Latest news with #ESR1m
Business Insider
3 days ago
- Business
- Business Insider
Arvinas downgraded to Market Perform from Outperform at Leerink
Leerink analyst Andrew Berens downgraded Arvinas (ARVN) to Market Perform from Outperform with a price target of $9, down from $10, after the company presented full results from the Phase 3 VERITAC-2 trial evaluating vepdegestrant in second-line HR+/HER2- metastatic breast cancer patients. The firm says that while the full presentation demonstrates the drug is active in patients with ESR1 mutations and likely approvable, it is not convinced vepdeg is best-in-class. Further, a number of key uncertainties in the rapidly evolving treatment paradigm for ESR1m breast cancer landscape have emerged, the analyst tells investors in a research note. Leerink 'gradually tempered the ESR1m rate in second-line from 30% to 15% to reflect potential impact from the SERENA-6 data, as well as ongoing first-line oral SERD trials, lowering its assumed worldwide peak vepdeg sales to $416M from $576M.
Yahoo
11-03-2025
- Business
- Yahoo
Pfizer and Arvinas's HER2-breast cancer drug extends PFS in certain patients
Pharma giant Pfizer and Arvinas's human epidermal growth factor receptor 2 (HER2) negative breast cancer therapy, vepdegestrant, has seen mixed results after it was only able to extend progression-free survival (PFS) in certain patients in a Phase III trial. Topline results from the company's Veritac-2 trial (NCT05654623) showed a clinically meaningful improvement in PFS in patients with oestrogen receptor 1-mutant (ESR1m) breast cancer. However, the company said that it was not able to improve PFS in the intent-to-treat (ITT) population. The global randomised study enrolled 624 patients at sites in 26 countries who had previously received treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors alongside endocrine therapy. The trial pitted vepdegestrant against AstraZeneca's Faslodex (fulvestrant). Data on overall survival (OS), a key secondary endpoint, was not yet mature with less than a quarter of the required number of events having occurred. Pfizer describes vepdegestrant as a potential first-in-class investigational oral proteolysis targeting chimera (PROTAC) oestrogen receptor degrader. Developed as part of a $2.4bn partnership between Pfizer and Arvinas, the oral drug was designed for a natural protein disposal system to specifically target and degrade oestrogen receptors. Following the announcement of the mixed results, Arvinas' stock price dropped more than 51% from $17.70 per share down to $8.59 at the time of publication (11 March 10am EST). Arvinas president John Houston said: 'The first Phase III data readout for a PROTAC degrader represents a significant achievement and these data show that vepdegestrant has the potential to provide clinically meaningful outcomes for thousands of patients with metastatic breast cancer whose tumours harbour oestrogen receptor 1 mutations.' It follows after the US Food and Drug Administration (FDA) granted fast track designation for the investigation of vepdegestrant as a monotherapy. Research by GlobalData estimates that by the end of next year, the breast cancer therapy could bring in as much as $75m for the two companies, with that figure expected to rise to $841m by the end of 2030. The World Health Organization (WHO) found that breast cancer caused 670,000 deaths globally in 2022. GlobalData is the parent company of Clinical Trials Arena. Pfizer oncology chief development officer Megan O'Meara said: 'Patients with advanced ER+/HER2- metastatic breast cancer face significant clinical challenges, with limited treatment options following disease progression and the development of resistance to available endocrine therapies. 'This data from the Veritac-2 trial supports the potential of vepdegestrant to give patients whose tumours harbour ESR1 mutations additional time without disease progression, compared to Faslodex.' Elsewhere in the field of HER2 breast cancer, NiKang Therapeutics has concluded the first cohort dosing in the open-label Phase I trial of NKT3964. Meanwhile, Phoenix Molecular Designs has started dosing in the Phase II arm of a trial examining its metastatic breast cancer candidate, PMD-026. "Pfizer and Arvinas's HER2-breast cancer drug extends PFS in certain patients" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
