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…
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…
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…
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…
The U.S. Food and Drug Administration (FDA) has cleared Ezra Prostate AI, an artificial intelligence (AI) program designed to increase the efficiency with which radiologists analyze images of the prostate in order to diagnose prostate cancer. The program, which is expected to decrease the cost of prostate MRIs, is the first-ever prostate segmentation AI to…
TransGene, NEC, and BostonGene have entered a strategic collaboration to test TG4050, an investigational personalized vaccine that aims to treat ovarian and head and neck cancers, according to a press release. TG4050 is an individualized therapy that stimulates a patient’s immune system into attacking cancer cells by “teaching” it which cells are malignant — based on the…
