Camizestrant significantly bettered progression-free survivalvs. Faslodex in SERENA- 2 Phase II trial in advanced ER-positive bone cancer

Camizestrant significantly bettered progression-free survivalvs. Faslodex in SERENA- 2 Phase II trial in advanced ER-positive bone cancer

Results support commitment to coming- generation oral SERD development programme
Positive high- position results from the SERENA- 2 Phase II trial showed that AstraZeneca’s coming- generation oral picky estrogen receptor inveigler( ngSERD) camizestrant met the primary endpoint of demonstrating a statistically significant and clinically meaningful progression-free survival( PFS) benefit at both 75 mg and 150 mg cure situations versus Faslodex( fulvestrant) 500 mg inpost-menopausal cases with estrogen receptor( ER)-positive locally advanced or metastatic bone cancer, preliminarily treated with endocrine remedy for advanced complaint.

Camizestrant was well permitted, and its safety profile was harmonious with that observed in former trials with no new safety signals linked.
Bone cancer is the most common cancer worldwide, with an estimated2.3 million cases diagnosed in2020.1 roughly 70 of bone cancer tumours are considered HR-positive and HER2-low or negative.2 Endocrine curatives are extensively used for the treatment of HR-positive bone cancer, but numerous cases with advanced complaint develop resistance to 1st- line CDK4/ 6 impediments and estrogen receptor- targeting curatives, emphasizing the need for fresh options.3

Mafalda Oliveira, MD, PhD, Vall d‘Hebron Institute of Oncology in Barcelona, Spain and lead investigator in the SERENA- 2 Phase II trial, said “ The results from SERENA- 2 show that camizestrant provides a significant enhancement in progression-free survival compared to fulvestrant, which has been used to treat cases with HR-positive bone cancer for nearly twenty times. These results are meaningful, pressing the eventuality of this coming- generation oral SERD and supporting the ongoing exploration program. ”
Susan Galbraith, EVP, Oncology R&D, AstraZeneca, said “ Our thing with our coming generation oral SERD camizestrant is to ameliorate on presently available endocrine curatives for cases with HR-positive bone cancer in early and metastatic complaint. The instigative efficacity and compelling safety results from the SERENA- 2 trial emphasize the eventuality for camizestrant to achieve this thing in cases with ER- driven bone cancer and we look forward to advancing our comprehensive Phase III clinical programme for camizestrant. ”

The data will be presented at a forthcoming medical meeting.
AstraZeneca has a broad clinical development programme for camizestrant in advanced bone cancer, including the vital SERENA- 6 Phase III trial assessing camizestrant in

combination with cyclin-dependent kinase4/6( CDK4/ 6) impediments( palbociclib or abemaciclib) in cases with HR-positive metastatic bone cancer who have sensible ESR1 mutations on 1st- line treatment and the SERENA- 4 Phase III trial assessing camizestrant plus palbociclib in HR-positive, locally advanced or metastatic bone cancer from the launch of remedy in the 1st- line setting. The suggestion for SERENA- 6 has been granted Fast Track Designation by the US Food and Drug Administration.
AstraZeneca has a comprehensive portfolio of approved and implicit new drugs in development for cases with bone cancer. In addition to these results, the Company has also blazoned moment positive results from the CAPitello- 291 Phase III trial of capivasertib in HR-positive advanced bone cancer.

HR-positive bone cancer
HR-positive bone cancer( expressing estrogen or progesterone receptors, or both), is the most common subtype of bone cancer, and the growth of HR-positive bone cancer cells is frequently driven byER.2,,5 Endocrine curatives that target ER- driven complaint are extensively used as 1st- line treatment for this form of bone cancer in the advanced setting, and frequently paired with CDK4/ 6 impediments.3 still, resistance to CDK4/ 6 impediments and current endocrine curatives develops in numerous cases with advanced complaint and treatment options are limited.3 Optimising endocrine remedy and prostrating resistance for cases with ER- driven complaint at all stages of treatment are active areas of focus for bone cancer exploration.

SERENA- 2 is a randomised, open- marker, resemblant group, multicentre Phase II trial assessing camizestrant at several cure situations compared to Faslodex in advanced ER-positive, HER2-negative bone cancer. The primary endpoints are PFS defined by response evaluation criteria in solid tumours( RECIST) interpretation1.1 for 75 mg camizestrant versus Faslodex( 500 mg) and for 150 mg camizestrant versus Faslodex. 240 cases were randomised to admit camizestrant or Faslodex until complaint progression. Secondary endpoints include safety, objective response rate and clinical benefit rate( CBR) at 24 weeks.

SERENA- 2 is part of a larger clinical programme concentrated on camizestrant, assessing the safety and efficacity when used as a monotherapy or in combination with other agents, to address a number of areas of unmet need in HR-positive bone cancer.
Camizestrant is a potent, coming- generation oral SERD and pure ERα antagonist, that has demonstratedanti-cancer exertion across a range of preclinical models, including those with ER- cranking mutations.

The SERENA- 1 Phase I trial demonstrated that camizestrant is well permitted and has a promisinganti-tumour profile when administered alone or in combination with palbociclib, a CDK4/ 6 asset. Combinations with other agents are ongoing in SERENA- 1.

AstraZeneca( LSE/ STO/ Nasdaq AZN) is a global, wisdom- led biopharmaceutical company that focuses on the discovery, development, and commercialisation of tradition drugs in Oncology, Rare conditions, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Grounded in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative drugs are used by millions of cases worldwide.

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