Seagen announces updated results from HER2CLIMB trial » 18:0212/0812/08/21
Seagen announced the…
Seagen announced the presentation of new data from exploratory analyses from the pivotal HER2CLIMB trial showing that improvement in overall survival was maintained after an additional 15.6 months of follow-up when TUKYSA was combined with trastuzumab and capecitabine in patients with HER2-positive metastatic breast cancer who had stable or active brain metastases. The data were featured today in a spotlight poster at the 2021 San Antonio Breast Cancer Symposium. "The risk of breast cancer spreading to the brain is more pronounced for patients with aggressive subtypes of breast cancer, including HER2-positive breast cancer," said Nancy U. Lin, M.D., Director of the Metastatic Breast Cancer Program in the Susan F. Smith Center for Women's Cancers at Dana-Farber in Boston, MA. "These analyses provide a hopeful outcome for patients with HER2-positive metastatic breast cancer when cancer has spread to the brain as they show that the TUKYSA regimen not only helped patients live longer but also slowed disease progression in the brain." "After more than two years of follow up, these exploratory analyses show the impact that TUKYSA can have on HER2-positive metastatic breast cancer patients and underscore its importance as a treatment option," said Roger D. Dansey, M.D., Chief Medical Officer of Seagen. After a median follow-up of 29.6 months, the TUKYSA regimen improved OS for patients with brain metastases by 9.1 months compared to trastuzumab and capecitabine alone. The benefit extended to patients with active or stable brain metastases. TUKYSA treatment continued to show clinically meaningful benefit in progression-free survival in the central nervous system, representing a delay of cancer progression in the brain. The rates for intracranial objective response rate and duration of objective response were consistent with previous analyses.
Regeneron, Sanofi: NEJM publishes positive results from Phase 3 Dupixent trial » 17:3212/0812/08/21
Regeneron (REGN) and…
Bristol-Myers initiated with an Equal Weight at Wells Fargo » 16:2912/0812/08/21
Wells Fargo analyst Mohit…
Merck initiated with an Overweight at Wells Fargo » 16:2512/0812/08/21
Wells Fargo analyst Mohit…
Wells Fargo analyst Mohit Bansal initiated coverage of Merck with an Overweight rating and $90 price target. The analyst views Keytruda growth as underappreciated as he sees $2B of upside potential to consensus estimates by 2025. The Street is also ignoring Merck's lifecycle management approach for Keytruda loss of exclusivity, Bansal tells investors in a research note.
Regeneron initiated with an Overweight at Wells Fargo » 16:2212/0812/08/21
Wells Fargo analyst Mohit…
Wells Fargo analyst Mohit Bansal initiated coverage of Regeneron Pharmaceuticals with an Overweight rating and $750 price target. The analyst says 2022 "may all be about Eylea" with high-dose data expected in the second half of 2022. He thinks the trial "has a good shot at working" and sees a positive risk/reward into the readout.
AstraZeneca says Evusheld authorized for U.S. emergency use for COVID prevention » 16:0412/0812/08/21
AstraZeneca's Evusheld, a long-acting antibody combination, has received emergency use authorization, or EUA, in the U.S. for the pre-exposure prophylaxis, or prevention, of COVID-19, with first doses expected to become available "very soon," the company announced. The Food and Drug Administration granted the EUA for Evusheld for pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 and older who weigh 40kg or more with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended. Recipients should not be currently infected with or had recent known exposure to a person infected with SARS-CoV-2. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "We are proud to play a leading role in fighting the COVID-19 pandemic and, with Evusheld, we now have the first antibody therapy authorised in the US to prevent COVID-19 symptoms before virus exposure, while also providing long lasting protection with a single dose. Evusheld neutralises all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant."
NICE issues guidance for Dupixent as add-on for severe asthma » 12:2912/0812/08/21
The U.K.'s National…
Novartis reports new data from MONALEESA Phase 3 program for Kisqali » 09:3812/0812/08/21
Novartis announced new…
Novartis announced new Kisqali data demonstrating a consistent overall survival, or OS, benefit with Kisqali plus endocrine therapy across genomic subtypes of hormone receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer, or mBC, similarly in the indolent as well as in the aggressive, endocrine therapy-resistant subtypes. The findings will be presented as a late-breaking oral presentation at the 2021 San Antonio Breast Cancer Symposium, or SABCS, the company said. A broad ad hoc exploratory analysis of nearly 1,000 tumor samples showed that Kisqali in combination with ET consistently provided significant OS benefit compared to ET alone across main intrinsic subtypes. Patients with the HER2-enriched subtype associated with endocrine resistance and poor prognosis in HR+/HER2- breast cancer, achieved a significant improvement in median OS of 40.3 months compared to 29.4 months for ET alone6. The longest survival benefit from Kisqali plus ET was seen in patients with the luminal A subtype, who achieved a median OS of 68.0 months compared to 54.6 months on ET alone6. Patients with basal-like subtype, which is known to behave more like triple-negative breast cancer, had poorer OS outcomes in both the Kisqali combination and ET alone groups with a median OS of 19.4 months and 21.2 months, respectively. These data follow the biomarker analysis of the MONALEESA trials presented at SABCS 2020 and published in Journal of Clinical Oncology, in which Kisqali demonstrated-progression free survival benefit across the most common intrinsic subtypes in metastatic breast cancer, the company said.
Philips receives FDA 510(k) clearance for acute patient monitors » 09:0312/0812/08/21
Royal Philips announced…
Royal Philips announced that its Philips Patient Monitors MX750 and MX850 have received 510(k) clearance from the U.S. Food and Drug Administration. Initially cleared for Emergency Use Authorization in 2020, the MX750 and MX850 are Philips' most advanced patient monitors uniquely designed to support scalability, alarm management, cybersecurity and enhanced infection prevention within the hospital. As health systems navigate the digital transformation, patient management solutions that can scale to meet hospital needs are in high demand. The MX750 and MX850 patient monitors are an integrated part of the company's future-focused acute patient management solution, enabling hospitals to standardize at a system level and customize the solution in a particular care setting, even virtual or decentralized, to help optimize patient care. The monitors provide full modularity and are interoperable with other devices and applications, including Philips Patient Information Center iX and IntelliVue XDS software, to display critical patient data remotely or at the point of care.
SOTIO enters clinical collaboration with MSD to evaluate SOT101 » 08:1212/0812/08/21
SOTIO Biotech has entered…