The first patient has been dosed in a Phase 2 extension study investigating the cancer vaccine DSP-7888 (ombipepimut-S) in combination with the checkpoint inhibitor Keytruda (pembrolizumab), in people with platinum-resistant ovarian cancer. The announcement follows promising data from the first portion of this Phase 1b/2 clinical trial (NCT03311334). The Phase 2 part is actively recruiting…
Daiichi Sankyo and AstraZeneca are initiating a global Phase 3 trial to compare Enhertu (fam-trastuzumab deruxtecan-nxki) to Kadcyla (ado-trastuzumab emtansine, also called T-DM1) as adjuvant therapy in patients with HER2-positive early breast cancer, who remain at high risk of recurrence after neo-adjuvant therapy. These two types of therapy— adjuvant and neo-adjuvant — address different aspects of cancer…
Efforts are underway this month to focus attention on Alzheimer’s, a disease that, along with other forms of dementia, affects some 44 million people globally and is swiftly growing in prevalence. During November in the U.S., Alzheimer’s Awareness Month observances include fundraisers, disseminating tips for healthy aging, downloadable Alzheimer’s information, “memory walks,” and information and resources for…
A heavily pretreated patient with metastatic castration-resistant prostate cancer (mCRPC) showed significant benefits, including a 94% decrease in the levels of the prostate-specific antigen (PSA) biomarker, one month after receiving MB-105 in a Phase 1 clinical trial. The promising initial data from Mustang Bio‘s investigational CAR T-cell therapy were shared at the 27th Annual Prostate Cancer…
The European Commission has approved Zejula (niraparib) as a first-line maintenance therapy for people with advanced ovarian, fallopian tube, or primary peritoneal cancer, who respond to platinum-based chemotherapy. This decision follows a positive recommendation issued by the Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency (EMA). Zejula is now…
An independent data monitoring committee has recommended that the GENESIS Phase 3 trial evaluating motixafortide (formerly BL-8040), as a means to improve stem cell transplants in multiple myeloma, ceases enrollment earlier, based on positive interim data. Trial enrollment is now complete at 122 participants, while the original target was 177, according to a press release by…
The U.S. Food and Drug Administration (FDA) has granted priority review to an application seeking the approval of Libtayo (cemiplimab) as a first-line therapy for advanced non-small cell lung cancer (NSCLC) and high PD-L1 levels, according to a press release. This priority status is expected to shorten Libtayo’s regulatory review to six months from the standard 10 months, and a decision…
The U.S. Food and Drug Administration (FDA) has expanded the approval of Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic test for identifying advanced or metastatic breast cancer patients suitable for treatment with Novartis‘ Piqray (alpelisib). The approval covers men and postmenopausal women who have experienced disease progression during or after endocrine therapy. Additional new indications include those for patients…
Using levity to battle a serious disease, entertainer Seth Rogen and his wife raised more than $325,000 for HFC, the couple’s national Alzheimer’s disease organization, during its first virtual game show. The funds will help in providing at-home care at no extra charge to Alzheimer’s patients, as well as online support for caregivers. Money will also support brain…
CLR 131, Cellectar Biosciences’ lead experimental candidate, resulted in a 40% response rate among people with multiple myeloma who failed to respond to three treatment modalities, according to additional data from the CLOVER-1 clinical trial. These triple-refractory patients, who previously failed to respond to at least one immunomodulatory treatment, one proteasome inhibitor, and one anti-CD38…
