, with manageable adverse events.
Imfinzi Approved for Limited-Stage Small Cell Lung Cancer, Redefining Treatment
• The FDA has approved AstraZeneca's Imfinzi (durvalumab) for treating adults with limited-stage small cell lung cancer (LS-SCLC) after platinum-based chemotherapy and radiation therapy.
• The approval was based on the ADRIATIC Phase III trial, which showed a 27% reduction in the risk of death compared to placebo, marking a significant breakthrough.
• Median overall survival improved to 55.9 months with Imfinzi versus 33.4 months with placebo, establishing a new benchmark for LS-SCLC treatment.
• Imfinzi is now the only immunotherapy approved for both limited and extensive-stage small cell lung cancer, underscoring its potential to improve survival rates.
DATROWAY® (Datopotamab Deruxtecan) Receives EU Approval for Previously Treated Metastatic HR+/HER2- Breast Cancer
• DATROWAY, a TROP2-directed antibody drug conjugate (ADC), has been approved in the European Union for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine therapy and at least one line of chemotherapy.
• The approval is based on the TROPION-Breast01 phase 3 trial, which showed DATROWAY reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median PFS of 6.9 months versus 4.9 months.
• This marks the second ADC approved for breast cancer based on Daiichi Sankyo's DXd technology and the third medicine from their oncology pipeline to receive EU approval, highlighting their commitment to developing innovative cancer treatments.
Real-World Data Suggests Elacestrant Offers Similar or Improved Outcomes in Advanced Breast Cancer
• A real-world analysis shows elacestrant demonstrates similar or slightly higher time to treatment discontinuation compared to the EMERALD trial.
• The median real-world time to next treatment with elacestrant was 6.43 months, and time to treatment discontinuation was 4.6 months.
• Patients with PIK3CA pathway alterations experienced worse outcomes with elacestrant, underscoring the need for precision medicine.
• Most patients received elacestrant beyond the second line of treatment, with outcomes remaining consistent across different lines of therapy.
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