Imfinzi (durvalumab) continues to demonstrate a sustained survival benefit in patients with inoperable, locally advanced non-small cell lung cancer (NSCLC) who had not progressed after platinum-based chemotherapy and radiation therapy, a four-year analysis shows. Updated findings from the PACIFIC Phase 3 trial (NCT02125461) demonstrate that, at four years, more participants receiving Imfinzi were alive, compared with…
Conditions
Conditions
CLR 131 Elicits Promising Response Rates in Triple-refractory Multiple Myeloma Trial
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…
Seth Rogen’s HFC ‘Game Show’ Raises $325K to Benefit Alzheimer’s Care
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…
FDA Approves FoundationOne Liquid CDx as Companion Diagnostic Test for Piqray Treatment
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…
Libtayo Given FDA Priority Review for Advanced NSCLC With High PD-L1 Levels
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…
No More Patients Needed in GENESIS Trial of Motixafortide, Committee Says
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…
Zejula Approved in Europe as Maintenance Therapy for Advanced Ovarian Cancers
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…
CAR T-Cell Therapy, MB-105, Shows Promise in Metastatic CRPC Patient in Phase 1 Trial
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…
Awareness Month Activities Shine Spotlight on Alzheimer’s, Dementia
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…
Phase 3 Trial to Compare Enhertu to Kadcyla in HER2-Positive, High Risk Patients
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…
First Patient Dosed in Phase 2 Study of Cancer Vaccine Combination in Ovarian Cancer
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…
Hold Lifted on Phase 1 Trial Testing P-PSMA-101 CAR T-cell Therapy in mCRPC
A Phase 1 trial evaluating Poseida Therapeutics’ autologous CAR T-cell therapy P-PSMA-101 for metastatic castration-resistant prostate cancer (mCRPC) is resuming immediately, after its clinical hold was lifted. The U.S. Food and Drug Administration (FDA) had placed a partial hold on the trial in August, after a patient died of liver failure a few weeks after…