SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of Camizestrant Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients

The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.

Start Date15 Jun 2026

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NCT07427394

/ RecruitingPhase 2

A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)

A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.

Start Date06 May 2026

Sponsor / Collaborator

AstraZeneca PLC

NCT07195227

/ RecruitingPhase 2

Phase II Study to Evaluate the Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Hormone Receptor Positive (HR+) Breast Cancer

This trial will study a type of breast cancer defined by the expression of hormone receptor in the cancer cells (HR+). Patients will be treated with ribociclib, a cyclin-dependent kinase inhibitor, and camizestrant, a selective estrogen receptor degrader (SERD) and complete ER antagonist. The main purpose of the Study is to analyze the efficacy (to find out how effective a treatment is) of ribociclib in combination with camizestrant in patients with advanced HR+ breast cancer who have received endocrine therapy (ET) in early breast cancer setting for at least 5 years, of which at least 2 years with aromatase inhibitor (AI). Ribociclib plus camizestrant efficacy will be determined by assessing the period from treatment initiation until disease progression, defined as progression free survival (PFS).
The anticipated favorable clinical benefits of the combination of ribociclib and camizestrant therapy are projected to outweigh the risks of this treatment. This Study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.

Start Date24 Mar 2026

Sponsor / Collaborator

Medica Scientia Innovation Research SL

100 Clinical Results associated with Camizestrant

100 Translational Medicine associated with Camizestrant

100 Patents (Medical) associated with Camizestrant

Literatures (Medical) associated with Camizestrant

01 Jun 2026·TOXICOLOGY AND APPLIED PHARMACOLOGY

Camizestrant-induced heart rate reduction is mediated via a sinoatrial node pacemaker channel mechanism

Article

Author: El-Haou, Saïd ; Pointon, Amy ; Wright, Lindsay ; Harding, Joanna ; Purbrick, Stuart ; Kwan, Maggie ; Harmer, Alexander ; Canzolino, Serena ; Molla, David ; Baruscotti, Mirko ; Villar, Inmaculada C ; Roberts, Liz ; Hawthorne, Glen ; Protze, Stephanie ; Henry, David ; Hall, Andrew ; Kirk, Jason ; Bucchi, Annalisa

Camizestrant, a next-generation selective estrogen receptor (ER) degrader and complete ER antagonist, has been associated with a reversible dose- and time-dependent heart rate (HR) reduction in clinical studies. This nonclinical investigation aimed to understand the mechanism of camizestrant-induced HR reduction. The effects of camizestrant on HR in vivo were assessed in rat and dog telemetry studies. Effects on pacemaker channel function in vitro were assessed using patch-clamp electrophysiology in Chinese hamster ovary cells expressing human hyperpolarization-activated cyclic nucleotide-gated channel 4 (hHCN4), human embryonic stem cell (hESC)-derived sinoatrial node (SAN) cardiomyocytes, and primary rat SAN cardiomyocytes. In dogs, 28-day repeat-dose camizestrant administration caused a reversible dose- and time-dependent HR reduction (maximum reduction of 53 beats per min [bpm] on Day 25 vs pre-study levels at 20 mg/kg). HR reduction was also noted in rats (maximum reduction 89 bpm vs vehicle [23%] on Day 5 of a 7-day study at 75 mg/kg). Responses to chronotropic stimuli (e.g., atropine and isoprenaline) were reduced in dogs treated with camizestrant. Camizestrant-induced HR reduction was still present following combined sympathetic (atenolol) and parasympathetic (atropine) inhibition in dogs, as well as vagotomy in rats. Camizestrant reduced hHCN4 current density in Chinese hamster ovary cells, as well as beat rate and "funny" pacemaker (I_f) current activity in hESC-derived SAN cardiomyocytes. Camizestrant at 75 mg/kg for 7 days significantly reduced I_f current activity versus vehicle in isolated SAN cardiomyocytes. These results support the hypothesis that camizestrant exerts a pharmacologic, reversible reduction in HR by decreasing SAN pacemaker current activity.

01 Apr 2026·DRUG METABOLISM AND DISPOSITION

Identification, synthesis, and characterization of a unique N-glucuronide of an acid metabolite of camizestrant (AZD9833) in humans

Article

Author: Brenchley, Guy ; Sykes, Andy ; Tran, Lâm Quang ; Wilkinson, Stephen ; Zhang, Zhoupeng ; Hopkins, Emily ; Chen, April ; Phipps, Richard ; Howe, Peter W A ; Hariparsad, Niresh

Camizestrant (AZD9833) is a next-generation oral selective estrogen receptor (ER) degrader and complete ER antagonist in phase 3 clinical development for the treatment of ER-positive breast cancer. Metabolite M14, an N-glucuronide of the acid metabolite M46 of camizestrant, is one of the major circulating metabolites in humans, in addition to a direct N-glucuronide M4. In light of the fact that the existence of the acidic functional group of the acid metabolite M46 prevented an efficient in vitro glucuronidation in human liver microsomes, a novel hybrid chemical and biological synthesis of AZ4678 (M14) was successfully achieved. The acidic functional group of AZ8713 (M46) was esterified with methanol to give the M46 methyl ester, which was then glucuronidated in human liver microsomes in the presence of UPDGA to form M14 methyl ester. Selective hydrolysis of M14 methyl ester by aqueous lithium hydroxide in tetrahydrofuran successfully generated AZ4678 (M14). The development of this synthesis route has introduced a new approach to synthesizing glucuronides of compounds with acidic functional groups that otherwise interfere with their susceptibility to glucuronidation. NMR analysis confirmed the structure of AZ4678 (M14) with the glucuronic acid attached to the position N45 of the azole nitrogen atom while retaining the original stereochemistry of camizestrant. Chromatography of AZ4678 (M14) was sensitive to 67% of organic content in samples as well as sensitive to solvents at a basic pH containing ammonium hydroxide, resulting in split peaks in liquid chromatography-mass spectrometry analysis. AZ4678 (M14) was stable in human feces and in aqueous solutions at a pH range of 1.5-12.0. SIGNIFICANCE STATEMENT: Metabolite M14 of camizestrant (AZD9833), a major circulating metabolite in humans, was successfully identified as an N-glucuronide of an acid metabolite of camizestrant, and its unusual chromatographic and stability properties were characterized. The development of a novel hybrid chemical and biological synthesis for M14 has introduced a new approach to synthesizing glucuronides of compounds with acidic functional groups that otherwise interfere with their own in vitro glucuronidation.

20 Mar 2026·JOURNAL OF CLINICAL ONCOLOGY

Pharmacodynamics of Camizestrant Treatment in Postmenopausal Women With Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Primary Breast Cancer: Results From the Randomized, Presurgical SERENA-3 Study

Article

Author: Cheung, Kwok-Leung ; Klinowska, Teresa ; Mathewson, Alastair ; Ajimi, Maxine ; Rocha, Juan Enrique Bargalló ; Nemsadze, Gia ; Robertson, John F.R. ; Sykes, Andy ; Moppett, Iain ; Dzagnidze, Giorgi ; Katashvili, Zaza ; Arkania, Ekaterine ; Nikolaou, Myria ; Morrow, Christopher J. ; Lindemann, Justin P.O. ; Gogitidze, Teimuraz ; Scaltriti, Maurizio

PURPOSE:

SERENA-3 is a presurgical window-of-opportunity (WOO) trial exploring the pharmacodynamic effects of camizestrant in postmenopausal women with newly diagnosed estrogen receptor (ER)–positive, human epidermal growth factor receptor 2–negative breast cancer.

METHODS:

This open-label, parallel-group trial randomly assigned 132 participants to receive camizestrant 75, 150, or 300 mg once daily for 5-7 days or 75 or 150 mg once daily for 12-15 days. The effects of camizestrant on ER expression, activity, and tumor proliferation were assessed in pre- and on-treatment tumor samples by immunohistochemical (IHC) analysis of ER, progesterone receptor (PgR), and Ki67. Exploratory analyses using transcriptomics and mass spectrometry were also performed.

RESULTS:

ER expression was reduced by approximately 65% for all camizestrant doses, regardless of treatment duration. Reduction in Ki67 expression was greater after 12-15 days of camizestrant treatment, compared with 5-7 days. Exploratory analyses including mass spectrometry and IHC image analysis aligned with IHC H-score, indicating equivalent, maximal effects of all tested doses of camizestrant on ER expression and activity and Ki67 expression. Of those participants receiving camizestrant 75 mg once daily, 90%-100% reported no treatment-emergent adverse events across all preferred terms; of those reported, all were Grade 1 except one participant with Grade 2 upper respiratory tract infection, not considered related to camizestrant.

CONCLUSION:

SERENA-3 demonstrates that camizestrant 75 mg once daily (Phase III dose) is well-tolerated and achieves maximal reduction in ER through known mechanisms, that is, antagonism and degradation, by 5-7 days, and proliferation suppression determined by Ki67 expression, by 12-15 days. These data support camizestrant 75 mg once daily as the preferred dose for ongoing clinical development and highlight the importance of presurgical WOO studies in guiding dose selection.

165

News (Medical) associated with Camizestrant

22 Jul 2026

·www.biospace.com

Wainua flop narrows AstraZeneca’s path to $80B goal ahead of high-risk readouts

iStock, Korakrich Suntornnites With a Phase 3 failure denting the rare disease drug’s prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target. As AstraZeneca exited the first quarter, initially skeptical analysts were coming around to the potential for the drugmaker to hit its goal of growing sales to $80 billion by 2030. But less than three months later, the shocking Phase 3 failure of rare disease drug Wainua has left the company needing wins in two high-risk readouts to maintain its trajectory toward the towering target. The FDA approved Wainua, an antisense oligonucleotide inhibitor, in December 2023 for the treatment of transthyretin amyloidosis (ATTR) with polyneuropathy. Months later, AstraZeneca named Wainua as one of the drugs underpinning its belief that it could grow sales to $80 billion by 2030. At the time, the consensus estimate of analysts put AstraZeneca’s 2030 sales at $66.8 billion. Wainua has yet to contribute significantly to AstraZeneca’s path to $80 billion, with sales totaling just $212 million last year. But the drugmaker was predicting peak revenues in excess of $5 billion until the Phase 3 flop derailed plans to expand Wainua’s label to cover ATTR cardiomyopathy (ATTR-CM). ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); AstraZeneca still thinks it can hit $80 billion, though. Before that disappointing readout, the company-sponsored consensus projected 2030 sales of $82.7 billion, Leerink Partners analysts said in a July 9 note to investors. Removing ATTR-CM reduced that forecast to $80.8 billion, reflecting about $1.9 billion in Wainua sales in 2030. AstraZeneca’s management acknowledged that the setback “decreases headroom” but is still confident the company can achieve the 2030 goal, the analysts said. Cardiovascular disease AstraZeneca, Ionis’ Wainua woes send waves across ATTR-CM space The failure of AstraZeneca and Ionis’ Wainua in a late-stage study of ATTR-CM casts doubt on Alnylam’s next-generation candidate but is good news for others in the space, including BridgeBio and Intellia Therapeutics. July 10, 2026 · 3 min read · Tristan Manalac Read more Plotting a path to $80B The coming months will feature readouts that could intensify questions about whether AstraZeneca can hit its target. This year, the company is scheduled to report data from SERENA-4 and AVANZAR, late-phase clinical trials that Leerink analysts called binary events subject to “prior investor uncertainty.” SERENA-4 is testing the investigational oral SERD camizestrant in first-line, HR-positive breast cancer. AVANZAR is assessing the antibody-drug conjugate Datroway, already marketed for second-line non-small cell lung cancer (NSCLC) and forms of breast cancer, in first-line NSCLC. Leerink analysts predicted that SERENA-4 could add non–risk adjusted peak sales of $2.8 billion for camizestrant and that AVANZAR could boost Datroway sales by $2.2 billion. AstraZeneca, which won its first FDA approval for Datroway in January 2025, reported sales of ¥47.6 billion (~$293 million) and $43 million in the first quarter of 2026. The analysts see the trials as risky, putting the probability of success at 20% for SERENA-4 and at 50% for AVANZAR. Skepticism about the chances of the studies succeeding extends beyond Leerink, with analysts at Guggenheim Securities characterizing investor expectations as “very low.” The failure of the trials would remove rungs from the ladder that AstraZeneca climbs toward its $80 billion target. AstraZeneca has tipped each drug to generate peak sales of $5 billion or more. SERENA-4 and AVANZAR are central to the blockbuster forecasts. Camizestrant is awaiting approval in another indication, but in a May 8 note to investors Guggenheim analysts called that commercial opportunity “limited.” Analysts have generally been less confident in the 2030 aim than AstraZeneca itself seems to be. Although the Guggenheim team said the consensus of its peers did reach $80 billion in December, the firm’s own estimate was lower, at $76.4 billion. It raised that number to $79.6 billion in April, based on developments including Phase 3 data on the chronic obstructive pulmonary disease prospect tozorakimab, but following the Wainua setback, Guggenheim’s 2030 forecast for the company fell back down to $78 billion. The analysts now foresee Wainua sales of $500 million, down from $2 billion before the Phase 3 flop. Removing the ATTR-CM opportunity from the Leerink model similarly resulted in a drop in risk-adjusted 2030 total revenues, from $79.5 billion to $78.6 billion. Earnings AstraZeneca bullish on $80B sales goal after beating expectations, Phase 3 data wins After a quarter in which sales topped $15 billion and key readouts went AstraZeneca’s way, the company is increasingly confident that its 2030 revenue target is in reach. April 29, 2026 · 2 min read · Nick Paul Taylor Read more Fallback options AstraZeneca has options if setbacks to SERENA-4 and AVANZAR impede its pursuit of the 2030 sales goal. The $80 billion objective “was on an organic basis, and that does not assume any M&A of any size and scale,” AstraZeneca CFO Aradhana Sarin said on the company’s earnings call in February. While AstraZeneca is aiming to hit its 2030 target without M&A, Sarin said the company has “substantial firepower” for deals. AstraZeneca will “remain very disciplined in terms of what type of assets we bring in,” partly because it requires “substantial investments in R&D” to create shareholder value after buying a drug candidate, Sarin said. Organically, AstraZeneca could smooth its path to $80 billion by beating sales expectations for its existing growth drivers and planned launches or by lessening the impact of loss of exclusivity on drugs such as Lynparza and Farxiga. Guggenheim analysts said elecoglipron, an oral GLP-1 asset, is “underappreciated,” but with the small molecule entering Phase 3 this year, it is not on AstraZeneca’s roadmap to $80 billion. The roadmap features assets including the cancer medicines Imfinzi and Imjudo, blood pressure drug Baxfendy and rare disease candidate efzimfotase alfa. Guggenheim analysts foresee a “standard, slow [cardiovascular disease] ramp” for Baxfendy, with Medicare Part D reimbursement negotiations expected in 2027 or 2028. If the pipeline stutters, AstraZeneca’s ability to squeeze more sales from existing assets could be key to hitting its 2030 target. The company’s commercial teams have impressed recently, helping to power sales past analyst expectations in the third and fourth quarters of 2025 and the first quarter of 2026. AstraZeneca plans to release its second-quarter earnings results on July 27.

Phase 3Drug Approval

26 Jun 2026

·www.astrazeneca.com

AstraZeneca and Daiichi Sankyo’sDatroway (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the 1st-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast02 Phase III trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “As one of the hardest cancers to treat, today only 15% of patients with metastatic triple-negative breast cancer survive beyond five years. This positive opinion from the CHMP marks an important step forward in bringing the potential of Datroway to transform outcomes for patients with this type of cancer in the EU.” John Tsai, MD, Global Head, R&D, Daiichi Sankyo, said: “Triple-negative breast cancer remains one of the most aggressive types of breast cancer, with limited treatment options for patients with metastatic disease who are not candidates for immunotherapy and are currently treated with traditional chemotherapy. This positive recommendation by the CHMP underscores the potential for Datroway to replace traditional chemotherapy in this setting and we look forward to working closely with the EMA to bring this new indication to patients in the EU.” In the trial, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0291) compared to chemotherapy as 1st-line treatment in this patient population. Median OS was 23.7 months for patients treated with Datroway versus 18.7 months for those treated with chemotherapy. Datroway reduced the risk of disease progression or death by 43% compared to chemotherapy (HR 0.57; 95% CI 0.47-0.69; p<0.0001) as assessed by blinded independent central review (BICR). Datroway was also associated with more robust treatment responses, including an objective response rate (ORR) of 62.5% compared to an ORR of 29.3% with chemotherapy.1 The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical trials of Datroway in breast cancer. Datroway was approved in the US in May 2026 for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. Additional reviews are underway in China and Japan, as well as Australia, Canada, Singapore and Switzerland as part of Project Orbis. Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Notes Triple-negative breast cancer TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.2,3 In Europe, there are an estimated 83,000 diagnoses of TNBC each year.2,4 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.5-7 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.5,8,9 While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.5 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.5 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.10,11However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, prior to the approval of Datroway, chemotherapy was the standard 1st-line treatment.12 TROP2 is a protein broadly expressed in several solid tumours, including TNBC.13 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.14,15 TROPION-Breast02 TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrolment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases. The dual primary endpoints of TROPION-Breast02 are OS and progression-free survival (PFS) as assessed by blinded independent central review. Secondary endpoints include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and safety. TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov. Datroway Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Datroway is also approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial. Datroway is approved in the US for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy based on the results from the TROPION-Breast02 trial. Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial. Datroway clinical development programme A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer, and one Phase II/III trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu (trastuzumab deruxtecan) in March 2019 and Datroway in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and expanding its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP2-directed ADC, Datroway, and next-generation oral SERD, Etcamah. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab).  AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial

Phase 3ImmunotherapyClinical ResultDrug Approval

17 Jun 2026

·allsci.com

Rigel closes USD 70m Veppanu deal with Arvinas and Pfizer

Rigel Pharmaceuticals (Nasdaq: RIGL) has closed its exclusive global license for Veppanu (vepdegestrant), paying USD 70 million upfront to Arvinas (Nasdaq: ARVN) and Pfizer (NYSE: PFE) — each receiving USD 35 million — for the first FDA-approved PROTAC in history. The deal, effective June 11, transfers commercialization rights for an approved oral estrogen receptor degrader to the San Francisco-based Rigel, a biotech with no prior presence in breast cancer. Rigel expects to launch Veppanu commercially in August 2026. The closing follows the original agreement announced May 12, 2026, under which Rigel will pay an additional USD 15 million upon completion of manufacturing and development transition activities, contribute up to USD 40 million toward ongoing development activities over four years, and is eligible to pay up to USD 320 million in regulatory and commercial milestones. Arvinas and Pfizer are entitled to tiered royalties ranging from mid-teens to mid-twenties percent on net sales, plus a share of sublicensing revenue Rigel generates outside the US. Vepdegestrant is the first approved PROTAC therapy, designed to degrade rather than simply inhibit the estrogen receptor. FDA approval on May 1, 2026 was based on data from VERITAC-2 (NCT05654623), a global, randomized Phase III trial comparing vepdegestrant to fulvestrant in patients with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. The deal’s economics are strikingly compressed relative to the asset’s history. When Pfizer originally partnered with Arvinas in July 2021 for vepdegestrant’s co-development, Pfizer paid USD 650 million upfront under a deal worth up to USD 1.4 billion plus a 50/50 profit share. Rigel’s USD 70 million upfront — for a post-approval, global asset — represents roughly a 90% discount from that original payment, highlighting the difference between the economics of an early-stage development partnership and a commercial-stage asset with a defined label. The drug enters an increasingly competitive ESR1-mutated breast cancer market that already includes approved oral estrogen receptor-targeting therapies elacestrant (Orserdu) and imlunestrant (Inluriyo), while AstraZeneca’s camizestrant has an FDA decision pending. Veppanu’s PROTAC mechanism offers theoretical differentiation through complete protein degradation, but no head-to-head clinical data against the approved SERDs have been reported. For Rigel, the transaction is a meaningful step-up in scope. Its prior commercial-stage acquisition — US rights to Gavreto (pralsetinib) from Blueprint Medicines in February 2024 for up to USD 102.5 million in milestones plus tiered royalties of 10%–30% — was US-only. Veppanu is Rigel’s first global license and its first oncology asset outside hematology. Notably, Eli Lilly terminated its USD 960 million ocadusertib collaboration with Rigel in April 2026, weeks before the Veppanu deal was announced, removing Rigel’s largest development partnership and creating both financial and strategic impetus to replace it with a commercial-stage asset. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

100 Deals associated with Camizestrant

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	European Union	AstraZeneca AB	20 Jul 2026
ER-positive/HER2-negative Breast Cancer	Iceland	AstraZeneca AB	20 Jul 2026
ER-positive/HER2-negative Breast Cancer	Liechtenstein	AstraZeneca AB	20 Jul 2026
ER-positive/HER2-negative Breast Cancer	Norway	AstraZeneca AB	20 Jul 2026
Hormone receptor positive HER2 negative breast cancer	Japan	AstraZeneca PLC	19 Jun 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
ER-positive/HER2-negative/ ESR1-mutated breast cancer	NDA/BLA	European Union	AstraZeneca AB	21 May 2026
Breast Cancer	NDA/BLA	Canada	AstraZeneca Canada, Inc.	01 Oct 2025
Early Stage Breast Carcinoma	Phase 3	United States	AstraZeneca PLC	31 Mar 2023
Early Stage Breast Carcinoma	Phase 3	China	AstraZeneca PLC	31 Mar 2023
Early Stage Breast Carcinoma	Phase 3	Japan	AstraZeneca PLC	31 Mar 2023
Early Stage Breast Carcinoma	Phase 3	Argentina	AstraZeneca PLC	31 Mar 2023
Early Stage Breast Carcinoma	Phase 3	Australia	AstraZeneca PLC	31 Mar 2023
Early Stage Breast Carcinoma	Phase 3	Austria	AstraZeneca PLC	31 Mar 2023
Early Stage Breast Carcinoma	Phase 3	Belgium	AstraZeneca PLC	31 Mar 2023
Early Stage Breast Carcinoma	Phase 3	Brazil	AstraZeneca PLC	31 Mar 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04964934 (SERENA-6, ESMO_BC2026)	Phase 2	Advanced breast cancer First line ESR1 mutations	315	camizestrant+CDK4/6i	sqftfowrln(nwawqfnwld) = ihabhwykhh ecssgnzgun (fhrkatrzhp, 6.9 - 9.3) View more	Positive	07 May 2026
AACR2026	Phase 2/3	Hormone receptor positive HER2 negative breast cancer HR Positive \| HER2 Negative	16	Imlunestrant alone	ewiqklhrzy(stbvtwntjf) = ykxlsinvyn jfaorvpvmi (bjqkkxucgj ) View more	Positive	21 Apr 2026
				Camizestrant 75mg	ewiqklhrzy(llzuxmawvv) = jekaocxznd hstjmsquqd (pgqbsrevdf ) View more
NCT04644068 (PETRA, SABCS2025)	Phase 1/2	Recurrent HER2-Negative Breast Carcinoma ER positive \| HER2 negative \| BRCA1/2 mutation ... View more	38	Saruparib + Camizestrant	dflvnfqqja(gykdqcshey) = gluqmwdctd kbvmpvowoo (thtcjzklva ) View more	Positive	10 Dec 2025
				Saruparib + Camizestrant (BRCA1/BRCA2 mutation or PALB2 mutation)	zwupqyttrx(qwmfspmwwg) = moyourltzl zcnaqasclw (pkmnjffqnq, 4.4 - 7.3)
NCT04964934 (SERENA-6, ESMO2025) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer First line HER2 Negative \| ESR1 Mutation \| HR Positive	315	Camizestrant + CDK4/6i	wdlfsfivyv(ooyaxkjpal) = oswqhjouyq rwhtbmflpq (hlcrkscfsu ) View more	Positive	17 Oct 2025
				Aromatase inhibitor + CDK4/6i	wdlfsfivyv(ooyaxkjpal) = jlzakgzpyw rwhtbmflpq (hlcrkscfsu ) View more
ESMO2025	Not Applicable	Advanced breast cancer HR+ \| HER2-	16	Camizestrant	-	Positive	17 Oct 2025
				Ribociclib plus ET
NCT04964934 (SERENA-6, ESMO2025)	Phase 3	Hormone receptor positive HER2 negative breast cancer First line ESR1m \| HR+ \| HER2-	310	camizestrant+CDK4/6i	xheurjotij(yxghwxpjpp) = qzogwvkmji fubxdcmuwd (hsgfoigvua ) View more	Positive	17 Oct 2025
				aromatase inhibitor + CDK4/6i	xheurjotij(yxghwxpjpp) = cmewtmjepi fubxdcmuwd (hsgfoigvua ) View more
NCT04964934 (SERENA-6, Pubmed \| N Engl J Med)	Phase 3	ER-positive/HER2-negative Breast Cancer \| Hormone receptor positive HER2 negative breast cancer First line	315	Camizestrant 75 mg once daily + CDK4/6 inhibitor + Placebo	fypmwcaqqs(szfovmwxzo) = xrbzzheeob oddzgjgrxu (lqbmftwiee, 12.7 - 18.2)	Positive	07 Aug 2025
				Aromatase inhibitor + CDK4/6 inhibitor + Placebo	fypmwcaqqs(szfovmwxzo) = diujyeoatn oddzgjgrxu (lqbmftwiee, 7.2 - 9.5)
NCT04964934 (SERENA-6, BusinessWire) Manual	Phase 3	ER-positive/HER2-negative/ ESR1-mutated breast cancer First line HR Positive \| HER2 Negative \| ESR1 Mutation	315	Camizestrant + CDK4/6i	jtjllloyhm(pjriwfzjvh) = a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS). rtjitkrlkh (tvasxsqcjx ) View more	Positive	26 Feb 2025
NCT04588298 (SERENA-3, CTgov)	Phase 2	ER-positive/HER2-negative Breast Cancer	135	AZD9833 (AZD9833 75 mg (Stage 1 + 2))	qiqayunfwm(qagqxxoefb) = ypcnphfscn qqgelvbgcp (pxvdkjlduu, hwjhsgwouz - tocwvionhk) View more	-	24 Jan 2025
				AZD9833 (AZD9833 150 mg (Stage 1 + 2))	qiqayunfwm(qagqxxoefb) = onzexoqrsz qqgelvbgcp (pxvdkjlduu, zakfeaixza - eysolpeksc) View more
NCT04214288 (SERENA-2, Literature) Manual	Phase 2	ER-positive/HER2-negative Breast Cancer HER2 Negative	240	camizestrant 75 mg	nxiojckfsk(ruhfgrduxw) = cpuuqzdkxp isbabaftbd (knteegtsxq, 3.7–10.9) View more	Positive	09 Nov 2024
				camizestrant 150 mg	nxiojckfsk(ruhfgrduxw) = frkyweubii isbabaftbd (knteegtsxq, 5.5–12.9) View more

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